Page last updated: 2024-11-05

fluorides

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID28179
CHEMBL ID1362
CHEBI ID17051
MeSH IDM0008615

Synonyms (42)

Synonym
CHEBI:17051 ,
fluoride(1-)
fluorine anion
f(-)
16984-48-8
fluorine ion(1-)
fluoride ion(1-)
fluorine ion
drinking water, fluoride treated
fluoride as dust
fluoride dust
perfluoride
fluoride ion(f-)
fluorides ,
fluoride
F- ,
C00742
fluoride ion
bdbm26978
chembl1362
unii-q80vpu408o
q80vpu408o ,
fluoride [vandf]
fluroride-ion
fluorine ion(f1-)
AKOS015903717
KRHYYFGTRYWZRS-UHFFFAOYSA-M
mfcd00144315
DB11257
DTXSID9049617 ,
Q407350
fluoride standard
fluoride standard: f- @ 1000 microg/ml in h2o
fluoride ion chromatography standard: f- @ 100microg/ml in h2o
fluoride standard: f- @ 10000 microg/ml in h2o
f?
fluoride standard: f- @ 100 microg/ml in h2o
fluorine-
dtxcid3029576
topex neutral ph fluoride gelstrawberry
topex neutral ph fluoride gel
topex neutral ph fluoride gelmint

Research Excerpts

Actions

ExcerptReferenceRelevance
"Fluorides can cause corrosion and degradation in mechanical properties of commonly used archwires by forming hydrofluoric acid HF and causing disruption of protective titanium oxide layer. "( Effect of fluoride mouth rinses on various orthodontic archwire alloys tested by modified bending test: an in vitro study.
Chandra, PK; Kamat, N; Srivastava, K,
)
1.57

Treatment

All treatments (fluorides and CHX) significantly reduced the biofilm viability compared to placebo varnish and negative control. Treatment with fluorides (F(-)) is known to be the main method for preventing plaque formation and dental caries.

ExcerptReferenceRelevance
"All treatments (fluorides and CHX) significantly reduced the biofilm viability compared to placebo varnish and negative control."( Protective Effect of 4% Titanium Tetrafluoride Varnish on Dentin Demineralization Using a Microcosm Biofilm Model.
Buzalaf, MAR; Dos Santos, DMS; Magalhães, AC; Pires, JG; Salomão, PMA; Silva, AB, 2019
)
0.85
"Treatment with fluorides (F(-)) is known to be the main method for preventing plaque formation and dental caries."( Influence of noble metals alloying additions on the corrosion behaviour of titanium in a fluoride-containing environment.
Borzone, G; Delsante, S; Rosalbino, F; Scavino, G, 2012
)
0.72

Toxicity

Inorganic fluorides were declared toxic under the Canadian Environmental Protection Act in 1993 based on their potential to cause long-term harmful effects. The other fluorides tested showed no toxic effects in dosages relevant for caries prophylaxis and with oral application.

ExcerptReferenceRelevance
" Phenobarbital treatment enhanced production of fluroxene metabolites, including the highly toxic trifluoroethanol."( Fluroxene toxicity induced by phenobarbital.
Embro, WJ; Fiserova-Bergerova, V; Holaday, DA; Malagodi, MH; Munson, ES; Perry, JC; Shields, RP; Tham, MK, 1975
)
0.25
" The Norwegian Adverse Drug Reaction Committe received 34 case reports of adverse effects ascribed to fluoride prophylaxis, from 1970 to 1977."( Acceptance, caries reduction and reported adverse effects of fluoride prophylaxis in Norway.
Birkeland, JM; Lökken, P, 1978
)
0.26
" The other fluorides tested showed no toxic effects in dosages relevant for caries prophylaxis and with oral application."( [Comparison of embryotoxic effects of inorganic fluorides].
Stratmann, KR, 1979
)
0.91
"Male and female Drosophila melanogaster with special sex chromosome or special autosome constitutions were fed with the mutagenic chemicals Trenimon (2,3,5-trisethyleneimino-1,4-benzoquinone) and PDMT (1-phenyl-3, 3-dimethyltriazene) and with the toxic substance Na2PO3F (sodium monofluorophosphate)."( Induced dominant lethal mutations and cytotoxic effects in germ cells of Drosophila melanogaster with Trenimon, PDMT and sodium monofluorophosphate.
Büchi, R, 1977
)
0.26
" The main purpose of the investigation reported here was to determine maximum possible fluoride intake in adults who were heavy tea drinkers in a fluoridated city and relate it to toxic thresholds."( Fluoride intake and its safety among heavy tea drinkers in a British fluoridated city.
Jenkins, GN, 1991
)
0.28
"The LD50 for fluoride was elevated from less than 60 mg F/kg body weight to 172 mg F/kg when magnesium (as MgCl2), equivalent to 3 times that of F, was administered by gavage 30 min after the F dose."( The LD50, excretion and serum and bone levels of F after a high single F and F + Mg dose in rats with findings on cardiac Ca and Mg.
Koskinen-Kainulainen, M; Luoma, H; Tuomisto, J, 1990
)
0.28
"Fasted Sprague-Dawley male rats were used in three experiments to determine the acute LD50 values of fluoride when it was administered intragastrically as NaF, disodium monofluorophosphate (Na2PO3F, MFP) or NaF and MFP."( Acute oral toxicity of sodium fluoride and monofluorophosphate separately or in combination in rats.
Birdsong-Whitford, NL; Finidori, C; Whitford, GM, 1990
)
0.28
" The concept of a "probably toxic dose" (PTD) is advanced."( Fluoride in dental products: safety considerations.
Whitford, GM, 1987
)
0.27
"Although ingestion of an acute toxic dose of fluoride is extremely rare in dental treatments, practitioners should be familiar with the signs and symptoms and with emergency measures of treating accidental overdosage."( Topical fluoride therapy: discussion of some aspects of toxicology, safety, and efficacy.
Newbrun, E, 1987
)
0.27
" Furthermore, (+)-catechin seems capable of protecting against the direct toxic effect of halothane metabolites resulting from the reductive pathways."( Halothane hepatotoxicity in glutathione depleted rats.
Sellin, D; Siegers, CP; Wilhelm, KP; Younes, M, 1987
)
0.27
" Comparisons of certainly lethal and safely tolerated doses for commonly used fluoride agents and procedures show that they can be applied with little or no risk of adverse acute effects, as long as they are used judiciously."( Amounts of fluoride in self-administered dental products: safety considerations for children.
Heifetz, SB; Horowitz, HS, 1986
)
0.27
" A clear dose-response pattern for the above toxic effects was evident with 10 ppm in the males being an effect level."( Inhalation toxicity of hexafluoroisobutylene.
Cramp, AL; Darr, RW; Gad, SC; Hoffman, GM; Peckham, JC; Rusch, GM, 1986
)
0.27
" The compound was found to be moderately toxic following single 4-hr exposures, with an LC50 of 980 mg/m3."( Inhalation toxicity of ammonium perfluorooctanoate.
Barnes, JR; Brittelli, MR; Chen, HC; Hall, GT; Kennedy, GL, 1986
)
0.27
" However, there is an increasing potential for ingestion of toxic doses of fluoride because of the increasing use of pleasant-tasting fluoride products."( Diagnosis and treatment of acute fluoride toxicity.
Bayless, JM; Tinanoff, N, 1985
)
0.27
" Based on this study, exposure to BF3 at 17 mg/m3 resulted in renal toxicity, while exposure at 6 mg/m3, although showing elevations of fluoride amounts, did not result in a toxic response."( Inhalation toxicity studies with boron trifluoride.
Hoffman, GM; McConnell, RF; Rinehart, WE; Rusch, GM, 1986
)
0.27
" It is concluded that the nature of the group substituted at the enzyme active site determines the toxic response."( Organophosphorus and other inhibitors of brain 'neurotoxic esterase' and the development of delayed neurotoxicity in hens.
Johnson, MK, 1970
)
0.25
" CLDs and STDs for most commonly used fluoride agents and procedures show that they can be applied with little or no risk of adverse effects, as long as they are handled judiciously."( The amounts of fluoride in current fluoride therapies: safety considerations for children.
Heifetz, SB; Horowitz, HS,
)
0.13
" The phosphate industry, along with university researchers and the Association of American Feed Control Officials, set up standards for safe levels of fluoride in feed phosphates."( Industrial considerations related to fluoride toxicity.
Thompson, DJ, 1980
)
0.26
" However, there is a need for further studies to evaluate the tissue accumulation of fluoride and its potential to cause toxic effects."( Safety of ciprofloxacin therapy in children: magnetic resonance images, body fluid levels of fluoride and linear growth.
Arora, NK; Bhan, MK; Jena, A; Pradhan, KM; Susheela, AK, 1995
)
0.29
"Methoxyflurane nephrotoxicity is mediated by cytochrome P450-catalyzed metabolism to toxic metabolites."( Human kidney methoxyflurane and sevoflurane metabolism. Intrarenal fluoride production as a possible mechanism of methoxyflurane nephrotoxicity.
Hankins, DC; Kharasch, ED; Thummel, KE, 1995
)
0.29
"In a prospective case controlled study, we evaluated the adverse effects of long-term fluoride ingestion on the gastrointestinal tract."( Toxic effects of chronic fluoride ingestion on the upper gastrointestinal tract.
Das, TK; Dasarathy, S; Gupta, IP; Susheela, AK; Tandon, RK, 1994
)
0.29
" Abundant scientific data accumulated over the years have demonstrated that other than dental fluorosis, there are no known adverse effects of long-term fluoride ingestion for caries prevention."( Fluoride: safety issues.
Li, Y,
)
0.13
" In repeat dose irritancy or oral toxicity tests in rabbits or rats, no adverse effects of Fomblin HC products were noted; in particular, daily oral administration (1000 mg/kg/day) to rats over 28 days produced no significant reaction."( Safety evaluation of perfluoropolyethers, liquid polymers used in barrier creams and other skin-care products.
Bootman, J; Malinverno, G; Pantini, G, 1996
)
0.29
" Moderate duration low-flow sevoflurane anesthesia, during which compound A formation occurs, appears to be as safe as low-flow isoflurane anesthesia."( Assessment of low-flow sevoflurane and isoflurane effects on renal function using sensitive markers of tubular toxicity.
Artru, A; Bowdle, TA; Frink, EJ; Kharasch, ED; Nogami, WM; Zager, R, 1997
)
0.3
" Our results suggest that the toxic effect of F- on the kidney may be more pronounced in the proximal tubule than the glomeruli region, and that the disorder of the proximal tubule is more serious in the S3 segment than S1 or S2 segment."( Urinary biomarkers monitoring for experimental fluoride nephrotoxicity.
Dote, T; Kono, K; Miyata, K; Nishiura, H; Nishiura, K; Shimahara, M; Sugimoto, K; Usuda, K, 1998
)
0.3
"Although an excess intake of fluoride has been reported to cause skeletal fluorosis, very little is known about the mechanism of adverse effects of fluoride on bone."( Fluoride mediates apoptosis in osteosarcoma UMR 106 and its cytotoxicity depends on the pH.
Ando, M; Hirano, S, 1997
)
0.3
" There were no compound-related, adverse effects on body weight, food consumption, survival, clinical signs of toxicity, ophthalmoscopically observable ocular lesions, serum hormone concentrations, or clinical pathology parameters at any exposure concentration in either male or female rats."( Chronic toxicity, oncogenicity, and mutagenicity studies with chlorotetrafluoroethane (HCFC-124).
Bentley, KS; Brock, WJ; Elliott, GS; Frame, SR; Malley, LA; Rusch, GM; Trochimowicz, HJ, 1998
)
0.3
" its toxicity resulted in a parabolic curve with nerve agents and other similarly toxic compounds in the center."( Effects of chemical reactivity of the toxicity of phosphorus fluoridates.
White, WE, 1999
)
0.3
" These findings demonstrate differences in aluminum species and highlights the importance of these factors in modulating the toxic effect of aluminum."( Ligand specific effects on aluminum incorporation and toxicity in neurons and astrocytes.
Fraser, PE; Lévesque, L; McLachlan, DR; Mizzen, CA, 2000
)
0.31
"This article reviews the different treatments currently available for osteoporosis and examines the benefits and adverse events that are associated with each."( Comparative safety of bone remodeling agents with a focus on osteoporosis therapies.
Kleerekoper, M; Schein, JR, 2001
)
0.31
" Many clients take multiple medications; therefore, dental hygienists must be aware of the issues related to drug use, including indications, interactions, and adverse drug effects."( Managing the side effects of medications.
Spolarich, AE, 2000
)
0.31
" Over the 6-month observation period, the sodium hexametaphosphate and the marketed control dentifrices were comparable in terms of adverse event type and severity, and no subject discontinued treatment due to an oral soft tissue adverse event."( Anticalculus efficacy and safety of a novel whitening dentifrice containing sodium hexametaphosphate: a controlled six-month clinical trial.
Baker, R; Gerlach, R; Liu, H; Ramsey, L; Segreto, V; Vastola, K, 2002
)
0.31
" All the toothbrushes tested in this investigation were found to be safe with no evidence of hard or soft tissue trauma."( A 3-month comparative investigation of the safety and efficacy of a new toothbrush: results from two independent clinical studies.
Galustians, HJ; Jacobs, DM; King, DW; Low, MA; Qaqish, JG; Sharma, NC; Weber, DA, 2000
)
0.31
" The treatment was well tolerated, with only few mild or moderate adverse events."( Monofluorophosphate combined with hormone replacement therapy in postmenopausal osteoporosis. An open-label pilot efficacy and safety study.
Ringe, JD; Setnikar, I, 2002
)
0.31
" The toxic effects of CFA, which is an excellent substrate but a poor inactivator of GSTZ1-1, have not been investigated."( Nephrotoxicity of chlorofluoroacetic acid in rats.
Anders, MW; Baggs, RB; Krenitsky, DM; Lantum, HB, 2002
)
0.31
"Inorganic fluorides were declared toxic under the Canadian Environmental Protection Act in 1993 based on their potential to cause long-term harmful effects in aquatic and terrestrial ecosystems, but information on the toxicity of sediment-associated fluoride to freshwater benthic organisms was considered incomplete."( Toxicity of aqueous and sediment-associated fluoride to freshwater organisms.
de Solla, SR; Holtze, KE; Metcalfe-Smith, JL; Reid, JJ; Sirota, GR, 2003
)
0.72
" The toxic action of fluoride resides in the fact that fluoride ions act as enzymatic poisons, inhibiting enzyme activity and, ultimately, interrupting metabolic processes such as glycolysis and synthesis of proteins."( Fluoride toxicity to aquatic organisms: a review.
Camargo, JA, 2003
)
0.32
" As hydrogen peroxide is a necessary factor for triggering a number of important toxic effects of nitrite, the latter increases its toxicity by inhibiting catalase."( Nitrite-catalase interaction as an important element of nitrite toxicity.
Petrenko, YM; Titov, VY, 2003
)
0.32
"During the 2-week treatment period, twelve adverse reactions were recorded as potentially attributable to the study products, evenly split between the two test groups."( Safety evaluation of a novel whitening gel, containing 6% hydrogen peroxide and a commercially available whitening gel containing 18% carbamide peroxide in an exaggerated use clinical study.
Collins, LZ; Gallagher, A; Maggio, B; Schäfer, F; York, M, 2004
)
0.32
" It is concluded that both products are safe for their intended use."( Safety evaluation of a novel whitening gel, containing 6% hydrogen peroxide and a commercially available whitening gel containing 18% carbamide peroxide in an exaggerated use clinical study.
Collins, LZ; Gallagher, A; Maggio, B; Schäfer, F; York, M, 2004
)
0.32
" In 1998, storm water from the cylinder storage yards was found to be toxic to Ceriodaphnia, at concentrations exceeding limits in the site's discharge permit."( Source of toxicity in storm water: zinc from commonly used paint.
Konetsky, BK; Kszos, LA; Morris, GW, 2004
)
0.32
"Many years have passed since domestic water fluoridation was adopted to reduce the incidence of caries in developed countries; however, since there is an additional dose of fluorides ingested with foods and drinks prepared with such waters, the problem has emerged of possible adverse effects on health associated to them, so that in some countries fluorine integrator selling is allowed only with preventive medical prescription."( [Fluoride toxicity].
Giachini, M; Pierleoni, F, 2004
)
0.52
" A 1- and 3-month recovery period was included to evaluate the reversibility of toxic effects."( Subchronic toxicity of a fluoroalkylethanol mixture in rats.
Buck, RC; Everds, NE; Ladics, GS; Makovec, GT; Stadler, JC, 2005
)
0.33
" The toxic effect of antibacterial agents was in the order: AgF>JJZ>NaF."( Cytotoxicity of direct current with antibacterial agents against host cells in vitro.
Nakamura, Y; Nishikawa, H; Sakagami, H; Shimetani, A; Takahashi, K, 2005
)
0.33
" In addition, it is urgent that governmental and international agencies adopt safe standards of fluoride content in tea commodities."( Fluoride levels in various black tea commodities: measurement and safety evaluation.
Cao, J; Deng, HJ; Li, Y; Liu, JW; Yi, J; Zhao, Y, 2006
)
0.33
" In conclusion, alpha-TCP- or CaF2-modified 4-META/MMA-TBB resin seemed to allow easy and safe debonding of orthodontic brackets without loss of proper bracket bond strength."( Modification of 4-META/MMA-TBB resin for safe debonding of orthodontic brackets--influence of the addition of degradable additives or fluoride compound.
Hayakawa, T; Kasai, K; Kawabata, R, 2006
)
0.33
" In conclusion, increased low-energy guanylate and inosylate as well as decreased xanthine concentrations in snail muscle can be indicators of the toxic influence of fluoride on the organism."( Guanine and inosine nucleotides, nucleosides and oxypurines in snail muscles as potential biomarkers of fluoride toxicity.
Dołegowska, B; Machoy, Z; Rać, ME; Safranow, K, 2007
)
0.34
" This study revealed that there were minimal aroma/flavor differences among the ham treatments between 0 and 36 mg/ml, and that dry cured ham that was fumigated with SF was safe and met legal requirements for consumption."( Sulfuryl fluoride fumigation effects on the safety, volatile composition, and sensory quality of dry cured ham.
Aikins, MJ; Hasan, MM; Mikel, WB; Phillips, TW; Schilling, MW; Sekhon, RK, 2010
)
0.36
" Therefore it can be concluded that black berry administration could minimize the toxic effects of fluoride indicating its free radical-scavenging and potent anti-oxidant activities."( Evaluation of free radical-scavenging and anti-oxidant properties of black berry against fluoride toxicity in rats.
Abdel-Aziz, AF; Hassan, HA,
)
0.13
" Here, we asked if F(-) was more toxic at low pH, as measured by increased cell stress and decreased cell function."( The acid test of fluoride: how pH modulates toxicity.
Bartlett, JD; Sharma, R; Skobe, Z; Tannous, BA; Tsuchiya, M, 2010
)
0.36
"The World Health Organization (WHO)/United Nations Children's Fund (UNICEF) Joint Monitoring Programme (JMP) for Water Supply and Sanitation was designed to provide reference figures for access in individual countries to safe water."( How safe are the global water coverage figures? Case study from Madhya Pradesh, India.
Godfrey, S; Labhasetwar, P; Pimpalkar, S; Wate, S, 2011
)
0.37
"Methods include examination of national health agency reviews, primarily the National Research Council (NRC), Agency for Toxic Substances & Disease Registry (ATSDR), standard medical toxicology references, text books, as well as reports and documents from both private and public research as well as consumer-based NGOs."( Fluorine--a current literature review. An NRC and ATSDR based review of safety standards for exposure to fluorine and fluorides.
Prystupa, J, 2011
)
0.58
" Based on an analysis of the affects of fluoride demonstrated consistently in the literature, safe levels have not been determined nor standardized."( Fluorine--a current literature review. An NRC and ATSDR based review of safety standards for exposure to fluorine and fluorides.
Prystupa, J, 2011
)
0.58
" Cases of serious systemic toxicity and fatalities due to acute exposures are now rare, but overexposures causing toxic signs and symptoms are not."( Acute toxicity of ingested fluoride.
Whitford, GM, 2011
)
0.37
"To determine the prevalence of signs and symptoms of suspected dental, skeletal, and non-skeletal fluorosis, along with food habits, addictions, and use of fluoride containing toothpaste among participants taking water with fluoride concentration above the permissible limit, and to assess the changes in clinical manifestations of the above participants after they started consuming safe drinking water."( Health impact of supplying safe drinking water containing fluoride below permissible level on flourosis patients in a fluoride-endemic rural area of West Bengal.
Majumdar, KK,
)
0.13
"A longitudinal intervention study was conducted in three villages in Rampurhat Block I of Birbhum district of West Bengal to assess the occurrence of various dental, skeletal, and non-skeletal manifestations of fluorosis, along with food habits, addictions, and use of fluoride containing toothpaste among the study population and the impact of taking safe water from the supplied domestic and community filters on these clinical manifestations."( Health impact of supplying safe drinking water containing fluoride below permissible level on flourosis patients in a fluoride-endemic rural area of West Bengal.
Majumdar, KK,
)
0.13
"Fuji Plus, Vitrebond and Fuji VIII, which released fluoride in higher quantities than other GICs, were highly toxic to human DPSCs."( Cytotoxic effects of glass ionomer cements on human dental pulp stem cells correlate with fluoride release.
Arsenijevic, N; Kanjevac, T; Lukic, A; Lukic, ML; Markovic, D; Milovanovic, M; Tesic, Z; Volarevic, V; Zdravkovic, N, 2012
)
0.38
" Intervention in the form of alternate safe water supply in five villages showed significant reduction in the urinary fluoride concentration when compared to the control village."( Urinary fluoride as a monitoring tool for assessing successful intervention in the provision of safe drinking water supply in five fluoride-affected villages in Dhar district, Madhya Pradesh, India.
Gautam, A; Jaiswal, SC; Singh, P; Srikanth, R, 2013
)
0.39
"In developing countries, the lack of safe water options leads to many health risks."( Determining behavioral factors for interventions to increase safe water consumption: a cross-sectional field study in rural Ethiopia.
Huber, AC; Mosler, HJ, 2013
)
0.39
"The results support the possibility of an adverse effect of high fluoride exposure on children's neurodevelopment."( Developmental fluoride neurotoxicity: a systematic review and meta-analysis.
Choi, AL; Grandjean, P; Sun, G; Zhang, Y, 2012
)
0.38
"Laboratory experiments were performed to examine the toxic effects of fluoride (F(-)) on the survival and behavior of white-clawed crayfish (Austropotamobius pallipes)."( Fluoride bioaccumulation and toxic effects on the survival and behavior of the endangered white-clawed crayfish Austropotamobius pallipes (Lereboullet).
Aguirre-Sierra, A; Alonso, A; Camargo, JA, 2013
)
0.39
"Long-term excessive fluoride intake is known to be toxic and can damage a variety of organs and tissues in the human body."( Fluoride-elicited developmental testicular toxicity in rats: roles of endoplasmic reticulum stress and inflammatory response.
Chen, Y; Cui, Y; Gao, H; Guan, Z; Jiang, C; Lei, R; Liu, H; Wang, A; Wang, Z; Wu, X; Xia, T; Yang, L; Yu, L; Zeng, Q; Zhang, C; Zhang, S; Zhang, X, 2013
)
0.39
" It was concluded that, regardless of the increase in enamel hardness due to the application of fluoride solutions, the treated enamel surface did not prevent the toxic effects caused by the 16% CP gel to odontoblast-like cells."( Effect of fluoride-treated enamel on indirect cytotoxicity of a 16% carbamide peroxide bleaching gel to pulp cells.
de Souza Costa, CA; Hebling, J; Lima, AF; Ribeiro, AP; Sacono, NT; Soares, DG, 2013
)
0.39
" Natural calcium fluoride with low solubility and toxicity from ingestion is distinct from fully soluble toxic industrial fluorides."( Physiologic conditions affect toxicity of ingested industrial fluoride.
Sauerheber, R, 2013
)
0.6
"Fluorine is an abundant element and is toxic to organisms from bacteria to humans, but the mechanisms by which eukaryotes resist fluoride toxicity are unknown."( Eukaryotic resistance to fluoride toxicity mediated by a widespread family of fluoride export proteins.
Breaker, RR; Davis, JH; Gordon, PB; Li, S; Smith, KD; Strobel, SA, 2013
)
0.39
" In the present study, we have synthesized europium doped NaYF4 (NaYF4:Eu(3+)) nanoparticles with three diameters and used endothelial cells (ECs) as a cell model to explore the potential toxic effect."( Size-dependent cytotoxicity of europium doped NaYF ₄ nanoparticles in endothelial cells.
Chen, S; Duan, J; Jia, G; Wang, S; Zhang, C; Zhang, J, 2014
)
0.4
" Soluble fluoride salts are toxic at high concentrations; their reproductive toxicity was assessed in this study by administering different fluoride salt concentrations to mice."( Adverse Effects of High Concentrations of Fluoride on Characteristics of the Ovary and Mature Oocyte of Mouse.
Chen, X; Song, C; Wu, H; Yin, S; Zhang, Y, 2015
)
0.42
"9 percent) were more likely to agree that it was safe (69."( Perceived safety and benefit of community water fluoridation: 2009 HealthStyles survey.
Griffin, S; Mork, N, 2015
)
0.42
" All ILs tested were not biodegradable; while some of them were toxic toward activated sludge."( Synthesis and toxicity evaluation of hydrophobic ionic liquids for volatile organic compounds biodegradation in a two-phase partitioning bioreactor.
Amrane, A; Biard, PF; Couvert, A; Guihéneuf, S; Le Guével, R; Paquin, L; Rodriguez Castillo, AS, 2016
)
0.43
"5 % of LD50 values for NaF."( Risk Assessment Study of Fluoride Salts: Probability-Impact Matrix of Renal and Hepatic Toxicity Markers.
Dote, T; Ito, Y; Kono, K; Tamaki, J; Ueno, T; Usuda, K; Yokoyama, H, 2016
)
0.43
" Previous studies indicate the highly toxic nature of SPL."( Cytotoxicity of Spent Pot Liner on Allium cepa root tip cells: A comparative analysis in meristematic cell type on toxicity bioassays.
Andrade-Vieira, LF; Campos, JM; Davide, LC; Dos Santos Gedraite, L; Palmieri, MJ, 2016
)
0.43
" Aluminum fluoride was comparatively more toxic than aluminum."( Role of Spirulina in mitigating hemato-toxicity in Swiss albino mice exposed to aluminum and aluminum fluoride.
Sharma, KP; Sharma, S, 2016
)
0.43
" Certainly, the new information will be added to those already established for regulatory purposes as a safe way to promote oral healthcare and prevent oral carcinogenesis."( Putative mechanisms of genotoxicity induced by fluoride: a comprehensive review.
Claudio, SR; da Silva, VHP; de Barros Viana, M; Estadella, D; Oshima, CTF; Ribeiro, DA; Yujra, VQ, 2017
)
0.46
" The present study has been undertaken with the aim to assess the F dose-dependent clinical and subclinical symptoms of fluorosis and reversal of the disease by providing safe drinking water."( Dose-dependent effect of fluoride on clinical and subclinical indices of fluorosis in school going children and its mitigation by supply of safe drinking water for 5 years: an Indian study.
Gopalan, V; Gourineni, SR; Khandare, AL; Nagalla, B; Validandi, V, 2018
)
0.48
" This paper reviews the present research on the potential adverse effects of overdose fluoride on various organisms and aims to improve our understanding of fluoride toxicity."( Toxic effects of fluoride on organisms.
Chen, K; Chen, L; Kong, M; Lü, P; Qiu, L; Wu, P; Yang, Y; Zuo, H, 2018
)
0.48
"The present study aimed to determine the serum trace elements (copper (Cu), zinc (Zn), calcium (Ca), magnesium (Mg)) along with erythrocyte carbonic anhydrase (CA) activity and effect of intervention with safe drinking water for 5 years in the school children of fluorosis endemic area."( Fluoride Alters Serum Elemental (Calcium, Magnesium, Copper, and Zinc) Homeostasis Along with Erythrocyte Carbonic Anhydrase Activity in Fluorosis Endemic Villages and Restores on Supply of Safe Drinking Water in School-Going Children of Nalgonda District
Boiroju, N; Khandare, AL; Validandi, V, 2018
)
0.48
" Many studies have shown that the chronic exposure of fluoride in high concentrations causes adverse effects in multiple organs; the use of bioactive compounds present in foods as a tool to mitigate the effects of fluoride could potentially be useful for populations in different parts of the world are exposed to fluoride in a chronic and systemic way."( Role of polyphenols and nonpolyphenols against toxicity induced by fluoride: a comprehensive review.
Aguiar, O; Claudio, SR; Gomes de Moura, CF; Handan, BA; Oshima, CTF; Ribeiro, DA; Viana, MB; Yamauchi, LY, 2019
)
0.51
" To determine whether this is also a relevant factor in retinal toxicity, we analyzed eight PFO batches associated with adverse ocular events."( How to Ward Off Retinal Toxicity of Perfluorooctane and Other Perfluorocarbon Liquids?
Dresp, J; Feltgen, N; Hoerauf, H; Lechner, T; Menz, DH; Menz, H; Müller, BK, 2018
)
0.48
" (C) A toxic PFO batch (061014) was purified to remove reactive and underfluorinated impurities."( How to Ward Off Retinal Toxicity of Perfluorooctane and Other Perfluorocarbon Liquids?
Dresp, J; Feltgen, N; Hoerauf, H; Lechner, T; Menz, DH; Menz, H; Müller, BK, 2018
)
0.48
" The H-value is a measure for reactive and underfluorinated impurities that cause toxicity of PFCLs and should be incorporated in each endotamponade specification with a limit of 10 ppm to prove the effectiveness of the ultra-purification required and ensure a safe product."( How to Ward Off Retinal Toxicity of Perfluorooctane and Other Perfluorocarbon Liquids?
Dresp, J; Feltgen, N; Hoerauf, H; Lechner, T; Menz, DH; Menz, H; Müller, BK, 2018
)
0.48
" To address these limitations, efforts to identify sublethal endpoints that increase FET test sensitivity and allow for the prediction of sublethal adverse effects have begun."( Identifying sublethal endpoints for evaluating neurotoxic compounds utilizing the fish embryo toxicity test.
Jeffries, MKS; Krzykwa, JC; Saeid, A, 2019
)
0.51
" We believe that dietary salt products are safe at retail, and the long-term dietary exposure of cooking salts will not pose any significant health risk."( Is the Cooking Salt Safe in China? Assessment of Chemical Contaminants in Cooking Salt.
Jia, X; Wang, Z; Zhou, J, 2019
)
0.51
" Two major genetic factors that are discussed include genetic polymorphisms in plasma membrane transporters that catalyze uptake and accumulation or efflux and elimination of environmental chemicals, and genetic polymorphisms in bioactivation enzymes that generate toxic and reactive metabolites."( Environmental and Genetic Factors Influencing Kidney Toxicity.
Lash, LH, 2019
)
0.51
" SDF treated discs were toxic to HGF and bacteria after 9 weeks of rinsing."( Cytotoxic effects of silver diamine fluoride.
Fancher, ME; Fournier, S; Lallier, TE; Townsend, J, 2019
)
0.51
" Excessive accumulation of the toxic methylglyoxal was reversed due to the activation of the glyoxalase system (comprising of glyoxalase I and II) and the ascorbate-glutathione cycle."( Spermine ameliorates prolonged fluoride toxicity in soil-grown rice seedlings by activating the antioxidant machinery and glyoxalase system.
Banerjee, A; Roychoudhury, A; Samanta, S, 2020
)
0.56
"The present study was undertaken to investigate the toxic effect of sodium fluoride (NaF)- and fluoride (F)-contaminated groundwater on male reproduction and it's reversibility in male rats."( A Comparative Analysis of Fluoride-Contaminated Groundwater and Sodium Fluoride-Induced Reproductive Toxicity and Its Reversibility in Male Rats.
Chaithra, B; Sarjan, HN, 2020
)
0.56
" Second, systemic fluoride uptake is suspected of causing adverse effects, in particular neurotoxicity during early development."( Developmental fluoride neurotoxicity: an updated review.
Grandjean, P, 2019
)
0.51
" Neurotoxicity appeared to be dose-dependent, and tentative benchmark dose calculations suggest that safe exposures are likely to be below currently accepted or recommended fluoride concentrations in drinking water."( Developmental fluoride neurotoxicity: an updated review.
Grandjean, P, 2019
)
0.51
" Recently, there has been renewed concern in the public sector as to whether fluoride is safe at the current exposure levels."( Principles of fluoride toxicity and the cellular response: a review.
Johnston, NR; Strobel, SA, 2020
)
0.56
" These findings suggest that Cd and F can potentiate their individual toxic effects on the liver tissue through disruption of the cellular redox status, inflammation, and apoptosis pathway."( Co-exposure to non-toxic levels of cadmium and fluoride induces hepatotoxicity in rats via triggering mitochondrial oxidative damage, apoptosis, and NF-kB pathways.
Ahangar, N; Amiri, FT; Arab-Nozari, M; Mohammadi, E; Shaki, F; Shokrzadeh, M, 2020
)
0.56
" This article reviews current scientific findings on health-related issues on drinking water and discusses the challenges for safe and healthy drinking water in China."( Challenges for Safe and Healthy Drinking Water in China.
Wu, J, 2020
)
0.56
" According to literature, water scarcity is still a severe ongoing issue, and regional disparity affects the access to safe and healthy drinking water."( Challenges for Safe and Healthy Drinking Water in China.
Wu, J, 2020
)
0.56
"Recently, epidemiological studies have suggested that fluoride is a human developmental neurotoxicant that reduces measures of intelligence in children, placing it into the same category as toxic metals (lead, methylmercury, arsenic) and polychlorinated biphenyls."( Toxicity of fluoride: critical evaluation of evidence for human developmental neurotoxicity in epidemiological studies, animal experiments and in vitro analyses.
Degen, G; Diel, P; Edlund, K; Eisenbrand, G; Engel, KH; Epe, B; Grune, T; Guth, S; Heinz, V; Hengstler, JG; Henle, T; Humpf, HU; Hüser, S; Jäger, H; Joost, HG; Kulling, SE; Lampen, A; Mally, A; Marchan, R; Marko, D; Mühle, E; Nitsche, MA; Nöthlings, U; Röhrdanz, E; Roth, A; Stadler, R; van Thriel, C; Vieths, S; Vogel, RF; Wascher, E; Watzl, C, 2020
)
0.56
" A priori, a product was considered safe if the change in measured SMH values over the course of six treatment cycles was both significantly greater than the negative control and was not significantly different from the positive control."( Laboratory screening evaluation of the safety of low pH oral care rinse products to dental enamel.
Chen, H; Grender, JM; Moore, J; Schneiderman, E; Strand, R; White, DJ, 2020
)
0.56
" One of the 10 marketed oral care rinses failed to meet the a priori criteria needed to be considered safe as the product was significantly better than the negative control but also significantly lower than the positive control treatment."( Laboratory screening evaluation of the safety of low pH oral care rinse products to dental enamel.
Chen, H; Grender, JM; Moore, J; Schneiderman, E; Strand, R; White, DJ, 2020
)
0.56
"The aims of this study were to: (i) examine the toxic effects of sodium fluoride (NaF) in blood, liver, spleen, and brain cells of Wistar rats after the subacute exposure; (ii) explore the potential protective properties of selenium (Se) against fluoride toxicity after the simultaneous administration."( Genotoxicity of fluoride subacute exposure in rats and selenium intervention.
Antonijević, B; Antonijević-Miljaković, E; Baralić, K; Bulat, Z; Ćurčić, M; Djordjevic, AB; Javorac, D; Kolarević, S; Kostić-Vuković, J; Kračun-Kolarević, M; Mandić, J; Mandinić, Z; Marić, JJ; Milutinović-Smiljanić, S; Radovanović, J; Sunjog, K; Vuković-Gačić, B; Đukić-Ćosić, D, 2021
)
0.62
" Primary outcome measures were antimicrobial effect and adverse events."( Effectiveness and Safety of Ozone Therapy in Dental Caries Treatment: Systematic Review and Meta-analysis.
Benavent Caldas Bellotto, EF; Bussadori, SK; de Oliveira Cruz Latorraca, C; Martimbianco, ALC; Mota, P; Pacheco, RL; Riera, R; Santos, EM; Santos, GM, 2020
)
0.56
" Regarding safety of ozone therapy, results from individual studies presented no adverse events during or after treatment."( Effectiveness and Safety of Ozone Therapy in Dental Caries Treatment: Systematic Review and Meta-analysis.
Benavent Caldas Bellotto, EF; Bussadori, SK; de Oliveira Cruz Latorraca, C; Martimbianco, ALC; Mota, P; Pacheco, RL; Riera, R; Santos, EM; Santos, GM, 2020
)
0.56
"Under the same parameters, the combined group and PDT have good germicidal efficacy, but PDT has fewer adverse reactions and less damage."( [Comparison of the effect and safety of Er:YAG laser combined with fluoride and methylene blue-photodynamic therapy on caries prevention].
Yao, LP; Yu, XH; Zhang, L, 2020
)
0.56
"To evaluate and describe the adverse events (AEs) related to fluoride varnish, the US Food and Drug Administration's Manufacturer and User Facility Device Experience database was used."( Is fluoride varnish safe?: Validating the safety of fluoride varnish.
Mascarenhas, AK, 2021
)
0.62
" Thus fluoride varnish can be considered a safe dental product."( Is fluoride varnish safe?: Validating the safety of fluoride varnish.
Mascarenhas, AK, 2021
)
0.62
" Although F is safe at optimal concentrations in water supply, human exposure to high levels could trigger neurofunctional deficits."( Human cultured IMR-32 neuronal-like and U87 glial-like cells have different patterns of toxicity under fluoride exposure.
Bittencourt, LO; Buzalaf, MAR; Lima, RR; Nogueira, IC; Oliveira, EH; Puty, B, 2021
)
0.62
" The fluoride in drinking water is evident to induce toxic effects including neurodegeneration, skeletal and dental fluorosis as well as organ damage."( Toxic effects of fluoride in intestinal epithelial cells and the mitigating effect of methanol extract of coconut haustorium by enhancing de novo glutathione biosynthesis.
Alfarhan, A; Job, JT; Narayanankutty, A; Rajagopal, R; Ramesh, V, 2021
)
0.62
" Alternatively, terminal fluorination could have induced a dose-dependent toxic effect on a wide range of cellular processes, leading to cell dysfunction and death."( Suicide by vaping the synthetic cannabinoid 4F-MDMB-BINACA: cannabinoid receptors and fluoride at the crossroads of toxicity?
Anseeuw, K; Covaci, A; Jacobs, W; Mahieu, B; Neels, H; van Nuijs, ALN; Van Rafelghem, B, 2021
)
0.62
" Fluoride generates reactive oxygen species and free radicals which induce oxidative stress in target cells and mediate its toxic effects."( 3,4-Dihydroxybenzaldehyde mitigates fluoride-induced cytotoxicity and oxidative damage in human RBC.
Anjum, R; Maheshwari, N; Mahmood, R, 2022
)
0.72
" Selenomethionine (Se-Met) at low levels has been reported to alleviate oxidative damage and inflammation caused by toxic substances, but whether it can alleviate fluoride-induced toxicity in zebrafish embryos has not been elucidated."( Selenomethionine alleviated fluoride-induced toxicity in zebrafish (Danio rerio) embryos by restoring oxidative balance and rebuilding inflammation homeostasis.
Cao, J; Chen, J; Cheng, F; Cheng, Y; Feng, C; Wang, G; Wang, T; Yun, S; Zhang, X, 2022
)
0.72
" Therefore, the aim of this study was to evaluate and compare the potential toxic effects of a wide range of commercially available SLS and NLS of varying physicochemical properties (lithium (Li) or fluoride (F) content and size)."( An in vitro assessment of the toxicity of two-dimensional synthetic and natural layered silicates.
Brown, DM; Maciaszek, K; Stone, V, 2022
)
0.72
"Groundwater co-contamination with toxic pollutants like arsenic-fluoride or lead-fluoride is a serious threat for safe rice cultivation, since major stretches of land, involved in cultivation of this staple food crop are presently experiencing severe endemic pollution from these xenobiotic combinations."( Rhizofiltration of combined arsenic-fluoride or lead-fluoride polluted water using common aquatic plants and use of the 'clean' water for alleviating combined xenobiotic toxicity in a sensitive rice variety.
Banerjee, A; Roychoudhury, A, 2022
)
0.72
" A large amount of fluoride accumulated in animals will not only produce the toxic effects, but it also causes cell damage and affect the normal physiological activities of the body."( Challenges of fluoride pollution in environment: Mechanisms and pathological significance of toxicity - A review.
Iqbal, M; Li, Y; Mehmood, K; Tang, Z; Wang, Y; Wu, S; Zhang, H, 2022
)
0.72
" Products that pass the non-inferiority test in ACD (surface softening) are proposed as safe for enamel as there is no suggestion from this data that teeth are at risk of tissue loss due to these products."( Application of non-inferiority testing in microhardness and its relationship to erosion: Relevance for hard tissue safety evaluations.
Chen, H; Grender, J; Hornsby, A; Moore, J; Schneiderman, E; St John, S; White, DJ, 2022
)
0.72
"To perform a 10-year scientometric analysis of the characteristics of the worldwide publication on the toxic effects of fluoride."( A 10-year Scientometric Analysis of the Characteristics of the Worldwide Publication on the Toxic Effects of Fluoride.
Calderón, KLM; Camayo, JS; Granda, VGC; Gutiérrez-Ilave, M; Mayta-Tovalino, F; Rodríguez, AC, 2022
)
0.72
"A bibliometric study of the worldwide scientific production on the toxic effects of fluoride during the years 2011-2020 was performed."( A 10-year Scientometric Analysis of the Characteristics of the Worldwide Publication on the Toxic Effects of Fluoride.
Calderón, KLM; Camayo, JS; Granda, VGC; Gutiérrez-Ilave, M; Mayta-Tovalino, F; Rodríguez, AC, 2022
)
0.72
"We found that the "Biological Trace Element Research" was the most productive journal with 22 published manuscripts and that the most productive universities on the systemic toxic effects of fluoride on the body were Shanxi Agricultural University, Guizhou Medical University, and Huazhong University of Science and Technology with 31, 11, and 10 manuscripts, respectively."( A 10-year Scientometric Analysis of the Characteristics of the Worldwide Publication on the Toxic Effects of Fluoride.
Calderón, KLM; Camayo, JS; Granda, VGC; Gutiérrez-Ilave, M; Mayta-Tovalino, F; Rodríguez, AC, 2022
)
0.72
" In all 3 days of cytotoxicity testing, the group that used Riva Silver was found to be the least toxic material, while the group that used ChemFil Rock did not have viable cells after the 1st day."( Comparison of Antibacterial Activity, Cytotoxicity, and Fluoride Release of Glass Ionomer Restorative Dental Cements in Dentistry.
Adiguzel, O; Cangul, S; Celenk, S; Eroglu Cakmakoglu, E; Gunay, A; Ozcan, N, 2023
)
0.91
"Sustainable remediation of arsenic-fluoride from rice fields through efficient bio-extraction is the need of the hour, since these toxicants severely challenge safe cultivation of rice and food biosafety."( Bio-priming with a Novel Plant Growth-Promoting Acinetobacter indicus Strain Alleviates Arsenic-Fluoride Co-toxicity in Rice by Modulating the Physiome and Micronutrient Homeostasis.
Banerjee, A; Roychoudhury, A, 2023
)
0.91
" Healthcare providers and dental professionals should emphasize the importance of promoting safe toothpaste use, especially in vulnerable populations such as young children who are more prone to accidental ingestion."( Toothpaste ingestion-evaluating the problem and ensuring safety: systematic review and meta-analysis.
Kojić, S; Luzio, A; Marković, E; Milić, L; Perić, T; Petrović, B; Stojanović, GM, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
" Blood, tissue, and urinary PCTFE concentrations measured postexposure were used to develop a physiologically based pharmacokinetic (PB-PK) model."( Polychlorotrifluoroethylene (PCTFE) oligomer pharmacokinetics in Fischer 344 rats: development of a physiologically based model.
Andersen, ME; Conolly, RB; Kinkead, ER; Pollard, DL; Seckel, CS; Vinegar, A, 1992
)
0.28
" Pharmacokinetic studies in growing dogs show that 90% of a single injected fluoride dose is retained shortly after birth, but at maturity it decreases to about 50%."( Pharmacokinetics of fluoride in man and its clinical relevance.
Ekstrand, J; Spak, CJ; Vogel, G, 1990
)
0.28
" The pharmacokinetic parameters were calculated according to a linear one-compartment open model."( Fluoride pharmacokinetics in good and poor responders to fluoride therapy.
Baylink, DJ; Farley, SM; Fitzsimmons, RJ; Kraenzlin, C; Kraenzlin, ME, 1990
)
0.28
" Pharmacokinetic data should, therefore, form part of the basis for the optimal and safe use of fluoride products."( Pharmacokinetic aspects of topical fluorides.
Ekstrand, J, 1987
)
0.55
"The present study was undertaken to estimate bio-availability and biological half-life of fluoride and accumulation of fluoride in bone in the domestic pig."( Pharmacokinetics of chronic fluoride ingestion in growing pigs.
Kragstrup, J; Nielsen-Kudsk, F; Richards, A, 1985
)
0.27
" The total estimation of the pharmacokinetic data was performed by a simultaneous curve fitting to all single values, using a direct search procedure based on an open two-compartment model and three-compartment model, respectively."( [Pharmacokinetics of a fluoride-calcium preparation for the treatment of osteoporosis].
Fuchs, C; Haase, W; Maurer, H, 1984
)
0.27
"The pharmacokinetic parameters of fluoride have been studied, after a single oral administration to human volunteers of two fluoridated compounds: sodium fluoride, and a new organic fluoride salt, nicomethanol hydrofluoride."( [Blood pharmacokinetics of fluorine in man after the oral administration of nicomethanol hydrofluoride].
Cheymol, G; Mahuzier, G; Poitou, P; Souleau, M, 1984
)
0.27
" Pharmacokinetic analysis of the net plasma F concentrations showed that the apparent plasma half-life of F was longer when urine was acid (4."( Fluoride pharmacokinetics during acid-base balance changes in man.
Ehrnebo, M; Ekstrand, J; Järnberg, PO; Whitford, GM, 1980
)
0.26
"A sex-specific, physiologically based pharmacokinetic (pbpk) model has been developed to describe the absorption, distribution, and elimination of fluorides in rats and humans."( A physiologically based pharmacokinetic model for fluoride uptake by bone.
Beliles, RP; Rao, HV; Turner, CH; Whitford, GM, 1995
)
0.49
"The pharmacokinetic profiles of a sustained-release monofluorophosphate (MFP-SR) preparation (76 mg) and of plain MFP (76 mg) were compared in six osteoporotic females."( Pharmacokinetic profile of a new fluoride preparation: sustained-release monofluorophosphate.
Baylink, D; Bettica, P; Farley, S; Libanati, C; Resch, H; Tabuenca, M; Talbot, J; Tritthart, W, 1994
)
0.29
"Fluoride pharmacokinetic data are presented for infants given a fluoride supplement."( Fluoride pharmacokinetics in infancy.
Ekstrand, J; Fomon, SJ; Nelson, SE; Ziegler, EE, 1994
)
0.29
" There were some significant differences in the maximum F concentration, the area under the salivary fluoride concentration curve (AUC) when plotted against time, and the salivary stimulating effect among the four products, but as a whole they were small and probably of minor clinical importance."( Salivary fluoride clearance after a single intake of fluoride tablets and chewing gums in children, adults, and dry mouth patients.
Birkhed, D; Norén, JG; Persson, LG; Sjögren, K, 1993
)
0.29
" The two products were found bioequivalent with regard to the release of fluoride, both on the basis of the AUC and Cmax of fluoride in plasma and of the urinary excretion of fluoride during the 48 h following the administration."( Bioavailability and pharmacokinetics of fluoride from two glutamine monofluorophosphate preparations.
Setnikar, I; Warneke, G, 1993
)
0.29
" The various pharmacokinetic parameters measured were not related to changes in LS BMD; however, there was an inverse relationship between trough fluoride concentration during long-term dosing and change in FN BMD."( Fluoride pharmacokinetics and changes in lumbar spine and hip bone mineral density.
Chan, JK; Hosking, DJ; Patel, S, 1996
)
0.29
" The method has been successfully used in a pharmacokinetic study."( Determination of the unstable drug otilonium bromide in human plasma by LC-ESI-MS and its application to a pharmacokinetic study.
Ding, L; Fan, HW; Leng, Y; Qi, XM; Rao, YK; Yu, Y; Zhao, YR, 2010
)
0.36
" Limited pharmacokinetic data is available in humans; however, human data exists for two communities with drinking water contaminated by PFAAs."( Evaluation and prediction of pharmacokinetics of PFOA and PFOS in the monkey and human using a PBPK model.
Andersen, ME; Campbell, JL; Clewell, HJ; Loccisano, AE, 2011
)
0.37
" While DSF has been available in various formulations for many years, most of its pharmacokinetic aspects within the therapeutic concentration range have never been fully characterized."( Short term serum pharmacokinetics of diammine silver fluoride after oral application.
Castillo, JL; Chirinos, E; Dills, R; Mancl, LL; Milgrom, P; Taves, DR; Vasquez, E; Watson, GE; Zegarra, G, 2012
)
0.38
" A classical three compartments pharmacokinetic model developed for the study of environmental contaminants was fitted to the breath data."( Post-operative elimination of sevoflurane anesthetic and hexafluoroisopropanol metabolite in exhaled breath: pharmacokinetic models for assessing liver function.
Catania, N; Comite, C; Di Francesco, F; Fuoco, R; Ghimenti, S; Onor, M; Pleil, JD; Stiegel, MA; Trivella, MG, 2013
)
0.39
" Therefore, a physiologically-based pharmacokinetic model for fluoride published in the literature was used and adapted in Excel for a typical 4-year-old and 8-year-old child."( A Physiologically-Based Pharmacokinetic Modeling Approach Using Biomonitoring Data in Order to Assess the Contribution of Drinking Water for the Achievement of an Optimal Fluoride Dose for Dental Health in Children.
Gagnon, F; Jean, KJ; Valcke, M; Wassef, N, 2018
)
0.48
" Serum fluoride and silver were measured, and population pharmacokinetic modeling was used to estimate pharmacokinetic parameters and simulate silver concentration versus time profiles in cohorts of children (15 to 50 kg)."( Pharmacokinetics of 38 Percent Silver Diamine Fluoride in Children.
Chen, KF; Ellenikiotis, H; Lin, YS; Milgrom, P; Rothen, ML; Soleimani-Meigooni, DN; Thompson, B, 2022
)
0.72
"3]), and a longer predicted silver half-life (15."( Pharmacokinetics of 38 Percent Silver Diamine Fluoride in Children.
Chen, KF; Ellenikiotis, H; Lin, YS; Milgrom, P; Rothen, ML; Soleimani-Meigooni, DN; Thompson, B, 2022
)
0.72

Compound-Compound Interactions

ExcerptReferenceRelevance
"A study has been made to determine the inhibitory action upon the progress of dental caries of two trace elements (fluorine and molybdenum) combined with chlorohexidine with the goal of increasing the efficiency of fluoride treatment."( [Effects of inorganic and organic fluorides combined with molybdenum and chlorohexidine upon processes of metabolism, fluoride content, and cariosity of the teeth of Wistar rats (author's transl)].
Kolesnik, AG; Novikov, LL; Schaper, R; Stösser, L; Treide, A, 1980
)
0.54
" The third group received topical treatment with the sodium fluoride varnish combined with a NaF + Mg addition to the diet."( Caries prevention in rats by fluoride varnish treatment combined with addition of fluoride to dietary sugar.
Koskinen, M; Luoma, H; Seppä, L; Syrjänen, S, 1984
)
0.27
" The results confirm that the change in fluorescence in the dentinal caries lesion is correlated with the very initial changes in mineral content, and that EPMA used in combination with COMPO images is a useful tool for determining small changes in mineral elements in the carious and adjacent areas of dentin."( Mineral element analysis of carious and sound rat dentin by electron probe microanalyzer combined with back-scattered electron image.
Hietala, EL; Larmas, M; Tjäderhane, L, 1995
)
0.29
" We thus performed a randomized, double-blind, placebo-controlled intervention study to prospectively investigate the effect of a low dose of fluoride, in combination with HRT, on BMD and biochemical markers of bone turnover."( Monofluorophosphate combined with hormone replacement therapy induces a synergistic effect on bone mass by dissociating bone formation and resorption in postmenopausal women: a randomized study.
Alexandersen, P; Christiansen, C; Riis, BJ, 1999
)
0.3
"To compare the effects of one year treatment of estrogen and tamoxifen, either alone or combined with fluoride on bone metabolism in ovariectomized rats."( [One year observation on effects of estrogen, tamoxifen combined with or without fluoride on preventing bone loss in ovariectomized rats].
Liu, H; Liu, J; Peng, H, 2002
)
0.31
"A 3-year, open-label, monocenter study was performed on 60 patients with postmenopausal established osteoporosis treated with monofluorophosphate and calcium supplement (MFP/Ca) combined with hormone replacement therapy (HRT)."( Monofluorophosphate combined with hormone replacement therapy in postmenopausal osteoporosis. An open-label pilot efficacy and safety study.
Ringe, JD; Setnikar, I, 2002
)
0.31
" The results indicate that mucin in combination with various fluorides seems to affect enamel remineralization significantly."( Effect of mucin alone and in combination with various dentifrices on in vitro Remineralization.
Hopfenmuller, W; Kielbassa, AM; Meyer-Lueckel, H; Umland, N,
)
0.37
"6 microm CO2 laser irradiation alone or combined with fluoridated products reduced demineralization progression in enamel."( Effect of the CO2 laser combined with fluoridated products on the inhibition of enamel demineralization.
Lima, EB; Nobre-dos-Santos, M; Rodrigues, LK; Steiner-Oliveira, C, 2008
)
0.35
" The aim of this in vitro study was to evaluate the effects of fluoride mouthrinses or gels in combination with de-/remineralizing saliva substitutes on dentinal subsurface lesions."( Mineral distribution of artificial dentinal caries lesions after treatment with fluoride agents in combination with saliva substitutes.
Meyer-Lueckel, H; Tschoppe, P, 2011
)
0.37
"Under the in vitro conditions chosen, use of fluoride agents in combination with a demineralizing saliva substitute resulted in reduced mineral loss."( Mineral distribution of artificial dentinal caries lesions after treatment with fluoride agents in combination with saliva substitutes.
Meyer-Lueckel, H; Tschoppe, P, 2011
)
0.37
" Therefore, this in vitro study evaluated the effects of fluoride toothpastes differing in fluoride concentration in combination with de- and remineralizing saliva substitutes using two lesion types."( Effects of regular and highly fluoridated toothpastes in combination with saliva substitutes on artificial enamel caries lesions differing in mineral content.
Meyer-Lueckel, H; Tschoppe, P, 2012
)
0.38
"The aim of this study was to evaluate the anticaries effect of low-fluoride toothpastes combined with hexametaphosphate (HMP) on enamel demineralization."( Effect of low-fluoride toothpastes combined with hexametaphosphate on in vitro enamel demineralization.
da Camara, DM; Danelon, M; Delbem, AC; Miyasaki, ML; Sassaki, KT, 2014
)
0.4
" In addition, ProSchmelz did not demonstrate beneficial effects in combination with SN on subsurface dentin lesion remineralization."( Saliva substitutes in combination with high-fluoride gel on dentin remineralization.
Kielbassa, AM; Sampaio, JE; Tschoppe, P; Zandim-Barcelos, DL, 2015
)
0.42
"Within the limitations of an in vitro study, it was concluded that the application of a high-fluoride gel did not promote additional effects on remineralization of subsurface dentin lesions in combination with saliva substitutes when compared to products with lower fluoride concentration."( Saliva substitutes in combination with high-fluoride gel on dentin remineralization.
Kielbassa, AM; Sampaio, JE; Tschoppe, P; Zandim-Barcelos, DL, 2015
)
0.42
"To test if a novel dual-phase gel system (calcium silicate and phosphate with 1450 ppmF, as NaF/MFP; TG) combined with a toothpaste (calcium silicate and sodium phosphate with 1450 ppmF, as MFP; TG) was able to re-harden previously acid-challenged enamel to a greater extent than other toothpastes."( Remineralisation effect of a dual-phase calcium silicate/phosphate gel combined with calcium silicate/phosphate toothpaste on acid-challenged enamel in situ.
Gupta, AK; Joiner, A; Naeeni, MM; Schäfer, F; Zero, DT, 2014
)
0.4
"It is concluded that the test regimen based on the novel dual-phase gel system combined with toothpaste was able to re-harden acid-challenged tooth enamel to a greater extent than a normal fluoride toothpaste."( Remineralisation effect of a dual-phase calcium silicate/phosphate gel combined with calcium silicate/phosphate toothpaste on acid-challenged enamel in situ.
Gupta, AK; Joiner, A; Naeeni, MM; Schäfer, F; Zero, DT, 2014
)
0.4
"This in situ study evaluated the effect of fluoride varnish combined with CO2 laser in controlling enamel demineralization caused by cariogenic challenges."( In situ study of the anticariogenic potential of fluoride varnish combined with CO2 laser on enamel.
Colucci, V; Corona, SA; Serra, MC; Souza-Gabriel, AE; Tenuta, LM; Turssi, CP, 2015
)
0.42
" It may be concluded that Er:YAG laser was able to control the permeability of eroded root dentin and the combination with fluoride varnish increased laser action."( Effect of Fluoride Varnish Combined with Er:YAG Laser on the Permeability of Eroded Dentin: An In Situ Study.
Carvalho, SC; Colucci, V; Corona, SA; Galo, R; Nemezio, MA; Scatolin, RS,
)
0.13
"Four adhesive systems also appropriate for use as enamel sealants were combined with four bracket types, resulting in 16 adhesive-bracket combinations, each of which was tested on 15 permanent bovine incisors."( Effects of enamel sealing on shear bond strength and the adhesive remnant index : Study of three fluoride-releasing adhesives in combination with metal and ceramic brackets.
Ebert, T; Elsner, L; Hanke, S; Hirschfelder, U; Hofmann, E, 2017
)
0.46
"To explore the clinical effect of fluoride coating combined with pit and fissure sealing or preventive resin filling on prevention of young first permanent molars caries."( [Evaluation of the clinical effect of fluoride coating combined with pit and fissure sealing or preventive resin filling on prevention of first permanent molars caries].
Jin, SQ; Luo, LP; Wu, QJ; Xu, Y, 2018
)
0.48
"For suspected young permanent molars caries, fluoride coating combined with pit and fissure sealing or separate pit and fissure sealing has a certain effect on prevent dental caries, but the fluoride coating combined with preventive resin filling is better."( [Evaluation of the clinical effect of fluoride coating combined with pit and fissure sealing or preventive resin filling on prevention of first permanent molars caries].
Jin, SQ; Luo, LP; Wu, QJ; Xu, Y, 2018
)
0.48
"To investigate the effect of pit and fissure sealant combined with fluorine protective paint on prevention of children caries aged 5-8 years old."( [Effects of pit and fissure sealant combined with fluorine protective paint on prevention of children caries aged 5-8 years old].
Lin, J; Yao, H, 2019
)
0.51
" They were grouped by random number table method: the control group (60 cases, 109 teeth) underwent pit and fissure sealant, and the experimental group (60 cases, 112 teeth) underwent pit and fissure sealant combined with fluorine protective paint."( [Effects of pit and fissure sealant combined with fluorine protective paint on prevention of children caries aged 5-8 years old].
Lin, J; Yao, H, 2019
)
0.51
"To compare the anti-caries effect and safety of Er:YAG laser combined with fluoride and methylene blue-photodynamic therapy (MB-PDT)."( [Comparison of the effect and safety of Er:YAG laser combined with fluoride and methylene blue-photodynamic therapy on caries prevention].
Yao, LP; Yu, XH; Zhang, L, 2020
)
0.56
"6 μm) combined with a stannous/fluoride-containing solution for preventing erosion in human/bovine enamel."( Effect of CO2 laser combined with AmF/NaF/SnCl2 solution on the prevention of human and bovine enamel erosion.
Engel, Y; Freitas, PM; Mantilla, TF; Ramos-Oliveira, TM; Silva, CVD; Tavares, JP, 2022
)
0.72
"To determine the effect of fluoride varnish application combined with a simulated oral environment prior to bracket bonding on the shear bond strength (SBS) between brackets and tooth enamel."( Effect of fluoride varnish in combination with simulated oral environment on enamel-bracket shear bond strength.
Kawamoto, B; Lohfeld, S; Walker, MP; Wang, Y, 2023
)
0.91
" However, the impact of Er:YAG laser irradiation combined with fluoride on the dynamic microbial changes that occur in dental plaques is still uncertain."( The impact of Er:YAG laser combined with fluoride treatment on the supragingival plaque microbiome in children with multiple caries: a dynamic study.
Pathak, JL; Pujue, Z; Sujuan, Z; Wenbin, W; Wenyan, H; Yuejun, W; Yuhang, H; Zhenni, L; Ziling, L, 2022
)
0.72
" IOS use, in combination with motivational texts and an anti-gingivitis toothpaste, could be further deployed to promote oral hygiene behaviour change in patients and improve gingival health, in a cost-effective manner."( A randomised controlled trial evaluating the impact of oral health advice on gingival health using intra oral images combined with a gingivitis specific toothpaste.
Claydon, N; Daly, S; Newcombe, R; Parkinson, C; Seong, J; West, N, 2023
)
0.91

Bioavailability

ExcerptReferenceRelevance
" The 100% bioavailability of sodium fluoride tablets during fasting was greatly decreased by coadministration of milk products: with Diet 1 the absolute bioavailability calculated from combined plasma and urine data was in the range 50--79% and with Diet 2 it ranged from 50--71%."( Influence of milk products on fluoride bioavailability in man.
Ehrnebo, M; Ekstrand, J, 1979
)
0.26
" When apparrent bioavailability was calculated from plasma and from urinary data, there was a great intra- and intersubject variation, as well as poor agreement between the two methods of calculations."( Fluoride bioavailability after intravenous and oral administration: importance of renal clearance and urine flow.
Boréus, LO; Ehrnebo, M; Ekstrand, J, 1978
)
0.26
"The bioavailability of Ossin, a drug for the treatment of osteoporosis, containing 40 mg of NaF, was investigated."( [Biological availability of Ossin, a sodium-fluoride dragee for osteoporosis therapy].
Becker, R, 1979
)
0.26
" The presence of iron and vitamins affect the bioavailability of fluoride as measured by the area under the time-plasma fluoride concentration curve."( Influence of vitamins and iron on plasma fluoride levels in rats.
Chan, JT; Jeske, AH; Stark, CM; Wild, TW,
)
0.13
"The aims of this work were (a) to assess the oral bioavailability of fluoride delivered from dentifrices and (b) to test for a possible link between the results and clinical data obtained with the same dentifrices."( Oral fluoride measurements for estimation of the anti-caries efficacy of fluoride treatments.
Duckworth, RM; Gilbert, RJ; Morgan, SN, 1992
)
0.28
" As the bioavailability of sodium fluoride (NaF) can be impaired by concomitant absorption of calcium, both drugs have to be ingested separately."( Bioavailability of fluoride in postmenopausal women: comparative study between sodium fluoride and disodium monofluorophosphate-calcium carbonate.
Bardin, C; Brouard, A; Kuntz, D; Lioté, F; Liou, A; Terrier, JL, 1992
)
0.28
" The release rate was related to the water absorption rate of the tablets."( Development and testing of bioadhesive, fluoride-containing slow-release tablets for oral use.
Bottenberg, P; Cleymaet, R; Coomans, D; de Muynck, C; Michotte, Y; Remon, JP; Slop, D, 1991
)
0.28
" Fluoride was measured in plasma and urine with a specific electrode and fluoride bioavailability from the three drugs was compared."( [Fluoride bioavailability from sodium fluoride alone or in association with different calcium salts].
Bellony, R; Brazier, M; Desmet, G; Fardelonne, P; Sebert, JL, 1991
)
0.28
" Compared with fluoride from NaF, the relative bioavailability of fluoride from sepiolite was found to be very weak."( Bioavailability of fluoride from dietary sepiolite in the lamb.
Chaso, A; Madrid, JA; Pascual, R; Salido, GM, 1991
)
0.28
" The bioavailability of fluorine was evaluated on the basis of the plasma levels and of the urinary excretion of fluoride."( Bioequivalence of sodium monofluorophosphate with sodium fluoride and compatibility with calcium.
Maurer, H; Setnikar, I, 1990
)
0.28
" The bioavailability of F in those dietary elements which have the highest F concentration was determined."( [Caries prevention through a nutritional vehicle].
Cisternas, P; Guerrero, S; Mönckeberg, F; Villa, A, 1990
)
0.28
" It is also very important to determine fluoride contents of foodstuffs and biological samples with regard to bioavailability of fluoride in vivo."( [Modified microdiffusion method for fluoride analysis of foodstuffs].
Hinoide, M; Koga, H; Takaesu, Y; Tanabe, Y, 1990
)
0.28
" In older patients, who may have achlorhydria, calcium carbonate should be taken with food or another form of calcium that is well absorbed should be used."( Treatment of osteoporosis. What is the role of calcium?
Trachtenbarg, DE, 1990
)
0.28
"003), suggesting that this difference in efficacy and tolerance is related to a better bioavailability of fluoride provided by MFP than by NaF."( Treatment of vertebral osteoporosis with disodium monofluorophosphate: comparison with sodium fluoride.
Chapuy, MC; Delmas, PD; Duboeuf, F; Dupuis, J; Meunier, PJ, 1990
)
0.28
" The bioavailability was evaluated on the basis of the plasma levels and of the urinary excretion of fluoride."( Relative bioavailability of fluoride from monofluorophosphate tablets after single oral administration.
Maurer, H; Setnikar, I, 1990
)
0.28
" The fluoride bioavailability from two preparations is identical with an areas under the curve corresponding to 61."( [Comparison of the fluoride bioavailability from two oral preparations of monofluorophosphate disodium in combination with various calcium salts].
Bellony, R; Brazier, M; Desmet, G; Fardelonne, P; Hary, L; Richard, MO; Sebert, JL,
)
0.13
"The relative bioavailability of enteric-coated sodium fluoride (NaF) tablets (10 mg F-) has been assessed following administration with a standard calcium-rich breakfast or calcium-poor lunch, and 2 h before or simultaneously with antacid administration (2."( Influence of food and antacid administration on fluoride bioavailability from enteric-coated sodium fluoride tablets.
Arnold, P; Biollaz, J; Chapuy, MC; Grandjean, EM; Meunier, PJ; Schelling, JL; Wermeille, M, 1989
)
0.28
"The bioavailability of fluoride (F) is not known to be reduced by any food except for milk and milk products."( [Effect of food on fluoride bioavailability].
Trautner, K, 1989
)
0.28
"The aim of the present work was to study the usefulness of disodium monofluorophosphate (MFP) as a milk-fluoridating agent by measuring the bioavailability of F from MFP in milk relative to that of F from NaF in water."( Fluoride bioavailability from disodium monofluorophosphate fluoridated milk in children and rats.
Cisternas, P; Guerrero, S; Monckeberg, F; Villa, A, 1989
)
0.28
" The relative bioavailability of F from seafoods was 40."( Pharmacokinetics of fluoride absorbed from dried seafoods by healthy adults.
Hattab, FN, 1988
)
0.27
" Bioavailability of F from four dentifrices with either aminefluoride (AMF) or monofluorophosphate (MFP) was compared with that of NaF."( Human plasma fluoride levels following intake of dentifrices containing aminefluoride or monofluorophosphate.
Einwag, J; Trautner, K, 1988
)
0.27
" Bioavailability of F from bone-meal, calcium and CaF2 tablets was evaluated in relation to that of NaF."( Factors influencing the bioavailability of fluoride from calcium-rich, health-food products and CaF2 in man.
Einwag, J; Trautner, K, 1987
)
0.27
"A factorial experiment was conducted with weanling rats fed a purified diet to determine the influence of dietary magnesium (200, 500 or 2500 ppm) as the carbonate on fluoride bioavailability (2 or 10 ppm as sodium fluoride)."( Influence of dietary magnesium on fluoride bioavailability in the rat.
Cerklewski, FL, 1987
)
0.27
"A factorial experiment was conducted with weanling rats fed a purified diet to determine the influence of dietary protein type (casein or lactalbumin) and level (120 or 360 g/kg) on fluoride bioavailability (2 or 10 mg/kg as NaF)."( Influence of type and level of dietary protein on fluoride bioavailability in the rat.
Boyde, CD; Cerklewski, FL, 1987
)
0.27
" This was presumably because of the lower, though still significant, bioavailability of 'insoluble' components of the fume particles."( Toxic and genotoxic action of electric-arc welding fumes on cultured mammalian cells.
Arlauskas, A; Baker, RS; Crisp, PT; Ellis, J; Tandon, RK, 1986
)
0.27
"50%) as sodium chloride on fluoride bioavailability (2 or 10 ppm as sodium fluoride)."( Influence of dietary chloride on fluoride bioavailability in the rat.
Bills, ND; Cerklewski, FL; Ridlington, JW, 1986
)
0.27
" During a 6-wk trial, neither divalent zinc nor divalent iron affected fluoride bioavailability based on skeletal uptake of fluoride."( Influence of zinc and iron on dietary fluoride utilization in the rat.
Cerklewski, FL; Ridlington, JW, 1985
)
0.27
" This should help develop the bioavailability profiles for individual foods and beverages essential for accurate assessment of dietary F intake."( Dietary intake and bioavailability of fluoride.
Rao, GS, 1984
)
0.27
" The bioavailability of F from the alginate was about 55% of the total F in the administered dose."( Absorption of fluoride following inhalation and ingestion of alginate impression materials.
Hattab, F, 1981
)
0.26
" The results showed a less-than-20% bioavailability of fluoride when administered with calcium-rich food."( Fluoride pharmacokinetics in the domestic pig.
Ekstrand, J; Fejerskov, O; Richards, A, 1982
)
0.26
" When the pH was less than 5, fluoride absorption rate was inversely related to pH."( Fluoride absorption through the hamster cheek pouch: a pH-dependent event.
Callan, RS; Wang, HS; Whitford, GM, 1982
)
0.26
" In contrast, there was no difference in the areas under the curves, indicating that the relative bioavailability of fluoride is the same in all preparations."( [Bioavailability of monofluoride preparations for dental caries prophylaxis (author's transl)].
Férault-Larue, DH; Fuchs, C; Heimann, G, 1980
)
0.26
" In conclusion, the sustained-release preparations of MFP led to a decrease of fluoride bioavailability and avoided high peak serum concentrations."( A comparative bioavailability study on two new sustained-release formulations of disodiummonofluorophosphate versus a nonsustained-release formulation in healthy volunteers.
Erlacher, L; Magometschnigg, D; Templ, H, 1995
)
0.29
"This investigation was done to determine the bioavailability of fluoride (F) after toothbrushing associated with different water rinsing procedures."( Effect of water rinsing after toothbrushing on fluoride ingestion and absorption.
Birkhed, D; Ekstrand, J; Sjögren, K, 1994
)
0.29
" The bioavailability in dogs was only 60%."( A biopharmaceutic approach in designing a controlled release tablet of sodium monofluorophosphate: 1. In vitro and in vivo studies in beagle dogs.
Ritschel, WA; Vattikonda, CS, 1994
)
0.29
" The results indicated that decaffeinated coffee and caffeine had no effect on F metabolism, whereas caffeinated coffee appeared to increase the initial absorption rate but not the 4-hour bio-availability."( Lack of significant effect of coffee and caffeine on fluoride metabolism in rats.
Chen, X; Whitford, GM, 1994
)
0.29
" These included fluoride bioavailability tests, enamel lesion de- and remineralisation studies ('pH-cycling') and in situ caries studies."( The caries preventive effect of a fluoride dentifrice containing Triclosan and zinc citrate, a compilation of in vitro and in situ studies.
ten Cate, JM, 1993
)
0.29
"A two-way cross-over study was conducted on 12 Caucasian male healthy volunteers aged between 25 and 38 years in order to determine the bioavailability and pharmacokinetics of fluoride after single oral administration in fasting conditions of two products (tablets and powder for oral use) of L-glutamine monofluorophosphate (G-MFP, CAS 116420-36-1)."( Bioavailability and pharmacokinetics of fluoride from two glutamine monofluorophosphate preparations.
Setnikar, I; Warneke, G, 1993
)
0.29
"A two-treatment cross-over study was conducted on 8 Caucasian male healthy volunteers aged between 26 and 32 years in order to determine the influence of a standard meal on the bioavailability and pharmacokinetics of fluoride after a single oral administration of tablets containing the equivalent of 10 mg fluoride as sodium monofluorophosphate (Na-MFP, CAS 10163-15-2) in a fixed combination with 300 mg Ca as calcium gluconate and calcium citrate."( Effects of meal on the pharmacokinetics of fluoride from oral monofluorophosphate.
Setnikar, I; Warneke, G, 1993
)
0.29
" Since the rate of absorption is also strongly influenced by the rapidity of gastric emptying, we have compared the relative importance of gastric acidity and gastric emptying in overall F absorption."( Influence of gastric acidity on fluoride absorption in rats.
Messer, HH; Ophaug, RH, 1993
)
0.29
" The main criticisms of milk fluoridation are decreased bioavailability of the fluoride, the cost and administrative burden involved, and (in some cases) lack of sound clinical conclusions regarding its preventive efficacy."( Should we use milk fluoridation? A review.
Mariño, R, 1995
)
0.29
" These figures are likely to be overestimates due to the intake of nutrients from other sources reducing formulae consumption and also due to the lower bioavailability of fluoride from milk-based formulae."( Fluoride content of infant formulae in Australia.
Reynolds, EC; Silva, M, 1996
)
0.29
"This paper reports a reassessment of the bioavailability of fluoride from monofluorophosphate (MFP, CAS 10163-15-2)."( Bioavailability of fluoride administered as sodium fluoride or sodium monofluorophosphate to human volunteers.
Morosano, M; Puche, RC; Rigalli, A, 1996
)
0.29
"The absolute bioavailability and other pharmacokinetic parameters of two fluoride formulations were investigated in 13 healthy volunteers, aged 61-70 years."( Absolute bioavailability of fluoride from disodium monofluorophosphate and enteric-coated sodium fluoride tablets.
Duursma, SA; Glerum, JH; van Asten, P; van Dijk, A; van Rijn, HJ; Ververs, FF, 1996
)
0.29
" MFP had significantly higher bioavailability [102."( Absolute bioavailability of fluoride from disodium monofluorophosphate and enteric-coated sodium fluoride tablets.
Duursma, SA; Glerum, JH; van Asten, P; van Dijk, A; van Rijn, HJ; Ververs, FF, 1996
)
0.29
"The MFP formulation showed higher bioavailability with smaller variation than the NaFor formulation."( Absolute bioavailability of fluoride from disodium monofluorophosphate and enteric-coated sodium fluoride tablets.
Duursma, SA; Glerum, JH; van Asten, P; van Dijk, A; van Rijn, HJ; Ververs, FF, 1996
)
0.29
" Since the therapeutic effect depends on the concentration of fluoride ions achieved in the plasma, differences in fluoride content and bioavailability must be taken into account when using sodium fluoride or sodium monofluorophosphate."( [Value of fluoride therapy in osteoporosis].
Ringe, JD, 1997
)
0.3
" In conclusion, the results of this study demonstrate that fluoride ingested with milk is excreted through the salivary glands, indicating that the bioavailability of fluoride from milk equals that of other vehicles."( Fluoride concentration in whole saliva and separate gland secretions in schoolchildren after intake of fluoridated milk.
Nederfors, T; Petersson, LG; Twetman, S, 1998
)
0.3
"Two studies on the rate and extent of bioavailability of fluoride from a single dose of oral preparations of sodium monofluorophosphate (Na2FPO3) combined with calcium supplement were conducted according to a cross-over design on 18 (Study 1) and 20 (Study 2) male healthy volunteers, respectively."( Bioavailability and pharmacokinetic characteristics of two monofluorophosphate preparations with calcium supplement.
Barkworth, MF; Rovati, LC; Schmid, K; Setnikar, I; Vens-Cappell, B, 1998
)
0.3
" The results showed that F absorption increased and F excretion/F absorption rate decreased in 2 groups of rats with fluorosis compared with control group and there were positive correlations between concentration of urine F and water F, as well as concentration of F urine and time of drinking F water."( [Accumulation and excretion of fluorine and effect of selenium on them in rats with chronic fluorosis].
Bian, J; Ji, Q; Xian, S; Ye, P, 1997
)
0.3
"According to previous pharmacokinetic studies the bioavailability of fluorine (F) from sodium monofluorophosphate (MFP) doubles that of sodium fluoride (NaF)."( In postmenopausal osteoporosis the bone increasing effect of monofluorophosphate is not dependent on serum fluoride.
Bocanera, R; Masoni, A; Morosano, M; Pera, L; Puche, RC; Rigalli, A; Tozzini, R, 1999
)
0.3
" MFP and P-NaF showed greater bioavailability than Neosten and much higher Cmax that exceeded the toxic threshold of Fser (190 ng/ml)."( A comparison of fluoride bioavailability from a sustained-release NaF preparation (Neosten) and other fluoride preparations.
Gitomer, WL; Pak, CY; Sakhaee, K, 2000
)
0.31
" The laboratory results indicate that the calcium and phosphate salts delivered by the remineralizing Enamelon dentifrice increase the bioavailability of fluoride to substantially exceed that of the clinically proven standard dentifrice."( Laboratory enamel solubility reduction and fluoride uptake from enamelon dentifrice.
Schemehorn, BR; Winston, AE; Wood, GD, 1999
)
0.3
"The bioavailability of fluoride from krill exoskeleton and the effect of additional calcium on the bioavailability of fluoride from krill paste were evaluated using young rats."( Reduction of the bioavailability of fluoride from Antarctic krill by calcium.
Alvarenga, RC; Tenuta-Filho, A, 1999
)
0.3
" Pharmacokinetic experiments done in human volunteers revealed that the bioavailability of fluoride from sodium fluoride (NaF, CAS 7681-49-4) enteric coated tablets was 33% of that of plain (immediate release) tablets."( Intestinal absorption of fluoride at high luminal concentration of fluoride.
Beinlich, A; Puche, RC; Rigalli, A, 2001
)
0.31
" The apparently missing detrimental effects of the alkaline deposits on soil microbial activities are probably due to the low bioavailability of contaminants in the calcareous soil."( Effects of alkaline dust deposits from phosphate fertilizer production on microbial biomass and enzyme activities in grassland soils.
Günther, T; Langer, U, 2001
)
0.31
" For a new fluoride product the bioavailability of the ion should be demonstrated."( How to measure the effects of fluoride treatments in clinical trials? The role of caries prevalence and caries assessment.
Reich, E, 2001
)
0.31
" The purpose of this study is to evaluate the effect of calcium and magnesium to decrease the bioavailability of fluoride in a lethal model of fluoride poisoning."( Calcium neutralizes fluoride bioavailability in a lethal model of fluoride poisoning.
Cairns, CB; Dart, RC; Heard, K; Hill, RE, 2001
)
0.31
"6 mM/kg intraperitoneally) to decrease the bioavailability of the fluoride ion."( Calcium neutralizes fluoride bioavailability in a lethal model of fluoride poisoning.
Cairns, CB; Dart, RC; Heard, K; Hill, RE, 2001
)
0.31
"Calcium chloride administered simultaneously with sodium fluoride reduces the bioavailability of fluoride poisoning in a mouse model."( Calcium neutralizes fluoride bioavailability in a lethal model of fluoride poisoning.
Cairns, CB; Dart, RC; Heard, K; Hill, RE, 2001
)
0.31
"To assess the bioavailability of fluoride added into milk."( [A study on the bioavailability of fluoride added into milk].
Bian, J; Cao, C; Wang, W, 2001
)
0.31
"The bioavailability of fluoride in fluoridated milk reached 80."( [A study on the bioavailability of fluoride added into milk].
Bian, J; Cao, C; Wang, W, 2001
)
0.31
"Fluoride bioavailability in fluoridated milk is still high and sufficient."( [A study on the bioavailability of fluoride added into milk].
Bian, J; Cao, C; Wang, W, 2001
)
0.31
" The bioavailability of fluoride from these diets was evaluated in relation to that of sodium fluoride in solution form."( Bioavailability of fluoride in humans from commonly consumed diets in India.
Gauba, K; Goyal, A; Tewari, A, 1998
)
0.3
" Furthermore, the bioavailability of dentifrices, in terms of formation of total fluorine (TF), CaF2, and fluorapatite (FA) on human dental enamel, was evaluated."( [Dose-response effect of a dentifrice formulation with low fluoride concentration - an in vitro study].
Cury, JA; Negri, HM,
)
0.13
" Aquatic organisms living in soft waters may be more adversely affected by fluoride pollution than those living in hard or seawaters because the bioavailability of fluoride ions is reduced with increasing water hardness."( Fluoride toxicity to aquatic organisms: a review.
Camargo, JA, 2003
)
0.32
"This paper reports that in the rat coadministration of calcium (calcium chloride, CAS 10043-52-4, Ca2+) enhances intestinal absorption and bioavailability of monofluorophosphate (sodium monofluorophosphate, CAS 10163-15-2, MFP)."( Intestinal absorption of disodium monofluorophosphate in the rat as affected by concurrent administration of calcium.
Beinlich, AD; Brun, LR; Puche, RC; Rigalli, A, 2003
)
0.32
" Therefore, a higher fluoride bioavailability is possible."( Total and acid-soluble fluoride content of infant cereals, beverages and biscuits from Brazil.
Buzalaf, MA; Cardoso, VE; de Almeida, BS; Furlani, Tde A; Olympio, KP, 2004
)
0.32
" Any differences in fluoride bioavailability between drinking waters in which fluoride is present naturally or added artificially, or the waters are hard or soft, were small compared with large within- and between-subject variations in F absorption."( Bioavailability of fluoride in drinking water: a human experimental study.
Hindmarch, PN; Maguire, A; Mathers, JC; Moynihan, PJ; Steen, IN; Zohouri, FV, 2005
)
0.33
" Concerns have been raised about the bioavailability of fluoride from artificially-fluoridated water compared with naturally-fluoridated water."( The interrelationship between diet and oral health.
Moynihan, P, 2005
)
0.33
"This double-blind study assessed the fluoride (F) concentration in whole saliva and F bioavailability after the use of low-F dentifrices with reduced pH."( Low-fluoride dentifrices with reduced pH: fluoride concentration in whole saliva and bioavailability.
Bardal, PA; Bastos, JR; Buzalaf, MA; Cardoso, VE; Oliveira, RC; Olympio, KP, 2007
)
0.34
" The results suggest a non-significant enhancement of oral Al bioavailability by citrate and maltolate, some Al complex dissociation in the GI tract, and less absorption of Al than citrate or maltolate."( The influence of citrate, maltolate and fluoride on the gastrointestinal absorption of aluminum at a drinking water-relevant concentration: A 26Al and 14C study.
Harris, WR; Yokel, RA; Zhou, Y, 2008
)
0.35
"Post-brushing water rinsing may reduce the risk of fluoride (F) ingestion from dentifrice, however the decreased salivary F bioavailability may compromise any consequent anticaries benefits."( Low-fluoride dentifrice and the effect of postbrushing rinsing on fluoride availability in saliva.
Cury, JA; Tenuta, LM; Zamataro, CB, 2008
)
0.35
"Changing food patterns in combination with ineffective oral hygiene measures and insufficient bioavailability of fluoride from drinking water and other sources seem to impair the dental health status in developing countries, especially in the younger population."( Fluoride availability from natural resources in The Gambia--implications for oral health care.
Gaengler, P; Jordan, RA; Markovic, L, 2008
)
0.35
"Age-related recommendations for oral health care and for additional fluoride bioavailability are given, taking into account local socio-economic conditions in the Republic of The Gambia and similar developing countries."( Fluoride availability from natural resources in The Gambia--implications for oral health care.
Gaengler, P; Jordan, RA; Markovic, L, 2008
)
0.35
"This study evaluated the bioavailability of fluoride after topical application of a dual-fluoride varnish commercially available in Brazil, when compared to Duraphat."( Urinary fluoride output in children following the use of a dual-fluoride varnish formulation.
Bijella, MF; Buzalaf, MA; Cardoso, VE; Delbem, AC; Olympio, KP; Pessan, JP,
)
0.13
" Consequently, the bioavailability of F tended to be higher on LP than NP or HP diets."( Effect of long-term fluoride exposure on growth, nutrient utilization and fluoride kinetics of calves fed graded levels of dietary protein.
Khan, SA; Lohakare, J; Pattanaik, A, 2010
)
0.36
" Because the bioavailability of fluoride is generally reduced in humans when consumed with milk or a calcium-rich diet, it is highly recommended that the inhabitants of fluoride-contaminated areas should incorporate calcium-rich foods in their routine diet."( Fluoride in the environment and its metabolism in humans.
Damodaran, T; Jha, SK; Mishra, VK; Sharma, DK, 2011
)
0.37
" Although POs-Ca+F gum was not superior in TMR recovery rate when compared with POs-Ca gum, WAXRD results highlighted the importance of fluoride ion bioavailability in the formation of HAp crystallites in enamel subsurface lesions in situ (NCT01377493)."( Effects of a chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on remineralization and crystallization of enamel subsurface lesions in situ.
Hamba, H; Ikeda, M; Kitasako, Y; Sadr, A; Tagami, J; Tanaka, M, 2011
)
0.37
" It has been reported that the fluoride bioavailability was reduced with increasing water hardness, however, the dietary fluoride derived from KM exoskeleton accumulates in vertebral bones of marine fish with growth inhibition, as has already been shown for freshwater fish."( Effect of dietary fluoride derived from Antarctic krill (Euphausia superba) meal on growth of yellowtail (Seriola quinqueradiata).
Nagano, I; Yoshitomi, B, 2012
)
0.38
" According to the highly individual profile of fluoride in saliva and plaque, both levels of bioavailability correlated for the first 30 minutes, and the fluoride content of saliva and plaque was back to baseline after 6 hours."( Fluoride bioavailability in saliva and plaque.
Arnold, WH; Gaengler, P; Hertenstein, P; Jordan, RA; Kuehnl, P; Markovic, L; Naumova, EA, 2012
)
0.38
" However, no significant difference in bioavailability between NaF and amine fluoride, in saliva, or in plaque was found."( Fluoride bioavailability in saliva and plaque.
Arnold, WH; Gaengler, P; Hertenstein, P; Jordan, RA; Kuehnl, P; Markovic, L; Naumova, EA, 2012
)
0.38
" Nanoindentation and TOF-SIMS results highlighted the benefits of bioavailability of fluoride ion on reinforcement of the superficial zone of subsurface lesions in situ (NCT01377493)."( Gum containing calcium fluoride reinforces enamel subsurface lesions in situ.
Hamba, H; Ikeda, M; Kitasako, Y; Sadr, A; Tagami, J, 2012
)
0.38
" These studies have focused on the availability of fluoride in the toothpaste formulations, its bioavailability in saliva and remnants of disturbed biofilm, its reaction with the dental substrate to form loosely bound reservoirs as well as the ultimate reduction of mineral loss and increase in mineral and fluoride content of caries lesions."( Laboratory and human studies to estimate anticaries efficacy of fluoride toothpastes.
Cury, JA; Tenuta, LM, 2013
)
0.39
" Fluoride bioavailability was higher in salivary sediment than in supernatant saliva."( Dynamic changes in saliva after acute mental stress.
Al Khatib, P; Arnold, WH; Bochnig, C; Lee, WK; Naumova, EA; Sandulescu, T; Zimmer, S, 2014
)
0.4
"According to translocation regulation of fluoride in the typical oasis soil-plant system under field, an ecological risk assessment model of fluoride was established, and this model was used to assess ecological risk to fluoride pollution from suburban oasis soils in Baiyin City, which was specifically expressed with the potential ecological risk of bioavailability (ER(bc)) model to assess ecological risk of fluoride pollution in oasis regions."( [Study on ecological risk assessment technology of fluoride pollution from arid oasis soil].
Li, P; Nan, ZR; Wang, SL; Xue, SY, 2014
)
0.4
" High-F dentifrice enhanced the bioavailability of salivary F, being an option for caries management in patients with high caries risk."( Salivary fluoride levels after use of high-fluoride dentifrice.
Bohn, AC; Cruz, PF; de Moura, MS; Vale, GC, 2015
)
0.42
" This is hypothetically attributed to the action of a partial barrier to fluoride transfer from blood to milk in lactating females and a low bioavailability of fluoride ingested together with milk."( Reconstructing temporal variation of fluoride uptake in eastern grey kangaroos (Macropus giganteus) from a high-fluoride area by analysis of fluoride distribution in dentine.
Death, C; Hufschmid, J; Kierdorf, H; Kierdorf, U; Rhede, D, 2016
)
0.43
" This finding is consistent with the expected high bioavailability of free Ni ions in halide solutions."( Differential Toxicities of Nickel Salts to the Nematode Caenorhabditis elegans.
Birdsey, JM; Dobbin, KK; Meyer, D; Wendolowski, MA; Williams, PL, 2016
)
0.43
" The soil F bioavailability is an important factor influencing its uptake and contents in teas."( Soil fluoride fractions and their bioavailability to tea plants (Camellia sinensis L.).
Ma, L; Qiao, S; Ruan, J; Wang, J; Yi, X, 2017
)
0.46
"This study highlighted the importance of calcium and fluoride ion bioavailability in the reinforcement of demineralized enamel lesions by chewing gums."( White spot lesion remineralization by sugar-free chewing gum containing bio-available calcium and fluoride: A double-blind randomized controlled trial.
Kitasako, Y; Sadr, A; Shimada, Y; Sugiura, M; Sumi, Y; Tagami, J, 2016
)
0.43
" Therefore, we suggest that the permitted level of F should be confined within soil quality standards for farmland of China in order to upset the effect of high F concentration on bioavailability of soil Cd."( Accumulation, interaction and fractionation of fluoride and cadmium in sierozem and oilseed rape (Brassica napus L.) in northwest China.
Bao, L; Huang, W; Li, Y; Nan, Z; Sun, H; Wang, S; Zang, F; Zhang, Q, 2018
)
0.48
" Evidence is presented to show that fluoride (F) inhibits Na + , K + -ATPase activity by altering biological pathways through modifying the expression of genes and the activity of glycolytic enzymes, metalloenzymes, hormones, proteins, neuropeptides and cytokines, as well as biological interface interactions that rely on the bioavailability of chemical elements magnesium and manganese to modulate ATP and Na + , K + -ATPase enzyme activity."( Fluoride Exposure Induces Inhibition of Sodium-and Potassium-Activated Adenosine Triphosphatase (Na
Waugh, DT, 2019
)
0.51
" In salivary sediment bioavailability of fluoride lasted longer after application of fluoridated bioactive glass."( Randomized investigation of the bioavailability of fluoride in saliva after administration of sodium fluoride, amine fluoride and fluoride containing bioactive glass dentifrices.
Arnold, WH; Hill, RG; Kouji, O; Modric, J; Naumova, EA; Pierchalla, T; Rybka, M; Staiger, M, 2019
)
0.51
"Toothbrushing with the fluoride containing bioactive glass dentifrices had positive effects on the fluoride bioavailability within two hours."( Randomized investigation of the bioavailability of fluoride in saliva after administration of sodium fluoride, amine fluoride and fluoride containing bioactive glass dentifrices.
Arnold, WH; Hill, RG; Kouji, O; Modric, J; Naumova, EA; Pierchalla, T; Rybka, M; Staiger, M, 2019
)
0.51
"Although soy beverages are promoted as healthy alternatives to bovine milk the added sugar and low calcium bioavailability of the soy drink makes frequent consumption a caries risk."( Effects of soy and bovine milk beverages on enamel mineral content in a randomized, double-blind in situ clinical study.
Fernando, JR; Reynolds, C; Reynolds, EC; Shen, P; Stanton, DP; Walker, GD; Yuan, Y, 2019
)
0.51
"Both CPP-ACP and bioactive glass enhanced ion release without compromising the bioavailability of fluoride."( A comparative evaluation of ion release characteristics of three different dental varnishes containing fluoride either with CPP-ACP or bioactive glass.
Baysan, A; Hill, RG; Karpukhina, NG; Sleibi, A; Tappuni, AR, 2019
)
0.51
" The toxicity and bioavailability of aluminum depends mainly on the form in which it occurs."( Chemical Speciation of Aluminum in Wine by LC-ICP-MS.
Frankowski, M; Karaś, K; Zioła-Frankowska, A, 2020
)
0.56
" TSF concentration (µg F/mL) in TR was determined as an indicator of fluoride bioavailability during toothbrushing and the areas under curves of saliva fluoride concentration versus time (area under the curve, AUC = µg F/mL × min) were calculated as an indicator of fluoride bioavailability after toothbrushing."( Chemically Soluble Fluoride in Na2FPO3/CaCO3-Based Toothpaste as an Indicator of Fluoride Bioavailability in Saliva during and after Toothbrushing.
Coelho, CSS; Cury, JA; Tabchoury, CPM, 2020
)
0.56
"The aim of this in vitro study was to determine the fluoride concentration in silver diamine fluoride (SDF) products and their bioavailability with demineralized dentine."( Fluoride Concentration in SDF Commercial Products and Their Bioavailability with Demineralized Dentine.
Cury, JA; Soares-Yoshikawa, AL; Tabchoury, CPM, 2020
)
0.56
"HCl significantly improved the fluoride bioavailability in CFDs (p<0."( Enhanced Fluoride Bioavailability with Incorporation of Arginine in Child Dentifrices.
Bijle, MN; Carey, CM; Ekambaram, M; Lo, ECM; Tsoi, J; Yiu, CKY, 2020
)
0.56
" Incorporating arginine (L-arginine or L-arginine monohydrochloride) at 2% w/w improves fluoride bioavailability of the child formula dentifrices."( Enhanced Fluoride Bioavailability with Incorporation of Arginine in Child Dentifrices.
Bijle, MN; Carey, CM; Ekambaram, M; Lo, ECM; Tsoi, J; Yiu, CKY, 2020
)
0.56
"Nano-hydroxyapatite (NHAP), possessing high defluoridation capacity, has been widely used to remove fluoride (F) from polluted water, but little is known about how it affects the bioavailability and toxicity of soil F towards plants."( Remediation of fluoride contaminated soil with nano-hydroxyapatite amendment: Response of soil fluoride bioavailability and microbial communities.
Gan, CD; Jia, YB; Yang, JY, 2021
)
0.62
"The use of fluoridated dentifrices is recognized as the main reason for the decline of dental caries and its effect is associated with the bioavailability of fluoride (F) in the oral cavity."( Nocturnal Salivary Fluoride Bioavailability After Brushing with a High-fluoride Dentifrice.
Carvalho, GAO; de Sousa Lopes, MS; Macena, NS; Mota, BIS; Prado, VLG; Santana, GB; Vale, GC, 2022
)
0.72
" Mouthrinses with 226 ppm F as NaF and low pH presented significantly greater bioavailability of fluoride on enamel than those with higher pH or lower NaF concentration."( Fluoride bioavailability on demineralized enamel by commercial mouthrinses.
Botelho, JN; Cury, JA; Giacaman, RA; Pedro Ricomini-Filho, A; Tabchoury, CPM; Valdivia-Tapia, AC,
)
0.13
" Mouth rinses with 226 ppm F as NaF and low pH presented significantly greater bioavailability of fluoride on enamel than those with higher pH or lower NaF concentration."( Fluoride bioavailability on demineralized enamel by commercial mouth rinses.
Botelho, JN; Cury, JA; Giacaman, RA; Pedro Ricomini-Filho, A; Tabchoury, CPM; Valdivia-Tapia, AC,
)
0.13
"Fluoride chemically soluble in toothpaste is an indicator of fluoride bioavailability when the teeth are brushed, and the same should be expected systemically when toothpaste is ingested."( Soluble Fluoride in Na2FPO3/CaCO3-Based Toothpaste as an Indicator of Systemically Bioavailable Fluoride.
Caldas da Rocha, DR; Cury, JA; Ricomini Filho, AP, 2022
)
0.72
"Fluoride (F) is an emerging pollutant that originates from multiple sources and adversely affects plant growth and nutrient bioavailability in soil."( Effects of soil fluoride pollution on wheat growth and biomass production, leaf injury index, powdery mildew infestation and trace metal uptake.
Ahmad, MN; Ahmad, Y; Alam, SS; Ashmore, M; Dawar, KM; Mahmood, R; Riaz, M; van den Berg, L; Zia, A, 2022
)
0.72
" Moreover, trace metal bioavailability was high in front of industrial discharge areas."( Assessment of trace elements and fluoride originating from phosphogypsum in the sediment of Gulf of Gabes (southeastern Tunisia): what are the potential sources of accumulation and bioavailability?
Aleya, L; Amri, S; Brik, B; Dahim, MA; Martins, MVA; Oueslati, W; Trabelsi, L; Zaaboub, N, 2023
)
0.91
" For this endeavor, 21-days-old mice received 10 or 50 mg/L of fluoride in drinking water for 60 days and the results indicated that the increased plasma fluoride bioavailability was associated with the triggering of short- and long-term memory impairments after high F concentration levels."( Prolonged exposure to high fluoride levels during adolescence to adulthood elicits molecular, morphological, and functional impairments in the hippocampus.
Aragão, WAB; Bittencourt, LO; Buzalaf, MAR; de Carvalho Cartágenes, S; Dionizio, A; do Socorro Ferraz Maia, C; Ferreira, MKM; Lima, RR; Puty, B; Zohoori, FV, 2023
)
0.91
"25%β-CaGPn into 1100F formulation increased the bioavailability of calcium and phosphate, promoting a higher remineralizing effect."( Effect of the association of microparticles and nano-sized β-calcium glycerophosphate in conventional toothpaste on enamel remineralization: In situ study.
Danelon, M; de Camargo, ER; Delbem, ACB; Emerenciano, NG; Gonçalves, FMC; Quinteiro, JP; Silva-Sousa, YTC, 2023
)
0.91

Dosage Studied

Clinicians prescribing home-applied high-concentration fluorides need to be cognizant of the symptoms of fluoride toxicity, carefully monitor the patient's compliance with the treatment regimen. A dose-response relationship has been recently described for fluoride exposure and bronchial hyper-responsiveness.

ExcerptRelevanceReference
" This view is supported by the following facts: (a) mersalyl acted with a similar dose-response curve upon an intact as well as a detergent-dispersed cyclase preparation while no effect was observed upon a solubilized Mg2+-ATPase preparation; (b) a covalent p-chloromercuribenzoate-Sephadex preparation (but not its supernatant) inhibited the cyclase from intact membranes."( Adenylate cyclase from rat-liver plasma membrane: inhibition by mersalyl and other mercurial derivatives.
Hanoune, J; Mavier, P, 1975
)
0.25
" In the described series of investigations this compound, with which treatment by gradual dosage is possible, has proved its effectiveness."( [Sodium fluoride in the therapy of osteoporosis].
Krokowski, E, 1979
)
0.26
" Dose-response curves to hormones, fluoride, and GMP-P (NH)P were not affected by age."( Hormone-sensitive fat cell adenylate cyclase in the rat. Influences of growth, cell size, and aging.
Cooper, B; Gregerman, RI, 1976
)
0.26
" Intravenous injection of parathyroid hormone over the dosage range from 1-50 mug/kg resulted in a dose-dependent increase in phosphate and cyclic AMP excretion with both D-fed and D-deficient thyroparathyroidectomized rats."( Renal adenylate cyclase and the interrelationship between parathyroid hormone and vitamin D in the regulation of urinary phosphate and adenosine cyclic 3',5'-monophosphate excretion.
Anast, CS; Forte, LR; Nickols, GA, 1976
)
0.26
" Noradrenaline affinity to the binding sites was decreased and the dose-response curve for the stimulation of adenylate cyclase activity by adrenaline was shifted to the right in hypothyroidism."( Influence of thyroid state on the specific binding of noradrenaline to a cardiac particulate fraction and on catecholamine-sensitive cardiac adenylate cyclase activity.
Will-Shahab, L; Wollenberger, A, 1976
)
0.26
" The possible role of cyclic AMP in the action of LH was reexamined by studying the dose-response effect of LH on the stimulation of progesterone synthesis, cyclic AMP-dependent protein kinase activation, and cyclic AMP accumulation."( Reevaluation of the role of cyclic adenosine 3',5'-monophosphate and protein kinase in the stimulation of steroidogenesis by luteinizing hormone in bovine corpus luteum slices.
Ling, WY; Marsh, JM, 1977
)
0.26
" Less fluoride was deposited in teeth and bone from AIF6, than from NaF at all dosage levels."( Dental fluorosis as related to the concentration of fluoride in teeth and bone.
Aasenden, R; Bakhos, Y; Brudevold, F, 1978
)
0.26
" It is suggested that the decreased bioavailability produced by dairy products should be taken into account when establishing flouride dosage regimens for prophylaxis of caries."( Influence of milk products on fluoride bioavailability in man.
Ehrnebo, M; Ekstrand, J, 1979
)
0.26
" Plasma and tissue SMFA concentrations were generally lower than the corresponding stomach fluid SMFA concentrations for all dosage groups."( Inorganic and organic fluoride concentrations in tissues after the oral administration of sodium monofluoroacetate (Compound 1080) to rats.
Egekeze, JO; Oehme, FW, 1979
)
0.26
" growth inhibition of cultured cells, and additional a two-peaked dose-response curve was found with cadmium."( 51Cr release cytotoxicity assay evaluated with fluoride and cadmium.
Holland, RI, 1978
)
0.26
" A dosage schedule is recommended that decreases the dose of fluoride in infancy and that is inversely related to the concentration of fluoride in the drinking water."( Dietary fluoride supplementation for the prevention of caries.
Newbrun, E, 1978
)
0.26
"This study provides the first morphological evidence of significant structural damage following high doses of enflurane alone and confirms previous findings of transient renal functional abnormalities following high dosage enflurane."( Enflurane nephrotoxicity and pre-existing renal dysfunction.
Cousins, MJ; David, W; Fulton, A; Haynes, G; Whitehead, R, 1978
)
0.26
" Daily dosage was 50-100 mg."( [Treatment of osteoporosis with a delayed-action sodium fluoride preparation].
Chlud, K,
)
0.13
" Older tooth germs were less affected overal when incubated at the same fluoride dosage and time of treatment."( Regeneration of tooth development in vitro following sodium fluoride treatment.
Kerley, MA; Kollar, EJ, 1977
)
0.26
" The drug acted with a similar dose-response curve upon intact as well as detergent-dispersed cyclase preparations."( RMI 12330 A, an inhibitor of adenylate cyclase in rat liver.
Berthelot, P; Guellaen, G; Hanoune, J; Mahu, JL; Mavier, P, 1977
)
0.26
" At this dosage of 1 MAC hour, which is equivalent to use as a supplement, UFV did not sub-anaesthetic doses of enflurane are administered at this time interval there appears to be no increased risk of nephrotoxicity."( Metabolism of enflurane in man following a second exposure.
Cousins, MJ; Norgate, CE; Sharp, JH, 1976
)
0.26
" The predominant factors in the production of methoxyflurane nephrotoxicity appear to be high methoxyflurane dosage and serum inorganic fluoride concentration."( Methoxyflurane nephropathy.
Mazze, RI, 1976
)
0.26
" In comparison to estimates of fluoride intake from communal water supplies, the recommended dosage from fluoride supplements results in daily doses that may be two to six times greater, on the average, for the infant less than age 6 months and three times greater for the average 3-year-old."( Dietary fluoride intake from supplements and communal water supplies.
Infante, PF, 1975
)
0.25
" Methoxyflurane dosage was sufficiently low that renal abnormalities did not occur except in rats treated also with phenobarbital; these animals developed polyuria and the morphologic lesion typically associated with F--induced nephrotoxicity."( A comparison of renal effects and metabolism of sevoflurane and methoxyflurane in enzyme-induced rats.
Beppu, WJ; Cook, TL; Hitt, BA; Kosek, JC; Mazze, RI,
)
0.13
" The techniques studied should be of particular importance to the pharmaceutical industry where efforts are being made to reduce the levels of particulate matter in parenteral dosage forms."( Glass for parenteral products: a surface view using the scanning electron microscope.
Brown, JA; Roseman, TJ; Scothorn, WW, 1976
)
0.26
" via toothpaste the narrow range between beneficial and detrimental dosage the avoidance of fluoride-enriched waste water the prerogative of minimal manipulation of drinking water content."( Drinking water fluoridation and caries prophylaxis: with special consideration of the experience in the former East Germany.
Hahn, T; Netuschil, L; Schweinsberg, F, 1992
)
0.28
" Throughout Europe, product dosage and age related dose recommendations for fluoride supplements vary widely."( A European view of fluoride supplementation.
Clarkson, J, 1992
)
0.28
"These results suggest that the fluoride dosage regimen commonly proposed is effective against dental caries and does not need any change to reduce the risk of fluorosis."( [Dental caries, fluoride tablets and enamel opacities].
D'Hoore, W; Van Nieuwenhuysen, JP,
)
0.13
" The direct dose-response relation between effectiveness and fluoride concentration of toothpastes is far from clear-cut and, at best, is weak."( The need for toothpastes with lower than conventional fluoride concentrations for preschool-aged children.
Horowitz, HS, 1992
)
0.28
" The results of this study suggest that the new rinse may provide a greater cariostatic effect at the same fluoride dosage than does a NaF rinse."( In vivo fluoride concentrations measured for two hours after a NaF or a novel two-solution rinse.
Carey, CM; Chow, LC; Mao, Y; Takagi, S; Vogel, GL, 1992
)
0.28
", dose-response effects."( Sample size considerations in designing studies with intra-oral models.
Beiswanger, BB; Dunipace, AJ; Katz, BP; Stookey, GK, 1992
)
0.28
" Plaque fluoride measured after four weeks' daily use of the dentifrices exhibited similar dose-response behavior."( Oral fluoride measurements for estimation of the anti-caries efficacy of fluoride treatments.
Duckworth, RM; Gilbert, RJ; Morgan, SN, 1992
)
0.28
" A reduction in the dosage of fluoride supplements is recommended for children aged from three to six years (14."( Current regulations and recommendations concerning water fluoridation, fluoride supplements, and topical fluoride agents.
Newbrun, E, 1992
)
0.28
"This study evaluated the dose-response relationship between four increasing levels of fluoride from 1000 to 2500 ppm F as sodium monofluorophosphate (MFP) and three-year dental caries increments, as measured by DMFS, DMFT, and DFS-A on 4424 schoolchildren."( A fluoride dose-response evaluation in an anticaries clinical trial.
Cancro, L; Conti, AJ; D'Agostino, R; Marks, RG; Moorhead, JE, 1992
)
0.28
" The lipopeptides N-palmitoyl-(S)-[2,3-bis(palmitoyloxy)-(2RS)- propyl]-(R)-cysteinylalanylglycine, N-palmitoyl-(S)-[2,3-bis(palmitoyloxy)- (2RS)-propyl]-(R)-cysteinylseryl-lysyl-lysyl-lysine and (S)-(1,2- dicarboxyhexadecyl)ethyl-N-palmitoylcysteinylseryl-lysyl-lys yl-lysine stimulated both parameters, but the maximal effects on nitrite formation and the shape of the dose-response curves did not parallel the effects on [Ca2+]i."( Induction and activity of NO synthase in bone-marrow-derived macrophages are independent of Ca2+.
Bessler, W; Busse, R; Hauschildt, S; Kohler, J; Lückhoff, A; Mülsch, A, 1990
)
0.28
"Proper dosage of dietary fluoride supplements is important for children without access to optimally fluoridated water to balance dental caries prevention and risks of dental fluorosis."( Provider compliance with recommended dietary fluoride supplement protocol.
Levy, SM; Muchow, G, 1992
)
0.28
" Hence the evidence does not suggest that this proven caries-inhibiting F- drop/tablet regime dosage should be reduced."( Incisor enamel mottling prevalence in child cohorts which had or had not taken fluoride supplements from 0-12 years of age.
Gilmour, WH; McCall, DR; Stephen, KW, 1991
)
0.28
"In order to achieve the greatest clinical benefit from the use of fluoride, we must understand its mechanism of action, so that fluoride can be given at the right time, by the best route, at the optimum dosage and in the most suitable form."( Fluoride and caries prevention: 2. Clinical rationale.
Blinkhorn, AS, 1991
)
0.28
" The dose-response curve for sugar and caries is approximately sigmoid (S-shaped)."( Why free sugars consumption should be below 15 kg per person per year in industrialised countries: the dental evidence.
Sheiham, A, 1991
)
0.28
" The AAPD guide is reviewed, with dosage recommendations provided."( Water purification systems and recommendations for fluoride supplementation.
Glass, RG,
)
0.13
"In order to achieve the greatest clinical benefit from the use of fluoride, we must understand its mechanism of action, so that fluoride can be given at the right time, by the best route, at the optimum dosage and in the most suitable form."( Fluoride and caries prevention: 1. Scientific rationale.
Levine, RS, 1991
)
0.28
" Hence, retrospective analyses of data were undertaken, from a 3-yr double-blind caries clinical trial where a linear fluoride dose-response had been obtained."( Improved sensitivity in caries clinical trials by selection on the basis of baseline caries experience.
Burchell, CK; Huntington, E; Schäfer, F; Stephen, KW, 1991
)
0.28
" The reasons for this could be due to the study design (unchanged high dosage over four years in contrast to the commonly used individual adaptation of dosage and time); however, also the earlier positive results could be an error."( [Fluoride therapy of osteoporosis].
Ziegler, R, 1991
)
0.28
" Studies on rats, sheep, and pigs have provided details of dosage regimens which produce lesions which resemble those described in human fluorosis."( Nature and mechanisms of dental fluorosis in animals.
Richards, A, 1990
)
0.28
" In a prospective study, 35 patients with osteoporosis were treated for about 44 months with a mean dosage of 31."( Urinary fluoride excretion in responders and nonresponders after fluoride therapy in osteoporosis.
De Raadt, ME; Duursma, SA; Glerum, J; Karsdorp, NJ; Raymakers, JA; Van Dijk, A, 1990
)
0.28
", co-incubation with fluoride shifted the biphasic calcitonin dose-response curve to a range of lower calcitonin concentrations)."( Calcitonin (but not calcitonin gene-related peptide) increases mouse bone cell proliferation in a dose-dependent manner, and increases mouse bone formation, alone and in combination with fluoride.
Farley, JR; Hall, SL; Tarbaux, NM, 1989
)
0.28
" Fluoride supplements beginning with the newborn infant at two weeks of age should be prescribed in accordance with the dosage schedules of the American Academy of Pediatrics and the American Dental Association."( A fluoride analysis program to reduce tooth decay in rural children.
Nichols, WA, 1989
)
0.28
" Therefore, the dosage schedule used by 56% of the physicians is higher than the optimal, 27."( [Fluoroprophylaxis of dental caries. Current status in the provinces of Genoa and Savona].
Cohen, A; Gandolfo, A; Mallamaci, L; Zecca, L; Zecca, M, 1989
)
0.28
" The correct dosage must be determined based on patient age and fluoride content of the patient's main water source(s)."( Dietary fluoride supplements for children--the role of the physician.
Alderman, EJ; Alley, JW; Kuthy, RA; Levy, SM, 1989
)
0.28
" The correct dosage must be determined based on patient age and fluoride content of the patient's main water source(s)."( Dietary fluoride supplements for Nebraska's children--the role of the physician.
Kuthy, RA; Levy, SM; Young, KL, 1989
)
0.28
" The correct dosage must be determined, based on patient age and fluoride content of the patient's drinking water."( Dietary fluoride supplements for Tennessee's children: the role of the physician.
Collier, DR; Kuthy, RA; Levy, SM; Light, R, 1989
)
0.28
" The link between phospholipase C activation and these early events of the mitogenic response is demonstrated by the similarity of all dose-response curves for NaF and AlCl3 and by the common sensitivity of the four events to pertussis toxin."( Coupling between phosphoinositide breakdown and early mitogenic events in fibroblasts. Studies with fluoroaluminate, vanadate, and pertussis toxin.
Chambard, JC; Paris, S; Pouysségur, J, 1987
)
0.27
" However, a significant anti-caries dose-response was demonstrated over the SMFP range used."( A 3-year oral health dose-response study of sodium monofluorophosphate dentifrices with and without zinc citrate: anti-caries results.
Burchell, CK; Creanor, SL; Downie, CF; Huntington, E; Russell, JI; Stephen, KW, 1988
)
0.27
"There exists such a wide margin of safety for prenatal fluoride in regard to fluorosis that 2 mg/day can be used as a simplified prenatal fluoride dosage in all areas, regardless of whether they are fluoridated."( Optimum dosage for prenatal fluoride supplementation (PNF): Part IX.
Glenn, FB; Glenn, WD,
)
0.13
" The impact of the variation in drinking-water fluoride concentrations on supplementary fluoride dosage is discussed and recommendations made."( Variations in the fluoride levels of drinking water in South Africa. Implications for fluoride supplementation.
Dreyer, AG; Grobler, SR, 1988
)
0.27
" The methoxydifluoroacetate is largely excreted without further metabolism, although a small percentage of this metabolite is broken down to yield fluoride and oxalate, as determined by urine analysis of rats dosed with synthetic methoxydifluoroacetate."( In vivo nuclear magnetic resonance studies of hepatic methoxyflurane metabolism. II. A reevaluation of hepatic metabolic pathways.
London, RE; Perlman, ME; Selinsky, BS, 1988
)
0.27
" In this way, the appropriate dosage supplement can be determined and prescribed, and unnecessary risks of fluorosis can be avoided."( Expansion of the proper use of systemic fluoride supplements.
Levy, SM, 1986
)
0.27
" Group I was intubated with the Maximum Tolerable Dosage (MTD) of NaF (70 mg/kg)."( Effects of fluoride on the mouse sperm morphology test.
Dunipace, AJ; Li, Y; Stookey, GK, 1987
)
0.27
"Three weeks after dosing male Fischer 344 rats with streptozotocin to induce diabetes, enflurane was administered ip, and 1 h later, fluoride levels were measured in plasma and livers were removed."( Effect of streptozotocin-induced diabetes in the rat on the metabolism of fluorinated volatile anesthetics.
Conney, AH; Pantuck, CB; Pantuck, EJ, 1987
)
0.27
" This should begin at about 2 weeks of age; the dosage will depend on the concentration of fluoride in the local water supply."( American Academy of Pediatrics. Fluoride supplementation. Committee on Nutrition.
, 1986
)
0.27
" A clear dose-response pattern for the above toxic effects was evident with 10 ppm in the males being an effect level."( Inhalation toxicity of hexafluoroisobutylene.
Cramp, AL; Darr, RW; Gad, SC; Hoffman, GM; Peckham, JC; Rusch, GM, 1986
)
0.27
" This means that, for dose-response studies of dental fluorosis in this animal, it is not possible to achieve steady-state plasma concentrations as a basis for correlations to the degrees of pathological change observed in the teeth."( Pharmacokinetics of chronic fluoride ingestion in growing pigs.
Kragstrup, J; Nielsen-Kudsk, F; Richards, A, 1985
)
0.27
"The aim of this study was to assess the practical value of peroral xylitol at low to moderate dosage as a caries preventive measure."( Xylitol and caries: the collaborative WHO oral disease preventive programme in Hungary.
Bánóczy, J; Scheinin, A, 1985
)
0.27
" Barriers to appropriate use include the following factors: complexity of the dosage schedule; priority of preventive regimens in educational institutions; economic factors; and lack of public knowledge--clearly a barrier to their acceptance, appropriate use, and compliance."( Ways to improve/increase appropriate use of dietary fluorides.
Horowitz, AM,
)
0.38
"Cumulative dose-response curves were obtained for contractions induced by fluoride in bovine facial veins and arteries in the presence and absence of external Ca (Cao)."( Effects of vasoactive drugs on fluoride-induced contractions of vascular smooth muscle in calcium-free solution.
Nguyen-Duong, H, 1985
)
0.27
" After dosage of hens with protective compounds, protection lasts until about 70% of the enzyme site again becomes available for phosphorylation."( Organophosphorus and other inhibitors of brain 'neurotoxic esterase' and the development of delayed neurotoxicity in hens.
Johnson, MK, 1970
)
0.25
" The dose-response curve for cAMP formation stimulated by epinephrine was shifted 1 log unit to the right in uremic muscle and adenylyl cyclase stimulation by epinephrine was shifted 1 log unit."( Skeletal muscle amino acid metabolism in chronic uremia.
Garber, AJ; Maillet, C, 1980
)
0.26
" There was an absence of relation of the exit dosage to the diameter of the patient and a proportionality of the heart dose to the exit dose."( Cardiac catheterization: dosimetry on patients.
Aletti, P; Claudon, M; Hoeffel, JC; Lostette, Y; Noel, A; Pernot, C, 1980
)
0.26
" This paper explores the relationships between microdosimetric concepts and a description of TL properties, such as TL dose-response curves and TL LET dependence."( Microdosimetry and thermoluminescence.
Kliauga, P; Li, K; Rossi, HH, 1984
)
0.27
" Twelve per cent of the samples warranted adjustment from the full dosage fluoride supplement."( Fluoride analyses of patient water supplies requested by North Carolina health professionals.
Bawden, JW; Bowden, BS; Levy, SM; Rozier, RG, 1984
)
0.27
"There is a dose-response relationship between the prevalence of the questionable category of dental fluorosis as reported by various authors and the drinking water fluoride level."( Dose-response relationship between water fluoride levels and the category of questionable dental fluorosis.
Myers, HM, 1983
)
0.27
"Fifteen patients with multiple myeloma were treated with sodium fluoride (50 mg twice daily) plus calcium carbonate (1 g four times daily) or with the same fluoride-calcium dosage plus vitamin D (50,000 U twice weekly)."( Effect of sodium fluoride, calcium carbonate, and vitamin D on the skeleton in multiple myeloma.
Jowsey, J; Kyle, RA, 1980
)
0.26
" Based on the available data an advice was given for the dosage of NaF in patients with osteoporosis."( Fluoride in serum and bone during treatment of osteoporosis with sodium fluoride, calcium and vitamin D.
Backer Dirks, O; Duursma, SA; van der Sluys Veer, J; van Kesteren, RG; Visser, WJ, 1982
)
0.26
" In general, the dog studies attest to the usefulness of the intravenous human studies for certain U6+ dose-response data and interface well with new retention data on intravenous uranyl citrate in dogs by Stevens et al."( Inhalation and intravenous studies of UF6/UO2F2 in dogs.
Beiter, H; Gelein, R; Morrow, P; Picano, J; Scott, J; Yuile, C, 1982
)
0.26
" This dosage turned out to be too low for an effective inhibition of caries."( [Dental caries in the cantons of Glarus and Waadt, 4 years and 8 years after the introduction of fluordized salt].
Marthaler, TM; Steiner, M, 1981
)
0.26
" Sodium fluoride in moderate therapeutic dosage possibly can retard or completely inhibit the activity of bone-resorbing enzymes in the otospongiotic focus, thus retarding or arresting active expansion of a focus and resulting in stabilizing or arresting the progression of sensorineural hearing loss that is associated with otospongiosis."( Effect of fluoride on alpha-chymotrypsin.
Kacker, SK; Shambaugh, GE, 1980
)
0.26
" Although salt effects clearly varied with the different anions, the magnitude and dose-response of stimulation of homogenates by Cl- salts were also dependent on the accompanying alkali cation (Li+, Na+, K+, Rb+, Cs+)."( Anions and cations as stimulators of liver adenylate cyclase.
Gregerman, RI; Katz, MS; Kelly, TM; Piñeyro, MA, 1980
)
0.26
" Dose-response curves of neuropeptide-induced inositol phosphate generation were dramatically displaced to the right by either 10 microM AntD or 20 microM AntG."( Substance P-related antagonists inhibit vasopressin and bombesin but not 5'-3-O-(thio)triphosphate-stimulated inositol phosphate production in Swiss 3T3 cells.
Freemont, PS; Newman, RH; Rozengurt, E; Seckl, MJ, 1995
)
0.29
" Increasing concentrations of NaF (5, 10, 15 ppm F), Na-Silicofluoride, or NaMFP showed similar caries-inhibiting effects without remarkable influence of the fluoride dosage used."( The effects of non-fluoridated and fluoridated milk on experimental caries in rats.
Grosser, W; Kneist, S; Stösser, L, 1995
)
0.29
" The dosage of 26."( Monofluorophosphate increases lumbar bone density in osteopenic patients: a double-masked randomized study.
Bisset, JP; Loeb, G; Mennecier, I; Richard, P; Sebert, JL, 1995
)
0.29
" However, because higher minimum alveolar concentration of sevoflurane requires a large dosage of anesthetic than other volatile anesthetics, air pollution with sevoflurane in the operating room might be of great concern."( [Air pollution by sevoflurane in operating room and serum and urine inorganic fluoride of anesthetists].
Fukushima, K; Ochiai, R; Sato, M; Shibata, K; Shimada, M; Takahashi, J; Takeda, J, 1995
)
0.29
" However, the number of teeth affected by these enamel defects and their severity did not follow the dose-response relationship expected from the fluoride levels in the drinking water."( Dental enamel opacities in three groups with varying levels of fluoride in their drinking water.
Ellwood, RP; O'Mullane, DM, 1995
)
0.29
" Two studies are underway that attempt to describe the dose-response relationship between waterborne fluoride and osteoporosis."( Fluoride and bone health.
Phipps, K, 1995
)
0.29
" The model applied for the analysis may be thought to be the best means for the moment to relate dose-response dependencies with what is known or can be hypothesized about the mechanisms underlying activation of adenylate cyclase."( Analysis of effects of corticotropin, forskolin and fluoride on activity of adenylate cyclase of bovine adrenal cortex.
de Foresta, B; Juska, A, 1995
)
0.29
" Pathological change in fetal femur presented dose-response relationship with their bone fluoride content."( [Relationship between bone fluoride content, pathological change in bone of aborted fetuses and maternal fluoride level].
Dai, G; Shi, J; Zhang, Z, 1995
)
0.29
" administration can be improved for controlled release dosage forms if the drug release is confined to segments of gastrointestinal tract responsible for absorption."( Biopharmaceutic approach in designing a controlled release tablet of sodium monofluoro phosphate. Characterization of absorption sites and evaluation of modified dosage form.
Herbert, C; Ritschel, WA; Vattikonda, CS, 1994
)
0.29
" It is concluded that in sevoflurane anesthesia of long duration, F, sevoflurane dosage and duration of administration do not affect renal function."( [Effects of inorganic fluoride, inhalation time and dosage of sevoflurane on renal function during sevoflurane anesthesia of long duration].
Hirasaki, A; Nagase, M; Nishiyama, T; Tamai, H; Watanabe, S, 1994
)
0.29
" With respect to fluoride levels, clear dose-response relationships have been demonstrated."( Fluoride toothpastes, rinses, and tablets.
Stephen, KW, 1994
)
0.29
" Dosage of ascorbic acid was increased to 750 mg per day, keeping the dosages of other drugs unchanged to Group B children."( Reversal of clinical and dental fluorosis.
Gupta, RC; Gupta, SK; Seth, AK, 1994
)
0.29
" The release mechanism from the developed dosage form followed the square root of time relationship."( A biopharmaceutic approach in designing a controlled release tablet of sodium monofluorophosphate: 1. In vitro and in vivo studies in beagle dogs.
Ritschel, WA; Vattikonda, CS, 1994
)
0.29
" Other drugs, such as fluoride, are employed for their known effects on bone, but in excess dosage can be harmful by producing mineralisation defects."( Drug-induced disorders of bone metabolism. Incidence, management and avoidance.
Jones, G; Sambrook, PN, 1994
)
0.29
" Bronchial responsiveness was expressed as the dose-response slope of the line through the origin and last data point."( Relation between exposure to fluoride and bronchial responsiveness in aluminium potroom workers with work-related asthma-like symptoms.
Boe, J; Ekstrand, J; Kongerud, J; Søyseth, V, 1994
)
0.29
" dosing with 200 mg/kg HFE to rat, trifluoroacetic acid and trifluoroacetaldehyde hydrate were identified as urinary metabolites."( Role of P4502E1 in the metabolism of 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoroethoxy)-ethane.
Dekant, W; Herbst, J; Kerssebaum, R; Köster, U, 1994
)
0.29
" Four studies examined the effects of different concentrations of fluoride, established dose-response profiles with NaF and Na2PO3F, and tested commercial dentifrices."( An in vitro model for studying the efficacy of fluoride dentifrices in preventing root caries.
Beiswanger, AJ; Dunipace, AJ; Stookey, GK; Zhang, W, 1994
)
0.29
" A re-evaluation of the need for and dosage schedules of fluoride supplements is warranted."( Fluoride supplements: current effectiveness, side effects, and recommendations.
Ismail, AI, 1994
)
0.29
" Dose-response studies were performed with aluminum fluoride and various inhibitors of cytosolic calcium oscillations."( Mechanisms underlying phasic contractions of pregnant rat myometrium stimulated with aluminum fluoride.
Phillippe, M, 1994
)
0.29
" Determining the effective dosage is essential."( [Indications and limitations of non-hormonal treatments of osteoporosis].
Avouac, B,
)
0.13
" As the phosphate concentration was increased, the biphasic fluoride dose-response curve was shifted to a lower range of fluoride concentrations."( Fluoride increases net 45Ca uptake by SaOS-2 cells: The effect is phosphate dependent.
Farley, JR; Hall, SL; Herring, S; Tanner, MA, 1993
)
0.29
" For each dose the average residual NTE activity in the three tissues 24 h after dosing and the clinical ataxia severity on peak days 15-17 (score out of 4) was: 5 mg/kg: 13, 14, 27% (2,2,2,1); 10 mg/kg: 10, 14, 12%, (4,3,2); 15 mg/kg: 10,11,17%, (3,3,4); 20 mg/kg: 6, 10, 8% (3,3,3,2)."( The R-(+)isomer of O-n-hexyl S-methyl phosphorothioamidate causes delayed neuropathy in hens after generation of a form of inhibited neuropathy target esterase (NTE) which can be reactivated ex vivo.
Johnson, MK; Safi, JM, 1993
)
0.29
" An appropriate new dosage schedule for fluoride supplements should be aimed only at identifiable high caries-risk individuals, not at groups defined by age or residence and should result in much lower fluoride intake in the age span birth-eight years than many current recommendations."( Fluoride supplements in caries prevention: a literature review and proposal for a new dosage schedule.
Riordan, PJ, 1993
)
0.29
" Australian randomized study of 50 patients is described where NaF dosage is varied proportional to the osteoblast response, and duration is dependent on densitometric and radiographic response."( Fluoride treatment of osteoporosis: cyclical non-blinded or continuous blinded studies?
Bhagat, CI; Gutteridge, DH; Jones, CE; Kent, GN; Nicholson, GC; Prince, RL; Retallack, RW; Stewart, GO; Stuckey, BG, 1993
)
0.29
" Internal validation of in situ models using fluoride dose-response controls is considered to be necessary for studies evaluating the efficacy of new fluoride dentifrice formulations."( In situ caries models.
Zero, DT, 1995
)
0.29
" These compounds are the most widely used sources of fluoride in dentifrices, and dose-response clinical standards are available for both."( The application of in situ models for evaluation of new fluoride-containing systems.
Faller, RV, 1995
)
0.29
" A limited number of in situ model studies has been conducted, and some fluoride dose-response information has been obtained."( Model investigations of caries inhibition by fluoride-releasing dental materials.
Erickson, RL; Glasspoole, EA, 1995
)
0.29
" We conducted a study using lithium fluoride chips to measure the radiation dosage to the surgeon and the operating theatre personnel."( Radiation dosage from use of the image intensifier in orthopaedic surgery.
Goh, PS; Khong, KS; Lo, NN, 1996
)
0.29
" If supplements are recommended for children, a more cautious dosage schedule should be used."( The place of fluoride supplements in caries prevention today.
Riordan, PJ, 1996
)
0.29
" Plasma fluoride absorption curves were measured from 0 to 6 h after ingestion of MFP at baseline and during long-term dosing in 21 patients with vertebral osteoporosis (T scores < or = 2)."( Fluoride pharmacokinetics and changes in lumbar spine and hip bone mineral density.
Chan, JK; Hosking, DJ; Patel, S, 1996
)
0.29
" Thus, periods of especially elevated plasma-fluoride levels in chronically fluoride-stressed deer can cause a disruption in the function of secretory ameloblasts similar to that following acute fluoride dosing in rodents."( Disturbances of the secretory stage of amelogenesis in fluorosed deer teeth: a scanning electron-microscopic study.
Kierdorf, H; Kierdorf, U, 1997
)
0.3
" (2) After 90 days of oral administration, no toxicity reaction was found in the lowest dosage group (25 mg/kg), but gastric mucosa was found to have slight injury in the highest dosage group (100 mg/kg), which was conformable to the result of the cumulative toxicity test."( [A toxicological study on ammonium oxofluoromolybdate [(NH4)2MoO2F4]].
Li, Y; Liu, X; Lu, L, 1996
)
0.29
" Cumulative dose-response studies were performed using oxytocin and aluminum fluoride with and without 2-nitro-4-carboxyphenyl-N, N-diphenylcarbamate (NCDC), an inhibitor of PI-PLC."( The relationship between oxytocin, phosphoinositide-specific phospholipase C, and phasic myometrial contractions.
Phillippe, M,
)
0.13
" PCMBS inhibited F uptake by up to 83% in a dose-response manner."( pH-dependent fluoride transport in intestinal brush border membrane vesicles.
Ganapathy, V; He, H; Isales, CM; Whitford, GM, 1998
)
0.3
" A dose-response relationship has been recently described for fluoride exposure and bronchial hyper-responsiveness, but whether fluorides are the causative agent, co-agent or simply markers for the causative agent(s) for potroom asthma, remains to be determined."( Exposures in the alumina and primary aluminium industry: an historical review.
Abramson, M; Benke, G; Sim, M, 1998
)
0.51
"The dose-response of LiF:Mg,Ti (TLD-100) exposed to 15 and 35 kVp (8."( Thermoluminescent response and relative efficiency of TLD-100 exposed to low-energy x-rays.
Brandan, ME; Buenfil, AE; Flores, A; Gamboa-deBuen, I; Rodríguez-Villafuerte, M; Ruiz, CG, 1998
)
0.3
" To optimise anticaries benefits and minimise the risk of fluorosis greater control of the fluoride dosing of the drinking water is required."( Urinary fluoride levels and prevalence of dental fluorosis in three Brazilian cities with different fluoride concentrations in the drinking water.
Bastos, JR; Bastos, R; Heintze, SD, 1998
)
0.3
"Despite limitations of available measurements in the early production period, we have concluded that the exposure estimates from this study provide a reasonable tool for the estimation of dose-response relations in subsequent epidemiological analyses."( Exposure to PAH and fluoride in aluminum reduction plants in Norway: historical estimation of exposure using process parameters and industrial hygiene measurements.
Haldorsen, T; Romundstad, P; Rønneberg, A, 1999
)
0.3
" The conclusions are limited to the information received but there is a clear trend to lower dosage recommendations and no fluoride supplementation to very young children."( International fluoride supplement recommendations.
Banting, DW, 1999
)
0.3
" Recent changes in fluoride dosage schedules and deferment of the age of commencing the use of supplements, implemented in many countries, have followed from these concerns."( Fluoride supplements for young children: an analysis of the literature focusing on benefits and risks.
Riordan, PJ, 1999
)
0.3
" It is apparent that the current ADA dosage schedule is too high and requires modification; however, the availability of this known-to-be-effective regimen should not be eliminated or restricted."( The role of dietary fluoride supplements in caries prevention.
Horowitz, HS, 1999
)
0.3
" This finding prompted another round of dosage schedule recommendations in the early 1990s."( Overview of the history and current status of fluoride supplementation schedules.
Adair, SM, 1999
)
0.3
" By altering the present recommended dosage we may deprive children from receiving a proven effective dose."( The case for retaining the current supplementation schedule.
Moss, SJ, 1999
)
0.3
" Fluorosis could be prevented, in part, by stopping the improper prescription of fluoride supplements in optimally fluoridated areas and by lowering the dosage currently recommended by the Council on Dental Therapeutics supplemental fluoride schedule."( The case for reducing the current Council on Dental Therapeutics fluoride supplementation schedule.
Newbrun, E, 1999
)
0.3
" In the case of supplements, for example, there are differences in the recommended dosage schedules."( Government policies on fluoride utilization in the Nordic countries.
Wang, NJ, 1999
)
0.3
" A dose-response relationship was recognized between these F doses and renal tissue injury."( Toxicokinetics of intravenous fluoride in rats with renal damage caused by high-dose fluoride exposure.
Dote, T; Hashiguchi, N; Kono, K; Miyata, K; Nishiura, H; Senda, J; Shimahara, M; Tagawa, T; Tanaka, Y; Usuda, K, 2000
)
0.31
" Animals dosed with 1,3-difluoroacetone did not display the 2-3 hour lag phase in either (-)-erythro-fluorocitrate synthesis or in citrate and fluoride accumulation characteristic of animals dosed with 1,3-difluoro-2-propanol."( The mode of toxic action of the pesticide gliftor: the metabolism of 1,3-difluoroacetone to (-)-erythro-fluorocitrate.
Feldwick, MG; Mead, RJ; Menon, KI; Noakes, PS, 2001
)
0.31
" Dose-response relations were investigated by internal comparisons using Poisson regression and by stratified analyses for standardized mortality ratio."( Nonmalignant mortality among workers in six Norwegian aluminum plants.
Andersen, A; Haldorsen, T; Romundstad, P, 2000
)
0.31
" Chronic, low-level dosage of silicofluoride (SiF) has never been adequately tested for health effects in humans."( Association of silicofluoride treated water with elevated blood lead.
Coplan, MJ; Dykes, JE; Hone, BT; Masters, RD, 2000
)
0.31
" There is clear evidence for a dose-response relationship between F(-) concentration and caries-preventive effect (25-30% caries reduction achieved with a 1,000 ppm F(-) dentifrice)."( Is the fluoride concentration limit of 1,500 ppm in cosmetics (EU guideline) still up-to-date?
Bloch-Zupan, A, 2001
)
0.31
" Eyes and eyelids were macroscopically scored for signs of irritation beginning 3 hours after dosing and periodically until recovery or 35 days."( Pathology of ocular irritation with acetone, cyclohexanol, parafluoroaniline, and formaldehyde in the rabbit low-volume eye test.
Carr, GJ; Cavanagh, HD; Jester, JV; Li, LI; Maurer, JK; Molai, A; Parker, RD; Petroll, WM,
)
0.13
" The current dose-response relationship between caries and extrinsic sugars suggests that the sugars levels above 60 g/person/day for teenagers and adults increases the rate of caries."( Dietary effects on dental diseases.
Sheiham, A, 2001
)
0.31
" The results of these experiments indicate that sodium fluoride administered at higher concentrations than the usual caries preventive dosage made the generation time of cariogenic oral bacteria and fungi longer, slowing down their multiplication."( Effect of fluoride on cariogenic oral microorganisms (an in vitro study).
Bánóczy, J; Gintner, Z; Herczegh, A; Kamotsay, K; Nász, I; Rozgonyi, F, 2002
)
0.31
" Oral administration of strontium salt at low dosage level stimulate bone formation and decrease bone resorption."( [New osteoformative agents for osteoporosis].
Chaouat, D, 2002
)
0.31
" Using the dose-response curves measured for MTS-N detectors after 137Cs gamma ray irradiation and local doses calculated using Monte Carlo generated electron tracks, it was possible to predict the relative TL effectiveness for different X ray energies."( Microdosimetric interpretation of the photon energy response of LiF:Mg,Ti detectors.
Bilski, P; Kim, JL; Olko, P, 2002
)
0.31
"5, with 275, 550 and 1,100 ppm F (NaF/silica) were developed in order to assess dose-response effects."( [Dose-response effect of a dentifrice formulation with low fluoride concentration - an in vitro study].
Cury, JA; Negri, HM,
)
0.13
"0 per cm(2), respectively for the rats with varied doses of fluoride, in a dose-response pattern but without statistical significance."( [Effects of fluoride on osteoclastic activity of rats in vitro].
Bu, LS; Hua, K; Li, GS, 2003
)
0.32
"This research suggests that the risk for proximal caries in the posterior primary dentition is raised if contact points are dosed compared to those that are open."( Interproximal contact points and proximal caries in posterior primary teeth.
Allison, PJ; Schwartz, S,
)
0.13
"Fluoride concentration in rat hippocampus was significantly correlated with the dosage of fluoride, and there were significant differences among high dosage group [(13."( [Studies on fluoride concentration and cholinesterase activity in rat hippocampus].
Guo, ZY; Hu, CL; Wang, QN; Zhai, JX; Zhu, QX, 2003
)
0.32
" In order to validate this modified model, a dose-response evaluation with fluoride was made."( A modified pH-cycling model to evaluate fluoride effect on enamel demineralization.
Argenta, RM; Cury, JA; Tabchoury, CP,
)
0.13
", the dose-response relationship."( Relationship between dentifrice fluoride concentration and clinical caries reduction.
Fisher, SW; Gambogi, RJ; Joziak, M; Mellberg, JR; Tavss, EA, 2003
)
0.32
" Reviews of the dental literature identified fair evidence supporting the effectiveness of both fluoride supplements and varnish, although information describing effectiveness and adverse outcomes of supplementation with the most recent dosage schedule is not available."( Physicians' roles in preventing dental caries in preschool children: a summary of the evidence for the U.S. Preventive Services Task Force.
Bader, JD; Frame, PS; Lohr, KN; Rozier, RG, 2004
)
0.32
" In addition, the short-term stability was measured to verify the validity of the fitted dose-response curve immediately after beam startup."( The stability of liquid-filled matrix ionization chamber electronic portal imaging devices for dosimetry purposes.
Louwe, RJ; Mijnheer, BJ; Tielenburg, R; van Herk, MB; van Ingen, KM, 2004
)
0.32
" It is imperative that each country calculates its own optimal level of fluoride in drinking water based on the dose-response relationship of fluoride in drinking water with the levels of caries and fluorosis."( Determining the optimal concentration of fluoride in drinking water in Pakistan.
Khan, AA; O'Mullane, D; Whelton, H, 2004
)
0.32
"There was significant dose-response relationship between the drinking water fluoride and the prevalence of dental fluorosis or the prevalence of defect dental fluorosis."( [Study on the application of benchmark dose and biological monitoring indexes of fluorides in drinking water].
Chen, BH; Chen, LS; Li, JF; Liang, YX; Wang, CS; Xiang, QY; Zhen, SQ; Zhou, MS, 2004
)
0.55
"To obtain baseline knowledge of levels of dental caries in 12-year-old children residing in areas with varying levels of fluoride in drinking water in Pakistan; and to observe a dose-response relationship between the prevalence of dental caries at different concentrations of fluoride in drinking water."( Is the fluoride level in drinking water a gold standard for the control of dental caries?
Khan, AA; O'Mullane, D; Whelton, H, 2004
)
0.32
" The influence of pH, temperature, agitation rate and gas concrete dosage on F(-) removal was investigated by conducting a series of batch adsorption experiments."( Adsorption of fluoride on gas concrete materials.
Oguz, E, 2005
)
0.33
" On the other hand, correct dosage is important to prevent the risk of dental fluorosis."( Recommendations for the use of fluoride in caries prevention.
Barthel, CR; Jahn, KR; Zimmer, S, 2003
)
0.32
"Clinicians prescribing home-applied high-concentration fluorides need to be cognizant of the symptoms of fluoride toxicity, carefully monitor the patient's compliance with the treatment regimen, and adjust the dosage or mode of application to control the total ingested dose of fluoride."( Controlling the fluoride dosage in a patient with compromised salivary function.
Carey, CM; Eichmiller, FC; Eidelman, N, 2005
)
0.58
" The dosage of SDS required for ECF was much less than those for dispersed air flotation (DiAF) or dissolved air flotation (DAF) processes because the CaF(2) particles can be collected by hydro-fluoro-aluminum flocs in ECF."( Removal of fluoride from semiconductor wastewater by electrocoagulation-flotation.
Hu, CY; Kuan, WH; Lee, YD; Lo, SL, 2005
)
0.33
" Broken and absent teeth were observed in rats dosed with 250 mg kg(-1) day(-1), and microscopic tooth lesions (ameloblast degeneration/disorganization) occurred at 100 and 250 mg kg(-1) day(-1) and persisted with decreased severity throughout recovery."( Subchronic toxicity of a fluoroalkylethanol mixture in rats.
Buck, RC; Everds, NE; Ladics, GS; Makovec, GT; Stadler, JC, 2005
)
0.33
" Since correct dosing is important not only for effective caries prophylaxis but also in order to guarantee food safety, the production of fluoridated salt must be accurately monitored."( Quality control in the production of fluoridated food grade salt.
Trachsel, S, 2005
)
0.33
"The aim of this study was to establish methodologies for verification of the fluoride solution dose-response relationship using bovine enamel and pH-cycling models."( Fluoride dose response in pH-cycling models using bovine enamel.
Cunha, RF; Cury, JA; Delbem, AC; Rodrigues, E; Sassaki, KT; Vieira, AE,
)
0.13
"Means and standard deviations of absorbance values for each group and percentage inhibitory dosage (%ID) for each test material were calculated."( Cytotoxicity of a new toothpaste based on an ion exchange resin mixture.
Li, Y; Muñoz, CA; Torrado, A; Valiente, M; Zhang, W, 2005
)
0.33
" The influence of varying the conditions for removal of fluoride, such as the pH of aqueous solution, the initial fluoride concentration, the dosage of adsorbent, and temperature on removal of fluoride have been investigated."( Factors influencing the removal of fluoride from aqueous solution by calcined Mg-Al-CO3 layered double hydroxides.
Duan, X; Evans, DG; He, J; Lv, L; Wei, M, 2006
)
0.33
" This study was designed to assess whether asthma occurs excessively among potroom workers and if so, delineate dose-response relationships for possible causal risk factors."( Incidence of asthma among aluminum workers.
Cantley, LF; Cullen, MR; Fiellin, MG; Rabinowitz, PM; Sircar, KD; Slade, MD; Taiwo, OA; Vegso, SJ, 2006
)
0.33
" This paper describes the studies and results of dose-response and linearity at much higher doses."( The dose-response of Harshaw TLD-700H.
Luo, LZ; Ramlo, MJ; Rotunda, JE; Velbeck, KJ, 2006
)
0.33
" In this study, regeneration temperature, regeneration duration, contact time, regenerated bone char dosage and particle size were investigated."( Optimization of regenerated bone char for fluoride removal in drinking water: a case study in Tanzania.
Kaseva, ME, 2006
)
0.33
"Optical absorption (OA) dose-response of LiF:Mg,Ti (TLD-100) is studied as a function of electron energy (ionisation density) and irradiation dose."( Search for ionisation density effects in the radiation absorption stage in LiF:Mg,Ti.
Avila, O; Brandan, ME; Buenfil, AE; Gamboa-Debuen, I; Horowitz, YS; Ipe, N; Nail, I; Olko, P; Oster, L; Rodríguez-Villafuerte, M; Ruiz-Trejo, C; Tovar, VM, 2006
)
0.33
" The acidified toothpastes showed a dose-response relationship with all variables."( In vitro evaluation of acidified toothpastes with low fluoride content.
Brighenti, FL; Buzalaf, MA; Delbem, AC; Oliveira, FA; Ribeiro, DB; Sassaki, KT, 2006
)
0.33
"87 mg/L in a dose-response manner."( Dose-effect relationship between drinking water fluoride levels and damage to liver and kidney functions in children.
Chen, X; He, P; He, W; Liu, J; Wang, A; Xia, T; Xiong, X; Yang, K, 2007
)
0.34
" Optimal parameters needed to obtain highly accurate dosage from LiF powder was investigated, including the setup of the Harshaw 4000 reader."( Optimum parameters of TLD100 powder used for radiotherapy beams calibration check.
Arib, M; Dari, F; Messadi, A; Yaich, A, 2006
)
0.33
" Influence of varying the conditions for removal of fluoride, such as the fluoride concentration, the pH of aqueous solution, the dosage of adsorbent, the temperature on removal of fluoride, and the adsorption-desorption studies were investigated."( Removal of fluoride from aqueous phase by biosorption onto algal biosorbent Spirogyra sp.-IO2: sorption mechanism elucidation.
Rajkumar, B; Ramanaiah, SV; Sarma, PN; Venkata Mohan, S, 2007
)
0.34
" In this study, we present the first report of a dose-response relationship after exposure to potassium aluminium tetrafluoride (KAlF(4)) and the influence of smoking and atopy."( Respiratory and ocular symptoms in workers exposed to potassium aluminium-tetrafluoride soldering flux.
Karlsson, JE; Larsson, B; Nielsen, J, 2007
)
0.34
" The beginning of an attempt to explain this unusual effect is offered in the framework of the track structure theory and kinetic modelling of the beta ray dose-response of the first and second readouts."( Ionisation density effects following optical excitation in LiF:Mg, Ti (TLD-100).
Horowitz, Y; Oster, L; Weiss, D, 2007
)
0.34
"Numerous methods have been described employing various materials for fluoride removal due to the risk of high fluoride dosing for human health."( Screening of commercial sorbents for removal of fluoride in synthetic and groundwater.
Elizalde-González, MP; Hernández-Montoya, V; Trejo-Vázquez, R, 2007
)
0.34
" Accordingly, adsorption characteristics of fluoride onto schwertmannite adsorbent were studied in a batch system with respect to changes in initial concentration of fluoride, equilibrium pH of sample solution, adsorbent dosage and co-existing ions."( Removal of fluoride ions from aqueous solution at low pH using schwertmannite.
Asai, S; Eskandarpour, A; Ochieng, A; Onyango, MS, 2008
)
0.35
" Dose-response curves for VX exposure were generated after applying the fluoride ion reactivation assay to the RBC fraction of serially collected whole blood samples that were taken after whole-body exposures that varied in both duration and concentration."( Gas chromatography-tandem mass spectrometry analysis of red blood cells from Göttingen minipig following whole-body vapor exposure to VX.
Burnett, DC; Byers, CE; Gaviola, BI; Hulet, SW; Jakubowski, EM; McGuire, JM; Thomson, SA,
)
0.13
" This sensitive method was successfully applied to the analysis of soman in rat plasma immediately post-exposure, resulting in the construction of dose-response plots."( Validation and application of a GC-MS method for determining soman concentration in rat plasma following low-level vapor exposure.
Dabisch, PA; Evans, RA; Jakubowski, EM; McGuire, JM; Renner, JA; Thomson, SA; Totura, AL,
)
0.13
" Analysis of the supplementation behavior indicated that the majority (58%) of the children that should have received fluoride supplements were receiving the incorrect dosage or not being supplemented."( Relationship of naturally occurring fluoride in Carroll County, Maryland to aquifers, well depths, and fluoride supplementation prescribing behaviors.
Osso, D; Roberts, M; Romberg, E; Syme, S; Tinanoff, N, 2008
)
0.35
" Diagnosis was based on the characteristic radiologic aspect, and confirmed by the dosage of serum and urine levels of fluorine."( [Cervical myelopathy revealing bone fluorosis].
Béjia, I; Ben Hammouda, M; Ben Othman, M; Bergaoui, N; Douki, W; Mahmoud, I; Najjar, MF; Touzi, M; Younes, M; Zrour-Hassen, S, 2008
)
0.35
" Bovine enamel blocks were subjected to the models and treated with F solutions containing from 70 to 280 microg F/mL in order to validate them in terms of dose-response effect."( pH-cycling models to evaluate the effect of low fluoride dentifrice on enamel de- and remineralization.
Cury, JA; Hara, AT; Paes Leme, AF; Queiroz, CS, 2008
)
0.35
" The debate for advocating xylitol use in caries prevention is advancing; however, chewing gum use by young schoolchildren in the United States is hindered by choking hazard concerns and lack of specific xylitol dosing recommendations."( The potential of dental-protective chewing gum in oral health interventions.
Ly, KA; Milgrom, P; Rothen, M, 2008
)
0.35
" There was a dose-response effect with respect to both impregnation time and the concentration of the F solution."( Uptake and release of fluoride from fluoride-impregnated chewing sticks (miswaks) in vitro and in vivo.
Baeshen, HA; Birkhed, D; Kjellberg, H; Lingström, P, 2008
)
0.35
" The influence of pH, dosage of polyanilines, initial fluoride concentration and temperature on the amount of fluoride removed by the polyanilines were studied."( Defluoridation of water via doping of polyanilines.
Elango, KP; Karthikeyan, M; Satheeshkumar, KK, 2009
)
0.35
" Based on the current state of the widespread presence of fluorides in oral hygienic means and employment of topical fluoride-containing preventives the recommendation of systemic administration of fluoride supplements addresses children at increased caries risk only, over three years old and invariably in individual dosage schedule related to fluoride intake background."( Is systemic fluoride supplementation for dental caries prevention in children still justifiable?
Broukal, Z; Lencová, E; Oganessian, E, 2007
)
0.58
"Eleven of the reports evaluated dosage schedules similar to that recommended by the American Dental Association."( Fluoride supplements, dental caries and fluorosis: a systematic review.
Hasson, H; Ismail, AI, 2008
)
0.35
"The current study proposes a pH-cycling model to verify the dose-response relationship of fluoride-releasing materials in their ability to reduce in vitro demineralization."( PH-cycling model to verify the efficacy of fluoride-releasing materials in enamel demineralization.
de Oliveira, MS; Delbem, AC; Pedrini, D; Rodrigues, E,
)
0.13
" The results showed that with increasing applied potential and electrolysis time, the Al(3+) dosage increases, and thereby favouring the fluoride ions removal."( Study on the treatment of photovoltaic wastewater using electrocoagulation: fluoride removal with aluminium electrodes--characteristics of products.
Aoudj, S; Drouiche, N; Ghaffour, N; Hecini, M; Lounici, H; Mameri, N, 2009
)
0.35
" Potential benefits include recovery of phosphate for reuse, lower required dosage of calcium for fluoride removal, and less amount of CaF(2) sludge."( Selective separation of phosphate and fluoride from semiconductor wastewater.
Liu, JC; Warmadewanthi, B, 2009
)
0.35
"6 mg/kg body weight) for the dose-response relationship study."( Time-dependent changes of blood parameters and fluoride kinetics in rats after acute exposure to subtoxic hydrofluoric acid.
Dote, T; Imanishi, M; Kono, K; Tanida, E; Tsuji, H; Yamadori, E, 2009
)
0.35
"Test products were: new dentifrice formulation in a fluoride dose-response (0; 675; 1426 ppm F as sodium fluoride [NaF-0; NaF-675; NaF]); Elmex Kariesschutz (1400 ppm F as amine fluoride [AmF]); and Oral-B Pro-Expert (1450 ppm F-1100 ppm F as stannous fluoride and 350 ppm F as sodium fluoride [SnNaF])."( Laboratory assessment of the anticaries potential of a new dentifrice.
Chauhan, VK; Lippert, F; Lynch, RJ; Newby, EE; Schemehorn, BR, 2009
)
0.35
"05) as compared to a benchmark commercial desensitizing toothpaste containing 2% potassium ion, dosed as potassium nitrate, after two weeks, four weeks, and eight weeks of product use."( Comparing the efficacy in reducing dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark commercial desensitizing toothpaste containing 2% potassium ion: an eight-week clinical study
Bartolino, M; Costacurta, M; Cummins, D; Delgado, E; DeVizio, W; Dibart, S; Docimo, R; Mateo, LR; Maturo, P; Montesani, L; Zhang, YP, 2009
)
0.35
"Compared with yogurt consumption at the lowest tertile (<1 time/week), its intake at the highest level (> or =4 times/week) was significantly associated with a lower prevalence of dental caries, showing a clear dose-response relationship (adjusted prevalence ratio=0."( Intake of dairy products and the prevalence of dental caries in young children.
Miyake, Y; Sasaki, S; Tanaka, K, 2010
)
0.36
"36-ppm-F community, our results indicate that the use of a low-fluoride dentifrice promotes a proportionally higher increase in plaque [F] when compared with that achieved with a conventional dentifrice, based on dose-response considerations."( Effects of regular and low-fluoride dentifrices on plaque fluoride.
Alves, KM; Buzalaf, MA; Pessan, JP; Ramires, I; Sampaio, FC; Taga, MF; Whitford, GM, 2010
)
0.36
" A dose-response regarding F(-) intake and excretion was detected."( Proteomic analysis of urine in rats chronically exposed to fluoride.
Buzalaf, MA; da Silva, TL; de Oliveira, RC; Domont, GB; dos Santos, LD; Kobayashi, CA; Leite, Ade L; Nogueira, FC; Palma, MS; Santos, KS,
)
0.13
" This critical review of literature showed that the currently available pH-cycling models are appropriate to detect dose-response and pH-response of fluoride dentifrices, and to evaluate the impact of new active principles on the effect of fluoridated dentifrices, as well as their association with other anti-caries treatments."( pH-cycling models for in vitro evaluation of the efficacy of fluoridated dentifrices for caries control: strengths and limitations.
Buzalaf, MA; Delbem, AC; Hannas, AR; Honório, HM; Magalhães, AC; Rios, D,
)
0.13
" Both the proton and alpha particle relative TL efficiencies of the high-temperature TL (HTTL) peaks 7 and 8 are underestimated by an order of magnitude suggesting that the HTTL efficiencies are affected by other factors in addition to radial electron dose; (3) the dose-response supralinearity of peaks 7 and 8 change rapidly with photon energy: this behaviour is explained in the framework of the unified interaction model as due to a very strong dependence on photon energy of the relative intensity of localised recombination and (4) the increased width and decrease in T(max) of composite peak 5 as a function of ionisation density is due to the greater relative intensity of peak 5a (a low-temperature component of peak 5 arising from two-energy transfer events, which leads to localised recombination)."( Mysteries of LiF TLD response following high ionisation density irradiation: nanodosimetry and track structure theory, dose response and glow curve shapes.
Datz, H; Fuks, E; Horowitz, Y; Livingstone, J; Oster, L; Rosenfeld, A, 2011
)
0.37
" Providers should carefully monitor the patient's adherence to the fluoride dosing schedule to maximize the potential therapeutic benefit."( Evidence-based clinical recommendations on the prescription of dietary fluoride supplements for caries prevention: a report of the American Dental Association Council on Scientific Affairs.
Adair, S; Aravamudhan, K; Frantsve-Hawley, J; Graham, F; Iafolla, T; Kingman, A; Kohn, W; Krol, D; Levy, S; Meyer, DM; Pollick, H; Rozier, RG; Strock, S; Whitford, G, 2010
)
0.36
"4 g/kg×d) and low dosage (0."( [The influence of fluoride on expression of OPGL and M-CSF genes and their proteins in rats with experimental fluorosis and the therapeutic effect of Danlan Xianpeng Liaofu caspule].
Sun, XJ; Xiao, YM; Yu, YN, 2010
)
0.36
" (4) Compared with that of the fluoride group animals, the expression intensity of OPGL mRNA decreased in animals of the control group, the high, mid- and low- dosage medication groups and the borax group."( [The influence of fluoride on expression of OPGL and M-CSF genes and their proteins in rats with experimental fluorosis and the therapeutic effect of Danlan Xianpeng Liaofu caspule].
Sun, XJ; Xiao, YM; Yu, YN, 2010
)
0.36
"This study proposes a pH-cycling model for verifying the dose-response relationship in fluoride-releasing materials on remineralization in vitro."( Enamel remineralization by fluoride-releasing materials: proposal of a pH-cycling model.
Cavassan, L; Delbem, AC; Pedrini, D; Rodrigues, E, 2010
)
0.36
" Meanwhile, there was a dose-response relationship between urine fluoride and dental fluorosis (P<0."( The relationships between low levels of urine fluoride on children's intelligence, dental fluorosis in endemic fluorosis areas in Hulunbuir, Inner Mongolia, China.
Ding, Y; Han, H; Ji, X; Liu, X; Sun, D; Sun, H; Wang, W, 2011
)
0.37
" Such input would greatly improve understanding of the human dose-response relationship."( Fluoride in the environment and its metabolism in humans.
Damodaran, T; Jha, SK; Mishra, VK; Sharma, DK, 2011
)
0.37
" UFC increased as ingested fluoride tablet dosage increased, and it returned to the baseline level on the following day and persisted throughout the study period."( Urinary fluoride concentration in children with disabilities following long-term fluoride tablet ingestion.
Chen, HS; Chen, JR; Hsiao, SY; Huang, ST; Hung, HC; Liu, HY,
)
0.13
" Both TLDs were calibrated using 18-MV X-ray beam to investigate their dose-response sensitivity and linearity."( The use of enriched 6Li and 7Li Lif:Mg,Cu,P glass-rod thermoluminescent dosemeters for linear accelerator out-of-field radiation dose measurements.
Bezak, E; Liu, G; Marcu, L; Takam, R, 2012
)
0.38
" Changes in mineral distribution effected by F were most pronounced in MeC lesions, with remineralization/mineral redeposition in the original lesion body at the expense of sound enamel beyond the original lesion in a dose-response manner."( Effect of fluoride, lesion baseline severity and mineral distribution on lesion progression.
Butler, A; Hara, AT; Lippert, F; Lynch, RJ, 2012
)
0.38
"The present mechanistic in vitro study aimed to investigate dose-response effects of zinc and fluoride on caries lesion remineralization and subsequent protection from demineralization."( Dose-response effects of zinc and fluoride on caries lesion remineralization.
Lippert, F, 2012
)
0.38
"05) and dose-response relationship between treatments."( Anticaries effect of dentifrices with calcium citrate and sodium trimetaphosphate.
Bergamaschi, M; Delbem, AC; Missel, EM; Rodrigues, E; Sassaki, KT; Vieira, AE, 2012
)
0.38
" The effects of HDTMA loading, pH (3-10), reaction time (5-60 min) and the adsorbent dosage (0."( The investigation of kinetic and isotherm of fluoride adsorption onto functionalize pumice stone.
Asgari, G; Ghanizadeh, G; Roshani, B, 2012
)
0.38
"To investigate the relative fluoride dose-response of human and bovine enamel caries lesions under remineralizing conditions and utilizing an established pH cycling model."( Fluoride dose-response of human and bovine enamel caries lesions under remineralizing conditions.
Hara, AT; Lippert, F, 2012
)
0.38
" Human and bovine enamel showed a good fluoride dose-response for REM and correlated well."( Fluoride dose-response of human and bovine enamel caries lesions under remineralizing conditions.
Hara, AT; Lippert, F, 2012
)
0.38
" There was no indication of a dose-response effect."( Results from the Xylitol for Adult Caries Trial (X-ACT).
Amaechi, BT; Bader, JD; Brown, JP; Funkhouser, KA; Gilbert, GH; Laws, RL; Leo, MC; Makhija, SK; Ritter, AV; Shugars, DA; Vollmer, WM, 2013
)
0.39
" Findings for intermediate fluoridation exposure suggested a dose-response relationship."( Effects of fluoridated drinking water on dental caries in Australian adults.
Do, L; Roberts-Thomson, K; Sanders, AE; Slade, GD; Spencer, AJ, 2013
)
0.39
" However, it seems that at the dosage used, fluoride toxicity may be a direct effect on the antioxidant enzymes."( Comparative study on the influence of fluoride on lipid peroxidation and antioxidants levels in the different brain regions of well-fed and protein undernourished rats.
Adebayo, OL; Adenuga, GA; Ajani, EO; Salau, BA; Shallie, PD, 2013
)
0.39
" The dose-response equation: I = min + (max - min)/(1 + 10(lgEC50-lgC)) may be used to fit the relationship between percent inhibition (I) and F(-) or Cl(-) concentration (C); however, F(-) was distinct from Cl(-) in terms of effects on parameter 'min'."( Effects of fluoride and chloride on the growth of Chlorella pyrenoidosa.
Li, Q; Wu, YD; Wu, YY, 2013
)
0.39
" A dose-response was observed between fluoride concentration in toothpastes and fluoride present in enamel, regardless of dilution."( In vitro enamel remineralization by low-fluoride toothpaste with calcium citrate and sodium trimetaphosphate.
Danelon, M; Delbem, AC; Freire, IR; Hirata, E, 2013
)
0.39
" Western blotting was done for confirmation of the proteomic data A dose-response was observed in serum F levels."( Proteomic analysis of liver in rats chronically exposed to fluoride.
Buzalaf, MA; Cestari, TM; Charone, S; Leite, Ade L; Lobo, JG; Pereira, HA; Peres-Buzalaf, C, 2013
)
0.39
" Unlike UC nanocrystals previously reported in the literature with multicolor emission obtained by varying the rare-earth dopants, the current work developed a new approach to tune the UC emission color by controlling the NaF concentration without changing the ratio and dosage of rare-earth ions."( Controllable multicolor upconversion luminescence by tuning the NaF dosage.
Li, H; Wang, L, 2014
)
0.4
" Adsorption studies were performed in a batch system, and the effects of various parameters, such as the pH value of the solution, adsorbent dosage and initial fluoride concentration, were evaluated."( Adsorption of fluoride from aqueous solution by enhanced chitosan/bentonite composite.
Huang, R; Liu, Q; Liu, Y; Yang, B, 2013
)
0.39
"No in situ protocol has assessed the dose-response effects of fluoride dentifrices involving low-fluoride formulations."( In situ protocol for the determination of dose-response effect of low-fluoride dentifrices on enamel remineralization.
Afonso, RL; Cantagallo, CF; Danelon, M; Delbem, AC; Igreja, BB; Pessan, JP,
)
0.13
"To assess the ability of an in situ remineralization model in determining dose-response effects of dentifrices containing low fluoride concentrations ([F]) on bovine enamel."( In situ protocol for the determination of dose-response effect of low-fluoride dentifrices on enamel remineralization.
Afonso, RL; Cantagallo, CF; Danelon, M; Delbem, AC; Igreja, BB; Pessan, JP,
)
0.13
" A dose-response effect of CPP-ACP usage on MS was observed, where MS was present in eight percent of regular CPP-ACP users, 28 percent of irregular users, and 47 percent of non-users (P<."( A randomized controlled trial of a 10 percent CPP-ACP cream to reduce mutans streptococci colonization.
Barnett, AG; Holcombe, TF; Plonka, KA; Pukallus, ML; Seow, WK; Walsh, LJ, 2013
)
0.39
"To study the dose-response relationship between fluoride content in drinking water and prevalence of dental fluorosis on the national scale, then to determine the safety threshold of fluoride in drinking water."( [Using fractional polynomials to estimate the safety threshold of fluoride in drinking water].
An, W; Li, H; Pan, S; Yang, M, 2014
)
0.4
" There was a better dose-response relationship among the varnishes exposed to water than to artificial saliva."( Evaluation of fluoride release from experimental TiF4 and NaF varnishes in vitro.
Buzalaf, MA; Comar, LP; Grizzo, LT; Magalhães, AC; Souza, BM, 2014
)
0.4
"We reviewed the literature on health effects, community exposure data, and dose-response relationships of the principal hazardous agents emitted."( Community health risk assessment of primary aluminum smelter emissions.
Larivière, C; Martin, SC, 2014
)
0.4
"There seems to be a dose-response relationship between frequency of SSB consumption and caries increment in adults."( Sugar-sweetened beverages and dental caries in adults: a 4-year prospective study.
Aromaa, A; Bernabé, E; Sheiham, A; Suominen, AL; Vehkalahti, MM, 2014
)
0.4
" Reanalysis of dose-response relationships between dietary sugars and caries incidence in teeth with different levels of caries susceptibility in children was done using data from Japanese studies conducted by Takeuchi and co-workers."( A new understanding of the relationship between sugars, dental caries and fluoride use: implications for limits on sugars consumption.
James, WP; Sheiham, A, 2014
)
0.4
" The objective of this study was to re-examine the dose-response and quantitative relationship between sugar intake and the incidence of dental caries and to see whether the WHO goal for sugar intake of 10% of energy intake (E) is optimum for low levels of caries in children and adults."( A reappraisal of the quantitative relationship between sugar intake and dental caries: the need for new criteria for developing goals for sugar intake.
James, WP; Sheiham, A, 2014
)
0.4
" A re-analysis of the dose-response relation between dietary sugar and caries incidence in teeth with different levels of susceptibility to dental caries in nationally representative samples of Japanese children."( A reappraisal of the quantitative relationship between sugar intake and dental caries: the need for new criteria for developing goals for sugar intake.
James, WP; Sheiham, A, 2014
)
0.4
"This laboratory study aimed to (a) compare the fluoride dose-response of different caries lesions created in human and bovine enamel (HE/BE) under pH-cycling conditions and (b) investigate the suitability of Knoop and Vickers surface microhardness (K-SMH/V-SMH) in comparison to transverse microradiography (TMR) to investigate lesion de- and remineralization."( Fluoride dose-response of human and bovine enamel artificial caries lesions under pH-cycling conditions.
Juthani, K; Lippert, F, 2015
)
0.42
" Thus, the law does not consider that both caries and fluorosis are dependent on the dosage and duration of fluoride exposure because they are both chronic diseases."( Fluoride concentrations in the water of Maringá, Brazil, considering the benefit/risk balance of caries and fluorosis.
Barbana, M; Bergamo, ET; Cury, JA; Fujimaki, M; Terada, RS, 2015
)
0.42
"Highly significant linear and, with the exception of SMHR, quadratic dose-response relationships were observed between all efficacy variables and fluoride concentration."( Dose-response effect of fluoride dentifrice on remineralisation and further demineralisation of erosive lesions: A randomised in situ clinical study.
Bosma, ML; Butler, A; Creeth, JE; Hara, AT; Kelly, SA; Lynch, RJ; Martinez-Mier, EA; Zero, DT, 2015
)
0.42
" Although not as visually prominent as the maxillary central incisors, some of the late-erupting teeth are esthetically important and this should be taken into consideration when making recommendations about dosing of fluoride intake."( Timing of fluoride intake and dental fluorosis on late-erupting permanent teeth.
Bhagavatula, P; Broffitt, B; Levy, SM; Warren, JJ; Weber-Gasparoni, K, 2016
)
0.43
"The aim of this exploratory double-blinded, randomized, cross-over, in situ study was to compare the effects of various model parameters ('intervention', 'brushing', 'position') on enamel caries lesions in a dose-response model."( The effect of various model parameters on enamel caries lesions in a dose-response model in situ.
Dörfer, CE; Gninka, B; Heldmann, P; Meyer-Lueckel, H; Paris, S; Wierichs, RJ, 2015
)
0.42
" Values for NaF1450 revealed a similar dose-response as LA1360."( The effect of various model parameters on enamel caries lesions in a dose-response model in situ.
Dörfer, CE; Gninka, B; Heldmann, P; Meyer-Lueckel, H; Paris, S; Wierichs, RJ, 2015
)
0.42
"The design of the present in situ study was able to reveal a fluoride dose-response to hamper further demineralization of enamel specimens for 'easily cleanable' and 'plaque-retaining' sites being brushed or not."( The effect of various model parameters on enamel caries lesions in a dose-response model in situ.
Dörfer, CE; Gninka, B; Heldmann, P; Meyer-Lueckel, H; Paris, S; Wierichs, RJ, 2015
)
0.42
"The TLD-100 dose-response curves were obtained."( Evaluation of LiF:Mg,Ti (TLD-100) for Intraoperative Electron Radiation Therapy Quality Assurance.
Cella, L; D'Avino, V; Liuzzi, R; Pugliese, M; Savino, F, 2015
)
0.42
" Fluoride dose-response effect was analysed by quadratic regression and the effects of toothpastes by Tukey's test."( Evaluation of low fluoride toothpaste using primary enamel and a validated pH-cycling model.
Cury, JA; Romão, DA; Tabchoury, CP; Velo, MM, 2016
)
0.43
"The developed pH-cycling model may be used to evaluate and compare the anti-caries potential of toothpaste formulations with low fluoride concentration because it presents dose-response effects on the reduction of primary enamel demineralization."( Evaluation of low fluoride toothpaste using primary enamel and a validated pH-cycling model.
Cury, JA; Romão, DA; Tabchoury, CP; Velo, MM, 2016
)
0.43
" This longitudinal study aimed to explore 1) the shape of the dose-response association between sugars intake and caries in adults, 2) the relative contribution of frequency and amount of sugars intake to caries levels, and 3) whether the association between sugars intake and caries varies by exposure to fluoride toothpaste."( The Shape of the Dose-Response Relationship between Sugars and Caries in Adults.
Bernabé, E; Lundqvist, A; Sheiham, A; Suominen, AL; Vehkalahti, MM, 2016
)
0.43
" All three fluoride toothpastes were more efficacious than placebo, and there were no safety concerns following single dosing in this short-term in situ model."( Erosion Remineralization Efficacy of Gel-to-Foam Fluoride Toothpastes in situ: A Randomized Clinical Trial.
Hara, AT; Jeffery, P; Lippert, F; Mason, S; Nehme, M; Zero, DT, 2016
)
0.43
" Recent evidence from high-quality systematic reviews supports the dose-response relationship between caries prevention and fluoride levels, and there is good evidence from randomised clinical trials to support the use of high fluoride dentifrices."( High Fluoride Concentration Toothpastes for Children and Adolescents.
Pretty, IA, 2016
)
0.43
"A dose-response relationship was verified between F concentrations in the dentifrices and in the biofilm fluid."( Fluoride and calcium concentrations in the biofilm fluid after use of fluoridated dentifrices supplemented with polyphosphate salts.
Buzalaf, MA; Delbem, AC; Hall, KB; Nagata, ME; Pessan, JP, 2017
)
0.46
"In order to reduce acid and alkali dosing in wastewater treatment process of polycrystalline silicon by using denitrification after fluoride removal."( [Feasibility and Economic Analysis of Denitrification of Photovoltaic Wastewater Containing High Fluorine].
Cui, JH; Huang, Y; Li, X; Ma, H; Yang, PB; Zhu, L, 2016
)
0.43
" The suitable dosage and supplementation periods of choline await further exploration."( Choline supplementation alleviates fluoride-induced testicular toxicity by restoring the NGF and MEK expression in mice.
Liang, C; Wang, J; Wang, N; Zhang, J; Zhang, Y; Zheng, H, 2016
)
0.43
" A clear dose-response relationship was seen between F concentration/amount of dentifrice applied and the mean area under the curve (AUC) of salivary F concentrations (P<0."( Influence of the Amount of Dentifrice and Fluoride Concentrations on Salivary Fluoride Levels in Children.
Cunha, RF; Danelon, M; de Moraes, FR; Delbem, AC; Hall, KB; Hosida, TY; Nagata, ME; Pessan, JP, 2016
)
0.43
"Model showed fluoride dose-response for both variables (2×F>F>placebo)."( The effects of fluoride, strontium, theobromine and their combinations on caries lesion rehardening and fluoridation.
Lippert, F, 2017
)
0.46
" The correlation between water fluoride concentration and intelligence level was assessed by a dose-response meta-analysis."( Association between water fluoride and the level of children's intelligence: a dose-response meta-analysis.
Chen, X; Duan, Q; Jiao, J; Wang, X, 2018
)
0.48
" The dose-response meta-analysis suggested a significant association between water fluoride dosage and intelligence (P < 0."( Association between water fluoride and the level of children's intelligence: a dose-response meta-analysis.
Chen, X; Duan, Q; Jiao, J; Wang, X, 2018
)
0.48
"To compare and explore the dose-response of phytate-containing 1150 ppm fluoride toothpastes on model caries lesions and to determine the impact of zinc ions."( Effect of phytate and zinc ions on fluoride toothpaste efficacy using an in situ caries model.
Budhawant, C; Burnett, GR; Creeth, JE; Hara, AT; Lippert, F; Lynch, RJM; Parkinson, CR; Zero, DT, 2018
)
0.48
" No differences between fluoride toothpastes were observed for any measure with little evidence of a dose-response for phytate."( Effect of phytate and zinc ions on fluoride toothpaste efficacy using an in situ caries model.
Budhawant, C; Burnett, GR; Creeth, JE; Hara, AT; Lippert, F; Lynch, RJM; Parkinson, CR; Zero, DT, 2018
)
0.48
" We examined the dose-response effects of low-to-moderate fluoride exposure on dental fluorosis (DF) and intelligence quotient (IQ), and evaluated the potential relationships between DF grades and intelligence levels using piecewise linear regression and multiple logistic regression, respectively."( Threshold effects of moderately excessive fluoride exposure on children's health: A potential association between dental fluorosis and loss of excellent intelligence.
Chen, J; Cui, Y; Dong, L; Hou, C; Li, P; Li, Y; Liu, H; Liu, L; Pang, S; Tang, S; Tian, K; Wang, A; Xu, C; Yu, X; Zeng, Q; Zhang, S; Zhang, X; Zhao, L; Zhao, Q; Zhou, Z, 2018
)
0.48
" Which sugar-reducing strategy is best for caries prevention? To answer this question, this manuscript discusses the shape of the dose-response association between sugar intake and caries, the influence of fluoridated toothpaste on the association of sugar intake and caries and the relative contribution of frequency and amount of sugar intake to caries levels."( Sugar Restriction for Caries Prevention: Amount and Frequency. Which Is More Important?
van Loveren, C, 2019
)
0.51
" However, there is a lack of global consensus regarding trace elements provision and dosing in pediatric parenteral nutrition."( Trace Element Provision in Parenteral Nutrition in Children: One Size Does Not Fit All.
Bines, JE; McCallum, Z; Zemrani, B, 2018
)
0.48
" The aim of the present study was investigate the dose-response effect of SDF on demineralized dentine in basal medium mucin (BMM) saliva substitute and human saliva."( Silver deposition on demineralized dentine surface dosed by silver diammine fluoride with different saliva.
Botelho, MG; Matinlinna, JP; Peng, JY; Tsoi, JKH, 2019
)
0.51
" In addition to high-contrast imaging and consequently high sensitivity detection of bladder cancer cells, highly selective optoporation-assisted chemotherapy was accomplished using a dosage of chemotherapy agent significantly lower than any previous reports, within a clinically relevant incubation time window."( Multifunctional nanoclusters of NaYF
Cho, SK; Flaig, TW; Mao, C; Park, W; Su, LJ; Wolenski, CD, 2019
)
0.51
" Evidence for the effects of different fluoride concentrations is more limited, but a dose-response effect was observed for D(M)FS in children and adolescents."( Fluoride toothpastes of different concentrations for preventing dental caries.
Glenny, AM; Jeroncic, A; Marinho, VC; Walsh, T; Worthington, HV, 2019
)
0.51
" A dose-response pattern of association was observed between mean fluoride levels and dementia in women (1."( Aluminium and fluoride in drinking water in relation to later dementia risk.
Batty, GD; Deary, IJ; Hannah, J; Killin, LOJ; Russ, TC; Starr, JM, 2020
)
0.56
" To explore the biological exposure limits for mixed exposures of fluoride and arsenic, we compared the contents of fluorine and arsenic in the environmental media of the control and fluoride-arsenic combined exposure areas and analyzed the dose-effect and dose-response relationship between fluoride, arsenic and the key proteins of Wnt signaling pathways."( [Biological exposure limits caused by co exposure to fluoride and arsenic based on Wnt signaling pathway].
Hong, F; Tu, CL; Xu, YY; Yang, J; Yu, X; Zeng, QB, 2019
)
0.51
"Although dietary fluoride (F) supplements (DFS) are recommended for children who use F-deficient drinking water, no studies have examined filled DFS prescriptions across multiple states to examine the dosage consistency with current recommendations or prescription length."( Filled dietary fluoride supplement prescriptions for Medicaid-enrolled children living in states with high and low water fluoridation coverage.
Espinoza, L; Gooch, BF; Griffin, SO; Li, CH, 2019
)
0.51
" For 2011, the authors calculated the mean percentage of children with filled DFS prescriptions and the change since 2000 across states with high and low fluoridation coverage, the percentage of children with filled DFS prescriptions containing F dosage consistent with current recommendations, and filled DFS prescription length and cost across states."( Filled dietary fluoride supplement prescriptions for Medicaid-enrolled children living in states with high and low water fluoridation coverage.
Espinoza, L; Gooch, BF; Griffin, SO; Li, CH, 2019
)
0.51
" Evidence for the effects of different fluoride concentrations was found to be more limited, but a dose-response effect was observed for D(M)FS in children and adolescents."( What concentration of fluoride toothpaste should dental teams be recommending?
Levine, RS, 2019
)
0.51
"001) for the lowly cariogenic model, indicating a fluoride dose-response for both."( Effects of Dentifrices Differing in Fluoride Content on Remineralization Characteristics of Dentin in vitro.
Apel, C; Esteves-Oliveira, M; Meyer-Lueckel, H; Rupp, K; Wierichs, RJ, 2020
)
0.56
"For both pH-cycling conditions a dose-response for fluoride could be revealed."( Effects of Dentifrices Differing in Fluoride Content on Remineralization Characteristics of Dentin in vitro.
Apel, C; Esteves-Oliveira, M; Meyer-Lueckel, H; Rupp, K; Wierichs, RJ, 2020
)
0.56
"All the UAE available infant formulae tested had lower than the maximum daily recommended dosage of fluoride."( Fluoride concentration of commercially available infant formulae in the United Arab Emirates.
Agha, Y; Al-Halabi, M; AlSalami, A; Hussein, I; Kowash, M, 2020
)
0.56
"Bone is the main target of fluorosis, and it has been perfectly elaborated that a moderate dosage of calcium (Ca) can alleviate bone fluorosis."( Calcium relieves fluoride-induced bone damage through the PI3K/AKT pathway.
Cheng, X; Ma, H; Manthari, RK; Ommati, MM; Wang, J; Xu, H; Yan, Z; Yang, J; Zhao, Y, 2020
)
0.56
" It concludes that fluoride has a dose-response effect on BMP-2 in fluorosis rats, and fluoride-induced hypomethylation of specific CpGs may play an essential role in the regulation of BMP-2 and BMP-7 expression in rats."( The dose-time effects of fluoride on the expression and DNA methylation level of the promoter region of BMP-2 and BMP-7 in rats.
Angwa, LM; Ma, Y; Pei, J; Yao, Y; Zhong, N, 2020
)
0.56
" Additional evidence is needed to assess the dose-response relationship between fluoride exposure and blood pressure."( Fluoride Exposure and Blood Pressure: a Systematic Review and Meta-Analysis.
Dong, N; Fan, Y; Feng, J; Gao, Y; Li, M; Liu, P; Qiu, Y; Tian, F; Tian, X; Xie, J; Yan, X; Zhao, Y, 2021
)
0.62
" This study was aimed to evaluate the dose-response effect of fluoride on DNA methylation in human and rat blood."( Effect of fluoride in drinking water on the level of 5-methylcytosine in human and rat blood.
Alphonse, S; Ma, Y; Meng, X; Pei, J; Yao, Y; Zhong, N, 2021
)
0.62
" In conclusion, a dose-response F effect was observed, and the high-fluoride dentifrice was effective in enhancing root dentine remineralization in this short-term in situ study."( Dose-Response Effect of Fluoride Dentifrices on De-/Remineralization of Root Dentine in situ.
Ferreira, R; Leal, J; Lingström, P; Tabchoury, C; Vale, G, 2020
)
0.56
" Furthermore, the low dosage of fluoride could promote the growth of beneficial gut microbiota, including Faecalibacterium and Lactobacillus."( The beneficial or detrimental fluoride to gut microbiota depends on its dosages.
Cai, H; Chen, G; Hu, P; Peng, C; Wan, X; Wang, Y; Xu, Z, 2021
)
0.62
" It was demonstrated that a fraction of the TL signal in LiF:Mg,Ti is generated in the supralinear dose-response range, due to the high local doses generated by photon-induced tracks."( MICRODOSIMETRIC UNDERSTANDING OF DOSE RESPONSE AND RELATIVE EFFICIENCY OF THERMOLUMINESCENCE DETECTORS.
Bilski, P; Olko, P, 2020
)
0.56
" This study aimed to evaluate the dose-response of fluoride on fecal microbes as well as the link between fluorosis and fecal microbes."( Effect of Fluoride in Drinking Water on Fecal Microbial Community in Rats.
Gao, Y; Huang, W; Ma, Y; Meng, X; Pei, J; Sowanou, A; Wu, L; Zhong, N, 2022
)
0.72
" No deviation from linearity was detected in the dose-response relationships, but boys showed lower BMC values than girls."( A Benchmark Dose Analysis for Maternal Pregnancy Urine-Fluoride and IQ in Children.
Bashash, M; Budtz-Jørgensen, E; Flora, D; Grandjean, P; Green, R; Hu, H; Lanphear, B; Song, PXK; Tellez-Rojo, MM; Till, C, 2022
)
0.72
" The results of single-factor tests showed that the optimal reaction conditions included a reaction temperature of 35°C, Citrobacter dosage of 35% (volume ratio) in the particles and hybrid material dosage of 300 mL; under these conditions, the removal rates of SO42-, Cr(VI), total chromium and F- were 70."( Remediation of chromium- and fluoride-contaminated groundwater by immobilized Citrobacter sp. on a nano-ZrO2 hybrid material.
Chang, J; Fan, M; Li, J; Li, X; Liu, L; Yi, F; Zhang, Y, 2021
)
0.62
"In vitro biofilm models have been extensively used, but only few of the models available to date had been validated in terms of the dose-response effect of anti-caries and/or antimicrobial substances."( Validation of a cariogenic biofilm model by evaluating the effect of fluoride on enamel demineralization.
Cury, JA; Marin, LM; Siqueira, WL, 2022
)
0.72
" A dose-response effect was observed."( Topical Fluoride Effectiveness in High Caries Risk Adults.
Cabral, HJ; Gibson, G; Jones, JA; Jurasic, MM; Orner, MB; Wehler, CJ, 2022
)
0.72
" However, to delineate its exact formulation, dosage or frequency, there is need for more well conducted randomised controlled trials."( Effectiveness of topical fluorides in prevention of radiation caries in adults: A systematic review and meta- analysis.
Agarwal, D; Kumar, V; Priya, H; Purohit, B; Ravi, P, 2022
)
1.02
" However, the dose-response of fluoride on oxidative DNA damage is barely studied in organisms."( Effect of Fluoride on the Expression of 8-Hydroxy-2'-Deoxyguanosine in the Blood, Kidney, Liver, and Brain of Rats.
Li, A; Li, H; Ma, Y; Meng, X; Pei, J; Sowanou, A; Wang, J; Yao, Y; Zhong, N, 2023
)
0.91
"01 mg/g at initial concentration range of 5 to 100 mg/L when 1 g/100 mL adsorbent dosage was used at initial pH of 6 ± 0."( Synthesis of porous hydroxysodalite from aluminosilicate rich clay soils: application towards fluoride and pathogen removal.
Gitari, WM; Mudzielwana, R; Obijole, OA, 2023
)
0.91
" Further studies are necessary to examine the extended effect of Resveratrol with increased dosage or time of treatment."( Resveratrol thyro-protective role in fluorosis rat model (histo-morphometric, biochemical and ultrastructural study).
Amin, MA; Hassan, NH, 2023
)
0.91
" Twenty-eight adult Wistar rats were divided equally and randomly into four groups: group one received distilled water; group two received NMO at a dosage of 250 mg/kg/body weight; group three received NaF at a dosage of 10 mg/kg/body weight; and group four received NaF and NMO."( Ameliorative effects of nano Moringa on fluoride-induced testicular damage via down regulation of the StAR gene and altered steroid hormones.
Abd-Allah, ER; El-Rahman, HAA, 2023
)
0.91
" The aim of this systematic review and meta-analysis was to characterize this relation through a dose-response approach, by comparing the intelligence quotient (IQ) scores in the highest versus the lowest fluoride exposure category with a random-effects model, within a one-stage dose-response meta-analysis based on a cubic spline random-effects model."( Fluoride exposure and cognitive neurodevelopment: Systematic review and dose-response meta-analysis.
Birnbaum, LS; Consolo, U; Filippini, T; Generali, L; Giannone, ME; Mazzoleni, E; Veneri, F; Vinceti, M, 2023
)
0.91
" At present, it is not possible to quantify health risks due to MPs because dose-response and toxicity assessments are not available."( Drinking hot beverages from paper cups: Lifetime intake of microplastics.
Goel, S; Joseph, A; Parveen, N; Ranjan, VP, 2023
)
0.91
" Adsorption maxima are obtained over a wide pH range from 4 to 9, with a contact time of 15 minutes at a dosage of 4 g/L."( Efficient removal of fluoride on aluminum modified activated carbon: an adsorption behavioral study and application to remediation of ground water.
Korra, MR; Kuntaiah, K; Nandakishore, SS; Thomas, AM, 2023
)
0.91
" The optimum treatment dosage of the isolated seed polysaccharides was determined using aqueous fluoride solutions of various ppm concentrations (1, 2, 3, 4, and 5 ppm)."( Defluoridation of potable water employed by natural polysaccharide isolated from Tamarindus indica L.
Alarifi, S; Ali, D; C, T; Chang, SW; D, S; Jones, S; Ramanujam, GM; Ravindran, B; Rembulan, GD; S T, A; Sahayarayan, JJ; Yadav, KK, 2023
)
0.91
"We observed a dose-response relation between F concentrations in the gels without TMP for %SHR and ΔKHN."( Effect of fluoride gels with nano-sized sodium trimetaphosphate on the in vitro remineralization of caries lesions.
Báez-Quintero, LC; Danelon, M; Delbem, ACB; Monteiro, DR; Nagata, ME; Pessan, JP; Sampaio, C; Wiegand, A, 2023
)
0.91
" The Central Composite Design (CCD), which uses four input variables including dosage (2-5 g/L), solution pH (4-8), contact time (30-70 min), and initial concentration (10-20 mg/L), was used to design the experiments."( Synthesis and application of lanthanum-doped magnetic biochar composite adsorbent for removal of fluoride from water.
Majamo, SL; Teju, MD, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (2)

ClassDescription
halide anionA monoatomic monoanion resulting from the addition of an electron to any halogen atom.
monoatomic fluorine
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (46)

PathwayProteinsCompounds
glycolysis IV (plant cytosol)1347
D-sorbitol biosynthesis I115
superpathway of cytosolic glycolysis (plants), pyruvate dehydrogenase and TCA cycle2856
phytate degradation I316
Rubisco shunt632
superpathway of anaerobic sucrose degradation3360
fluoroacetate and fluorothreonine biosynthesis016
fluoroacetate and fluorothreonine biosynthesis422
superpathway of cytosolic glycolysis (plants), pyruvate dehydrogenase and TCA cycle2459
superpathway of glycolysis and the Entner-Doudoroff pathway2358
Rubisco shunt832
superpathway of glycolysis, pyruvate dehydrogenase, TCA, and glyoxylate bypass3989
(aminomethyl)phosphonate degradation1231
photosynthetic 3-hydroxybutanoate biosynthesis (engineered)6373
L-tryptophan degradation I (via anthranilate)126
phenylacetate degradation I (aerobic)1530
D-galactarate degradation I530
superpathway of L-lysine degradation33112
L-lysine degradation V133
superpathway of sulfate assimilation and cysteine biosynthesis1241
superpathway of microbial D-galacturonate and D-glucuronate degradation3592
fluoroacetate degradation15
L-serine biosynthesis I1115
trehalose degradation IV023
4-hydroxymandelate degradation638
D-glucarate degradation I531
hexitol fermentation to lactate, formate, ethanol and acetate736
superpathway of aromatic compound degradation via 2-hydroxypentadienoate5095
phytate degradation I021
superpathway of aromatic compound degradation via 3-oxoadipate3681
superpathway of N-acetylneuraminate degradation3979
gluconeogenesis I2862
superpathway of hexitol degradation (bacteria)2960
glycogen degradation I850
mannitol cycle315
superpathway of L-serine and glycine biosynthesis I920
protocatechuate degradation II (ortho-cleavage pathway)518
alkylnitronates degradation350
glycolysis II (from fructose 6-phosphate)2149
glycolysis I (from glucose 6-phosphate)3751
glycolysis IV (plant cytosol)747
glycolysis III (from glucose)3725
aromatic compounds degradation via u03B2-ketoadipate1127
guanosine nucleotides degradation III1425
superpathway of D-glucarate and D-galactarate degradation637
Entner-Doudoroff pathway I1639
superpathway of anaerobic sucrose degradation2661
rutin degradation230
trehalose biosynthesis I719
trehalose biosynthesis414
Ethanol metabolism resulting in production of ROS by CYP2E1117
Ethanol metabolism production of ROS by CYP2E1117

Protein Targets (5)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Carbonic anhydrase 1Homo sapiens (human)Ki180,024.88000.00001.372610.0000AID1798763; AID1803484
Carbonic anhydrase 2Homo sapiens (human)Ki180,024.88000.00000.72369.9200AID1798763; AID1803485
Carbonic anhydrase 4Homo sapiens (human)Ki150,031.10000.00021.97209.9200AID1798763
Carbonic anhydraseMethanosarcina thermophilaKi21,300.00000.06000.97148.5000AID1803493
Carbonic anhydrase 15Mus musculus (house mouse)Ki150,031.10000.00091.884610.0000AID1798763
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (13)

Processvia Protein(s)Taxonomy
one-carbon metabolic processCarbonic anhydrase 1Homo sapiens (human)
morphogenesis of an epitheliumCarbonic anhydrase 2Homo sapiens (human)
positive regulation of synaptic transmission, GABAergicCarbonic anhydrase 2Homo sapiens (human)
positive regulation of cellular pH reductionCarbonic anhydrase 2Homo sapiens (human)
angiotensin-activated signaling pathwayCarbonic anhydrase 2Homo sapiens (human)
regulation of monoatomic anion transportCarbonic anhydrase 2Homo sapiens (human)
secretionCarbonic anhydrase 2Homo sapiens (human)
regulation of intracellular pHCarbonic anhydrase 2Homo sapiens (human)
neuron cellular homeostasisCarbonic anhydrase 2Homo sapiens (human)
positive regulation of dipeptide transmembrane transportCarbonic anhydrase 2Homo sapiens (human)
regulation of chloride transportCarbonic anhydrase 2Homo sapiens (human)
carbon dioxide transportCarbonic anhydrase 2Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 2Homo sapiens (human)
bicarbonate transportCarbonic anhydrase 4Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 4Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (6)

Processvia Protein(s)Taxonomy
arylesterase activityCarbonic anhydrase 1Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 1Homo sapiens (human)
protein bindingCarbonic anhydrase 1Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 1Homo sapiens (human)
hydro-lyase activityCarbonic anhydrase 1Homo sapiens (human)
cyanamide hydratase activityCarbonic anhydrase 1Homo sapiens (human)
arylesterase activityCarbonic anhydrase 2Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 2Homo sapiens (human)
protein bindingCarbonic anhydrase 2Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 2Homo sapiens (human)
cyanamide hydratase activityCarbonic anhydrase 2Homo sapiens (human)
protein bindingCarbonic anhydrase 4Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 4Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 4Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (19)

Processvia Protein(s)Taxonomy
cytosolCarbonic anhydrase 1Homo sapiens (human)
extracellular exosomeCarbonic anhydrase 1Homo sapiens (human)
cytoplasmCarbonic anhydrase 2Homo sapiens (human)
cytosolCarbonic anhydrase 2Homo sapiens (human)
plasma membraneCarbonic anhydrase 2Homo sapiens (human)
myelin sheathCarbonic anhydrase 2Homo sapiens (human)
apical part of cellCarbonic anhydrase 2Homo sapiens (human)
extracellular exosomeCarbonic anhydrase 2Homo sapiens (human)
cytoplasmCarbonic anhydrase 2Homo sapiens (human)
plasma membraneCarbonic anhydrase 2Homo sapiens (human)
apical part of cellCarbonic anhydrase 2Homo sapiens (human)
basolateral plasma membraneCarbonic anhydrase 4Homo sapiens (human)
rough endoplasmic reticulumCarbonic anhydrase 4Homo sapiens (human)
endoplasmic reticulum-Golgi intermediate compartmentCarbonic anhydrase 4Homo sapiens (human)
Golgi apparatusCarbonic anhydrase 4Homo sapiens (human)
trans-Golgi networkCarbonic anhydrase 4Homo sapiens (human)
plasma membraneCarbonic anhydrase 4Homo sapiens (human)
external side of plasma membraneCarbonic anhydrase 4Homo sapiens (human)
cell surfaceCarbonic anhydrase 4Homo sapiens (human)
membraneCarbonic anhydrase 4Homo sapiens (human)
apical plasma membraneCarbonic anhydrase 4Homo sapiens (human)
transport vesicle membraneCarbonic anhydrase 4Homo sapiens (human)
secretory granule membraneCarbonic anhydrase 4Homo sapiens (human)
brush border membraneCarbonic anhydrase 4Homo sapiens (human)
perinuclear region of cytoplasmCarbonic anhydrase 4Homo sapiens (human)
extracellular exosomeCarbonic anhydrase 4Homo sapiens (human)
plasma membraneCarbonic anhydrase 4Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (8)

Assay IDTitleYearJournalArticle
AID1803485ChEMBL_158305 (CHEMBL763190) from Article 10.1016/j.bmc.2016.05.029: \\Anion inhibition profiles of a-, u00DF- and u00BF-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.\\2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Anion inhibition profiles of α-, β- and γ-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.
AID1803487ChEMBL_158307 (CHEMBL763192) from Article 10.1016/j.bmc.2016.05.029: \\Anion inhibition profiles of a-, u00DF- and u00BF-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.\\2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Anion inhibition profiles of α-, β- and γ-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.
AID1803254CA Inhibition Assay from Article 10.3109/14756366.2011.649268: \\Inhibition of the alpha- and beta-carbonic anhydrases from the gastric pathogen Helycobacter pylori with anions.\\2013Journal of enzyme inhibition and medicinal chemistry, Apr, Volume: 28, Issue:2
Inhibition of the alpha- and beta-carbonic anhydrases from the gastric pathogen Helycobacter pylori with anions.
AID1798763CA Inhibition Assay from Article 10.1016/j.bmcl.2008.12.082: \\Carbonic anhydrase inhibitors: the membrane-associated isoform XV is highly inhibited by inorganic anions.\\2009Bioorganic & medicinal chemistry letters, Feb-15, Volume: 19, Issue:4
Carbonic anhydrase inhibitors: the membrane-associated isoform XV is highly inhibited by inorganic anions.
AID1803486ChEMBL_158306 (CHEMBL763191) from Article 10.1016/j.bmc.2016.05.029: \\Anion inhibition profiles of a-, u00DF- and u00BF-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.\\2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Anion inhibition profiles of α-, β- and γ-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.
AID1803484ChEMBL_158304 (CHEMBL763189) from Article 10.1016/j.bmc.2016.05.029: \\Anion inhibition profiles of a-, u00DF- and u00BF-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.\\2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Anion inhibition profiles of α-, β- and γ-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.
AID1803493ChEMBL_158313 (CHEMBL763370) from Article 10.1016/j.bmc.2016.05.029: \\Anion inhibition profiles of a-, u00DF- and u00BF-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.\\2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Anion inhibition profiles of α-, β- and γ-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.
AID1803491ChEMBL_158311 (CHEMBL763368) from Article 10.1016/j.bmc.2016.05.029: \\Anion inhibition profiles of a-, u00DF- and u00BF-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.\\2016Bioorganic & medicinal chemistry, 08-15, Volume: 24, Issue:16
Anion inhibition profiles of α-, β- and γ-carbonic anhydrases from the pathogenic bacterium Vibrio cholerae.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (25,484)

TimeframeStudies, This Drug (%)All Drugs %
pre-199011974 (46.99)18.7374
1990's3211 (12.60)18.2507
2000's3439 (13.49)29.6817
2010's4818 (18.91)24.3611
2020's2042 (8.01)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 92.12

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index92.12 (24.57)
Research Supply Index10.29 (2.92)
Research Growth Index4.59 (4.65)
Search Engine Demand Index217.15 (26.88)
Search Engine Supply Index2.49 (0.95)

This Compound (92.12)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,456 (5.23%)5.53%
Reviews1,711 (6.15%)6.00%
Case Studies293 (1.05%)4.05%
Observational18 (0.06%)0.25%
Other24,365 (87.51%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (501)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth (Randomized Clinical Trial) [NCT03865680]Phase 2180 participants (Actual)Interventional2019-04-28Completed
Randomized Double-blind Placebo-controlled Trial of Silver Diamine Fluoride for Caries Prevention in Removable Partial Dentures Wearers [NCT03185104]196 participants (Actual)Interventional2013-11-01Active, not recruiting
Phase 1 Safety and Pharmacokinetics of Methane Sulfonylfluoride (MSF or SNX-001) After Single and Multiple Oral Dose Administration in Healthy Adult Aged Volunteers [NCT01269476]Phase 127 participants (Actual)Interventional2009-12-31Completed
A Medical Device Study to Measure the Efficacy of a Toothpaste Containing Calcium-silicate/Phosphate on Dentinal Hypersensitivity Compared to a Control Toothpaste Containing Fluoride. [NCT03244618]272 participants (Actual)Interventional2017-06-19Completed
The Clinical Investigation of a New Toothpaste Containing SnF as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in China [NCT03852056]Phase 398 participants (Actual)Interventional2017-05-25Completed
The Effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate (MI Varnish) and 5% Sodium Fluoride Plus Xylitol (PreviDent Varnish) on Non Cavitated Interproximal Lesions. Randomised Clinical Trial [NCT03925740]Phase 490 participants (Anticipated)Interventional2019-01-01Active, not recruiting
Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste - an in Situ Study [NCT05485662]15 participants (Anticipated)Interventional2022-09-06Recruiting
[NCT00497029]219 participants (Actual)Interventional2004-06-30Completed
Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride in a Group of Preschool Children [NCT05941429]Phase 178 participants (Anticipated)Interventional2023-08-31Not yet recruiting
Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization [NCT03780270]90 participants (Actual)Interventional2014-06-16Completed
18F-DCFPyL PET/CT in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-Contributory CT Scans [NCT03501940]0 participants Expanded AccessNo longer available
Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients: A Randomized Clinical Trial [NCT04472182]Phase 1105 participants (Actual)Interventional2020-12-20Completed
Grape Seeds Versus Standard Measures for Prevention of Caries Incidence in Young Egyptian Adults: A Randomized Controlled Trial [NCT03724578]Phase 180 participants (Anticipated)Interventional2019-01-01Not yet recruiting
Comparative Study on the Outcomes of Restoring Untreated and SDF-treated Dentine Caries Lesions in Primary Teeth of Preschool Children [NCT03657862]195 participants (Actual)Interventional2017-09-15Active, not recruiting
Postoperative Pain After Application of Silver Diamine Fluoride and Glass Ionomer Versus Glass Ionomer Alone Following Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries. A Randomized Pilot Study. [NCT03568474]Phase 440 participants (Anticipated)Interventional2018-10-31Not yet recruiting
Effect of a Triclosan Containing Dentifrice on Oral Bacteria and Postoperative Complications Following Third Molar Surgery [NCT01292343]141 participants (Actual)Interventional2008-02-29Completed
A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Gingival Inflammation, Oral Malodor and Tooth Whitening [NCT03196648]39 participants (Actual)Interventional2015-05-01Completed
Effectiveness of Different Fluoride Varnishes on Salivary Bacteria Levels in Children With Early Childhood Caries [NCT03625310]88 participants (Actual)Interventional2016-11-30Completed
Radiographic Assessment of Glass Ionomer Restorations With and Without Prior Application of Nano Silver Fluoride in Occlusal Carious Molars Treated With Partial Caries Removal Technique (Randomized Clinical Trial) [NCT03193606]22 participants (Actual)Interventional2018-07-03Completed
Enhancing the Fluoride Retention in the Mouth by Chewing a Calcium Supplement Before Fluoride Rinse [NCT04620252]Early Phase 118 participants (Actual)Interventional2021-02-01Completed
Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02705716]409 participants (Actual)Interventional2016-03-01Completed
Comparison of MI Paste Plus and Resin Infiltration in Improvement of White Spot Lesions Following Fixed Orthodontic Treatment: A Randomized Controlled Trial [NCT05733676]62 participants (Anticipated)Interventional2023-05-30Recruiting
Clinical Research Study to Evaluate the Antibacterial Effect 12 Hours After 4-week Use of a Toothpaste Containing Amine Base, Sodium Fluoride and Zinc Lactate [NCT05628571]Phase 3130 participants (Anticipated)Interventional2023-02-01Not yet recruiting
Phase 1 Trial to Determine Safety and Feasibility in Treating Biochemical Recurrence Post-Prostatectomy With PSMA PET Guided External Beam Radiotherapy Followed by Consolidative Radioligand Therapy [NCT06105918]Phase 110 participants (Anticipated)Interventional2023-11-29Recruiting
Effect of CPP-ACP Pastes With/Without Fluoride on White Spot Lesion Progression, Salivary pH and Fluoride Release in High Caries Risk Patients A Randomized Clinical Trial [NCT03656432]Phase 342 participants (Anticipated)Interventional2018-10-31Not yet recruiting
Motivational Effect of Choosing the Taste of te Fluoride Varnish on Acceptance and Behavior During Dental Visit in Children - a Single Blind RCT [NCT05285228]70 participants (Anticipated)Interventional2022-03-31Not yet recruiting
Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial [NCT01049503]Phase 3315 participants (Actual)Interventional2009-11-30Completed
Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model [NCT03383783]Phase 328 participants (Actual)Interventional2017-12-19Completed
Assessment of a Potassium Oxalate-Containing Formulation for the Relief of Dentinal Hypersensitivity [NCT01345292]226 participants (Actual)Interventional2011-04-30Completed
18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules [NCT03824535]Phase 250 participants (Anticipated)Interventional2019-02-04Recruiting
Effect of Water Rinsing After APF Application on Dental Plaque Acidogenicity [NCT01569165]25 participants (Actual)Interventional2011-02-28Completed
A Randomized, 8 Week Clinical Study to Evaluate the Efficacy of an Experimental Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity [NCT03310268]185 participants (Actual)Interventional2017-11-18Completed
A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents [NCT02055586]10 participants (Actual)Observational2013-10-22Completed
Clinical Feasibility Study of Hypoxia Imaging -Guided IMRT on the Individualized Radiotherapy of Nasopharyngeal Carcinoma [NCT02089204]300 participants (Anticipated)Observational2010-06-30Enrolling by invitation
A Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice [NCT04123665]Phase 398 participants (Actual)Interventional2013-05-28Completed
Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (A Randomized Clinical Trial) [NCT03554980]Phase 446 participants (Anticipated)Interventional2018-12-01Not yet recruiting
A Method Development Clinical Study Investigating the Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity [NCT03238352]Phase 289 participants (Actual)Interventional2017-08-07Completed
A Proof of Principal Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices [NCT03160703]220 participants (Actual)Interventional2017-07-10Completed
Post-operative Pain After Silver Diamine Fluoride Application in Primary Molars With Deep Caries Versus Interim Restorative Therapy [NCT03563534]Phase 420 participants (Anticipated)Interventional2017-09-15Recruiting
Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial [NCT03557996]Phase 442 participants (Anticipated)Interventional2018-12-01Not yet recruiting
A Study to Evaluate the Efficacy of an Experimental Occlusion Technology Dentifrice in the Relief of Dentinal Hypersensitivity [NCT02861664]135 participants (Actual)Interventional2016-09-21Completed
"Randomized Clinical Trial to Evaluate the Impact on Oral Health of the Oral Health Package Law (School Daily Brushing Program) Combined, or Not, With Fluor Varnish Application on Schoolchildren of Mérida, Mexico." [NCT05960110]Phase 3900 participants (Anticipated)Interventional2023-06-22Recruiting
The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride [NCT04577716]102 participants (Actual)Observational2021-04-01Active, not recruiting
Evaluation Of Changes in Children's Oral Health-Related Quality of Life Following Treatment of Early Childhood Caries With Caries Arrest Technique Using Silver Diamine Fluoride Versus Conventional Drill and Fill Technique A Randomized Clinical Trial [NCT05337449]40 participants (Anticipated)Interventional2022-07-15Not yet recruiting
A Pilot Study to Evaluate Gingivitis Using Traditional and Molecular Methods [NCT05326373]40 participants (Actual)Interventional2022-04-11Completed
Study to Investigate the Impact on Oral Health Related Quality of Life of Managing Dentine Hypersensitivity With a Daily Use Anti-Sensitivity Toothpaste [NCT02752958]75 participants (Actual)Interventional2016-05-23Completed
A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity [NCT02753075]240 participants (Actual)Interventional2015-09-08Completed
18F Sodium Fluoride PET/CT in Acute Aortic Syndrome [NCT03647566]76 participants (Actual)Observational2018-10-01Completed
Clinical Efficacy of an Experimental Toothpaste [NCT01079910]Phase 10 participants (Actual)Interventional2009-12-09Withdrawn
A Randomized, Controlled, Examiner-Blind Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% w/w Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks [NCT06143670]160 participants (Anticipated)Interventional2023-11-29Recruiting
"Immediate And Sustained Treatment Response Of Commercially Available BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In Dentin Hypersensitivity - A Randomized Clinical Trial" [NCT04249336]Phase 3140 participants (Actual)Interventional2019-09-27Completed
Miswak Versus Standard Measures to Prevent the Incidence of Caries Young Egyptian Adults: A Randomized Controlled Clinical Trial [NCT03732040]82 participants (Anticipated)Interventional2019-01-01Recruiting
Clinical Evaluation of Clinpro™ 2.1% Sodium Fluoride Aqueous Solution in the Treatment of Dentin Hypersensitivity [NCT05768373]101 participants (Actual)Interventional2023-04-04Completed
"Quantitative Evaluation of Silver Diamine Fluoride Modified Restoration In Treating Hypomineralized First Permanent Molar In A Group Of Children-A Clinical Study" [NCT05931822]42 participants (Actual)Interventional2020-09-01Completed
Clinical Effectiveness of Silver Diamine Fluoride on Arresting Caries Lesions in Children [NCT05872542]Phase 460 participants (Anticipated)Interventional2023-06-01Recruiting
Efficacy of a Novel Fluoride Varnish Formula in Preventing White Spot Lesions During and After Treatment With Fixed Orthodontic Appliances [NCT03725020]180 participants (Actual)Interventional2014-06-01Active, not recruiting
Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology [NCT01094210]30 participants (Actual)Observational2010-09-30Completed
PET Imaging as a Biomarker of Systemic Treatment Response for Men With Metastatic Castration-Resistant Prostate Cancer [NCT02169063]0 participants (Actual)Interventional2015-12-31Withdrawn
Different Concentrations of Potassium Nitrate in In-office Tooth Bleaching Sensitivity: a Randomized Clinical Trial [NCT03323372]Phase 256 participants (Actual)Interventional2016-12-21Completed
A Randomized Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children [NCT04054635]84 participants (Actual)Interventional2019-10-01Completed
In Vivo Comparison of Genotoxic and Cytotoxic Effects of Different Brands of Toothpaste - Without and With Fluoride [NCT03325400]40 participants (Actual)Interventional2016-01-01Completed
Efficacy of Silver Diamine Fluoride (SDF) and Fluoride Varnish in Arresting and Preventing Dental Caries in Primary School Children: Randomized Controlled Clinical Trial [NCT03480516]300 participants (Actual)Interventional2017-09-01Completed
A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice [NCT02750943]253 participants (Actual)Interventional2015-11-01Completed
"Combined One Stop Shop NaF/FDG PET/MRI Evaluation of Response to Xofigo® in mCRPC Patients: A Pilot Study" [NCT02429804]Phase 14 participants (Actual)Interventional2015-04-30Terminated(stopped due to Accrual factor)
PET MRI for Evaluation of Knee Osteoarthritis in Patients With Bilateral Knee OA [NCT03174080]150 participants (Anticipated)Observational2017-07-16Not yet recruiting
Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions [NCT05231330]36 participants (Actual)Interventional2020-03-01Completed
Evaluation of F-18 Tetrafluoroborate (18F-TFB) PET/CT in Patients With Differentiated Thyroid Cancer [NCT05575440]24 participants (Anticipated)Observational2022-04-22Recruiting
Impact of a Triclosan-containing Toothpaste During the Progression of Experimental Peri-implant Mucositis: Clinical Parameters and Local Pattern of Osteo-immunoinflammatory Mediators in Peri-implant Fluid [NCT03145610]22 participants (Actual)Interventional2013-06-01Completed
Study on Children's Dental Caries Prevention and Mechanism [NCT02341352]Phase 3500 participants (Anticipated)Interventional2013-04-30Active, not recruiting
Principal Investigator,Resident at Cairo University [NCT05948228]Phase 1330 participants (Anticipated)Interventional2023-08-31Not yet recruiting
A Prospective, Open Label, Randomized Control Trial to Study the Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention [NCT04788550]30 participants (Anticipated)Interventional2021-03-17Recruiting
A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity [NCT03072719]Phase 3120 participants (Actual)Interventional2012-03-01Completed
The Evaluation of Resin Infiltration or Fluoride Varnish Effect on Non-cavited Proximal Caries Lesion Progress at Individuals Modarate/High Caries Risk [NCT05202665]60 participants (Actual)Interventional2017-09-26Active, not recruiting
Clinical Evaluation of the Efficacy of SPR-G (Surface Pre-reacted Glass Ionomer) Barrier Coat Versus Fluoride Varnish Versus the MI Paste (CPP-ACP) in the Treatment of Early White Spot Lesions in Pediatric Patients [NCT05202821]Phase 160 participants (Anticipated)Interventional2021-01-01Recruiting
Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health [NCT02999230]170 participants (Actual)Interventional2017-02-22Active, not recruiting
Effect of Calcium Fluoride Nanoparticles in Prevention of Demineralization During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial [NCT04994314]Phase 331 participants (Anticipated)Interventional2021-02-15Recruiting
Cost Effectiveness of Sodium Fluoride Varnish Application in Prevention of Dental Caries in School Children Between Age of 6 and 7 Years [NCT03571815]328 participants (Actual)Interventional2015-01-02Completed
An Open-Label Study to Investigate the AMPAɣ8 Receptor Occupancy of JNJ-64140284 With the Newly Developed TARP-γ8 PET Tracer [18F]JNJ-64511070 in Healthy Men [NCT03693391]Phase 122 participants (Actual)Interventional2018-10-17Terminated(stopped due to stopped because of a business decision)
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02751450]263 participants (Actual)Interventional2016-02-01Completed
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02832375]Phase 3242 participants (Actual)Interventional2016-03-01Completed
Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age [NCT05670743]Phase 223 participants (Actual)Interventional2023-03-01Active, not recruiting
Non-invasive Detection of Bicuspid Aortic Valve-Related Thoracic Aortopathy [NCT04083118]95 participants (Actual)Observational2019-04-01Completed
Effect of Silver Diamine Fluoride on the Treatment of Gingivitis in Geriatric Patients [NCT03445286]48 participants (Actual)Interventional2019-01-29Completed
Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis [NCT02102295]Phase 3300 participants (Actual)Interventional2006-09-30Completed
18F-Fluoride Assessment of Aortic Bioprosthesis Durability and Outcome [NCT02304276]80 participants (Actual)Interventional2015-01-31Active, not recruiting
Comparative Evaluation of Remineralizing Efficacy of Fluoride Varnish and Its Combination Varnishes on White Spot Lesions in Children With ECC: A Randomized Clinical Trial [NCT03360266]60 participants (Actual)Interventional2016-03-21Completed
Randomized Metabolic Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma FDOPA PET-CT [NCT02176720]Phase 131 participants (Actual)Interventional2014-05-31Terminated(stopped due to PI left HMRI)
Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients With Gingivitis [NCT02235532]20 participants (Actual)Interventional2013-09-30Completed
Clinical Study to Evaluate Dental Plaque [NCT00758290]Phase 323 participants (Actual)Interventional2008-05-31Completed
A Feasibility Study to Determine Whether a Randomised Controlled Trial of Silver Diamine Fluoride Compared to Usual Care for the Management of Caries in Children's Primary Teeth is Feasible in UK Primary Dental Care [NCT06092151]80 participants (Anticipated)Interventional2023-06-22Recruiting
Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and Gingivitis: a 6-month Clinical Study [NCT06048627]Phase 390 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Comparison of the Remineralization Potential of an Optimized Fluoride Dentifrice With a Control Fluoride Dentifrice Using an in Situ Caries Model [NCT06010732]Phase 365 participants (Anticipated)Interventional2023-10-02Recruiting
18F-Sodium Fluoride (18F-NaF) PET-CT Imaging to Identify Vulnerable Plaques in Patients With Diabetes [NCT03530176]98 participants (Actual)Interventional2015-01-01Completed
Effect of Fluoride and Casein Phosphopeptide-amorphous Calcium Phosphate on Remineralization of Early Caries Lesions in Primary Teeth: an in Vivo Study [NCT03526276]118 participants (Actual)Interventional2016-03-31Completed
Effect of an Amine Fluoride/Stannous Fluoride Containing Mouthrinse on Gingival Inflammation,Plaque Development, Discoloration and Bacterial Plaque Composition Over Six Months. [NCT01317446]Phase 4180 participants (Actual)Interventional2010-11-30Completed
Clinical and Laboratory Effectiveness of Different Toothpastes in Treating White Spot Lesions [NCT06128434]21 participants (Anticipated)Interventional2023-11-30Recruiting
A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management [NCT06045026]536 participants (Actual)Interventional2023-09-21Active, not recruiting
Comparison of Silver Modified and Conventional Atraumatic Restorative Treatment Modalities in Primary Molars in a Group of Egyptian School Children. A Randomized Controlled Trial [NCT03881020]Phase 4100 participants (Actual)Interventional2020-08-03Completed
Maintaining Oral Health With Bio-products: a Randomized, Cross-over, in Situ Study [NCT04033263]45 participants (Anticipated)Interventional2022-09-30Not yet recruiting
Effect of Low-level Light Therapy Associated With Potassium Nitrate in the Control of Post-bleaching Dental Sensitivity: a Randomized, Double-blind, Split-mouth, Controlled Trial [NCT03434782]Phase 150 participants (Actual)Interventional2017-04-24Completed
Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice: Clinical Trial - Epidemiological Study With Children Residing in an área Without Public Water Fluoridation [NCT03761485]Phase 4452 participants (Actual)Interventional2015-01-15Completed
A Clinical Method Development Study to Characterise The Efficacy of An Experimental Dual Active Combination Dentifrice For The Relief Of Dentin Hypersensitivity [NCT03361774]Phase 20 participants (Actual)Interventional2018-10-01Withdrawn(stopped due to Cancelled before Active)
Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth: A Randomized Clinical Trial [NCT03855527]Phase 260 participants (Actual)Interventional2018-01-12Completed
"Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on Their Child's Anterior and Posterior Teeth Before and After Masking the Colour With Glass Ionomer" [NCT04509232]82 participants (Actual)Interventional2019-10-12Completed
A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population. [NCT02937636]128 participants (Actual)Interventional2017-09-19Completed
Clinical Efficacy of Giomer Versus Sodium Fluoride Varnish for Management of Hypersensitivity: Randomized Control Trail [NCT03818945]Phase 4104 participants (Anticipated)Interventional2019-03-01Recruiting
Optimizing Fluoride Retention in the Mouth of Older Adults With Distinct Salivary Flow Rates [NCT04239872]Phase 120 participants (Actual)Interventional2020-03-11Completed
Comparison of the Effect of Fluoride Remineralizer Gel and Foam: a Randomized Clinical Trial [NCT02490592]Phase 458 participants (Actual)Interventional2014-03-31Completed
Retention of Fluoride Formed on Enamel by Fluoride Gel or Varnish Application and Its Release to Dental Biofilm Fluid - in Vivo Study [NCT02486458]Early Phase 162 participants (Actual)Interventional2015-04-30Completed
Effect of Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised Study [NCT02724592]Phase 1/Phase 270 participants (Actual)Interventional2013-02-28Completed
A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance [NCT05852041]Early Phase 140 participants (Anticipated)Interventional2023-08-07Recruiting
Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on Plaque, Gingival Inflammation and Bleeding Upon Probing [NCT05258721]Phase 260 participants (Actual)Interventional2021-07-06Completed
Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial) [NCT05255913]360 participants (Actual)Interventional2022-03-15Completed
Effectiveness in Dental Plaque Reduction of Two Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride: a Comparative Study [NCT04977778]34 participants (Actual)Interventional2021-09-01Completed
Evaluating Commercial Anti-Plaque Products and Oral Rinse [NCT01014143]Phase 226 participants (Actual)Interventional2007-08-31Completed
Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Patients Affected by Spondyloarthritis [NCT02869100]26 participants (Actual)Interventional2013-01-31Completed
Utility of 18F-DOPA PET/MRI Metrics as a Biomarker for Treatment Response Assessment in Sarcoma Patients: A Pilot Study [NCT05560009]10 participants (Anticipated)Observational2022-11-10Recruiting
"Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath; Randomized Clinical Trial, Double-blind Cross-sectional Study" [NCT04279106]36 participants (Actual)Interventional2018-09-03Completed
Periodontal Disease and Cardiovascular Disease [NCT00763165]Phase 3438 participants (Actual)Interventional2000-11-30Active, not recruiting
Effect of Weekly Professional Oral Care, During 12 Months, on the Composition of the Oral Flora and Related Variables in Dependent Elderly Residents [NCT02627469]68 participants (Actual)Interventional2007-08-31Completed
Effectiveness of Silver Diamine Fluoride/ Potassium Iodide in Indirect Pulp Capping of Young Permanent Molars (a Randomized Controlled Clinical Trial) [NCT04236830]Phase 2/Phase 3108 participants (Actual)Interventional2019-11-01Completed
Effect of Toothpaste Containing Novamin on Streptococcous Mutans Count in Dental Plaque of High Caries Risk Children (Randomized Controlled Clinical Trial) [NCT05979636]36 participants (Actual)Interventional2022-12-06Completed
Efficacy, Cost-efficacy and Parental Acceptability of Using Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces [NCT02789202]100 participants (Anticipated)Interventional2014-10-31Active, not recruiting
Clinical Study of Tooth Enamel Remineralization Using DoReMin Product [NCT06166849]40 participants (Anticipated)Interventional2023-03-28Recruiting
Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients With Newly Diagnosed Glioblastoma [NCT03778294]Phase 243 participants (Actual)Interventional2019-03-28Completed
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases [NCT00375830]Phase 2114 participants (Actual)Interventional2006-01-31Completed
A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer [NCT06179303]Phase 260 participants (Anticipated)Interventional2024-06-01Not yet recruiting
Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma? [NCT01020097]5 participants (Actual)Interventional2009-03-31Completed
Train New Examiners Via Modified Gingival Margin Plaque [NCT00758563]Phase 315 participants (Actual)Interventional2008-03-31Completed
Long-term Bi-center Trial to Compare the Radiological Cavity Progression of Approximal Caries Following Infiltration or Standard Treatment [NCT02191943]0 participants (Actual)Interventional2014-11-30Withdrawn
Efficacy of Two Protocols for Applying Fluorine Varnish to Initial Active Lesions of Deciduous Teeth: a Randomized Clinical Trial [NCT03827889]168 participants (Anticipated)Interventional2024-01-01Suspended(stopped due to Outbreak of COVID-19.)
A Prospective, Randomized Clinical Study on the Effects of CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2 [NCT00670618]325 participants (Actual)Interventional2008-10-01Completed
Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study [NCT03353103]Phase 220 participants (Anticipated)Interventional2018-09-03Recruiting
An 8-week, Randomised, Controlled, Examiner-Blind, Proof of Principle Study Investigating the Ability of a 3% Methyl Vinyl Ether/Maleic Anhydride Co-Polymer (PVM/MA) + 5% Potassium Nitrate (KNO3) Combination Toothpaste to Protect From Dentine Hypersensiti [NCT05243745]120 participants (Actual)Interventional2022-02-28Completed
Evaluation of Effectiveness of a Novel Remineralizing Agent: A Randomized Controlled Clinical Trial [NCT06131294]23 participants (Actual)Interventional2023-02-24Active, not recruiting
Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment of Anterior Teeth in Children With Molar Incisor Hypomineralization: A Prospective Clinical Study. [NCT05727475]156 participants (Actual)Interventional2021-11-12Completed
Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Split-mouth, Post-marketing Study [NCT02101255]25 participants (Actual)Interventional2014-07-31Completed
EFFECTIVENESS OF A HOMECARE DESENSITIZER FOR PATIENTS WITH DENTIN HYPERSENSITIVITY [NCT02128633]Phase 2/Phase 3126 participants (Actual)Interventional2009-11-30Completed
A Pilot Study to Evaluate the Effect of Livionex on Reducing Plaque Accumulation and Improving Oral Health in Children [NCT04368533]78 participants (Actual)Interventional2019-02-08Completed
Effect of a Triclosan-containing Toothpaste as a Preventive Strategy of Peri-implant Experimental Mucositis in Cigarette Smokers: Clinical and Osteo-immunoinflammatory Response in a Randomized Crossover Study. [NCT03241407]26 participants (Actual)Interventional2013-07-01Completed
Effects of a Toothpaste Containing 0.3% Triclosan in the Maintenance Phase of Peri-implantitis Treatment. [NCT03191721]Phase 3102 participants (Actual)Interventional2010-06-30Completed
A Randomized Clinical Trial on the Use of Sodium Fluoride Varnish and Silver Diamine Fluoride Solution for Arresting Active Dental Caries in Preschool Children [NCT02426619]Phase 2/Phase 3371 participants (Actual)Interventional2012-09-30Completed
FISSURE-Project. Improved Dental Decay Management in Dental Service for Children: Fissure Sealants or Fluoride Varnish? [NCT03315312]Phase 4410 participants (Actual)Interventional2017-02-01Active, not recruiting
Comparison of the Clinical Efficacy From the Retention Phase of Fluoride Delivery of Fluoride Toothpastes Using an in Situ Caries Model [NCT00708123]Phase 360 participants (Actual)Interventional2007-11-30Completed
A Prospective, Randomized, Clinical Study on the Effects of Casein Phosphopeptide Amorphous Calcium Phosphate Paste, Fluoride and a Combination on the Evolution of White Spot Lesions in Orthodontic Patients After Debonding. [NCT05710874]107 participants (Actual)Interventional2016-09-23Completed
Effectiveness of Toothpaste Containing the Active Ingredient of Galla Chinensis Extract on Treating Dentin Hypersensitivity '' A Randomized Clinical Trial '' [NCT05483062]90 participants (Actual)Interventional2021-05-20Completed
A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity [NCT02574221]60 participants (Actual)Interventional2015-08-31Completed
Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study [NCT00723515]Phase 445 participants (Actual)Interventional2007-02-28Completed
A Three-Month Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices [NCT06140784]120 participants (Anticipated)Interventional2023-09-02Active, not recruiting
A Three-Month Clinical Study to Assess the Gingivitis Effects of Various Dentifrices [NCT06140771]115 participants (Actual)Interventional2021-10-20Completed
Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model [NCT06140758]12 participants (Anticipated)Interventional2023-07-31Active, not recruiting
Evaluation of Efficacy of Experimental Dentifrice Formulations With Different Forms of Fluoride and/or Other Agents to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind Randomized In-Situ Clinical Trial [NCT06140745]10 participants (Actual)Interventional2020-10-05Completed
A Randomized, Controlled Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health, Compared to Existing Oral Hygiene, in a Population of Partial Denture Wearers With Generalized Mild-moderate Plaque-induced Gi [NCT04290624]Phase 458 participants (Actual)Interventional2020-10-14Completed
A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Dental Plaque [NCT04006483]2,359 participants (Actual)Observational2018-01-08Completed
Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion [NCT04006470]172 participants (Actual)Observational2018-01-08Completed
Training and Calibration of Dental Examiners [NCT00765167]Phase 318 participants (Actual)Interventional2007-11-30Completed
Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults [NCT02647203]Phase 1/Phase 2345 participants (Actual)Interventional2014-07-31Completed
Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial [NCT05791669]Phase 345 participants (Actual)Interventional2021-08-01Completed
Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children [NCT03526315]127 participants (Actual)Interventional2016-03-31Completed
Is Xylitol Toothpaste Effective in Preventing Dental Caries Among Young Children With Moderate-to-high Caries Risk? - a Randomized Controlled Trial [NCT04096599]579 participants (Actual)Interventional2018-11-18Active, not recruiting
Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model [NCT02708160]Phase 20 participants (Actual)Interventional2016-03-31Withdrawn(stopped due to Withdrawn due to business reasons)
Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries in Non-fluoridated Areas: A 24-month Randomized Controlled Trial [NCT02742038]275 participants (Actual)Interventional2012-03-31Completed
Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR [NCT02726984]15 participants (Actual)Interventional2016-01-15Completed
Clinical and Radiographic Evaluation of Nano Silver Fluoride Versus Calcium Hydroxide in Indirect Pulp Treatment of Deep Carious Second Primary Molars, Randomized Clinical Trial [NCT04005872]40 participants (Actual)Interventional2019-10-01Completed
Development and Validation of a Multi-Mineral Fluoride Mouthrinse [NCT00642252]Phase 130 participants (Actual)Interventional2012-01-31Completed
An 8 Week, Randomised, Examiner-blind, Controlled Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population [NCT04950465]271 participants (Actual)Interventional2021-07-27Completed
Validation of Imaging-Based Biomarkers of Treatment Response in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide [NCT02677376]7 participants (Actual)Observational2016-06-27Completed
Effectiveness of the Use of Desensitizing Dentifrices Based on Nanocrystals of Hydroxyapatite / 5% Potassium Nitrate / 1450ppm Sodium Monofluorophosphate and Potassium Nitrate 5% / 1426ppm Sodium Floride in the Treatment of Dentine Hypersensitivity. Test [NCT04156152]32 participants (Anticipated)Interventional2020-04-10Not yet recruiting
Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being [NCT02536352]Early Phase 143 participants (Actual)Interventional2015-10-31Completed
The Influence of Preventive Regimens Containing Different Toothpastes on Caries Risk of High Risk Patients: A Randomized Clinical Trial [NCT04032210]66 participants (Anticipated)Interventional2019-10-01Not yet recruiting
Comparison of the Potential for Dentine Discoloration of Silver Diamino Fluoride and Silver Diamino Fluoride Associated With Potassium Iodide [NCT04001959]40 participants (Anticipated)Interventional2019-05-02Recruiting
Clinical and Microbiological Effects of Three Different Mouth Rinses Made of Sodium Fluoride, Guava Leaves Extract or Pomegranate Peel Extract on Dental Plaque in Children [NCT06013735]40 participants (Actual)Interventional2020-02-17Completed
Assessment of Effect of an Experimental Pregabalin Gel in Reducing Post-operative Tooth Sensitivity Surgery Caused by Bleaching With 35% Hydrogen Peroxide [NCT06180707]Phase 375 participants (Anticipated)Interventional2024-01-05Not yet recruiting
A Randomized Clinical Trial on the Effectiveness of Oral Health Preventive Programmes in School Children in Uganda [NCT06081868]610 participants (Anticipated)Interventional2024-09-01Not yet recruiting
Preventing Early Childhood Caries With Silver Diamine Fluoride - a Randomised Clinical Trial [NCT04075474]Phase 2730 participants (Anticipated)Interventional2020-10-27Recruiting
Treatment of White Spot Lesions After Orthodontic Treatment: A Practice-based Randomized Controlled Trial [NCT01059058]240 participants (Anticipated)Interventional2010-03-31Completed
Reducing Disease Burden and Health Inequalities Arising From Chronic Dental Disease Among Indigenous Children: an Early Childhood Caries Intervention [NCT02151916]Phase 3544 participants (Actual)Interventional2011-06-30Active, not recruiting
Assessment of Dentine Tubule Occlusion in a Modified in Situ Model [NCT02768194]26 participants (Actual)Interventional2016-07-06Completed
Remineralization Potential of MI Varnish(CPP-ACP and Fluoride) Versus Fluoride Varnish in Controlling White Spot Lesions in Maxillary Primary Incisors: A Randomized Clinical Trial [NCT03731403]60 participants (Actual)Interventional2019-03-01Completed
Caries Management by Risk Assessment in Children [NCT01310283]120 participants (Anticipated)Interventional2010-04-30Completed
Assessing Hypoxia by 18F-EF5 PET Scanning and Glycolysis by 18FFDG PET Scanning in Subjects With Non-Small Cell Lung Cancer [NCT01017133]Phase 156 participants (Anticipated)Interventional2009-05-31Completed
The Efficacy of a Toothpaste to Reduce Sensitivity [NCT00763269]Phase 3626 participants (Actual)Interventional2008-09-30Completed
Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish Versus Casein Phosphopeptide Amorphous Calcium Phosphate Containing Fluoride Varnish: Randomized Clinical Trial [NCT04614727]50 participants (Anticipated)Interventional2021-02-10Not yet recruiting
Clinical Study to Compare Dental Plaque Control [NCT00758394]Phase 329 participants (Actual)Interventional2007-09-30Completed
Medical Management of Caries in the Primary Dentition Using Silver Nitrate: A Pilot Study [NCT02604134]Early Phase 1122 participants (Actual)Interventional2014-07-31Completed
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration [NCT05758662]180 participants (Anticipated)Observational2023-04-30Not yet recruiting
The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract [NCT04136639]30 participants (Actual)Interventional2019-06-01Completed
Imaging for Prostate Cancer Metastasis Detection - Traditional Imaging (Bone Scan and CT) Versus PSMA-PET-CT, SPECT-CT and Whole-Body MRI [NCT03537391]80 participants (Actual)Interventional2018-03-01Completed
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics [NCT00763256]Phase 333 participants (Actual)Interventional2006-05-31Completed
Early Childhood Caries in Jordanian Children: Prevalence, Risk Factors and Prevention Using Silver Diamine Fluoride [NCT05748054]159 participants (Actual)Interventional2019-11-01Completed
Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars [NCT02592278]Phase 4180 participants (Actual)Interventional2015-03-31Completed
Caries Preventive Effect of Salt Fluoridation in Preschool Children in The Gambia [NCT02585882]441 participants (Actual)Interventional2012-03-31Completed
An Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body PET Scans in Patients for Whom 99m Tc MDP Bone Scans Would Normally be Indicated. [NCT00922519]9,999 participants (Anticipated)Observational2009-06-30Recruiting
Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer [NCT00928252]Phase 1/Phase 225 participants (Actual)Interventional2009-06-30Completed
The Effect of Periodontal Treatment and the Use of a Triclosan/Copolymer/Fluoride Toothpaste on Glycaemic Control in Diabetics. [NCT00762762]Phase 360 participants (Actual)Interventional2006-03-31Completed
EVALUATION OF AN ALTERNATIVE TECHNIQUE FOR THE APPLICATION OF SODIUM FLUOROPHOSPHATE: A 2-YEARS DOUBLE-BLIND RCT [NCT05810389]Phase 4300 participants (Actual)Interventional2017-04-01Completed
Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City. [NCT05314660]Phase 4135 participants (Actual)Interventional2020-01-15Completed
A Randomised Controlled Trial to Measure Effectiveness of Sodium Fluoride Varnish to Prevent Dental Caries in School Children Between Age of 6 and 7 Years [NCT02877888]Phase 1/Phase 2320 participants (Actual)Interventional2016-08-31Completed
In Vivo Evaluation of the Antimicrobial Activity of Diamine Silver Fluoride and Potassium Iodide on Dentin Carious Lesions in Kuwaiti Subjects. [NCT02771704]5 participants (Actual)Interventional2015-10-31Completed
Randomized Clinical Trial on Preventing and Arresting Root Surface Caries Using Silver Diammine Fluoride Solution in Older Adults Living in Fluoridated and Non-fluoridated Areas [NCT02742142]Phase 2/Phase 3534 participants (Actual)Interventional2012-10-31Completed
A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as a Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor, in Men With Castration-Resistant Prostate Cancer and Bone Metastases (BMS #180-279) [NCT00936975]Phase 218 participants (Actual)Interventional2009-09-30Completed
Effectiveness Silver Diamine Fluoride Versus Sodium Fluoride in Arresting Caries Around Crown Margins in Older Adults [NCT04255251]Early Phase 1200 participants (Anticipated)Interventional2021-06-26Recruiting
A Randomized Controlled Clinical Trial to Evaluate Late First to Mid-Second Trimester Introduction of Advanced Daily Oral Hygiene on Gingivitis and Maternity Outcomes [NCT01549587]746 participants (Actual)Interventional2012-02-29Completed
Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth: a Randomized Placebo-controlled Study. [NCT01477385]183 participants (Anticipated)Interventional2012-01-31Recruiting
18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques [NCT00882609]Phase 3550 participants (Anticipated)Interventional2009-01-31Recruiting
A Randomised, Controlled, Examiner Blind, Methodology Development Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral Microbiome [NCT06048809]50 participants (Anticipated)Interventional2024-06-01Not yet recruiting
Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions Among a Group of Egyptian Children : A Randomized Clinical Trial [NCT05064137]30 participants (Anticipated)Interventional2022-03-31Not yet recruiting
Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial [NCT05761041]Phase 3140 participants (Actual)Interventional2022-03-28Completed
Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes [NCT00066963]Phase 3376 participants (Actual)Interventional2002-10-31Completed
Phase 2 Efficacy & Safety Evaluation of Advantage Anti-Caries Varnish for Primary Prevention [NCT04947527]Phase 2274 participants (Actual)Interventional2022-06-04Active, not recruiting
The Use of Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients: A Randomised Controlled Trial [NCT04710927]38 participants (Actual)Interventional2019-12-01Completed
A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity When Comparing Two-step Toothpaste to a Regular Dentifrice [NCT02543060]60 participants (Actual)Interventional2015-06-30Completed
[NCT02613130]60 participants (Actual)Interventional2015-11-30Completed
Comparison of the Clinical Effectiveness of 8% Arginine/1450 Ppm Sodium Monofluorophosphate Versus 5% Potassium Nitrate/2500 Ppm Sodium Fluoride in Dentin Hypersensitivity Therapy: A Randomized Controlled Clinical Trial [NCT02829879]Phase 350 participants (Anticipated)Interventional2015-12-31Recruiting
Investigation of Dental Plaque and Gingival Index [NCT00759031]Phase 319 participants (Actual)Interventional2008-02-29Completed
Total Salivary Fluoride Concentration of Healthy Adult Subjects Following Toothbrushing With Different Formulations of Fluoridated Toothpastes With and Without Post-brushing Water Rinsing. A Double Blinded Randomised Controlled Trial [NCT02740803]120 participants (Actual)Interventional2016-04-30Completed
Phase II Trial of Radium-223 in Biochemically Recurrent Prostate Cancer [NCT04206319]Phase 226 participants (Anticipated)Interventional2020-09-22Recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Mineral Trioxide Aggregate as Indirect Pulp Capping Agents in Deeply Carious Young Permanent Molars Randomized Controlled Clinical Trial [NCT05425368]30 participants (Anticipated)Interventional2022-08-01Not yet recruiting
Reducing Oral Health Disparities of Older Adults: Comparative Effectiveness of 2 Treatments [NCT03916926]590 participants (Anticipated)Interventional2019-09-18Active, not recruiting
F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study [NCT00956163]Early Phase 150 participants (Actual)Interventional2010-03-31Completed
Randomized Controlled Examiner-Blind Phase II Exploratory Clinical Study to Characterize the Efficacy Profile of an Experimental Dual Active Combination Dentifrice for the Relief of Dentin Hypersensitivity, in Subjects With Clinically Diagnosed Dentin Hyp [NCT03943095]Phase 2123 participants (Actual)Interventional2019-05-13Completed
The Behavioural Engagement of Dental Nurses Applying the Fluoride Varnish to Young Children: the BEHAVE Study [NCT00881790]509 participants (Actual)Observational2009-04-30Completed
A Randomised Controlled Trial Investigating a Comparison of Fluoride Varnish vs Self-Etching Dentine Bonding Agent in the Reduction of Cervical Dentine Sensitivity in Patients Attending a General Dental Practice in West Sussex, UK. [NCT02919202]26 participants (Actual)Interventional2016-10-26Completed
Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion [NCT04005417]1,036 participants (Actual)Observational2018-01-08Completed
Role of the Serotoninergic System in Impulse Control Disorders in Parkinson's Disease [NCT03970239]45 participants (Anticipated)Interventional2019-05-13Recruiting
A Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell Cancer [NCT04981509]Phase 265 participants (Anticipated)Interventional2022-06-10Recruiting
Effects of DIammine SIlver Fluoride Placed Over Cervical Lesions of Permanent Teeth to Reduce Tooth Sensitivity [NCT01063530]144 participants (Anticipated)Interventional2010-02-28Not yet recruiting
Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth [NCT01881100]81 participants (Actual)Interventional2011-01-31Completed
18F- Sodium Fluoride PET Imaging as a Replacement for Bone Scintigraphy [NCT01930812]Phase 3286 participants (Actual)Interventional2014-07-31Completed
Cariostatic and Remineralizing Effects of Three Different Dental Varnishes (A Clinical Trial) [NCT04887389]Phase 4115 participants (Anticipated)Interventional2021-08-01Active, not recruiting
Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction [NCT04642846]155 participants (Anticipated)Interventional2020-11-21Recruiting
Preventive Therapy of White Spot Lesions Using Different Remineralizing Agents in Children From 3 to 12 Years Old [NCT04705428]75 participants (Actual)Interventional2021-01-01Completed
Phase III RCT of the Effectiveness of Silver Diamine Fluoride in Arresting Cavitated Caries Lesions [NCT03649659]Phase 3831 participants (Actual)Interventional2018-10-08Completed
Effect of Therapeutic Measures in Dental Caries Reduction in Children With Primary Dentition From Metropolitan Area Sorrounded Medellín City. A Clinical Trial [NCT00475618]Phase 3180 participants (Actual)Interventional2007-05-31Completed
Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water [NCT01978041]Phase 120 participants (Actual)Interventional2013-01-31Completed
Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Fissure Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children : A Randomized Clinical Trial ( Part 1) [NCT04603573]91 participants (Anticipated)Interventional2021-07-10Recruiting
Efficacy of a Fluoride Varnish and a Glass Ionomer Sealant on Cervical Dentin Hypersensitivity: A Randomized Clinical Trial [NCT04591444]Phase 3121 participants (Actual)Interventional2017-01-31Completed
Fluoride Varnish Trial in High Caries Preschoolers [NCT00067353]Phase 3500 participants Interventional2003-11-30Completed
Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial [NCT02016001]380 participants (Anticipated)Interventional2013-04-30Recruiting
Effectiveness of Biannual Application of Silver Nitrate Solution Followed by Sodium Fluoride Varnish in Arresting Early Childhood Caries in Preschool Children: a 30-month, Randomised, Double-blind, Non-inferiority Trial [NCT02019160]Phase 31,070 participants (Actual)Interventional2014-09-30Completed
Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions: A Mono-centre, Split-mouth, Double-blinded, Placebo Controlled, Randomised, Post Marketing Clinical Study [NCT02020681]40 participants (Actual)Interventional2013-09-30Completed
Impact of Maternal Xylitol Consumption on Mutans Sterptococci ,Plaque and Caries Levels in Children [NCT02036151]Phase 460 participants (Actual)Interventional2009-02-28Completed
Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02773758]Phase 4143 participants (Actual)Interventional2016-01-01Completed
Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs [NCT01116739]Phase 32,060 participants (Actual)Interventional2011-04-30Completed
Nanosilver Fluoride: a Microbiological and Clinical Trial [NCT01950546]Phase 130 participants (Actual)Interventional2014-09-30Completed
To Access the Effects of Mucositis in Adults With Dental Implants [NCT01072201]Phase 360 participants (Actual)Interventional2007-06-30Completed
Positron Emission Tomography Study in Patients With Non-Hodgkin Lymphoma [NCT00712556]55 participants (Actual)Observational2008-05-31Completed
A Pilot Study of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumors [NCT01165632]Early Phase 124 participants (Actual)Interventional2010-07-26Active, not recruiting
An Observational Multi-cite Study to Evaluate and Compare the Effectiveness of Various Tooth Specific Treatments in the Management of Early Caries Lesions [NCT04933331]744 participants (Anticipated)Observational2020-12-07Active, not recruiting
Clinical Evaluation of the Effect of an Experimental Toothpaste on the Reduction of Dental Plaque and Gingival Inflammation [NCT02552589]241 participants (Actual)Interventional2015-09-30Completed
A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Gingival Health [NCT03970759]2,890 participants (Actual)Observational2018-01-08Completed
[NCT02637830]12 participants (Actual)Interventional2012-01-31Completed
Glass Ionomer Sealant Versus Fluoride Varnish Application to Prevent Occlusal Caries Among Preschool Children - a Randomized Controlled Trial [NCT04163354]348 participants (Anticipated)Interventional2018-04-11Enrolling by invitation
Impact of Basic Periodontal Therapy in the Levels of Porphyromonas Gingivalis and Aggregatibacter Actinomycetemcomitans Subgingival and Its Association With Vascular Function [NCT02716259]120 participants (Anticipated)Interventional2016-03-31Recruiting
Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial [NCT00612469]69 participants (Actual)Interventional2005-10-31Completed
Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate [NCT04213573]Phase 2/Phase 360 participants (Anticipated)Interventional2020-01-21Suspended(stopped due to because of corona virus epidemic)
Assessment of the Oral Tissue Tolerance of a Potassium Oxalate Containing Mouthrinse [NCT01009554]96 participants (Actual)Interventional2009-10-31Completed
Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model [NCT01005966]Phase 365 participants (Actual)Interventional2008-11-30Completed
Determination of the Oral Irritation and Sensitization Potential of Two Experimental Potassium Oxalate Containing Mouthrinses [NCT01156376]80 participants (Actual)Interventional2010-06-30Completed
Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma [NCT02876991]110 participants (Anticipated)Interventional2016-02-29Recruiting
Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial [NCT04032184]66 participants (Anticipated)Interventional2019-10-01Not yet recruiting
An in Situ Clinical Trial to Evaluate the Efficacy of a Calcium and Phosphate Enriched Sodium Monofluorophosphate Toothpaste on Enamel Lesion Remineralisation [NCT04155658]55 participants (Actual)Interventional2019-11-25Completed
Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial [NCT04245787]48 participants (Anticipated)Interventional2020-02-29Not yet recruiting
Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study [NCT02591147]41 participants (Actual)Interventional2016-01-07Completed
Pharmacokinetics of Advantage Arrest in Children [NCT04186663]Phase 259 participants (Actual)Interventional2019-08-01Completed
Prevention of Transmission of Mutans Streptococci From Mother to Child [NCT00066040]280 participants Interventional2001-01-31Completed
Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents: 2-years Randomized Clinical Trial [NCT05296213]45 participants (Actual)Interventional2019-12-01Completed
A Prospective Study of the RefleXion [18F]- DCFPyL PET-CT Subsystem Imaging Performance in Patients With Prostate Cancer [NCT05470699]30 participants (Actual)Interventional2022-08-29Active, not recruiting
18F-fluoride (18F-NaF) Positron Emission Tomography (PET) for Identification of Ruptured and High-Risk Coronary Atherosclerotic Plaques [NCT02607748]Phase 441 participants (Actual)Interventional2015-11-13Completed
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis [NCT00926328]Phase 3120 participants (Actual)Interventional2007-06-30Completed
A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries [NCT01446107]502 participants (Actual)Interventional2007-12-31Completed
The Effect of Brushing With Fluoride Toothpaste on Dental Plague Control for Elementary School Students [NCT06116825]400 participants (Actual)Interventional2022-10-20Completed
Organizing Family-based Health Promotion for Young Children in Public Dental Service [NCT01854502]804 participants (Actual)Interventional2008-01-31Completed
Salivary Levels of Fluoride and Silver 7 Days After Treatment With Diammine Silver Fluoride [NCT01860391]6 participants (Actual)Interventional2012-12-31Completed
FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients [NCT01864083]Early Phase 130 participants (Actual)Interventional2013-05-31Completed
Comparative Evaluation of Giomer Varnish vs Fluoride Varnish as Desensitizing Agents Among a Group of Children With Molar Incisor Hypomineralization : A Controlled Clinical Trial [NCT05542667]Phase 324 participants (Anticipated)Interventional2025-02-28Not yet recruiting
Imaging Cell Proliferation With FLT PET: A Pilot Study in Paediatric Lymphoma Patients With Equivocal FDG PET Findings [NCT04028804]8 participants (Actual)Observational2011-07-31Completed
Phase 3 Randomized Trial Of PSMA PET Prior to Definitive Radiation Therapy for Unfavorable Intermediate-Risk or High-Risk Prostate Cancer [PSMA dRT] [NCT04457245]Phase 354 participants (Actual)Interventional2020-08-14Terminated(stopped due to accrual)
Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction [NCT01040169]79 participants (Actual)Interventional2008-05-31Completed
Effectiveness of Sylc Air Abrasion Bioactive Glass Technology Versus Fluoride Varnish Application in Management of Hypersensitivity of Non-Carious Cervical Lesions: Randomized Clinical Trial. [NCT03285360]Phase 150 participants (Actual)Interventional2017-10-01Completed
Plaque Removal Efficacy of Four Dentifrices in a Single Brushing Model [NCT03285984]56 participants (Actual)Interventional2012-03-27Completed
Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children [NCT00435500]Phase 31,320 participants Interventional2003-06-30Active, not recruiting
Assessing Three Oral Care Regimen on Plaque, Gingivitis, and Tooth Whitening [NCT02940821]142 participants (Actual)Interventional2016-05-30Completed
Comparative Study Using Biomimetic Remineralization Versus Fluoride Varnish In Management Of White Spot Lesion In Post Orthodontic Treated Patient: (Split Mouth Technique ) A Randomized Clinical Trial [NCT02913885]Phase 264 participants (Anticipated)Interventional2017-01-31Not yet recruiting
The Biodistribution of N-{4-[3'-[F-18] Fluoroethylphenyl)Amino]-6-quinazolinyl}-Acrylamide ([F-F18]FEQA) in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC) and in Healthy Subjects: A Pilot Study [NCT00444223]3 participants (Actual)Interventional2004-05-04Terminated(stopped due to poor recruitment)
Clinical Evaluation of Silver Diamine Fluoride Combined With Potassium Iodide Versus Silver Diamine Fluoride in Management of Class I Carious Lesions Over a Period of 12 Months Follow-up: A Randomized Controlled Clinical Trial [NCT05485272]42 participants (Anticipated)Interventional2022-02-01Recruiting
A 12-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population [NCT05750745]245 participants (Actual)Interventional2023-05-08Completed
Eficácia de dentifrício Com Sistema de liberação Controlada de flúor Para remineralização de lesões Iniciais de cárie: Estudo clínico Randomizado. [NCT05139966]Phase 2/Phase 321 participants (Actual)Interventional2017-08-03Completed
Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-Targeted Therapy [NCT02149173]29 participants (Actual)Interventional2010-09-15Terminated(stopped due to Terminated due to low accrual)
Efficacy of Salivary Bacteria and Post Brushing [NCT00981825]Phase 322 participants (Actual)Interventional2007-10-31Completed
Evaluation of the Antibacterial Effect of Nano Silver Fluoride Versus Chlorhexidine on Occlusal Carious Molars Treated With Partial Caries Removal Technique: A Randomized Clinical Trial [NCT03186261]Phase 344 participants (Actual)Interventional2018-04-01Completed
Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel [NCT00268138]Phase 4314 participants (Anticipated)Interventional2006-04-30Recruiting
Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period Between a Single Topical Application of a Dentin-desensitizing Agent (Gluma) and Other Materials: A Randomized Clinical Trial [NCT04351412]55 participants (Actual)Interventional2020-01-10Completed
The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial [NCT05221749]Phase 350 participants (Actual)Interventional2022-03-15Terminated(stopped due to Only the 1 month follow-up was completed. The principal investigator could not complete the 3 month follow-up appointments and was not calibrated with other dentists who were available at the time.)
An Investigation of the Role of 18F-Sodium Fluoride and 18F-Flurodeoxyglucose PET CT and USPIO Enhanced MRI in Imaging Carotid Artery Inflammation and Mineralization. [NCT01674257]60 participants (Anticipated)Observational2013-01-31Recruiting
Comparative Effectiveness of Treatments to Prevent Dental Caries Given to Rural Children in School-based Settings: Protocol for a Cluster Randomized Controlled Trial [NCT03448107]3,960 participants (Anticipated)Interventional2017-09-20Recruiting
Fluoride Administered and Retained After Topical Fluoride Varnish [NCT01754831]Early Phase 16 participants (Actual)Interventional2011-12-31Completed
A Randomized, Crossover, Controlled, Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101 in Healthy Adult Subjects [NCT06182267]Phase 130 participants (Anticipated)Interventional2023-11-27Active, not recruiting
Effect of Vitamin D Supplementation on Salivary Biomarkers; Certain Proteins and Cariogenic Oral Microbiome for Medical Management of Dental Caries: A Randomized Controlled Trial [NCT06172764]Phase 490 participants (Anticipated)Interventional2023-12-12Recruiting
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT [NCT03604315]Phase 1120 participants (Anticipated)Interventional2018-12-18Recruiting
Phase 2 Efficacy Evaluation Of Advantage Anti-Caries Varnish [NCT03082196]Phase 2284 participants (Actual)Interventional2017-03-30Completed
Effectiveness and Retention of Pit and Fissure Sealants in Rural Setup: A School-based Clinical Trial in Nepal [NCT05894200]377 participants (Anticipated)Observational [Patient Registry]2023-08-10Enrolling by invitation
Clinical Efficacy of Caries Infiltration (Icon) - A Randomized, Blinded and Controlled Pilot Study of Early Caries Progression Detection [NCT01796106]12 participants (Actual)Interventional2015-03-31Terminated(stopped due to Recruitment slower than expected.)
Effect on Bacterial Glycolytic Acid Formation on Plaque [NCT00762450]Phase 36 participants (Actual)Interventional2008-04-30Completed
Compare Anti-inflammatory Dentifrices [NCT00762528]Phase 449 participants (Actual)Interventional2009-02-28Completed
Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Six-month Study in Italy [NCT05821712]Phase 380 participants (Actual)Interventional2021-03-08Completed
Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste [NCT01072188]Phase 345 participants (Actual)Interventional2008-07-31Completed
Progression of Active Microcavitated Carious Lesions on Primary Teeth Occlusal Surfaces: Randomize Clinical Trial [NCT04127357]22 participants (Actual)Interventional2015-03-05Completed
Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion [NCT01128972]Phase 236 participants (Actual)Interventional2009-08-31Completed
Glass Ionomer Sealant and Fluoride Varnish Randomized Clinical Trial [NCT01129440]Phase 2597 participants (Actual)Interventional2011-06-30Completed
Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer [NCT01541358]2 participants (Actual)Interventional2012-05-31Terminated(stopped due to Low accrual and no funding)
Effectiveness of Nano-hydroxyapetite Care Paste in Reducing Dentinhypersenstitivity: A Double Blind Randomized Control Trial [NCT02936830]Phase 463 participants (Actual)Interventional2016-10-31Completed
Evaluation of the Efficacy of Two Potassium Oxalate Containing Mouthrinses for Relieving Dentinal Hypersensitivity [NCT01133379]174 participants (Actual)Interventional2010-05-31Completed
Compare the Clinical Efficacy of Prototype Toothpastes [NCT00926029]Phase 398 participants (Actual)Interventional2008-01-31Completed
Effectiveness of Silver Diamine Fluoride in Arresting Early Childhood Caries: Randomized Controlled Clinical Trial [NCT04514094]100 participants (Actual)Interventional2018-01-01Completed
A Long-term Retrospective Cohort Study in Children With Autism Spectrum Disorders on the Effectiveness of Dental Sealants and Fluoride Varnish to Prevent the Occurrence of New Caries [NCT05146479]232 participants (Actual)Observational2006-01-01Completed
NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either an Antimicrotubule Directed Agent or Androgen Receptor (AR)-Directed Therapies [NCT01516866]58 participants (Actual)Observational2011-11-30Completed
Effectiveness of Remineralization Agents on the Prevention of Dental Bleaching Induced Sensitivity [NCT04855279]64 participants (Actual)Interventional2019-01-07Completed
Evaluation of the Efficacy of Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth [NCT04804423]Phase 2/Phase 330 participants (Actual)Interventional2020-01-13Completed
Comparative Evaluation of Two-Year Clinical Performance of Three Universal Adhesives in Posterior Restorations [NCT05696431]30 participants (Anticipated)Interventional2022-11-05Recruiting
The Effect of Fluoride Varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate, and Resin Infiltration in the Treatment of White Spot Lesions After Orthodontic Therapy: A Randomized Controlled Trial [NCT06051981]Phase 488 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA) [NCT05781321]Phase 2170 participants (Anticipated)Interventional2023-03-23Recruiting
Clinical and Radiographic Evaluation of Deep Occlusal Carious Molars Treated With Partial Caries Removal With and Without Using Silver Diamine Fluoride (SDF) Prior to Resin Composite Restoration. (A Randomized Clinical Trial) [NCT04561934]Phase 140 participants (Anticipated)Interventional2020-12-01Not yet recruiting
Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial. [NCT04731766]42 participants (Anticipated)Interventional2021-11-01Not yet recruiting
Combination Osteogenic Therapy in Established Osteoporosis [NCT00018447]Phase 20 participants Interventional1998-11-30Completed
Clinical Efficacy of Combined Application of Diode Laser and Different Remineralizing Agents on Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions [NCT05871619]45 participants (Actual)Interventional2022-05-05Completed
NCI-Sponsored Trial for the Evaluation of Safety and Preliminary Efficacy Using [F18] Fluorothymidine (FLT) As a Marker of Proliferation in Patients With Primary Brain Tumors [NCT00276770]12 participants (Actual)Interventional2006-02-28Completed
Minimally Invasive Treatment Approach for Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride With Functionalized Tricalcium Phosphate and Their Effects on Oral Health Related Quality of Life: A Pragmatic Randomized Control Trial [NCT05772039]Phase 472 participants (Anticipated)Interventional2022-01-18Enrolling by invitation
F-18 Sodium Fluoride PET/CT Guided Robotic Arm-assisted Pain Palliation in Chronic Nociceptive Low Backache [NCT05560165]30 participants (Anticipated)Interventional2022-01-01Recruiting
Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar: Randomized Clinical Trial. [NCT04765904]120 participants (Anticipated)Interventional2021-08-01Not yet recruiting
Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin [NCT04145102]80 participants (Actual)Interventional2019-01-01Completed
Evaluate Clinical Research From Commerical Oral Care Products [NCT00759187]Phase 325 participants (Actual)Interventional2008-01-31Completed
Clinical Study to Examine Brushing on Dental Implants [NCT00762619]Phase 3105 participants (Actual)Interventional2007-04-30Completed
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing [NCT00762853]Phase 320 participants (Actual)Interventional2008-05-31Completed
Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes [NCT00762515]Phase 344 participants (Actual)Interventional2008-02-29Completed
[NCT02513212]24 participants (Actual)Interventional2015-07-31Completed
Xylitol for Caries Prevention in Inner-City Children [NCT01901250]562 participants (Actual)Interventional2007-08-31Completed
F18 NaF PET/CT and Whole Body and Axial MRI for the Detection of Metastases in Patients With Biochemical Recurrence of Prostate Cancer [NCT01967862]54 participants (Actual)Interventional2013-12-31Completed
Randomized Clinical Trial on Preventing and Arresting Dental Root Surface Caries Using Silver Diamine Fluoride Solution in Community-dwelling Older Adults [NCT02360124]Phase 2/Phase 3323 participants (Actual)Interventional2012-01-31Completed
Efficacy of Miswak When Compared to Fluoridated Toothpaste for the Maintenance of Oral Hygiene in Young Adults [NCT04561960]Phase 430 participants (Actual)Interventional2020-09-30Completed
The Effect of Light-cured Fluoride Varnish to Remineralize Post-orthodontic White Spot Lesions and Change the Oral Microbiome: a Double-blind, Split-mouth Randomized Clinical Trial [NCT04528134]120 participants (Anticipated)Interventional2022-02-07Recruiting
NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity. [NCT01610167]151 participants (Actual)Interventional2011-09-30Completed
Pilot Clinical Study to Evaluate Efficacy of a Professionally Delivered Fluoride Varnish on Erosive Tooth Wear in an In-Situ Mode [NCT06136754]Phase 324 participants (Actual)Interventional2022-04-08Completed
Prospective Cohort Study: Efficacy of the Use of 38% Silver Diamine Fluoride and 5% Sodium Fluoride Varnish in Patients 4 to 12 Years for the Treatment of Caries and Its Association With Other Aspects of Relevance [NCT05638217]199 participants (Actual)Observational2022-11-07Completed
Evaluation of Silver Diamine Fluoride Application in Molar-Incisor Hypomineralisation-Affected Molars [NCT06165042]120 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Cost-efficacy of Silver Diammine Fluoride to Control Caries Lesions in Erupting Permanent First Molars - Randomized Clinical Trial. [NCT01508611]192 participants (Actual)Interventional2015-02-28Active, not recruiting
Low-fluoride Acidic Liquid Dentifrice in Non-fluoridated Communities: a Randomized Clinical Trial [NCT01623362]Phase 3212 participants (Actual)Interventional2010-09-30Completed
Comparison of Fluoride Varnish With Two Different Desensitizers in Reducing Dentinal Hypersensitivity [NCT03177109]Phase 360 participants (Anticipated)Interventional2017-05-03Recruiting
Characterization of Fluoride and Silver Pharmacokinetics of Diammine Silver Fluoride Applied Topically to Teeth of Adults [NCT01664871]Phase 16 participants (Actual)Interventional2011-07-31Completed
Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina [NCT01665248]20 participants (Actual)Interventional2012-08-31Terminated
Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa [NCT05596149]80 participants (Anticipated)Interventional2022-11-01Recruiting
Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model. [NCT02388178]Phase 20 participants (Actual)Interventional2015-04-30Withdrawn(stopped due to The study was stopped due to business reasons.)
Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter Toothpastes Followed by Fluoride Mouthrinses [NCT05601154]Early Phase 120 participants (Anticipated)Interventional2023-03-23Enrolling by invitation
Prevention Management Model for Early Childhood Caries [NCT00066950]Phase 3361 participants (Actual)Interventional2003-03-31Completed
Effect of Fluoride Varnish and CPP-ACP Paste on Oral and Salivary Symptoms of Patients Under Chemotherapy: A Double-blind Clinical Trial [NCT01737307]Phase 230 participants (Actual)Interventional2011-03-31Completed
Masking and Therapeutic Effect of Different Mouth Rinses in Patients With Oral Malodor. [NCT01747226]96 participants (Anticipated)Interventional2013-03-31Not yet recruiting
Caries-preventive Effectiveness of a Dentifrice Containing 5.000 Ppm Fluoride - a Randomized Controlled Trial in Adolescents With Fixed Orthodontic Appliances [NCT01768390]Phase 4500 participants (Actual)Interventional2008-01-31Completed
Three Month Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis [NCT01821261]0 participants (Actual)Interventional2014-04-30Withdrawn(stopped due to Business Decision)
A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth [NCT01829334]Phase 2329 participants (Actual)Interventional2006-06-30Completed
Clinical Efficacy in Reducing Established Dental Plaque and Gingivitis of a Toothpaste Containing 0.3% Triclosan, 2% Copolymer / Sodium Fluoride and a Manual Toothbrush as Compared to an Oral Hygiene Multi-component Regimen Encompassing the Use of a Manua [NCT02366689]Phase 4179 participants (Actual)Interventional2014-06-30Completed
[NCT02613117]104 participants (Actual)Interventional2015-11-30Completed
Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes [NCT00708305]Phase 365 participants (Actual)Interventional2008-06-30Completed
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02731833]Phase 4229 participants (Actual)Interventional2016-04-01Completed
Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar: [NCT04737057]72 participants (Anticipated)Interventional2021-05-01Not yet recruiting
Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer [NCT00928174]Phase 1/Phase 227 participants (Actual)Interventional2009-06-30Completed
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02923895]Phase 4197 participants (Actual)Interventional2016-10-11Completed
Pilot Trial of Oral Cabozantinib/XL184 in Metastatic Castrate Resistant Prostate Cancer to Explore the Changes in Bone and Tumor Imaging Related Pathways [NCT01812668]20 participants (Actual)Interventional2013-03-31Completed
Pharmacokinetics of Advantage Arrest [NCT04184271]Phase 216 participants (Actual)Interventional2017-08-01Completed
Functional Imaging of T-Cell Activation With [18F]F-AraG in Urothelial Carcinoma Patients Receiving Neoadjuvant Therapy or Patients With Cancer Receiving Standard of Care Anti-PD-1/L1 [NCT03007719]Phase 24 participants (Actual)Interventional2017-03-07Terminated(stopped due to Low Accrual)
Evaluation of Caries Prevention Based on Genetic Etiology and Risk: Protocol for a Multicenter Randomized Controlled and Adaptive Trial for Oral Personalized Care (PRECARIES) [NCT05600517]520 participants (Anticipated)Interventional2021-08-25Recruiting
Assessment of a Potassium Oxalate Containing Formulation for the Relief of Dentinal Hypersensitivity [NCT02113579]375 participants (Actual)Interventional2014-03-31Completed
Changes in Streptococcus Mutans Colonization With Different Oral Hygiene Protocols in Adult Patients With Fixed Orthodontic Appliance:A Randomized Clinical Trial [NCT05016713]27 participants (Anticipated)Interventional2021-06-01Recruiting
The Effect of Toothpastes Based on Alkaline Thermal Water With and Without Fluorinated Derivative on Gingivitis, Dentin Hypersensitivity, and Oral Hygiene: a Randomized Clinical Trial [NCT05623761]Phase 484 participants (Actual)Interventional2022-11-01Completed
18F-FMAU for Imaging in Cancer Patients [NCT02079181]30 participants (Anticipated)Interventional2014-01-31Recruiting
The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars [NCT01438866]Phase 4148 participants (Actual)Interventional2011-10-31Completed
Efficacy and Cost-effectiveness of Different Caries Preventive Protocols in a High -Risk Group of Young Egyptian Adults: A Randomized Control Trial [NCT05962632]Early Phase 144 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Comparing Chlorhexidine Gluconate Rinse, Sodium Fluoride Rinse, Water Rinse, and Chewing Gum in Regard to Streptococcus Mutans Reduction [NCT02598778]Phase 212 participants (Actual)Interventional2015-11-01Terminated(stopped due to Study discontinued early due to time constraints and lack of selectivity in agar used in the identification of the target (Streptococcus mutans). Only 12 participants out of a planned 40 were enrolled.)
Short- and Long Term Antibacterial Effects of a Single Rinse With Different Mouthwashes: a Randomized Clinical Trial [NCT05178823]Phase 4171 participants (Actual)Interventional2017-06-01Completed
Evaluation of Remineralization Potential of Self Assembling Peptide P11-4 Combined With Fluoride Compared to Fluoride Varnish in Management of Incipient Carious Lesions Using Laser Fluorescence: Randomized Clinical Trial [NCT05094492]58 participants (Anticipated)Interventional2021-10-30Not yet recruiting
Remineralization Effect of NaF, NaF With TCP, NaF With CPP-ACP, and NaF With CXP Varnishes on Newly Erupted First Permanent Molars: a Randomised Controlled Trial [NCT04124887]40 participants (Actual)Interventional2017-02-03Completed
The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars: Randomized Clinical Trial [NCT04889196]Phase 340 participants (Anticipated)Interventional2021-09-01Not yet recruiting
Avaliação da Carga do vírus SARS-CoV-2 na Cavidade Oral e na Saliva após desinfecção Com soluções Antimicrobianas Orais e dentifrícios. [NCT04537962]202 participants (Actual)Interventional2020-07-14Completed
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02612064]488 participants (Actual)Interventional2015-11-01Completed
Open-label Clinical Trial on the Safety and Efficacy of 18F-sodium Fluoride (NaF) PET Imaging in Patients in Need of a Standard 99mTc Bone Scintigraphy [NCT04842071]Phase 32,500 participants (Anticipated)Interventional2008-01-01Recruiting
Effectiveness of a Bonding and a Fluoride Varnish for Long-term Dentin Hypersensitivity Treatment: a Split-mouth Randomized Clinical Trial [NCT04813848]38 participants (Actual)Interventional2020-01-07Completed
Post-operative Pain and Child Behavior of Hall Technique Versus Silver Diamine Fluoride in the Management of Carious Primary Molars: Randomized Clinical Trial [NCT04794426]Phase 340 participants (Anticipated)Interventional2021-06-01Not yet recruiting
Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children: A Randomized Clinical Trial(Part 2). [NCT04793256]91 participants (Anticipated)Interventional2021-04-30Not yet recruiting
A Randomized, Open-Label, Crossover, Controlled, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases of Malignant Tumors Compared With 99mTc⁃MDP-BS±SPECT [NCT05614518]Phase 3280 participants (Actual)Interventional2021-03-29Completed
NUPRO Sensodyne Prophylaxis Paste With NovaMin for the Treatment of Dentin Hypersensitivity. [NCT01669785]139 participants (Actual)Interventional2012-03-31Completed
Comparison of the Salivary Levels of Streptococcus Mutans in Pediatric Patients With Early Childhood Caries After the Application of Silver Diamine Fluoride or 5% Sodium Fluoride Varnish [NCT03089567]Early Phase 10 participants (Actual)Interventional2017-09-15Withdrawn(stopped due to Study was not conducted. No participants were enrolled)
A Prospective Randomized Controlled Trial for Prevention of Enamel White Spot Lesions During Fixed Orthodontic Treatment [NCT04342858]Phase 299 participants (Actual)Interventional2017-09-15Active, not recruiting
An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy [NCT01665911]28 participants (Actual)Interventional2012-08-31Completed
PET Imaging of Lung Cancer and Indeterminate Pulmonary Nodules With 18F-FSPG [NCT02448225]Phase 246 participants (Actual)Interventional2015-06-16Completed
A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity [NCT02542943]240 participants (Actual)Interventional2015-09-30Completed
Clinical Evaluation of Oral Hygiene Products in an In Situ Caries Model [NCT02399163]80 participants (Actual)Interventional2015-04-30Completed
A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model [NCT01657903]56 participants (Actual)Interventional2011-11-30Completed
Clinical Investigation Examining the Anticaries Efficacy of Three Dentifrices (1.5% Arginine in a Calcium Base, 8.0% Arginine in a Calcium Base, and 0.32% Sodium Fluoride in a Silica Base): a Two-year Caries Clinical Study [NCT05560945]Phase 36,000 participants (Actual)Interventional2019-04-15Completed
Phase II Study to Evaluate the Performance of PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Clinically Significant Prostate Cancer in Men Presenting Following a Positive Screen for Prostate Cancer [NCT04910425]Phase 2106 participants (Anticipated)Interventional2023-06-17Not yet recruiting
Evaluation of Remineralizing Efficacy of Grape Seed Extract Oil Versus Fluoride Mouthwash in Management of Post-Orthodontic White Spot Lesions: Randomized Clinical Trial [NCT04357093]40 participants (Anticipated)Interventional2021-02-28Not yet recruiting
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02924350]205 participants (Actual)Interventional2016-11-07Completed
Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients [NCT05527483]40 participants (Anticipated)Observational2022-04-21Recruiting
Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars [NCT05969756]114 participants (Anticipated)Interventional2023-07-31Recruiting
Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count :Randomized Controlled Trial [NCT03108313]Phase 258 participants (Anticipated)Interventional2017-03-03Recruiting
Effiacacy of Desensitizing Agent,After an In-office Vital Tooth Bleaching. A Randomized Double Blind Clinical Trial Trial. [NCT05569590]90 participants (Actual)Interventional2021-05-14Completed
Quantitative-imaging in Cardiac Transthyretin Amyloidosis [NCT05776212]140 participants (Anticipated)Observational2021-08-25Recruiting
Evaluation Of Fluoride Uptake By Dentine Following Pretreatment With Silver Diamine Fluoride And Potassium Iodide Under Resin Modified Glass Ionomer Restoration Versus Resin Modified Glass Ionomer Restoration Alone In Carious Primary Molars: (In Vitro Stu [NCT04777968]Phase 420 participants (Actual)Interventional2020-08-01Completed
A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity [NCT01831817]Phase 2140 participants (Actual)Interventional2013-01-31Completed
Fissure Caries Inhibition Study With Solea CO2-9.3μm Short-pulsed Laser - A Randomized, Single Blind, Prospective, Split Mouth Controlled, Clinical Trial [NCT02357979]60 participants (Actual)Interventional2018-02-08Completed
The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ [NCT01641237]Phase 372 participants (Actual)Interventional2012-03-31Completed
MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study [NCT02424097]Phase 440 participants (Actual)Interventional2013-05-31Completed
The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ [NCT02195583]62 participants (Actual)Interventional2014-06-30Completed
The Clinical Investigation of Colgate Total Toothpaste as Compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical St [NCT02360995]Phase 4129 participants (Actual)Interventional2014-06-30Completed
A Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity [NCT02371616]304 participants (Actual)Interventional2014-09-29Completed
A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity [NCT01827670]Phase 3119 participants (Actual)Interventional2013-02-28Completed
A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity [NCT03965039]120 participants (Actual)Interventional2019-07-08Completed
A Clinical Study to Evaluate the Efficacy of Pre-procedural and Pre-surgical Rinsing With an Antimicrobial Agent in Reducing Bacteria in Dental Aerosols and in the Oral Cavity [NCT02319668]Phase 438 participants (Actual)Interventional2015-02-01Completed
A Pharmacodynamic Study Using NaF PET/CT Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Metastatic Castrate Resistant Prostate Cancer to Bone [NCT01816048]Phase 28 participants (Actual)Interventional2013-05-31Terminated(stopped due to Study supporter (Takeda) ended study drug for prostate cancer; enrollment ended prematurely.)
Parental Satisfaction of Hall Technique Versus Silver Diamine Fluoride (SDF) in the Management of Carious Primary Molars Randomized Clinical Trial [NCT05249231]22 participants (Anticipated)Interventional2022-04-30Not yet recruiting
The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial [NCT02601833]Phase 398 participants (Actual)Interventional2016-01-31Completed
Evaluating the Impact of 18F-DOPA-PET on Neurosurgical Planning for Gliomas [NCT02020720]Early Phase 172 participants (Actual)Interventional2014-01-22Active, not recruiting
Imaging Using the Novel Radiotracer [18F] FluorThanaTrace([18F]FTT) by PET/CT in Patients With Breast Cancer [NCT05226663]Phase 236 participants (Anticipated)Interventional2022-04-01Recruiting
Study to Investigate the Initial Stages of Enamel Erosion in Vivo [NCT02533466]30 participants (Actual)Interventional2015-10-01Completed
Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest [NCT02536040]Phase 366 participants (Actual)Interventional2016-01-31Completed
Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis [NCT05731778]Phase 426 participants (Actual)Interventional2018-12-22Completed
A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms [NCT02207400]Phase 2246 participants (Actual)Interventional2014-08-25Completed
Effect of Sodium Fluoride at 1.1%, Associated or Not With the Low-level Light Therapy in the Prevention of Post-bleaching Sensitivity: a Randomized, Double-blind, Controlled Trial [NCT03044171]Phase 125 participants (Actual)Interventional2016-08-01Completed
The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions Using HOMINGS Technology. A Clinical Study [NCT02953886]Phase 421 participants (Actual)Interventional2016-11-30Completed
Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream [NCT02918617]Phase 2203 participants (Actual)Interventional2015-05-31Completed
A Randomized, Examiner Blind, Crossover, in Situ Erosion Study to Investigate the Efficacy of an Experimental Dentifrice in Remineralization of Previously Softened Enamel Compared to a Placebo Dentifrice [NCT03296072]Phase 362 participants (Actual)Interventional2017-11-13Completed
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial [NCT03063307]119 participants (Actual)Interventional2016-09-20Completed
A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity [NCT03405259]22 participants (Actual)Interventional2013-06-26Completed
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Preschool Children: a Randomized Clinical Trial With Different Periodicity and Concentration. [NCT02385474]Phase 3888 participants (Actual)Interventional2013-03-31Completed
Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions [NCT02341872]32 participants (Actual)Interventional2013-08-31Completed
Evaluation of Prevention Potential of Preventive Regimens Containing Herbal-based and Fluoride-based Toothpastes Versus Fluoride Varnish and Fluoride Toothpaste Only in High Caries Risk Patients: A Randomized Clinical Trial [NCT04436913]54 participants (Actual)Interventional2021-01-16Completed
A Pilot Study to Evaluate Stannous Fluoride in GCF and Subgingival Plaque [NCT03296657]20 participants (Actual)Interventional2017-08-23Completed
Caries Inhibition With CO2-Laser During Orthodontic Treatment [NCT04903275]41 participants (Anticipated)Interventional2021-09-01Not yet recruiting
Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: A Randomized Clinical Trial [NCT04485299]Phase 2/Phase 368 participants (Anticipated)Interventional2020-10-31Not yet recruiting
Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults [NCT04756557]192 participants (Actual)Interventional2021-01-01Completed
Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model [NCT00708097]Phase 357 participants (Actual)Interventional2008-04-30Completed
Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste in High Caries Risk Patients: Randomized Clinical Trial [NCT05109299]32 participants (Anticipated)Interventional2021-12-01Not yet recruiting
Clinical Efficacy of SDF and Laser in Preventing Initial Caries Progression With and Without Fissure Sealants in Primary and Permanent Molars [NCT06119126]Phase 223 participants (Actual)Interventional2020-06-01Completed
A Phase 2 Randomized, Double-blind, Active-controlled Multi-center Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices With 1.5%, 4.0% and 8.0% Arginine Each in Comparison With 0.24% Sodium Fluor [NCT04750902]Phase 22,000 participants (Actual)Interventional2021-01-21Active, not recruiting
Silver Diamine Fluoride: Novel Addition to the Prophylactic Bundle for Dental Management of Radiation-Induced Dental Caries in Oral and Pharyngeal Cancer Patients [NCT05403125]60 participants (Anticipated)Interventional2022-06-01Not yet recruiting
A Three-Month Bleeding-Model Clinical Study [NCT05916521]90 participants (Actual)Interventional2021-11-15Completed
A One-Month Bleeding-Model Clinical Study [NCT05916508]90 participants (Actual)Interventional2020-10-19Completed
Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid Using Chair Side(Potential of Hydrogen) pH Meter Assessment Method in Adult Population: Randomized Clinical Trial [NCT03143023]28 participants (Anticipated)Interventional2017-06-30Not yet recruiting
A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period [NCT03027908]239 participants (Actual)Interventional2016-10-19Completed
Cost-efficacy and Applicability of the Treatment of Moderate Caries Using Sealants as an Alternative to the Restorations on Occlusal Surfaces of Deciduous Teeth: a Randomized Controlled Trial [NCT03005405]96 participants (Anticipated)Interventional2015-02-28Active, not recruiting
A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene [NCT02221349]30 participants (Actual)Interventional2014-08-31Completed
A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model [NCT01607411]Phase 355 participants (Actual)Interventional2012-02-29Completed
A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste [NCT02207907]Phase 2247 participants (Actual)Interventional2014-08-31Completed
Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD) [NCT03015818]Phase 425 participants (Actual)Interventional2017-01-30Completed
The Comparative Efficacy of Three Oral Hygiene Multi-component Regimens Encompassing the Use of a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Established Dental Plaque and Gingivitis. [NCT02193165]Phase 3120 participants (Actual)Interventional2014-07-31Completed
Root Caries Prevention Using Fluoride Varnish Fortified With Strontium-doped Bioactive Glass Ceramic: a Randomized Double-blind Controlled Clinical Trial [NCT06131957]540 participants (Anticipated)Interventional2024-01-31Not yet recruiting
A Pilot Study to Evaluate Sampling Methods for Subgingival Plaque [NCT02841839]20 participants (Actual)Interventional2016-06-30Completed
Effect of Evolocumab on Coronary Artery Plaque Volume and Composition by Coronary CTA (CCTA) and Microcalcification by F18-NaF PET: A Phase 3 Study [NCT03689946]Phase 355 participants (Actual)Interventional2019-03-19Completed
Evaluation of an Experimental Mouth Rinse Device for Relieving Dentinal Hypersensitivity [NCT01727258]153 participants (Actual)Interventional2012-12-31Completed
Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Three Month Study [NCT04033575]Phase 488 participants (Actual)Interventional2019-03-06Completed
The Pharmacokinetics of Silver Diamine Fluoride (SDF) in Healthy Children [NCT04766775]15 participants (Actual)Interventional2020-07-03Active, not recruiting
Comparative Evaluation of Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride in Carious Primary Anterior Teeth [NCT04196829]Phase 415 participants (Actual)Interventional2020-01-02Active, not recruiting
Collection of Gingival Crevicular Fluid From Periodontitis Patients [NCT00763048]Phase 339 participants (Actual)Interventional2008-03-31Completed
Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo [NCT00875212]Phase 112 participants (Actual)Interventional2006-01-31Completed
Esthetic Effect of Casein Phosphopeptide-Amorphous Calcium Phosphate Varnish Versus Tricalcium Phosphate Varnish on Postorthodontic White Spot Lesions: A Randomized Pilot Study [NCT03217084]Phase 420 participants (Anticipated)Interventional2017-12-17Recruiting
A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity [NCT01592864]Phase 3120 participants (Actual)Interventional2012-03-31Completed
Non-invasive and Minimal Intervention in Dental Caries Management: Randomized Clinical Study [NCT04373356]30 participants (Anticipated)Interventional2020-07-01Not yet recruiting
Comparison Of The Caries-Protective Effect Of Fluoride Varnish (Duraphat®) With Treatment As Usual In Nursery School Attendees Receiving Preventive Oral Health Support Through The Childsmile Oral Health Improvement Programme: An RCT [NCT01674933]Phase 41,610 participants (Anticipated)Interventional2012-10-31Completed
Silver Diamine Fluoride Treatment of Active Root Caries Lesions in Older Adults: A Case Series [NCT04370080]63 participants (Actual)Interventional2017-01-03Completed
Evaluate Inflammation Caused by Gingivitis in Adults [NCT00941668]Phase 449 participants (Actual)Interventional2007-01-31Completed
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse [NCT01024738]Phase 322 participants (Actual)Interventional2008-03-31Completed
A Randomized Controlled Trial on the Remineralization Agents Used for the Treatment of White Spot Lesions [NCT04827966]12 participants (Actual)Interventional2022-09-01Terminated(stopped due to Funding issues)
Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children [NCT03442309]7,418 participants (Actual)Interventional2019-02-01Completed
Treatment of Interproximal Carious Lesions on Primary Molar Teeth With SDF and Super Floss Application Versus SDF Without Super Floss Versus Fluoride Varnish Alone: a Pilot Phase 3 Randomized Controlled Trial [NCT03770286]Phase 360 participants (Anticipated)Interventional2019-01-22Recruiting
Comparison of the Efficacy of Silver Diamine Fluoride Solution and Sodium Fluoride Varnish for the Prevention and Arrest of Root Caries in a Group of Older Adults [NCT04432415]90 participants (Actual)Interventional2017-09-01Suspended(stopped due to Coronavirus Pandemic)
Cost-effectiveness Analysis of Fluoride Foam and Fluoride Varnish in Preventing Dental Caries in the Primary Teeth of Preschool Children With High Caries Risk [NCT05025163]1,083 participants (Actual)Interventional2016-07-01Completed
Effectiveness of Self-assembling Peptide (P11-4) and Nano-silver Fluoride Varnish in Management of Enamel White Spot Lesions in Young People (Randomized Controlled Clinical Trial) [NCT04929509]66 participants (Anticipated)Interventional2020-12-05Recruiting
Enhancing Effect of the Application of 1% Chlorhexidine Varnish With Silane Fluoride and Oral Health Promotion on the Streptococcus Mutans Counts Reduction in Pregnant Women and on Early Mother-infant Transmission [NCT04868513]Phase 458 participants (Actual)Interventional2015-01-31Completed
Evaluation of the Response of Caries Lesions in Dentin After Application of Silver Diamine Fluoride Gel: A Case Series [NCT05395065]235 participants (Actual)Observational2022-07-11Active, not recruiting
Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH in Children - Protocol for a Blinded Randomized Clinical Trial. [NCT05370417]Phase 1/Phase 250 participants (Anticipated)Interventional2022-10-01Not yet recruiting
A Prospective Pilot Study Investigating rhPSMA 7.3 PET/MRI in Detecting Recurrent Disease and Aid in Radiotherapy Planning in Patients With Biochemically Recurrent Prostate Cancer [NCT04978675]Phase 125 participants (Anticipated)Interventional2021-08-04Recruiting
Influence of Fluoride Varnish, Ozone and Octenidin on the Incidence of White Spot Lesions and Caries During Orthodontic Treatment - a Randomized Clinical Trial [NCT04992481]150 participants (Actual)Interventional2013-02-01Completed
Comparison of the Clinical Effectiveness of Self Etch Adhesive and Fluoride Varnish in Reducing Dentin Hypersensitivity in Patients With Gingival Recession: Randomized Clinical Trial [NCT05895526]142 participants (Anticipated)Interventional2023-06-12Not yet recruiting
Strategy to Reduce Bladder Activity With RhPSMA 7.3: Comparison of 18F-RhPSMA 7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer [NCT05779943]Phase 220 participants (Anticipated)Interventional2023-04-27Recruiting
A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Short Term Relief From Dentinal Hypersensitivity [NCT01592851]Phase 3113 participants (Actual)Interventional2012-04-30Completed
Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia: a Multicentre Randomized Controlled Trial [NCT04872907]Phase 360 participants (Anticipated)Interventional2021-06-01Not yet recruiting
Compare the Clinical Efficacy of Prototype Toothpastes. [NCT00761930]Phase 3103 participants (Actual)Interventional2008-03-31Completed
A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity [NCT01691560]Phase 2140 participants (Actual)Interventional2012-08-31Completed
PET Imaging of Hepatocellular Carcinoma With 18F-FSPG [NCT02379377]Phase 180 participants (Anticipated)Interventional2022-02-15Recruiting
The Effect of Sodium Fluoride Application on the Prevention of Radiation Caries in Nasopharyngeal Carcinoma Patients: A Prospective, Open, Randomized Controlled Phase II Trial [NCT06174012]Phase 2135 participants (Anticipated)Interventional2023-12-15Not yet recruiting
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing. [NCT00966953]Phase 325 participants (Actual)Interventional2007-10-31Completed
Effectiveness of Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth of Preschool Children: a 30-month Randomized Clinical Trial [NCT05084001]Phase 2/Phase 3769 participants (Anticipated)Interventional2020-03-01Recruiting
A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity [NCT02226562]Phase 2191 participants (Actual)Interventional2014-09-02Completed
A Randomised, Controlled Trial to Assess the Effect of Different Modes of Fluoride Delivery on Enamel Demineralisation, During Orthodontic Treatment With Fixed Appliances [NCT05005689]Phase 4130 participants (Anticipated)Interventional2023-10-20Recruiting
Remineralization of Dentine Caries Using Nanosilver Fluoride and Casein Phosphopeptides-amorphous Calcium Phosphate (A Randomized Clinical Trial) [NCT04930458]135 participants (Anticipated)Interventional2021-08-10Recruiting
Investigate Oral Bacteria in Adult Population [NCT00762177]Phase 324 participants (Actual)Interventional2008-05-31Completed
A Study to Evaluate the Effect of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Digluconate Tooth Staining [NCT01962493]Phase 4160 participants (Actual)Interventional2013-09-30Completed
Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy: A Prospective Cohort Study [NCT03317275]50 participants (Actual)Interventional2017-05-26Completed
Clinical Evaluation of Efficacy of Shield Force Plus Varnish Versus Sodium Fluoride on Cervical Dentin Hypersensitivity on Adult Patients: A Randomized Clinical Trial [NCT04484844]Phase 2/Phase 368 participants (Anticipated)Interventional2020-10-31Not yet recruiting
Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients: Randomized Clinical Trial [NCT03222960]40 participants (Anticipated)Interventional2017-10-31Not yet recruiting
Effectiveness of Self-assembling Peptide (p11-4) in Conjunction With Fluoride Varnish in the Management of White Spot Lesions in Primary Teeth (Randomized Controlled Clinical Trial) [NCT05721586]24 participants (Actual)Interventional2020-06-01Completed
A Real-World Evidence Study Evaluating Oral Health Related Quality of Life Following the Use of Antisensitivity Toothpaste for Dentine Hypersensitivity Management [NCT04964063]655 participants (Actual)Interventional2021-08-31Completed
A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model [NCT01563172]Phase 465 participants (Actual)Interventional2009-01-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00066963 (1) [back to overview]Number of Caries Incident Cases
NCT00375830 (9) [back to overview]Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions
NCT00375830 (9) [back to overview]Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy
NCT00375830 (9) [back to overview]Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
NCT00375830 (9) [back to overview]Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
NCT00375830 (9) [back to overview]Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
NCT00375830 (9) [back to overview]Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
NCT00375830 (9) [back to overview]Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
NCT00375830 (9) [back to overview]Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions
NCT00375830 (9) [back to overview]Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI
NCT00708097 (5) [back to overview]Enamel Fluoride Uptake (Demineralized Specimens)
NCT00708097 (5) [back to overview]Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)
NCT00708097 (5) [back to overview]Enamel Fluoride Uptake (Sound Enamel Specimens)
NCT00708097 (5) [back to overview]Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)
NCT00708097 (5) [back to overview]Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)
NCT00708123 (3) [back to overview]Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)
NCT00708123 (3) [back to overview]Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
NCT00708123 (3) [back to overview]Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)
NCT00708305 (7) [back to overview]Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments
NCT00708305 (7) [back to overview]Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments
NCT00708305 (7) [back to overview]Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments
NCT00708305 (7) [back to overview]Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments
NCT00708305 (7) [back to overview]Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments
NCT00708305 (7) [back to overview]Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours
NCT00708305 (7) [back to overview]Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours
NCT00758290 (1) [back to overview]Dental Plaque Index
NCT00758394 (1) [back to overview]Dental Plaque Index
NCT00758563 (1) [back to overview]Mean Gingival Plaque Units
NCT00759031 (1) [back to overview]Gingival Margin Plaque Index
NCT00759187 (1) [back to overview]Dental Plaque Index
NCT00761930 (3) [back to overview]Gingivitis Score
NCT00761930 (3) [back to overview]Dental Plaque
NCT00761930 (3) [back to overview]Bleeding Index (EIBI)
NCT00762177 (24) [back to overview]Antimicrobial Species in Plaque(Actinomyces)
NCT00762177 (24) [back to overview]Antimicrobial Species in Plaque(Sulfur Bacteria)
NCT00762177 (24) [back to overview]Antimicrobial Species in Tongue(Fusobacteria)
NCT00762177 (24) [back to overview]Antimicrobial Species in Tongue(Oral Streptococci)
NCT00762177 (24) [back to overview]Antimicrobial Species in Saliva(Veillonella)
NCT00762177 (24) [back to overview]Antimicrobial Species in Saliva(Total Anaerobic)
NCT00762177 (24) [back to overview]Antimicrobial Species in Saliva(Sulfur Bacteria)
NCT00762177 (24) [back to overview]Antimicrobial Species in Saliva(Oral Streptococci)
NCT00762177 (24) [back to overview]Antimicrobial Species in Saliva(Fusobacteria)
NCT00762177 (24) [back to overview]Antimicrobial Species in Saliva(Actinomyces)
NCT00762177 (24) [back to overview]Antimicrobial Species on the Cheek(Veillonella)
NCT00762177 (24) [back to overview]Antimicrobial Species in Plaque(Veillonella)
NCT00762177 (24) [back to overview]Antimicrobial Species in Plaque(Total Anaerobic)
NCT00762177 (24) [back to overview]Antimicrobial Species in Plaque(Oral Streptococci)
NCT00762177 (24) [back to overview]Antimicrobial Species in Plaque(Fusobacteria)
NCT00762177 (24) [back to overview]Antimicrobial Species on the Tongue(Actinomycetes)
NCT00762177 (24) [back to overview]Antimicrobial Species in Tongue(Sulfur Bacteria)
NCT00762177 (24) [back to overview]Antimicrobial Species on the Cheek(Total Anaerobic)
NCT00762177 (24) [back to overview]Antimicrobial Species on the Cheek(Sulfur Bacteria)
NCT00762177 (24) [back to overview]Antimicrobial Species on the Cheek(Oral Streptococci)
NCT00762177 (24) [back to overview]Antimicrobial Species on the Cheek(Fusobacteria)
NCT00762177 (24) [back to overview]Antimicrobial Species on the Cheek(Actinomyces)
NCT00762177 (24) [back to overview]Antimicrobial Species in Tongue(Veillonella)
NCT00762177 (24) [back to overview]Antimicrobial Species in Tongue(Total Anaerobic)
NCT00762450 (1) [back to overview]ph of Dental Plaque After Sucrose Challenge
NCT00762515 (2) [back to overview]Control Established Plaque in Adults
NCT00762515 (2) [back to overview]Control Gingivitis in Adults
NCT00762528 (8) [back to overview]Interleukin - 1 Beta (IL-ß)
NCT00762528 (8) [back to overview]Gingival Index (GI)
NCT00762528 (8) [back to overview]Dental Plaque Index (PI)
NCT00762528 (8) [back to overview]8-iso-prostaglandinF2α (8-iso-PGF2α)
NCT00762528 (8) [back to overview]Prostaglandin E2 (PGE2)
NCT00762528 (8) [back to overview]Nuclear Factor Kappa B Ligand (RANK-L)
NCT00762528 (8) [back to overview]Interleukin-6 (IL-6)
NCT00762528 (8) [back to overview]Bleeding on Probing (BOP)
NCT00762619 (68) [back to overview]F.Nucleatum (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant
NCT00762619 (68) [back to overview]F.Nucleatum (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]E.Saburreum (DNA Probe Analysis)- Natural Teeth
NCT00762619 (68) [back to overview]E.Saburreum (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]P.Intermedia (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]E.Saburreum (DNA Probe Analysis) - Dental Implant
NCT00762619 (68) [back to overview]E.Saburreum (DNA Probe Analysis) - Dental Implant
NCT00762619 (68) [back to overview]E.Corrodens (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]E.Corrodens (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]E.Corrodens (DNA Probe Analysis) - Dental Implant
NCT00762619 (68) [back to overview]E.Corrodens (DNA Probe Analysis) - Dental Implant
NCT00762619 (68) [back to overview]Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant
NCT00762619 (68) [back to overview]Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant
NCT00762619 (68) [back to overview]C.Rectus (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]C.Rectus (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]C.Rectus (DNA Probe Analysis) - Dental Implant
NCT00762619 (68) [back to overview]C.Rectus (DNA Probe Analysis) - Dental Implant
NCT00762619 (68) [back to overview]A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth
NCT00762619 (68) [back to overview]P.Gingivalis (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant
NCT00762619 (68) [back to overview]Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth
NCT00762619 (68) [back to overview]Veillonella sp.(DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]Veillonella sp.(DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]Veillonella sp.(DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]Veillonella sp.(DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]T.Forsythia (DNA Probe Analysis)-Natural Teeth
NCT00762619 (68) [back to overview]T.Forsythia (DNA Probe Analysis)- Natural Teeth
NCT00762619 (68) [back to overview]T.Forsythia (DNA Probe Analysis)- Dental Implants
NCT00762619 (68) [back to overview]T.Forsythia (DNA Probe Analysis)- Dental Implants
NCT00762619 (68) [back to overview]Streptococci (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]Streptococci (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]Streptococci (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]Streptococci (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]P.Melaninogenica (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]P.Melaninogenica (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]P.Melaninogenica (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]P.Melaninogenica (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]P.Intermedia (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]P.Intermedia (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]P.Intermedia (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]P.Gingivalis (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]P.Gingivalis (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]P.Gingivalis (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]Neissera sp. (DNA Probe Analysis) Natural Teeth
NCT00762619 (68) [back to overview]Neissera sp. (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]Neissera sp. (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]Neissera sp. (DNA Probe Analysis) - Dental Implants
NCT00762619 (68) [back to overview]Mombelli Plaque Index (mPI) for Natural Teeth
NCT00762619 (68) [back to overview]Mombelli Plaque Index (mPI) for Natural Teeth
NCT00762619 (68) [back to overview]Mombelli Plaque Index (mPI) for Dental Implants
NCT00762619 (68) [back to overview]Mombelli Plaque Index (mPI) for Dental Implants
NCT00762619 (68) [back to overview]Löe-Silness Gingival Index Score (GI)- Dental Implants
NCT00762619 (68) [back to overview]Löe-Silness Gingival Index Score (GI)- Dental Implants
NCT00762619 (68) [back to overview]Löe-Silness Gingival Index Score (GI) - Natural Teeth
NCT00762619 (68) [back to overview]Löe-Silness Gingival Index Score (GI) - Natural Teeth
NCT00762619 (68) [back to overview]Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants
NCT00762619 (68) [back to overview]Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants
NCT00762619 (68) [back to overview]Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth
NCT00762619 (68) [back to overview]F.Nucleatum (DNA Probe Analysis) - Natural Teeth
NCT00762619 (68) [back to overview]F.Nucleatum (DNA Probe Analysis) - Natural Teeth
NCT00762762 (6) [back to overview]HbA1c Levels in Blood
NCT00762762 (6) [back to overview]TNF-α (Tumor Necrosis Factor - Alpha)
NCT00762762 (6) [back to overview]IL-6 (Interleukin - 6)
NCT00762762 (6) [back to overview]High Sensitivity CRP (C-Reactive Protein)
NCT00762762 (6) [back to overview]HbA1c Levels in Blood
NCT00762762 (6) [back to overview]C-Peptide
NCT00762853 (1) [back to overview]Triclosan Concentration in Dental Plaque
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Putrescine)
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Cadaverine)
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Choline)
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Isoleucine)
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Hypoxanthine)
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Inosine)
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Leucine)
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Lysine)
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Phenylalanine)
NCT00763048 (10) [back to overview]Metabolite Associated With Inflammation (Xanthine)
NCT00763256 (5) [back to overview]C-Peptide
NCT00763256 (5) [back to overview]High Sensitivity CRP (C-Reactive Protein)
NCT00763256 (5) [back to overview]HbA1c Levels in Blood
NCT00763256 (5) [back to overview]P. Gingivalis
NCT00763256 (5) [back to overview]Gingivitis Score (GI)
NCT00763269 (4) [back to overview]Hypersensitivity Tactile (Yeaple Probe)
NCT00763269 (4) [back to overview]Hypersensitivity Tactile(Yeaple Probe)
NCT00763269 (4) [back to overview]Air Blast Hypersensitivity (4 Week)
NCT00763269 (4) [back to overview]Air Blast Hypersensitivity (8 Week)
NCT00875212 (2) [back to overview]Minimum pH After 14 Days of Use of Dentifrice
NCT00875212 (2) [back to overview]Minimum pH
NCT00926029 (2) [back to overview]Plaque Index
NCT00926029 (2) [back to overview]Gingivitis Index
NCT00926328 (2) [back to overview]Plaque Index
NCT00926328 (2) [back to overview]Gingivitis Index
NCT00928174 (1) [back to overview]Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT
NCT00928252 (3) [back to overview]Metabolically Active Tumor Volume (MATV) Response
NCT00928252 (3) [back to overview]Proportional Hazards Regression Analysis of Time to PSA Progression
NCT00928252 (3) [back to overview]Time to PSA Progression
NCT00936975 (6) [back to overview]Changes in 18F-fluoride PET SUV - Normal Bone
NCT00936975 (6) [back to overview]Changes in 18F-fluoride PET (SUV) - Tumor Bone
NCT00936975 (6) [back to overview]Changes in 18F-fluoride Ki - Normal Bone
NCT00936975 (6) [back to overview]Changes in 18F-fluoride Ki - Tumor Bone
NCT00936975 (6) [back to overview]Changes in 18F-fluoride Transport (by Patlak Flux) - Normal
NCT00936975 (6) [back to overview]Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor
NCT00941668 (2) [back to overview]Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours
NCT00941668 (2) [back to overview]Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours
NCT00966953 (1) [back to overview]Plaque Index
NCT00981825 (1) [back to overview]CFU (Colony Forming Units)
NCT01005966 (3) [back to overview]Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)
NCT01005966 (3) [back to overview]Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)
NCT01005966 (3) [back to overview]Change From Baseline in Enamel Fluoride Uptake Potential
NCT01009554 (64) [back to overview]Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Lingual Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Lingual Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Lingual Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score Over All Tooth Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score Over All Tooth Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score Over All Tooth Sites at 8 Weeks
NCT01009554 (64) [back to overview]Oral Tissue Tolerance
NCT01009554 (64) [back to overview]Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks
NCT01009554 (64) [back to overview]Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment
NCT01009554 (64) [back to overview]Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment
NCT01009554 (64) [back to overview]Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment
NCT01009554 (64) [back to overview]Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment
NCT01009554 (64) [back to overview]Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment
NCT01009554 (64) [back to overview]Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment
NCT01009554 (64) [back to overview]Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment
NCT01009554 (64) [back to overview]Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment
NCT01009554 (64) [back to overview]Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment
NCT01009554 (64) [back to overview]Mean Stain Area for Body Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Body Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Body Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Facial Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Facial Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Facial Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Gingival Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Gingival Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Gingival Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Lingual Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Lingual Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area for Lingual Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area Over All Tooth Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area Over All Tooth Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Area Over All Tooth Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Body Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Body Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Body Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Facial Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Facial Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Facial Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Gingival Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Gingival Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Gingival Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Lingual Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Lingual Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity for Lingual Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity Over All Tooth Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity Over All Tooth Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Intensity Over All Tooth Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Body Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Body Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Body Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Facial Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Facial Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Facial Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Gingival Sites at 4 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Gingival Sites at 6 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Gingival Sites at 8 Weeks
NCT01009554 (64) [back to overview]Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks
NCT01014143 (1) [back to overview]Plaque Index
NCT01024738 (1) [back to overview]Plaque Index
NCT01040169 (2) [back to overview]Tooth Hypersensivity Stimuli to Air
NCT01040169 (2) [back to overview]Tooth Hypersensitity to Touch Stimuli (Tactile)
NCT01049503 (7) [back to overview]Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used
NCT01049503 (7) [back to overview]Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
NCT01049503 (7) [back to overview]Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))
NCT01049503 (7) [back to overview]Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))
NCT01049503 (7) [back to overview]Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used
NCT01049503 (7) [back to overview]Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.
NCT01049503 (7) [back to overview]Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.
NCT01072188 (2) [back to overview]Hypersensitivity to Touch (Tactile)
NCT01072188 (2) [back to overview]Air Blast
NCT01072201 (3) [back to overview]Bleeding on Probing
NCT01072201 (3) [back to overview]Mean Percentage of Plaque Scores
NCT01072201 (3) [back to overview]Mean Pocket Depth
NCT01116739 (7) [back to overview]Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3
NCT01116739 (7) [back to overview]Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
NCT01116739 (7) [back to overview]Acquisition of Dental Knowledge of the Caregivers of the Children
NCT01116739 (7) [back to overview]Evaluation of Caries Patterns
NCT01116739 (7) [back to overview]Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
NCT01116739 (7) [back to overview]Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1
NCT01116739 (7) [back to overview]Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2
NCT01128972 (6) [back to overview]Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse
NCT01128972 (6) [back to overview]Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse
NCT01128972 (6) [back to overview]Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse
NCT01128972 (6) [back to overview]Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse
NCT01128972 (6) [back to overview]Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse
NCT01128972 (6) [back to overview]Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water
NCT01129440 (6) [back to overview]Retention of Glass Ionomer Sealants
NCT01129440 (6) [back to overview]Caries Patterns
NCT01129440 (6) [back to overview]Caries Increment
NCT01129440 (6) [back to overview]Caries Incidence
NCT01129440 (6) [back to overview]Adverse Event
NCT01129440 (6) [back to overview]Salivary Fluoride Level
NCT01133379 (16) [back to overview]Global Subjective VAS Score at Week 6
NCT01133379 (16) [back to overview]Global Subjective VAS Score at Week 4
NCT01133379 (16) [back to overview]Mean Tactile Sensitivity VAS Score at Week 6
NCT01133379 (16) [back to overview]Mean Tactile Sensitivity VAS Score at Week 4
NCT01133379 (16) [back to overview]Mean Tactile Sensitivity VAS Score at Week 2
NCT01133379 (16) [back to overview]Mean Tactile Sensitivity Score at Week 6
NCT01133379 (16) [back to overview]Mean Tactile Sensitivity VAS Score at Week 1
NCT01133379 (16) [back to overview]Mean Cold Air Stimulus VAS Score at Week 6
NCT01133379 (16) [back to overview]Mean Tactile Sensitivity Score at Week 1
NCT01133379 (16) [back to overview]Mean Tactile Sensitivity Score at Week 2
NCT01133379 (16) [back to overview]Mean Tactile Sensitivity Score at Week 4
NCT01133379 (16) [back to overview]Mean Cold Air Stimulus VAS Score at Week 2
NCT01133379 (16) [back to overview]Mean Cold Air Stimulus VAS Score at Week 1
NCT01133379 (16) [back to overview]Global Subjective VAS Score at Week 2
NCT01133379 (16) [back to overview]Global Subjective VAS Score at Week 1
NCT01133379 (16) [back to overview]Mean Cold Air Stimulus VAS Score at Week 4
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Tongue at Screening
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Tongue at Day 5
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Tongue at Day 3
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Tongue at Day 25
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25
NCT01156376 (72) [back to overview]Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment
NCT01156376 (72) [back to overview]Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment
NCT01156376 (72) [back to overview]Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25
NCT01156376 (72) [back to overview]Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3
NCT01156376 (72) [back to overview]Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5
NCT01156376 (72) [back to overview]Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Gingiva at Day 25
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Gingiva at Day 3
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Gingiva at Day 5
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Gingiva at Screening
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment
NCT01156376 (72) [back to overview]Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment
NCT01345292 (8) [back to overview]Mean Tactile Sensitivity Score at Week 4
NCT01345292 (8) [back to overview]Mean Tactile Sensitivity Score at Week 2
NCT01345292 (8) [back to overview]Mean Cold Air Stimulus VAS Score at Week 4
NCT01345292 (8) [back to overview]Mean Cold Air Stimulus VAS Score at Week 2
NCT01345292 (8) [back to overview]Global Subjective VAS Score at Week 4
NCT01345292 (8) [back to overview]Global Subjective VAS Score at Week 2
NCT01345292 (8) [back to overview]Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2
NCT01345292 (8) [back to overview]Mean Tactile Sensitivity VAS Score at Week 4
NCT01541358 (3) [back to overview]Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy
NCT01541358 (3) [back to overview]Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
NCT01541358 (3) [back to overview]Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
NCT01549587 (6) [back to overview]Gestational Age (Weeks)
NCT01549587 (6) [back to overview]Neonate Birth Weight (Grams)
NCT01549587 (6) [back to overview]Preterm Birth (Gestational Age < 37 Weeks)
NCT01549587 (6) [back to overview]Change From Baseline in Löe-Silness Gingivitis Index
NCT01549587 (6) [back to overview]Change From Baseline in Löe-Silness Gingivitis Index
NCT01549587 (6) [back to overview]Change From Baseline in Löe-Silness Gingivitis Index
NCT01563172 (10) [back to overview]Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
NCT01563172 (10) [back to overview]Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
NCT01563172 (10) [back to overview]Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
NCT01563172 (10) [back to overview]Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
NCT01563172 (10) [back to overview]Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
NCT01563172 (10) [back to overview]Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
NCT01563172 (10) [back to overview]Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
NCT01563172 (10) [back to overview]Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.
NCT01563172 (10) [back to overview]Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
NCT01563172 (10) [back to overview]Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.
NCT01592851 (6) [back to overview]Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment
NCT01592851 (6) [back to overview]Change From Baseline in Tactile Pain Threshold Score at Day 14
NCT01592851 (6) [back to overview]Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14
NCT01592851 (6) [back to overview]Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3
NCT01592851 (6) [back to overview]Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment
NCT01592851 (6) [back to overview]Change From Baseline in Tactile Pain Threshold Score at Day 3
NCT01592864 (4) [back to overview]Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8
NCT01592864 (4) [back to overview]Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4
NCT01592864 (4) [back to overview]Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4
NCT01592864 (4) [back to overview]Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
NCT01607411 (4) [back to overview]Percent Net Acid Resistance (%NAR) of Enamel Specimens
NCT01607411 (4) [back to overview]Enamel Fluoride Uptake
NCT01607411 (4) [back to overview]%SMHR of Enamel Specimens Exposed to Test Treatments
NCT01607411 (4) [back to overview]Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
NCT01610167 (5) [back to overview]Extended Sensitivity Relief. Tactile Sensitivity.
NCT01610167 (5) [back to overview]Immediate Sensitivity Relief. Air Blast Sensitivity.
NCT01610167 (5) [back to overview]Immediate Sensitivity Relief. Tactile Sensitivity.
NCT01610167 (5) [back to overview]Adverse Events.
NCT01610167 (5) [back to overview]Extended Sensitivity Relief. Air Blast Sensitivity.
NCT01641237 (4) [back to overview]Enamel Fluoride Uptake (Corrected Data)
NCT01641237 (4) [back to overview]Percentage Relative Erosion Resistance
NCT01641237 (4) [back to overview]Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship
NCT01641237 (4) [back to overview]%SMHR
NCT01657903 (4) [back to overview]Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure
NCT01657903 (4) [back to overview]SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure
NCT01657903 (4) [back to overview]RER of Enamel Specimens Post 2 Hours of Treatment Exposure
NCT01657903 (4) [back to overview]Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure
NCT01665911 (3) [back to overview]% Acid Resistance Score Per Each of Five Arms
NCT01665911 (3) [back to overview]Enamel Fluoride Uptake Per Each of Five Arms
NCT01665911 (3) [back to overview]% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms
NCT01669785 (10) [back to overview]Long-term Sensitivity Relief (Self-Assessment)
NCT01669785 (10) [back to overview]Post-prophylaxis Sensitivity Relief (Self-Assessment)
NCT01669785 (10) [back to overview]Sensitivity Relief (Self-Assessment)
NCT01669785 (10) [back to overview]Post- Scaling Sensitivity Relief (Self-Assessment)
NCT01669785 (10) [back to overview]Long-term Sensitivity Relief (Tactile Sensitivity)
NCT01669785 (10) [back to overview]Baseline Pre-Prophy Assessment (Air Blast Sensitivity)
NCT01669785 (10) [back to overview]Baseline Pre-Prophy Assessment (Tactile Sensitivity)
NCT01669785 (10) [back to overview]Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)
NCT01669785 (10) [back to overview]Immediate Sensitivity Relief (Tactile Sensitivity)
NCT01669785 (10) [back to overview]Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)
NCT01691560 (6) [back to overview]Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8
NCT01691560 (6) [back to overview]Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
NCT01691560 (6) [back to overview]Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4
NCT01691560 (6) [back to overview]Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8
NCT01691560 (6) [back to overview]Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4
NCT01691560 (6) [back to overview]Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
NCT01727258 (6) [back to overview]Mean Cold Air Stimulus VAS Score at Week 2
NCT01727258 (6) [back to overview]Mean Tactile Sensitivity VAS Score at Week 4
NCT01727258 (6) [back to overview]Mean Cold Air Stimulus VAS Score at Week 4
NCT01727258 (6) [back to overview]Mean Tactile Sensitivity Score at Week 2
NCT01727258 (6) [back to overview]Mean Tactile Sensitivity VAS Score at Week 2
NCT01727258 (6) [back to overview]Mean Tactile Sensitivity Score at Week 4
NCT01796106 (1) [back to overview]Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging
NCT01812668 (6) [back to overview]Time to Progression
NCT01812668 (6) [back to overview]Number of Participants With Indicated Toxicities Grade 3 or Higher
NCT01812668 (6) [back to overview]PET Response Based on the RECIST Criteria 1.1
NCT01812668 (6) [back to overview]Number of Participants With Indicated Clinical Response Based on the RECIST Criteria 1.1
NCT01812668 (6) [back to overview]PSA Response Based on the RECIST Criteria 1.1
NCT01812668 (6) [back to overview]Change in PET Standard Uptake Value SUV Levels Pre-treatment to Post-treatment.
NCT01816048 (2) [back to overview]Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles
NCT01816048 (2) [back to overview]Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700
NCT01827670 (6) [back to overview]Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)
NCT01827670 (6) [back to overview]Mean Change From Baseline in Tactile Sensitivity
NCT01827670 (6) [back to overview]Mean Change From Baseline in Tactile Sensitivity
NCT01827670 (6) [back to overview]Mean Change From Baseline in Schiff Sensitivity Score
NCT01827670 (6) [back to overview]Mean Change From Baseline in Schiff Sensitivity Score
NCT01827670 (6) [back to overview]Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)
NCT01831817 (8) [back to overview]Mean Change From Baseline in Schiff Sensitivity Score at Week 8
NCT01831817 (8) [back to overview]Median Change From Baseline in Tactile Sensitivity at Week 8
NCT01831817 (8) [back to overview]Median Change From Baseline in Tactile Sensitivity at Week 4
NCT01831817 (8) [back to overview]Mean Change From Baseline in Visual Rating Scale Score at Week 8
NCT01831817 (8) [back to overview]Mean Change From Baseline in Visual Rating Scale Score at Week 4
NCT01831817 (8) [back to overview]Mean Change From Baseline in Schiff Sensitivity Score at Week 4
NCT01831817 (8) [back to overview]Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4
NCT01831817 (8) [back to overview]Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8
NCT01901250 (1) [back to overview]Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade
NCT01962493 (8) [back to overview]Overall Interproximal MLSI at Week 3
NCT01962493 (8) [back to overview]Overall Interproximal MLSI at Week 6
NCT01962493 (8) [back to overview]Modified Lobene Stain Index (MLSI) at Week 6
NCT01962493 (8) [back to overview]Overall Facial MLSI at Week 6
NCT01962493 (8) [back to overview]Overall Gingival and Interproximal MLSI at Week 3
NCT01962493 (8) [back to overview]Overall Facial MLSI at Week 3
NCT01962493 (8) [back to overview]Overall Gingival and Interproximal MLSI at Week 6
NCT01962493 (8) [back to overview]Overall MLSI at Week 3
NCT01967862 (1) [back to overview]Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
NCT02113579 (10) [back to overview]Mean Cold Air Stimulus VAS Score at Week 2
NCT02113579 (10) [back to overview]Mean Cold Air Stimulus VAS Score at Week 4
NCT02113579 (10) [back to overview]Mean Tactile Sensitivity Score at Week 2
NCT02113579 (10) [back to overview]Mean Tactile Sensitivity Score at Week 4
NCT02113579 (10) [back to overview]Mean Tactile Sensitivity VAS Score at Week 4
NCT02113579 (10) [back to overview]Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4
NCT02113579 (10) [back to overview]Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2
NCT02113579 (10) [back to overview]Mean Tactile Sensitivity VAS Score at Week 2
NCT02113579 (10) [back to overview]Global Subjective VAS Score at Week 2
NCT02113579 (10) [back to overview]Global Subjective VAS Score at Week 4
NCT02149173 (4) [back to overview]Time to Disease Progression
NCT02149173 (4) [back to overview]Proportion of Patients Experienced a Threshold in Percentage Change, or Surpassed a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)
NCT02149173 (4) [back to overview]Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV), Assessed by a One-sample Test of the Percent Change in FES SUV
NCT02149173 (4) [back to overview]F-18 16 Alpha-fluoroestradiol (FES) Uptake
NCT02193165 (6) [back to overview]Gingivitis Scores
NCT02193165 (6) [back to overview]Gingivitis Scores
NCT02193165 (6) [back to overview]Gingivitis Scores
NCT02193165 (6) [back to overview]Dental Plaque Scores
NCT02193165 (6) [back to overview]Dental Plaque Scores
NCT02193165 (6) [back to overview]Dental Plaque Scores
NCT02195583 (4) [back to overview]Percentage Comparative Acid Resistance (% CAR)
NCT02195583 (4) [back to overview]Enamel Fluoride Uptake
NCT02195583 (4) [back to overview]Percentage Surface Microhardness Recovery (% SMHR)
NCT02195583 (4) [back to overview]Percentage Net Acid Resistance (% NAR)
NCT02207400 (7) [back to overview]Number of Gingival Bleeding Sites at 24 Weeks
NCT02207400 (7) [back to overview]Modified Gingival Index (MGI)) at 6 and 12 Weeks.
NCT02207400 (7) [back to overview]Number of Gingival Bleeding Sites at 6 and 12 Weeks
NCT02207400 (7) [back to overview]Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
NCT02207400 (7) [back to overview]Bleeding Index (BI) at 6, 12 and 24 Weeks
NCT02207400 (7) [back to overview]Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
NCT02207400 (7) [back to overview]Modified Gingival Index (MGI) at 24 Weeks
NCT02207907 (6) [back to overview]Bleeding Index at 6, 12 and 24 Weeks
NCT02207907 (6) [back to overview]Modified Gingival Index (MGI) at 6 and 12 Weeks.
NCT02207907 (6) [back to overview]Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
NCT02207907 (6) [back to overview]Number of Gingival Bleeding Sites at 6 and 12 Weeks.
NCT02207907 (6) [back to overview]Number of Gingival Bleeding Sites at 24 Weeks
NCT02207907 (6) [back to overview]Modified Gingival Index (MGI) at 24 Weeks
NCT02221349 (2) [back to overview]Change From Baseline Visual Analog Scale
NCT02221349 (2) [back to overview]Change From Baseline Air Challenge
NCT02226562 (6) [back to overview]Mean Change From Baseline in Schiff Sensitivity Score at Week 4
NCT02226562 (6) [back to overview]Mean Change From Baseline in Tactile Threshold at Week 4
NCT02226562 (6) [back to overview]Mean Change From Baseline in Tactile Threshold at Week 8
NCT02226562 (6) [back to overview]Mean Change From Baseline in Schiff Sensitivity Score at Week 8
NCT02226562 (6) [back to overview]Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8
NCT02226562 (6) [back to overview]Mean Change From Baseline in VRS at Week 4
NCT02319668 (4) [back to overview]Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery
NCT02319668 (4) [back to overview]Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis
NCT02319668 (4) [back to overview]Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7)
NCT02319668 (4) [back to overview]Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery
NCT02357979 (2) [back to overview]International Caries Detection and Assessment System (ICDAS II) - Number of Molars With ICDAS Score of 3 or More - ICDAS Score 3, Cavity -
NCT02357979 (2) [back to overview]Change in ICDAS Scores - International Caries Detection and Assessment System (ICDAS II) -
NCT02360124 (2) [back to overview]Number of New Tooth Root Caries Lesions
NCT02360124 (2) [back to overview]Proportion of Inactive Root Caries Lesions
NCT02360995 (6) [back to overview]Gingivitis Scores
NCT02360995 (6) [back to overview]Dental Plaque Scores
NCT02360995 (6) [back to overview]Gingivitis Scores
NCT02360995 (6) [back to overview]Gingivitis Scores
NCT02360995 (6) [back to overview]Dental Plaque Scores
NCT02360995 (6) [back to overview]Dental Plaque Scores
NCT02366689 (6) [back to overview]Dental Plaque Scores
NCT02366689 (6) [back to overview]Dental Plaque Scores
NCT02366689 (6) [back to overview]Gingivitis Scores
NCT02366689 (6) [back to overview]Gingivitis Scores
NCT02366689 (6) [back to overview]Gingivitis Scores
NCT02366689 (6) [back to overview]Dental Plaque Scores
NCT02371616 (4) [back to overview]Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8
NCT02371616 (4) [back to overview]Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4
NCT02371616 (4) [back to overview]Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8
NCT02371616 (4) [back to overview]Change From Baseline in Tactile Threshold at Week 4 and Week 8
NCT02399163 (5) [back to overview]Enamel Fluoride Uptake
NCT02399163 (5) [back to overview]Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14
NCT02399163 (5) [back to overview]Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse
NCT02399163 (5) [back to overview]Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse
NCT02399163 (5) [back to overview]Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14
NCT02424097 (2) [back to overview]Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)
NCT02424097 (2) [back to overview]Change in International Caries Detection and Assessment System (ICDAS II) to Score for Smooth Surfaces White Spot Lesions (WSL)
NCT02448225 (4) [back to overview]Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules
NCT02448225 (4) [back to overview]CD44 and xC- Expression Levels in Tissue Samples(0-3)
NCT02448225 (4) [back to overview]Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)
NCT02448225 (4) [back to overview]Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the Tumor)
NCT02513212 (2) [back to overview]Change From Baseline Visual Analog Scale
NCT02513212 (2) [back to overview]Change From Baseline Air Challenge
NCT02533466 (10) [back to overview]Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge
NCT02533466 (10) [back to overview]Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge
NCT02533466 (10) [back to overview]Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.
NCT02533466 (10) [back to overview]Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge
NCT02533466 (10) [back to overview]Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge
NCT02533466 (10) [back to overview]Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge
NCT02533466 (10) [back to overview]Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge
NCT02533466 (10) [back to overview]Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge
NCT02533466 (10) [back to overview]Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge
NCT02533466 (10) [back to overview]Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge
NCT02536040 (1) [back to overview]Dental Caries Activity
NCT02542943 (7) [back to overview]Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
NCT02542943 (7) [back to overview]Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
NCT02542943 (7) [back to overview]Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
NCT02542943 (7) [back to overview]Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8
NCT02542943 (7) [back to overview]Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4
NCT02542943 (7) [back to overview]Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
NCT02542943 (7) [back to overview]Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
NCT02598778 (2) [back to overview]Change in Salivary Streptococcus Mutans Levels After 30 Second Oral Rinse Time (Chlorhexidine Gluconate, Sodium Fluoride, or Deionized Water) or 2 Minute Chew Time (Paraffin Wax Chewing Gum)
NCT02598778 (2) [back to overview]Change in Salivary Streptococcus Mutans Levels After 30 Second Oral Rinse Time (Chlorhexidine Gluconate, Sodium Fluoride, or Deionized Water) or 2 Minute Chew Time (Paraffin Wax Chewing Gum)
NCT02601833 (3) [back to overview]Time of Treatment Procedures (Duration of Time in Minutes)
NCT02601833 (3) [back to overview]Costs of Treatment (Dollars)
NCT02601833 (3) [back to overview]Caries Arrest of Teeth in the SDF Group Measured by Change in Size
NCT02612064 (3) [back to overview]Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3
NCT02612064 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
NCT02612064 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score on Day 3
NCT02613117 (1) [back to overview]Did Participants Notice a Difference in the Areas Noted?
NCT02647203 (2) [back to overview]Root Caries Activity
NCT02647203 (2) [back to overview]Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)
NCT02705716 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score on Day 14
NCT02705716 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score on Day 7
NCT02705716 (3) [back to overview]Change From Baseline in Tactile Threshold on Day 7 and 14
NCT02724592 (4) [back to overview]Caries Activity Assessment According to Nyvad Criteria
NCT02724592 (4) [back to overview]ICDAS Classification Index
NCT02724592 (4) [back to overview]Visual Analog Scale of Lesion Progression (VAS)
NCT02724592 (4) [back to overview]Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device.
NCT02731833 (4) [back to overview]Change From Baseline in Schiff Sensitivity Score on Day 3
NCT02731833 (4) [back to overview]Change From Baseline in Tactile Threshold Post First Treatment by Direct Application
NCT02731833 (4) [back to overview]Change From Baseline in Tactile Threshold on Day 3
NCT02731833 (4) [back to overview]Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
NCT02750943 (5) [back to overview]Bleeding Index (BI) at Week 4 and Week 12
NCT02750943 (5) [back to overview]Number of Bleeding Sites at Week 4
NCT02750943 (5) [back to overview]Number of Bleeding Sites at Week 12
NCT02750943 (5) [back to overview]Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
NCT02750943 (5) [back to overview]Modified Gingival Index (MGI) at Week 4 and Week 12
NCT02751450 (4) [back to overview]Change From Baseline in Tactile Threshold Post First Treatment by Direct Application
NCT02751450 (4) [back to overview]Change From Baseline in Tactile Threshold on Day 3
NCT02751450 (4) [back to overview]Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
NCT02751450 (4) [back to overview]Change From Baseline in Schiff Sensitivity Score on Day 3
NCT02752958 (66) [back to overview]Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 - Question (Q) No. 7 At Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16
NCT02752958 (66) [back to overview]Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12
NCT02752958 (66) [back to overview]Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8
NCT02753075 (7) [back to overview]Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
NCT02753075 (7) [back to overview]Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4
NCT02753075 (7) [back to overview]Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8
NCT02753075 (7) [back to overview]Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8
NCT02753075 (7) [back to overview]Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8
NCT02753075 (7) [back to overview]Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4
NCT02753075 (7) [back to overview]Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8
NCT02768194 (2) [back to overview]Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
NCT02768194 (2) [back to overview]Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
NCT02773758 (3) [back to overview]Change From Baseline in Tactile Threshold at Day 7 and Day 14
NCT02773758 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score at Day 7
NCT02773758 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score at Day 14
NCT02832375 (3) [back to overview]Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3
NCT02832375 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score After Single Use
NCT02832375 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score on Day 3
NCT02861664 (3) [back to overview]Change From Baseline in Tactile Threshold at Week 4 and 8
NCT02861664 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score at Week 8
NCT02861664 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score at Week 4
NCT02918617 (4) [back to overview]Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation
NCT02918617 (4) [back to overview]Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation
NCT02918617 (4) [back to overview]Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation
NCT02918617 (4) [back to overview]Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation
NCT02923895 (4) [back to overview]Change From Baseline in Tactile Threshold on Day 3
NCT02923895 (4) [back to overview]Change From Baseline in Tactile Threshold After a Single Use
NCT02923895 (4) [back to overview]Change From Baseline in Schiff Sensitivity Score After a Single Use
NCT02923895 (4) [back to overview]Change From Baseline in Schiff Sensitivity Score on Day 3
NCT02924350 (3) [back to overview]Change From Baseline (Day 0 Pre-treatment) in Schiff Sensitivity Score on Day 0 (After 60 Seconds of Single Direct Application)
NCT02924350 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score on Day 3
NCT02924350 (3) [back to overview]Change From Baseline (Day 0 Pre-treatment) in Tactile Threshold on Day 0 (After 60 Seconds of Single Direct Application) and Day 3
NCT02937636 (4) [back to overview]Number of Bleeding Sites
NCT02937636 (4) [back to overview]Mean Plaque Index (PI) (Overall and Interproximal)
NCT02937636 (4) [back to overview]Mean Bleeding Index (BI)
NCT02937636 (4) [back to overview]Mean Modified Gingival Index (MGI)
NCT02953886 (3) [back to overview]Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
NCT02953886 (3) [back to overview]Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
NCT02953886 (3) [back to overview]Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
NCT03072719 (3) [back to overview]Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14
NCT03072719 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3
NCT03072719 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score on Day 14
NCT03082196 (4) [back to overview]Child Response to First Treatment
NCT03082196 (4) [back to overview]Child Response to Fifth Treatment
NCT03082196 (4) [back to overview]Dental Caries for All Primary Teeth Sound at Baseline
NCT03082196 (4) [back to overview]Dental Caries for Primary Molars Sound at Baseline
NCT03160703 (1) [back to overview]Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4
NCT03186261 (1) [back to overview]Bacterial Count of Streptococus Mutans
NCT03238352 (2) [back to overview]Change From Baseline in Tactile Threshold
NCT03238352 (2) [back to overview]Change From Baseline in Schiff Sensitivity Score
NCT03244618 (6) [back to overview]Thermo-evaporative (Schiff Air Blast) Stimuli
NCT03244618 (6) [back to overview]Thermo-evaporative (Schiff Air Blast) Stimuli
NCT03244618 (6) [back to overview]Visual Analogue Scale
NCT03244618 (6) [back to overview]Visual Analogue Scale
NCT03244618 (6) [back to overview]Tactile (Yeaple Probe) Stimuli
NCT03244618 (6) [back to overview]Tactile (Yeaple Probe) Stimuli
NCT03285984 (2) [back to overview]Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks
NCT03285984 (2) [back to overview]Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks
NCT03296072 (6) [back to overview]% Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel)
NCT03296072 (6) [back to overview]% Relative Erosion Resistance (RER; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Inhibit Demineralization of Enamel)
NCT03296072 (6) [back to overview]% RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
NCT03296072 (6) [back to overview]% SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
NCT03296072 (6) [back to overview]EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
NCT03296072 (6) [back to overview]Enamel Fluoride Uptake (EFU; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Promote Fluoride Uptake in Enamel)
NCT03310268 (2) [back to overview]Change From Baseline in Tactile Threshold After 8 Weeks of Treatment
NCT03310268 (2) [back to overview]Change From Baseline in Schiff Sensitivity Score After 8 Weeks of Treatment
NCT03383783 (7) [back to overview]Net Acid Resistance (NAR)
NCT03383783 (7) [back to overview]Transverse Microradiography (TMR) - Lesion Depth - L
NCT03383783 (7) [back to overview]Transverse Microradiography (TMR) - Integrated Mineral Loss - ∆Z
NCT03383783 (7) [back to overview]Comparative Acid Resistance (CAR)
NCT03383783 (7) [back to overview]Enamel Fluoride Uptake (EFU)
NCT03383783 (7) [back to overview]Percentage Surface Microhardness Recovery (%SMH)
NCT03383783 (7) [back to overview]Transverse Microradiography (TMR) - Maximum Mineral Density at the Surface-zone
NCT03405259 (2) [back to overview]Change From Baseline Air Challenge
NCT03405259 (2) [back to overview]Change From Baseline Visual Analog Scale
NCT03778294 (2) [back to overview]Progression Free Survival
NCT03778294 (2) [back to overview]Overall Survival (OS)
NCT03943095 (20) [back to overview]Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
NCT03943095 (20) [back to overview]Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
NCT03943095 (20) [back to overview]Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7
NCT03943095 (20) [back to overview]Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56
NCT03943095 (20) [back to overview]Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3
NCT03943095 (20) [back to overview]Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28
NCT03943095 (20) [back to overview]Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7
NCT03943095 (20) [back to overview]Change From Baseline (Day 0) in Tactile Threshold on Day 56
NCT03943095 (20) [back to overview]Change From Baseline in Schiff Sensitivity Score at Day 56
NCT03943095 (20) [back to overview]Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)
NCT03943095 (20) [back to overview]Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14
NCT03943095 (20) [back to overview]Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7
NCT03943095 (20) [back to overview]Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56
NCT03943095 (20) [back to overview]Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3
NCT03943095 (20) [back to overview]Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28
NCT03943095 (20) [back to overview]Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)
NCT03943095 (20) [back to overview]Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)
NCT03943095 (20) [back to overview]Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
NCT03943095 (20) [back to overview]Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14
NCT03943095 (20) [back to overview]Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
NCT03965039 (12) [back to overview]Baseline Air Challenge
NCT03965039 (12) [back to overview]Air Challenge
NCT03965039 (12) [back to overview]Air Challenge
NCT03965039 (12) [back to overview]Air Challenge
NCT03965039 (12) [back to overview]Tactile Threshold
NCT03965039 (12) [back to overview]Air Challenge
NCT03965039 (12) [back to overview]Air Challenge
NCT03965039 (12) [back to overview]Baseline Yeaple Probe
NCT03965039 (12) [back to overview]Tactile Threshold
NCT03965039 (12) [back to overview]Tactile Threshold
NCT03965039 (12) [back to overview]Tactile Threshold
NCT03965039 (12) [back to overview]Tactile Threshold
NCT04054635 (3) [back to overview]Anterior Teeth Arrest Rates
NCT04054635 (3) [back to overview]Posterior Arrest Rates
NCT04054635 (3) [back to overview]Overall Arrest Rates
NCT04123665 (9) [back to overview]Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks
NCT04123665 (9) [back to overview]Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks
NCT04123665 (9) [back to overview]Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks
NCT04123665 (9) [back to overview]Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
NCT04123665 (9) [back to overview]Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks
NCT04123665 (9) [back to overview]Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
NCT04123665 (9) [back to overview]Number of Bleeding Sites After 12 and 24 Weeks
NCT04123665 (9) [back to overview]Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks
NCT04123665 (9) [back to overview]Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks
NCT04184271 (6) [back to overview]Observed Silver Tmax
NCT04184271 (6) [back to overview]Observed Fluoride Urinary Recovery
NCT04184271 (6) [back to overview]Observed Silver 24 Hour Urinary Concentration
NCT04184271 (6) [back to overview]Observed Silver Baseline-Corrected Cmax
NCT04184271 (6) [back to overview]Observed Silver t1/2
NCT04184271 (6) [back to overview]Observed Silver Cmax
NCT04186663 (7) [back to overview]Average Serum Fluoride Concentrations
NCT04186663 (7) [back to overview]Apparent Oral Clearance of Silver (CL/F)
NCT04186663 (7) [back to overview]Predicted Time to Peak Serum Silver Concentration (Tmax)
NCT04186663 (7) [back to overview]Serum Silver Exposure (AUC)
NCT04186663 (7) [back to overview]Silver Half-life
NCT04186663 (7) [back to overview]Apparent Volume of Distribution of Silver (V/F)
NCT04186663 (7) [back to overview]Predicted Peak Serum Silver Concentration (Cmax)
NCT04239872 (29) [back to overview]Area Under the Curve of Calcium Concentration in Saliva Overtime
NCT04239872 (29) [back to overview]Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime
NCT04239872 (29) [back to overview]Calcium Concentration in Dental Biofilm Solids at Baseline
NCT04239872 (29) [back to overview]Calcium Concentration in Saliva at 121 Minutes
NCT04239872 (29) [back to overview]Calcium Concentration in Saliva at 16 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Dental Biofilm Solids at 60 Minutes
NCT04239872 (29) [back to overview]Calcium Concentration in Saliva at 30 Minutes
NCT04239872 (29) [back to overview]Calcium Concentration in Saliva at 61 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Dental Biofilm Solids at Baseline
NCT04239872 (29) [back to overview]Fluoride Concentration in Saliva at 16 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Saliva at 30 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Saliva at 61 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Saliva at 90 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Saliva at Baseline
NCT04239872 (29) [back to overview]Fluoride Concentration in Saliva at 121 Minutes
NCT04239872 (29) [back to overview]Calcium Concentration in Dental Biofilm Solids at 60 Minutes
NCT04239872 (29) [back to overview]Calcium Concentration in Saliva at 90 Minutes
NCT04239872 (29) [back to overview]Calcium Concentration in Saliva at Baseline
NCT04239872 (29) [back to overview]Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Dental Biofilm Fluid at Baseline
NCT04239872 (29) [back to overview]Fluoride Concentration in Dental Biofilm Solids at 120 Minutes
NCT04239872 (29) [back to overview]Fluoride Concentration in Dental Biofilm Solids at 15 Minutes
NCT04239872 (29) [back to overview]Calcium Concentration in Dental Biofilm Solids at 15 Minutes
NCT04239872 (29) [back to overview]Calcium Concentration in Dental Biofilm Solids at 120 Minutes
NCT04239872 (29) [back to overview]Area Under the Curve of Fluoride Concentration in Saliva Overtime
NCT04239872 (29) [back to overview]Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid Overtime
NCT04239872 (29) [back to overview]Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids Overtime
NCT04249336 (3) [back to overview]Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus
NCT04249336 (3) [back to overview]Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus
NCT04249336 (3) [back to overview]Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus
NCT04290624 (10) [back to overview]Mean Oral Hygiene Index (OHI) at Week 6 and Week 12
NCT04290624 (10) [back to overview]Mean Oral Debris Index (ODI) at Week 6 and Week 12
NCT04290624 (10) [back to overview]Mean Number of Bleeding Sites (NBS) at Week 6 and Week 12
NCT04290624 (10) [back to overview]Mean Modified Gingival Index (MGI) at Week 6 and Week 12
NCT04290624 (10) [back to overview]Mean Interproximal TPI at Week 6 and Week 12
NCT04290624 (10) [back to overview]Mean Calculus Index (CI) at Week 6 and Week 12
NCT04290624 (10) [back to overview]Mean Bleeding Index (BI) at Week 12
NCT04290624 (10) [back to overview]Mean BI at Week 6
NCT04290624 (10) [back to overview]Mean Partial Denture Cleanliness Index (PDCI) at Week 6 and 12
NCT04290624 (10) [back to overview]Mean Overall Turesky Plaque Index (TPI) at Week 6 and Week 12
NCT04710927 (2) [back to overview]Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months
NCT04710927 (2) [back to overview]Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months
NCT04950465 (5) [back to overview]Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control)
NCT04950465 (5) [back to overview]Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)
NCT04950465 (5) [back to overview]Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control)
NCT04950465 (5) [back to overview]Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control)
NCT04950465 (5) [back to overview]Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control)
NCT05221749 (1) [back to overview]Antibacterial Effect in Active Dental Caries Lesions
NCT05258721 (3) [back to overview]Changes in Modified Gingival Index (MGI)
NCT05258721 (3) [back to overview]Changes in Bleeding On Probing (BOP)
NCT05258721 (3) [back to overview]Changes in Plaque Index (PI)

Number of Caries Incident Cases

A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit. (NCT00066963)
Timeframe: two years

Interventionparticipants (Number)
Counseling Only42
FV 1x/Year + Counseling23
FV 2x/Year + Counseling14

[back to top]

Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions

Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. (NCT00375830)
Timeframe: 30 days

,
Interventionpercentage of particpants (Number)
SensitivityAccuracy
Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan96.289.8
Cohort 2 - WB-MRI Scan81.474.7

[back to top]

Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy

Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. (NCT00375830)
Timeframe: 30 days

,
Interventionpercentage of participants (Number)
SensitivityAccuracy
Cohort 2 Combined 18F-NaF-CT/18F-FDG-PET Scan95.787.6
Cohort 2 WB-MRI & 99mTc-MDP Bone Scintigraphy91.683.0

[back to top]

Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI

Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, participants with skeletal lesions were identified. The outcome is reported as the number of Cohort 3 participants for whom skeletal lesions were identified by each scan methodology, a number without dispersion. (NCT00375830)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Cohort 3 - 99mTc-methyl Diphosphonate (MDP) Bone Scan37
Cohort 3 - 18F-NaF / 18F-FDG PET/MRI45

[back to top]

Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI

Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, the total number skeletal lesions identified in the participants was determined. The outcome is reported as the total number skeletal lesions identified by each scan methodology, a number without dispersion. (NCT00375830)
Timeframe: 30 days

Interventionlesions (Number)
Cohort 3 - 99mTc-methyl Diphosphonate (MDP) Bone Scan81
Cohort 3 - 18F-NaF / 18F-FDG PET/MRI140

[back to top]

Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT

The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant diagnosed with osseous (skeletal) metastases. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18-NaF PET/CT compared to 18F-FDG PET/CT, the same between both scans, or inferior for 18-NaF PET/CT compared to 18F-FDG PET/CT. The outcome result is represented as a number without dispersion. (NCT00375830)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
18F-NaF > 18F-FDG18F-NaF = 18F-FDG18F-NaF < 18F-FDG
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans300

[back to top]

Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy

"The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF > 99mTc-MDP), the same between both scans (18F-NaF = 99mTc-MDP), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF < 99mTc-MDP)." (NCT00375830)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
18F-NaF > 99mTc-MDP18F-NaF = 99mTc-MDP18F-NaF < 99mTc-MDP
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans1000

[back to top]

Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions

"Sensitivity; positive predictive value (PPV); and accuracy for the detection of extraskeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI).~Sensitivity is a percentage that defines the proportion of true positive participants with the disease in a total group of participants.~PPV is the probability that participants with a positive screening test truly have the disease.~Accuracy is the proportion of true results (both true positives and true negatives) among the total number of cases examined.~Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity, PPV, and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection." (NCT00375830)
Timeframe: 30 days

,
Interventionpercentage of particpants (Number)
SensitivityPositive predictive valueAccuracy
Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan92.981.376.5
Cohort 2 - Whole Body-MRI Scan92.986.782.4

[back to top]

Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions

Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. (NCT00375830)
Timeframe: 30 days

,
Interventionpercentage of participants (Number)
SensitivityAccuracy
Cohort 2 - 99mTc-MDP Bone Scintigraphy Scan64.665.9
Cohort 2 Combined 18F-NaF-CT/18F-FDG-PET Scan96.289.8

[back to top]

Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI

Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. (NCT00375830)
Timeframe: 30 days

,
Interventionpercentage of participants (Number)
SensitivityAccuracy
Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan95.787.6
Cohort 2 - Whole Body Magnetic Resonance Imaging (WB-MRI) Scan83.376.0

[back to top]

Enamel Fluoride Uptake (Demineralized Specimens)

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel. (NCT00708097)
Timeframe: Baseline to 14 days

Interventionμg*F/cm^2 (Least Squares Mean)
NaF Toothpaste(1450ppmF)2499.47
NaF Toothpaste (1400ppmF)2513.37
NaMFP/NaF Toothpaste (1450ppmF)1923.76
NaF Toothpaste (675ppmF)1861.80
Placebo Toothpaste (0ppmF)686.18

[back to top]

Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)

SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100. (NCT00708097)
Timeframe: Baseline to 14 days

InterventionPercentage SMHR (Least Squares Mean)
NaF/Carbopol Toothpaste(1450ppmF)28.31
NaF Toothpaste(1400ppmF)26.32
NaMFP/NaF Toothpaste (1450ppmF)26.13
NaF Toothpaste (675ppmF)25.52
Placebo Toothpaste (0ppmF)53.38

[back to top]

Enamel Fluoride Uptake (Sound Enamel Specimens)

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel. (NCT00708097)
Timeframe: Baseline to 14 days

Interventionmicrograms (μg)*F/centimeters(cm)^2] (Least Squares Mean)
NaF Toothpaste (1450ppmF)648.06
NaF Toothpaste (1400ppmF)650.07
NaMFP/ NaF Toothpaste (1450ppmF)541.16
NaF Toothpaste (675ppmF)487.14
Placebo Toothpaste (0ppmF)425.59

[back to top]

Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)

SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100. (NCT00708097)
Timeframe: Baseline to 14 days

InterventionPercentage SMHR (Least Squares Mean)
NaF Toothpaste(1450ppmF)34.62
NaF Toothpaste(1400ppmF)36.06
NaMFP/NaF Toothpaste (1450ppmF)31.12
NaF Toothpaste (675ppmF)27.15
Placebo Toothpaste (0ppmF)11.10

[back to top]

Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)

SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100. (NCT00708097)
Timeframe: Baseline to 14 days

InterventionPercentage SMHR (Least Squares Mean)
NaF Toothpaste (1450ppmF)28.31
NaF Toothpaste (1400ppmF)26.32

[back to top]

Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)

%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100. (NCT00708123)
Timeframe: Baseline to 14 days

Intervention%SMHR (Least Squares Mean)
NaF/Carbopol Toothpaste (1400 Ppm F)33.54
NaF Toothpaste (1350ppm F)35.23
NaF Toothpaste (250 Ppm F)24.98
NaMFP/NaF Toothpaste (1450 Ppm F)29.57
Placebo Toothpaste (0 Ppm F)22.05

[back to top]

Adjusted Mean Change From Baseline in Enamel Fluoride Uptake

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel. (NCT00708123)
Timeframe: Baseline to 14 days

Interventionµg*F/cm^2 (Least Squares Mean)
NaF/ Carbopol Toothpaste (1400 Ppm F)1283.13
NaF Toothpaste (1350ppm F)1333.09
NaF Toothpaste (250 Ppm F)680.20
NaMFP/NaF Toothpaste (1450 Ppm F)1086.39
Placebo Toothpaste (0 Ppm F)435.58

[back to top]

Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)

%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100. (NCT00708123)
Timeframe: Baseline to 14 days

Intervention%SMHR (Least Squares Mean)
NaF/Carbopol Toothpaste (1400 Ppm F)33.54
NaF Toothpaste (1350 Ppm F)35.23
NaMFP/NaF Toothpaste (1450 Ppm F)29.57

[back to top]

Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments

Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 1 hour post single application of study treatment

Interventionμg*F/g (Median)
NaF Toothpaste(1450ppmF)0.20
NaF Toothpaste (1400ppmF)0.22
NaMFP/NaF Toothpaste (1450ppmF)0.12
Placebo Toothpaste (0ppmF)0.01

[back to top]

Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments

Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 15 minutes post single application of study treatment

Interventionμg*F/g (Median)
NaF Toothpaste(1450ppmF)2.00
NaF Toothpaste (1400ppmF)1.56
NaMFP/NaF Toothpaste (1450ppmF)0.76
Placebo Toothpaste (0ppmF)0.03

[back to top]

Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments

Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 2 hour post single application of study treatment

Interventionμg*F/g (Median)
NaF Toothpaste(1450ppmF)0.09
NaF Toothpaste (1400ppmF)0.09
NaMFP/NaF Toothpaste (1450ppmF)0.07
Placebo Toothpaste (0ppmF)0.00

[back to top]

Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments

Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 30 minutes post single application of study treatment

Interventionμg*F/g (Median)
NaF Toothpaste(1450ppmF)0.71
NaF Toothpaste (1400ppmF)0.72
NaMFP/NaF Toothpaste (1450ppmF)0.28
Placebo Toothpaste (0ppmF)0.02

[back to top]

Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments

Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 4 hours post single application of study treatment

Interventionμg*F/g (Median)
NaF Toothpaste(1450ppmF)0.04
NaF Toothpaste (1400ppmF)0.04
NaMFP/NaF Toothpaste (1450ppmF)0.02
Placebo Toothpaste (0ppmF)-0.01

[back to top]

Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours

To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data. (NCT00708305)
Timeframe: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment

Interventionln(μg*F*minutes/cm^2) (Least Squares Mean)
NaF Toothpaste(1450 Ppm F)0.54
NaF Toothpaste (1400 Ppm F)0.54

[back to top]

Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours

To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data. (NCT00708305)
Timeframe: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment

Interventionln(μg*F*minutes/cm^2) (Log Mean)
NaF Toothpaste(1450ppmF)0.54
NaF Toothpaste (1400ppmF)0.54
NaMFP/NaF Toothpaste (1450ppmF)0.05
Placebo Toothpaste (0ppmF)-0.90

[back to top]

Dental Plaque Index

Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque (NCT00758290)
Timeframe: 4 Day

InterventionUnits on a scale (Mean)
Fluoride/Triclosan2.48
Triclosan/Fluoride2.42

[back to top]

Dental Plaque Index

plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque. (NCT00758394)
Timeframe: 4-Day

InterventionUnits on a scale (Mean)
Fluoride - A3.12
Fluoride/Triclosan - B2.90
Triclosan/Fluoride/Arginine2.92
Triclosan/Fluoride/Cavistat2.94

[back to top]

Mean Gingival Plaque Units

Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). (NCT00758563)
Timeframe: 1 day

InterventionUnits on a scale (Mean)
Fluoride13.38
Triclosan14.29

[back to top]

Gingival Margin Plaque Index

Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment. (NCT00759031)
Timeframe: 1 day

InterventionUnits on a scale (Mean)
Fluoride15.4
Triclosan + Fluoride12.81

[back to top]

Dental Plaque Index

Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth) (NCT00759187)
Timeframe: 4-Day

InterventionUnits on a scale (Mean)
Fluoride2.79
Fluoride/Triclosan2.82
Chlorhexidine Gluconate1.99

[back to top]

Gingivitis Score

"Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored." (NCT00761930)
Timeframe: 6 weeks

InterventionUnits on a scale (Mean)
A- Placebo Comparator0.942
B - Active Comparator0.722
C - Experimental Toothpaste0.705

[back to top]

Dental Plaque

Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored. (NCT00761930)
Timeframe: 6 weeks

InterventionUnits on a scale (Mean)
A- Placebo Comparator2.273
B - Active Comparator1.806
C - Experimental Toothpaste2.041

[back to top]

Bleeding Index (EIBI)

Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100. (NCT00761930)
Timeframe: 6 weeks

InterventionUnits on a scale (Mean)
A- Placebo Comparator0.325
B - Active Comparator0.164
C - Experimental Toothpaste0.141

[back to top]

Antimicrobial Species in Plaque(Actinomyces)

After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo Toothpaste0.023
Active Comparator0.3881
Experimental0.0538

[back to top]

Antimicrobial Species in Plaque(Sulfur Bacteria)

After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo0.0174
Active Comparator0.3083
Experimental-0.0416

[back to top]

Antimicrobial Species in Tongue(Fusobacteria)

After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0742
Active Comparator0.377
Experimental0.1668

[back to top]

Antimicrobial Species in Tongue(Oral Streptococci)

After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.1284
Active Comparator0.2233
Experimental0.0525

[back to top]

Antimicrobial Species in Saliva(Veillonella)

After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo0.0167
Active Comparator0.3062
Experimental0.0901

[back to top]

Antimicrobial Species in Saliva(Total Anaerobic)

After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0247
Active Comparator0.1505
Experimental0.05

[back to top]

Antimicrobial Species in Saliva(Sulfur Bacteria)

After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.1213
Active Comparator0.1556
Experimental-0.603

[back to top]

Antimicrobial Species in Saliva(Oral Streptococci)

After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0436
Active Comparator0.1445
Experimental0.087

[back to top]

Antimicrobial Species in Saliva(Fusobacteria)

After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0096
Active Comparator0.194
Experimental0.0539

[back to top]

Antimicrobial Species in Saliva(Actinomyces)

Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo0.016
Active Comparator0.3209
Experimental0.1116

[back to top]

Antimicrobial Species on the Cheek(Veillonella)

After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0732
Active Comparator0.2579
Experimental-0.0676

[back to top]

Antimicrobial Species in Plaque(Veillonella)

After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo0.0007
Active Comparator0.3658
Experimental0.0316

[back to top]

Antimicrobial Species in Plaque(Total Anaerobic)

After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0629
Active Comparator0.312
Experimental0.0762

[back to top]

Antimicrobial Species in Plaque(Oral Streptococci)

After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0848
Active Comparator0.2593
Experimental-0.0096

[back to top]

Antimicrobial Species in Plaque(Fusobacteria)

After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.2973
Active Comparator0.2703
Experimental-0.0095

[back to top]

Antimicrobial Species on the Tongue(Actinomycetes)

After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0132
Active Comparator0.2612
Experimental-0.0536

[back to top]

Antimicrobial Species in Tongue(Sulfur Bacteria)

After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.083
Active Comparator0.2065
Experimental-0.0248

[back to top]

Antimicrobial Species on the Cheek(Total Anaerobic)

After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0551
Active Comparator0.2009
Experimental-0.0531

[back to top]

Antimicrobial Species on the Cheek(Sulfur Bacteria)

After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.1788
Active Comparator0.2036
Experimental-0.0815

[back to top]

Antimicrobial Species on the Cheek(Oral Streptococci)

After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo0.0126
Active Comparator0.2088
Experimental-0.0251

[back to top]

Antimicrobial Species on the Cheek(Fusobacteria)

After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0319
Active Comparator0.1887
Experimental0.111

[back to top]

Antimicrobial Species on the Cheek(Actinomyces)

After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo0.0099
Active Comparator0.2949
Experimental-0.1875

[back to top]

Antimicrobial Species in Tongue(Veillonella)

After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.002
Active Comparator0.2724
Experimental-0.0424

[back to top]

Antimicrobial Species in Tongue(Total Anaerobic)

After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar. (NCT00762177)
Timeframe: 14 days

Interventionlog CFU (Colony forming units) (Log Mean)
Placebo-0.0445
Active Comparator0.2691
Experimental0.0926

[back to top]

ph of Dental Plaque After Sucrose Challenge

Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth. (NCT00762450)
Timeframe: 1 week

Interventionph of dental plaque (Mean)
Active Comparator4.88
Placebo - Silica Control5.04
Experimental Toothpaste4.98

[back to top]

Control Established Plaque in Adults

Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored. (NCT00762515)
Timeframe: 6 weeks

InterventionUnits on a scale (Mean)
A -Placebo Comparator2.42
B- Active Comparator2.45

[back to top]

Control Gingivitis in Adults

Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored). (NCT00762515)
Timeframe: 6 weeks

InterventionUnits on a scale (Mean)
A -Placebo Comparator0.54
B- Active Comparator0.63

[back to top]

Interleukin - 1 Beta (IL-ß)

Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. (NCT00762528)
Timeframe: 29 days

Interventionpg/µl (Log Mean)
Total Toothpaste6.9
Fluoride Toothpaste6.6

[back to top]

Gingival Index (GI)

"Gingival Index(GI)recorded on scale of 0-3 detailed below:~0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed" (NCT00762528)
Timeframe: 29 days

Interventionunits on a scale (Mean)
Total Toothpaste1.04
Fluoride Toothpaste1.01

[back to top]

Dental Plaque Index (PI)

measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces. (NCT00762528)
Timeframe: 29 days

InterventionUnits on a scale (Mean)
Total Toothpaste1.69
Fluoride Toothpaste1.65

[back to top]

8-iso-prostaglandinF2α (8-iso-PGF2α)

Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. (NCT00762528)
Timeframe: 29 days

Interventionpg/µl (Log Mean)
Total Toothpaste14.2
Fluoride Toothpaste15.2

[back to top]

Prostaglandin E2 (PGE2)

Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. (NCT00762528)
Timeframe: 29 days

Interventionpg/µl (Log Mean)
Total Toothpaste5.8
Fluoride Toothpaste5.2

[back to top]

Nuclear Factor Kappa B Ligand (RANK-L)

Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. (NCT00762528)
Timeframe: 29 days

Interventionpg/µl (Log Mean)
Total Toothpaste4.5
Fluoride Toothpaste4.4

[back to top]

Interleukin-6 (IL-6)

Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. (NCT00762528)
Timeframe: 29 days

Interventionpg/µl (Log Mean)
Total Toothpaste2.8
Fluoride Toothpaste2.7

[back to top]

Bleeding on Probing (BOP)

Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing. (NCT00762528)
Timeframe: 29 days

InterventionUnits on a scale (Mean)
Total Toothpaste0.24
Fluoride Toothpaste0.26

[back to top]

F.Nucleatum (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.602
B - Positive Control2.425

[back to top]

A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.664
B - Positive Control4.339

[back to top]

F.Nucleatum (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.89
B - Positive Control3.637

[back to top]

E.Saburreum (DNA Probe Analysis)- Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.079
B - Positive Control3.571

[back to top]

E.Saburreum (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.229
B - Positive Control4.385

[back to top]

P.Intermedia (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.329
B - Positive Control3.803

[back to top]

E.Saburreum (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.733
B - Positive Control3.372

[back to top]

E.Saburreum (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.012
B - Positive Control3.861

[back to top]

E.Corrodens (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.417
B - Positive Control5.682

[back to top]

E.Corrodens (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.47
B - Positive Control5.822

[back to top]

E.Corrodens (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.242
B - Positive Control5.482

[back to top]

E.Corrodens (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.21
B - Positive Control5.639

[back to top]

Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.644
B - Positive Control4.411

[back to top]

Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.676
B - Positive Control4.526

[back to top]

Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.356
B - Positive Control4.268

[back to top]

Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.391
B - Positive Control4.243

[back to top]

C.Rectus (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.578
B - Positive Control2.798

[back to top]

C.Rectus (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.69
B - Positive Control3.322

[back to top]

C.Rectus (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.318
B - Positive Control2.758

[back to top]

C.Rectus (DNA Probe Analysis) - Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.46
B - Positive Control3.015

[back to top]

A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.201
B - Positive Control4.669

[back to top]

P.Gingivalis (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.784
B - Positive Control4.926

[back to top]

A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (Colony Forming Units) (Least Squares Mean)
A - Fluoride Only Control6.269
B - Positive Control5.002

[back to top]

A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant

14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.814
B - Positive Control4.446

[back to top]

Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth

Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema. (NCT00762619)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
A - Fluoride Control0.877
B - Postive Control0.53

[back to top]

Veillonella sp.(DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.746
B - Positive Control4.563

[back to top]

Veillonella sp.(DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM) (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.82
B - Positive Control4.927

[back to top]

Veillonella sp.(DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM) (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.364
B - Positive Control4.186

[back to top]

Veillonella sp.(DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM) (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.472
B - Positive Control4.485

[back to top]

T.Forsythia (DNA Probe Analysis)-Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.286
B - Positive Control4.926

[back to top]

T.Forsythia (DNA Probe Analysis)- Natural Teeth

14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.408
B - Positive Control5.143

[back to top]

T.Forsythia (DNA Probe Analysis)- Dental Implants

14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.08
B - Positive Control4.633

[back to top]

T.Forsythia (DNA Probe Analysis)- Dental Implants

14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.19
B - Positive Control4.628

[back to top]

Streptococci (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.995
B - Positive Control4.495

[back to top]

Streptococci (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.867
B - Positive Control4.109

[back to top]

Streptococci (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.665
B - Positive Control2.404

[back to top]

Streptococci (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5
B - Positive Control3.263

[back to top]

Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.511
B - Positive Control5.237

[back to top]

Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.081
B - Positive Control4.487

[back to top]

Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.046
B - Positive Control3.899

[back to top]

Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.767
B - Positive Control4.701

[back to top]

P.Melaninogenica (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.066
B - Positive Control3.935

[back to top]

P.Melaninogenica (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.062
B - Positive Control3.691

[back to top]

P.Melaninogenica (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.387
B - Positive Control3.155

[back to top]

P.Melaninogenica (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.406
B - Positive Control3.363

[back to top]

P.Intermedia (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.007
B - Positive Control3.803

[back to top]

P.Intermedia (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.091
B - Positive Control3.853

[back to top]

P.Intermedia (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.544
B - Positive Control3.853

[back to top]

P.Gingivalis (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM) (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.071
B - Positive Control4.951

[back to top]

P.Gingivalis (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control6.166
B - Positive Control5.183

[back to top]

P.Gingivalis (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.562
B - Positive Control4.642

[back to top]

Neissera sp. (DNA Probe Analysis) Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.702
B - Positive Control4.658

[back to top]

Neissera sp. (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.638
B - Positive Control4.508

[back to top]

Neissera sp. (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.585
B - Positive Control4.415

[back to top]

Neissera sp. (DNA Probe Analysis) - Dental Implants

14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control4.405
B - Positive Control3.955

[back to top]

Mombelli Plaque Index (mPI) for Natural Teeth

"Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth." (NCT00762619)
Timeframe: 3 months

Interventionunits on a scale (Mean)
A - Fluoride Control1.96
B - Postive Control1.82

[back to top]

Mombelli Plaque Index (mPI) for Natural Teeth

"Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth." (NCT00762619)
Timeframe: 6 months

Interventionunits on a scale (Mean)
A - Fluoride Control2.05
B - Postive Control1.73

[back to top]

Mombelli Plaque Index (mPI) for Dental Implants

"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth." (NCT00762619)
Timeframe: 6 months

Interventionunits on a scale (Mean)
A - Fluoride Control1.71
B - Postive Control1.45

[back to top]

Mombelli Plaque Index (mPI) for Dental Implants

"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth." (NCT00762619)
Timeframe: 3 months

Interventionunits on a scale (Mean)
A - Fluoride Control1.62
B - Postive Control1.35

[back to top]

Löe-Silness Gingival Index Score (GI)- Dental Implants

Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. (NCT00762619)
Timeframe: 3 months

Interventionunits on a scale (Mean)
A - Fluoride Control1.27
B - Postive Control1.12

[back to top]

Löe-Silness Gingival Index Score (GI)- Dental Implants

Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. (NCT00762619)
Timeframe: 6 months

Interventionunits on a scale (Mean)
A - Fluoride Control1.24
B - Postive Control0.99

[back to top]

Löe-Silness Gingival Index Score (GI) - Natural Teeth

Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. (NCT00762619)
Timeframe: 6 months

Interventionunits on a scale (Mean)
A - Fluoride Control1.29
B - Postive Control1.01

[back to top]

Löe-Silness Gingival Index Score (GI) - Natural Teeth

Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. (NCT00762619)
Timeframe: 3 months

Interventionunits on a scale (Mean)
A - Fluoride Control1.3
B - Postive Control1.17

[back to top]

Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants

Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (NCT00762619)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
A - Fluoride Control0.81
B - Postive Control0.45

[back to top]

Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants

Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. (NCT00762619)
Timeframe: 3 months

InterventionUnits on a scale (Mean)
A - Fluoride Control0.65
B - Postive Control0.48

[back to top]

Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth

Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema. (NCT00762619)
Timeframe: 3 months

InterventionUnits on a scale (Mean)
A - Fluoride Control0.77
B - Postive Control0.51

[back to top]

F.Nucleatum (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM). (NCT00762619)
Timeframe: 3 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.337
B - Positive Control4.403

[back to top]

F.Nucleatum (DNA Probe Analysis) - Natural Teeth

14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) (NCT00762619)
Timeframe: 6 months

InterventionLog cfu (colony forming units) (Least Squares Mean)
A - Fluoride Only Control5.243
B - Positive Control3.405

[back to top]

HbA1c Levels in Blood

Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood. (NCT00762762)
Timeframe: 12 months

Interventionpercentage of HbA1c levels in blood (Mean)
Triclosan/Copolymer/Fluoride Toothpaste11.42
Fluoride Mouthrinse10.81

[back to top]

TNF-α (Tumor Necrosis Factor - Alpha)

Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation. (NCT00762762)
Timeframe: 12 months

Interventionpg/ml (Mean)
Active Comparator4.13
Placebo Comparator3.50

[back to top]

IL-6 (Interleukin - 6)

Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms) (NCT00762762)
Timeframe: 12 months

Interventionpg/ml (Mean)
Active Comparator1.93
Placebo Comparator2.89

[back to top]

High Sensitivity CRP (C-Reactive Protein)

CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. (NCT00762762)
Timeframe: 12 months

Interventionµg/ml (Mean)
Active Comparator14.94
Placebo Comparator10.76

[back to top]

HbA1c Levels in Blood

Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood. (NCT00762762)
Timeframe: 12 months

Interventionpercentage of HbA1c levels (Mean)
Active Comparator11.42
Placebo Comparator10.81

[back to top]

C-Peptide

C-Peptide levels in blood indicate whether or not a person is producing insulin (NCT00762762)
Timeframe: 12 months

Interventionng/ml (Mean)
Active Comparator5.39
Placebo Comparator4.61

[back to top]

Triclosan Concentration in Dental Plaque

Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards. (NCT00762853)
Timeframe: 12 hours

Interventionppm levels of triclosan (Mean)
Fluoride Toothpaste (Placebo)0
Active Toothpaste1.8

[back to top]

Metabolite Associated With Inflammation (Putrescine)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator1.050398
B - Active Comparator0.74134

[back to top]

Metabolite Associated With Inflammation (Cadaverine)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator1.119186
B - Active Comparator0.92077

[back to top]

Metabolite Associated With Inflammation (Choline)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator1.2264
B - Active Comparator1.169513

[back to top]

Metabolite Associated With Inflammation (Isoleucine)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator1.20033
B - Active Comparator1.048449

[back to top]

Metabolite Associated With Inflammation (Hypoxanthine)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator0.76984
B - Active Comparator0.701628

[back to top]

Metabolite Associated With Inflammation (Inosine)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator1.11183
B - Active Comparator0.84462

[back to top]

Metabolite Associated With Inflammation (Leucine)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator1.10064
B - Active Comparator1.018989

[back to top]

Metabolite Associated With Inflammation (Lysine)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator1.063873
B - Active Comparator1.09704

[back to top]

Metabolite Associated With Inflammation (Phenylalanine)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator1.16994
B - Active Comparator1.057373

[back to top]

Metabolite Associated With Inflammation (Xanthine)

One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment. (NCT00763048)
Timeframe: 6 weeks

Interventionion count (Mean)
A - Control Comparator1.05189
B - Active Comparator1.011732

[back to top]

C-Peptide

C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). (NCT00763256)
Timeframe: 12 months

Interventionnmol/L (Mean)
Active Comparator1.20
B - Placebo Comparator1.04

[back to top]

High Sensitivity CRP (C-Reactive Protein)

CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). (NCT00763256)
Timeframe: 12 months

Interventionmg/L (Mean)
Active Comparator6.16
B - Placebo Comparator5.37

[back to top]

HbA1c Levels in Blood

Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). (NCT00763256)
Timeframe: 12 months

InterventionPercentage (Mean)
Active Comparator9.47
B - Placebo Comparator10.27

[back to top]

P. Gingivalis

Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation. (NCT00763256)
Timeframe: 12 months

InterventionPg/ng DNA (Median)
Active Comparator209
B - Placebo Comparator22

[back to top]

Gingivitis Score (GI)

"Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)" (NCT00763256)
Timeframe: 12 months

InterventionUnits on a scale (Mean)
Active Comparator0.89
B - Placebo Comparator0.88

[back to top]

Hypersensitivity Tactile (Yeaple Probe)

Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth (NCT00763269)
Timeframe: 8 weeks

InterventionUnits on a scale (Mean)
A-Experimental Toothpatse31.90
B -Control Toothpaste17.28

[back to top]

Hypersensitivity Tactile(Yeaple Probe)

Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth (NCT00763269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
A-Experimental Toothpatse19.81
B -Control Toothpaste13.94

[back to top]

Air Blast Hypersensitivity (4 Week)

"Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth." (NCT00763269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
A-Experimental Toothpatse1.61
B -Control Toothpaste2.18

[back to top]

Air Blast Hypersensitivity (8 Week)

"Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth." (NCT00763269)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
A-Experimental Toothpatse0.89
B -Control Toothpaste1.80

[back to top]

Minimum pH After 14 Days of Use of Dentifrice

measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days). (NCT00875212)
Timeframe: 14 days

InterventionpH (Mean)
Control4.78
Calcium Glycerophosphate5.24
Fluoride5.25
Calcium Glycerophosphate and Fluoride5.44

[back to top]

Minimum pH

The dental biofilm pH was measured in vivo with the microtouch method, using a palladium microelectrode + reference electrode. Data represents the mean values of the lowest pH observed each time after the use of sucrose. (NCT00875212)
Timeframe: at 1 minute (minimum fermenting pH) or at 7 minutes

InterventionpH (Mean)
Control5.40
Calcium Glycerophosphate5.48
Fluoride5.25
Calcium Glycerophosphate and Fluoride5.70

[back to top]

Plaque Index

Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT00926029)
Timeframe: 6 weeks

InterventionUnits on a scale (Mean)
Placebo Control0.91
Positive Control0.84
Experimental1.77

[back to top]

Gingivitis Index

Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT00926029)
Timeframe: 6 Weeks

InterventionUnits on a scale (Mean)
Placebo Control0.63
Positive Control0.51
Experimental0.98

[back to top]

Plaque Index

Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT00926328)
Timeframe: 6 Months

InterventionUnits on a scale (Mean)
Experimental Treatment2.22
Placebo Control2.88

[back to top]

Gingivitis Index

"Units on a scale 0 to 3 (0 = no inflammation ,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing.~3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)" (NCT00926328)
Timeframe: 6 months

InterventionUnits on a scale (Mean)
Experimental Treatment1.00
Placebo Control1.27

[back to top]

Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT

The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer. (NCT00928174)
Timeframe: Concurrent with PET Procedure

Intervention%PET-positive cases in a given PSA range (Number)
PSA > 4 ng/mL (19 cases)PSA 2-4 ng/mL (2 cases)PSA > 0.5 - 2 ng/mL (1 cases)PSA <= 0.5 ng/mL (0 cases)
Single Arm1001001000

[back to top]

Metabolically Active Tumor Volume (MATV) Response

Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT (NCT00928252)
Timeframe: 21 to 98 days

InterventionParticipants (Count of Participants)
Received 18F-fluorocholine PET/CT20

[back to top]

Proportional Hazards Regression Analysis of Time to PSA Progression

PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines. (NCT00928252)
Timeframe: Up to 15 week post-chemotherapy

InterventionHazard Ratio (Number)
Positive Metabolically Active Tumor Response0.246

[back to top]

Time to PSA Progression

Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%. (NCT00928252)
Timeframe: 2 years

Interventiondays (Mean)
MATV reduction > or = 30%MATV reduction < 30%
Received 18F-fluorocholine PET/CT194116

[back to top]

Changes in 18F-fluoride PET SUV - Normal Bone

Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax (NCT00936975)
Timeframe: Baseline and 12 weeks

InterventionSUVmax (Mean)
18F-Fluoride PET0.31

[back to top]

Changes in 18F-fluoride PET (SUV) - Tumor Bone

Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax (NCT00936975)
Timeframe: Baseline and 12 weeks

InterventionSUVmax (Mean)
18F-Fluoride PET-6.67

[back to top]

Changes in 18F-fluoride Ki - Normal Bone

Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone (NCT00936975)
Timeframe: Baseline and 12 weeks

InterventionmL/min/mL (Mean)
18F-Fluoride PET0.0

[back to top]

Changes in 18F-fluoride Ki - Tumor Bone

Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone (NCT00936975)
Timeframe: Baseline and 12 weeks

InterventionmL/min/mL (Mean)
18F-Fluoride PET-0.02

[back to top]

Changes in 18F-fluoride Transport (by Patlak Flux) - Normal

Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis. (NCT00936975)
Timeframe: Baseline and 12 weeks

InterventionmL/min/mL (Mean)
Overall0.01

[back to top]

Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor

Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant. (NCT00936975)
Timeframe: Baseline and 12 weeks

InterventionmL/min/mL (Mean)
Overall-0.01

[back to top]

Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours

Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms) (NCT00941668)
Timeframe: 4 weeks

InterventionMicrograms (Mean)
Total Toothpaste (Active)12.8
Colgate Cavity Protection (Placebo)21.3

[back to top]

Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours

Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms) (NCT00941668)
Timeframe: 4 weeks

InterventionMicrograms (Mean)
Total Toothpaste (Active)492.2
Colgate Cavity Protection (Placebo)326.3

[back to top]

Plaque Index

Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT00966953)
Timeframe: 8 weeks

InterventionUnits on a scale (Mean)
Fluoride Only2.45
Total/Whitening2.22
Herbal Extract Toothpaste2.54
Herbal Extract Toothpaste2.56

[back to top]

CFU (Colony Forming Units)

Total number of salivary bacterial colony forming units (lower number = less colonies present) (NCT00981825)
Timeframe: 4 hours

Interventionnumber of colony forming units (Mean)
Fluoride Toothpaste (Control)7.18
Triclosan/Fluoride Toothpaste6.94

[back to top]

Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)

SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF). (NCT01005966)
Timeframe: Baseline to 14 days

InterventionPercentage SMHR (Mean)
NaF Toothpaste (1426ppmF)38.05
AmF Toothpaste (1400ppmF)41.06

[back to top]

Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)

SMH test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated. (NCT01005966)
Timeframe: Baseline to 14 days

InterventionPercentage SMHR (Mean)
NaF Toothpaste (1426ppmF)38.05
AmF Toothpaste (1400ppmF)41.06
NaMFP/NaF Toothpaste (1450ppmF)33.48
NaF Toothpaste (675ppmF)29.08
Placebo Toothpaste (0ppmF)14.49

[back to top]

Change From Baseline in Enamel Fluoride Uptake Potential

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel. (NCT01005966)
Timeframe: Baseline to 14 days

Interventionmicrograms (μg)* F/centimeters(cm)^2 (Mean)
NaF Toothpaste (1426ppmF)2342.35
AmF Toothpaste (1400ppmF)2305.11
Na MFP/NaF Toothpaste (1450ppmF)1809.74
NaF Toothpaste (675ppmF)1649.44
Placebo Toothpaste (0ppmF)462.95

[back to top]

Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.451
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.994

[back to top]

Mean Stain Score for Lingual Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.596
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.716

[back to top]

Mean Stain Score for Lingual Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.586
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)1.106

[back to top]

Mean Stain Score for Lingual Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.677
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)1.244

[back to top]

Mean Stain Score Over All Tooth Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.329
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.386

[back to top]

Mean Stain Score Over All Tooth Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.349
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.621

[back to top]

Mean Stain Score Over All Tooth Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.394
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.791

[back to top]

Oral Tissue Tolerance

Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event. (NCT01009554)
Timeframe: through 8 weeks

,
Interventionpercentage of participants (Number)
Participants with ≥ one treatment-related AESensitivity of teeth
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.00.0
Crest® Regular Toothpaste2.12.1

[back to top]

Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.210
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.475

[back to top]

Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.408
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.463

[back to top]

Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.077
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)-0.117

[back to top]

Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.123
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)-0.212

[back to top]

Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.107
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)-0.107

[back to top]

Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.875
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.882

[back to top]

Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.805
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)1.040

[back to top]

Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.909
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)1.035

[back to top]

Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.013
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.054

[back to top]

Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.071
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)-0.090

[back to top]

Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment

The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.158
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)-0.043

[back to top]

Mean Stain Area for Body Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.064
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.056

[back to top]

Mean Stain Area for Body Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.076
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.100

[back to top]

Mean Stain Area for Body Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.067
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.124

[back to top]

Mean Stain Area for Facial Sites at 4 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.032
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.033

[back to top]

Mean Stain Area for Facial Sites at 6 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.059
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.075

[back to top]

Mean Stain Area for Facial Sites at 8 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.047
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.160

[back to top]

Mean Stain Area for Gingival Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.186
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.263

[back to top]

Mean Stain Area for Gingival Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.184
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.352

[back to top]

Mean Stain Area for Gingival Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.250
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.444

[back to top]

Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.202
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.236

[back to top]

Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.206
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.383

[back to top]

Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.218
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.483

[back to top]

Mean Stain Area for Lingual Sites at 4 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.293
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.359

[back to top]

Mean Stain Area for Lingual Sites at 6 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.277
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.533

[back to top]

Mean Stain Area for Lingual Sites at 8 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.325
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.598

[back to top]

Mean Stain Area Over All Tooth Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.162
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.196

[back to top]

Mean Stain Area Over All Tooth Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.166
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.303

[back to top]

Mean Stain Area Over All Tooth Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.188
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.383

[back to top]

Mean Stain Intensity for Body Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.058
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.045

[back to top]

Mean Stain Intensity for Body Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.075
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.100

[back to top]

Mean Stain Intensity for Body Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.063
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.112

[back to top]

Mean Stain Intensity for Facial Sites at 4 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.027
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.025

[back to top]

Mean Stain Intensity for Facial Sites at 6 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.054
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.065

[back to top]

Mean Stain Intensity for Facial Sites at 8 Weeks

The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.042
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.144

[back to top]

Mean Stain Intensity for Gingival Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.180
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.252

[back to top]

Mean Stain Intensity for Gingival Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.180
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.358

[back to top]

Mean Stain Intensity for Gingival Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.241
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.438

[back to top]

Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.192
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.224

[back to top]

Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.205
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.379

[back to top]

Mean Stain Intensity for Lingual Sites at 4 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.282
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.344

[back to top]

Mean Stain Intensity for Lingual Sites at 6 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.279
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.541

[back to top]

Mean Stain Intensity for Lingual Sites at 8 Weeks

The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.314
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.596

[back to top]

Mean Stain Intensity Over All Tooth Sites at 4 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.154
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.184

[back to top]

Mean Stain Intensity Over All Tooth Sites at 6 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.164
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.302

[back to top]

Mean Stain Intensity Over All Tooth Sites at 8 Weeks

The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.181
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.375

[back to top]

Mean Stain Score for Body Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.132
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.112

[back to top]

Mean Stain Score for Body Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.160
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.215

[back to top]

Mean Stain Score for Body Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.143
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.258

[back to top]

Mean Stain Score for Facial Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.063
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.058

[back to top]

Mean Stain Score for Facial Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.118
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.140

[back to top]

Mean Stain Score for Facial Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.097
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.319

[back to top]

Mean Stain Score for Gingival Sites at 4 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.383
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.521

[back to top]

Mean Stain Score for Gingival Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.395
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.732

[back to top]

Mean Stain Score for Gingival Sites at 8 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.526
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.920

[back to top]

Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks

The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks

Interventionunits on a scale (Least Squares Mean)
Crest® Regular Toothpaste0.427
11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)0.776

[back to top]

Plaque Index

Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT01014143)
Timeframe: Four days

InterventionUnits on a scale (Mean)
Fluoride Toothpaste2.63
Total Toothpaste2.65
Chlorhexidine Oral Rinse1.23

[back to top]

Plaque Index

Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT01024738)
Timeframe: 4 Days

InterventionUnits on a scale (Mean)
Fluoride Toothpaste3.31
Total Toothpaste3.31
Chlorhexidine Oral Rinse2.91

[back to top]

Tooth Hypersensivity Stimuli to Air

Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. (NCT01040169)
Timeframe: 12 weeks (Final)

InterventionUnits on a scale (Mean)
Nupro C Prophylaxis Paste2.69
ProClude Prophylaxis Paste2.73

[back to top]

Tooth Hypersensitity to Touch Stimuli (Tactile)

Units on a scale:Measured with an electronic force sensing probe(Yeaple Probe):10, 20, 30, 40,up to 50 grams of force are applied to hypersensitive tooth until pain is felt. This calibrated instrument measures grams of force applied to each tooth before pain is felt. This data is recorded as the hypersensitivity score. The lower the score, the higher the hypersensitivity.Changes in this score to potentially painful stimulus are determined based on how many grams of force can be applied before the subject reports feeling pain. Grams of force is therefore the unit measurement for sensitivity (NCT01040169)
Timeframe: 12 weeks (Final)

InterventionUnits on a scale (Mean)
Nupro C Prophylaxis Paste10.83
ProClude Prophylaxis Paste10.63

[back to top]

Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used

The lesions' progression was evaluated by the data from the examinations at baseline and after 12 months. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an ANC lesion or cavity (untreated cavity or filled tooth). (NCT01049503)
Timeframe: baseline and 12 months

Interventionprogressed lesions/child (Mean)
Caries-inactive 550 Ppm F, pH 7.00.14
Caries-inactive 550 Ppm F, pH 4.50.03
Caries-inactive 1100 Ppm F, pH 7.00.10

[back to top]

Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used

The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface. (NCT01049503)
Timeframe: baseline and 12 months

Interventionregressed lesions/child (Mean)
Caries-active 550ppmF, pH 7.01.34
Caries-active 550ppmF, pH 4.51.44
Caries-active 1100ppmF, pH 7.01.84

[back to top]

Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))

The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%. A negative ∆F value indicates caries regression. (NCT01049503)
Timeframe: baseline and 12 months

Interventionlesions/child (Mean)
Caries-active 550ppmF, pH 7.02.66
Caries-active 550ppmF, pH 4.5-3.46
Caries-active 1100ppmF, pH 7.0-2.72

[back to top]

Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))

The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline - 12 months)were calculated by the software at the QLF threshold of 5%. (NCT01049503)
Timeframe: baseline and 12 months

Interventionlesions/child (Mean)
Caries-active 550ppmF, pH 7.0-1.03
Caries-active 550ppmF, pH 4.50.13
Caries-active 1100ppmF, pH 7.0-0.06

[back to top]

Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used

The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface. (NCT01049503)
Timeframe: baseline and 12 months

Interventionprogressed lesions/child (Mean)
Caries-active 550 Ppm F, pH 7.02.12
Caries-active 550 Ppm F, pH 4.50.97
Caries-active 1100 Ppm F, pH 7.01.75

[back to top]

Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.

Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). (NCT01049503)
Timeframe: 6 months

InterventionµgF/g (Mean)
550 Ppm F, pH 7.01.73
550 Ppm F, pH 4.51.80
1100 Ppm F, pH 7.02.56

[back to top]

Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.

Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS). (NCT01049503)
Timeframe: 6 months

Interventionmmol/kg (Mean)
550 Ppm F, pH 7.00.80
550 Ppm F, pH 4.51.32
1100 ppmF , pH 7.01.74

[back to top]

Hypersensitivity to Touch (Tactile)

Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity. (NCT01072188)
Timeframe: Immediately after product application

InterventionUnits on a scale (Mean)
ProClude Prophylaxis Paste-A42.2
Nupro-M Prophylaxis Paste-B20.1

[back to top]

Air Blast

Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. (NCT01072188)
Timeframe: Immediately after product application

InterventionUnits on a scale (Mean)
ProClude Prophylaxis Paste-A1.26
Nupro-M Prophylaxis Paste-B2.17

[back to top]

Bleeding on Probing

Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored. (NCT01072201)
Timeframe: 6 months

InterventionPercentage of bleeding sites (Mean)
Total Toothpaste53.8
Ultrabrite Toothpaste52.3

[back to top]

Mean Percentage of Plaque Scores

Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored. (NCT01072201)
Timeframe: 6 Months

Interventionpercentage of dental plaque (Mean)
Total Toothpaste13.2
Ultrabrite Toothpaste16.0

[back to top]

Mean Pocket Depth

Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth. (NCT01072201)
Timeframe: 6 Months

InterventionMillimeters (Mean)
Total Toothpaste4.4
Ultrabrite Toothpaste4.5

[back to top]

Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3

The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries. (NCT01116739)
Timeframe: 3 Years

Interventiondmfs (Mean)
COHS Administered Fluoride Varnish and Oral Health Education32.8
Usual Care33.6

[back to top]

Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children

An automated computer assisted survey interview (ACASI)will be done of the caregivers of the children. The questions have been standardized across 6 studies from the Collaborating Research Centers to Reduce Oral Health Disparities. The survey assessing attitudes and behaviors is comprised of 12 items. Scores are calculated as a percentage of appropriate responses. Therefore, possible scores range from 0-100. (NCT01116739)
Timeframe: Over 3 years

,
Interventionscore on a scale (Mean)
BaselineYear 1Year 2Year 3
COHS Administered Fluoride Varnish and Oral Health Education54.462.763.465.6
Usual Care56.158.261.166.4

[back to top]

Acquisition of Dental Knowledge of the Caregivers of the Children

An automated computer assisted survey interview (ACASI)will be done of the caregivers of the children. The questions have been standardized across 6 studies from the Collaborating Research Centers to Reduce Oral Health Disparities. The survey assessing knowledge is comprised of 14 items. Scores are calculated as a percentage of correct answers. Therefore, possible scores range from 0-100. (NCT01116739)
Timeframe: Over 3 years

,
Interventionscore on a scale (Mean)
BaselineYear 1Year 2Year 3
COHS Administered Fluoride Varnish and Oral Health Education75.180.481.481.2
Usual Care73.676.878.079.5

[back to top]

Evaluation of Caries Patterns

Caries patterns will be studied in terms of the specific teeth and tooth surfaces that are affected. Caries prevalence is defined as the presence of more than 0 dmfs (decayed, missing, or filled surfaces) in the child participant. The percentage of child participants with caries prevalence is reported. (NCT01116739)
Timeframe: Over 3 years

,
Interventionpercentage of participants (Number)
BaselineYear 1Year 2Year 3
COHS Administered Fluoride Varnish and Oral Health Education86.589.995.496.6
Usual Care90.190.996.198.2

[back to top]

Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline

The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries. (NCT01116739)
Timeframe: Baseline

Interventiondmfs (Mean)
COHS Administered Fluoride Varnish and Oral Health Education19.9
Usual Care22.8

[back to top]

Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1

The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries. (NCT01116739)
Timeframe: 1 Year

Interventiondmfs (Mean)
COHS Administered Fluoride Varnish and Oral Health Education23.3
Usual Care27.1

[back to top]

Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2

The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries. (NCT01116739)
Timeframe: 2 Years

Interventiondmfs (Mean)
COHS Administered Fluoride Varnish and Oral Health Education28.5
Usual Care31.2

[back to top]

Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse

SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period.

InterventionPercent SMH (Least Squares Mean)
Test Dentifrice + Test MR42.14
Test Dentifrice + Sterile Water Rinse38.02
Reference Dentifrice + Sterile Water Rinse30.88
Placebo Dentifrice + Sterile Water Rinse30.57

[back to top]

Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse

Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period

InterventionPercent NER (Least Squares Mean)
Placebo Dentifrice + Test MR-3.76
Test Dentifrice + Test MR-2.88
Test Dentifrice + Sterile Water Rinse-14.54
Reference Dentifrice + Sterile Water Rinse-29.48
Placebo Dentifrice + Sterile Water Rinse-40.05

[back to top]

Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse

Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period

InterventionPercent NER (Least Squares Mean)
Test Dentifrice + Sterile Water Rinse-2.88
Reference Dentifrice + Sterile Water Rinse-29.48

[back to top]

Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse

Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period

InterventionPercent NER (Least Squares Mean)
Test Dentifrice + Test MR-2.88
Test Dentifrice + Sterile Water Rinse-14.54
Reference Dentifrice + Sterile Water Rinse-29.48
Placebo Dentifrice + Sterile Water Rinse-40.05

[back to top]

Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse

SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period

InterventionPercent SMH (Least Squares Mean)
Test Dentifrice + Sterile Water Rinse38.02
Reference Dentifrice + Sterile Water Rinse30.88

[back to top]

Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water

SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period

InterventionPercent SMH (Least Squares Mean)
Placebo Dentifrice + Test MR37.75
Test Dentifrice + Test MR42.14
Test Dentifrice + Sterile Water Rinse38.02
Reference Dentifrice + Sterile Water Rinse30.88
Placebo Dentifrice + Sterile Water Rinse30.57

[back to top]

Retention of Glass Ionomer Sealants

Retention and maintenance of fluoride-releasing glass ionomer sealants will be recorded from a subset of children using an intraoral digital camera (NCT01129440)
Timeframe: Assessed every at 12 months and 24 months (plus minus 1 month); Month 24 reported

InterventionParticipants (Count of Participants)
FV + Glass Ionomer Sealants249

[back to top]

Caries Patterns

"Determine and compare caries patterns (maxillary incisor smooth surfaces, posterior occlusal surfaces) across study arms over time.~Occlusal surface dmfs>0 in baseline eligible molar teeth." (NCT01129440)
Timeframe: Assessed every 12 months (plus or minus 1 month); Month 36 reported

InterventionParticipants (Count of Participants)
Fluoride Varnish117
FV + Glass Ionomer Sealants106

[back to top]

Caries Increment

Caries increment by 36 months measured by the amount of change in dmfs index from baseline (NCT01129440)
Timeframe: Assessed every 12 months (plus or minus 1 month); Month 36 reported

Interventiontooth surfaces (Mean)
Fluoride Varnish4.9
FV + Glass Ionomer Sealants4.1

[back to top]

Caries Incidence

Caries incidence by 36 months measured by whether the change in the number of decayed, missing, or filled primary tooth surfaces (dmfs) index increased from baseline (ie. change in dmfs >0) (NCT01129440)
Timeframe: Assessed every 12 months (plus or minus 1 month); Month 36 reported

InterventionParticipants (Count of Participants)
Fluoride Varnish137
FV + Glass Ionomer Sealants123

[back to top]

Adverse Event

Clinician mediated adverse event up to 7 days after fluoride varnish application, ascertained through follow-up telephone call 5-14 days after application. (NCT01129440)
Timeframe: every 6 months; up to 7 days after application

InterventionParticipants (Count of Participants)
Fluoride Varnish0
FV + Glass Ionomer Sealants1

[back to top]

Salivary Fluoride Level

Relative changes in salivary fluoride levels pre- and post-treatment will be measured from a subsample of participating children (NCT01129440)
Timeframe: Every 6 months (plus minus 1 month); Month 30 reported

Interventionppm (Mean)
Fluoride Varnish0.072
FV + Glass Ionomer Sealants0.128

[back to top]

Global Subjective VAS Score at Week 6

"At Week 6, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT01133379)
Timeframe: 6 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)31.15
12027-01926.74
12027-02025.31

[back to top]

Global Subjective VAS Score at Week 4

"At Week 4, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT01133379)
Timeframe: 4 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)35.92
12027-01933.60
12027-02031.85

[back to top]

Mean Tactile Sensitivity VAS Score at Week 6

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01133379)
Timeframe: 6 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)25.50
12027-01924.80
12027-02026.86

[back to top]

Mean Tactile Sensitivity VAS Score at Week 4

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01133379)
Timeframe: 4 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)31.06
12027-01929.25
12027-02032.97

[back to top]

Mean Tactile Sensitivity VAS Score at Week 2

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01133379)
Timeframe: 2 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)37.69
12027-01935.71
12027-02034.79

[back to top]

Mean Tactile Sensitivity Score at Week 6

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. (NCT01133379)
Timeframe: 6 Weeks

Interventiongrams (Least Squares Mean)
12027-021 (Vehicle Control)37.91
12027-01936.77
12027-02030.16

[back to top]

Mean Tactile Sensitivity VAS Score at Week 1

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01133379)
Timeframe: 1 Week

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)40.09
12027-01939.61
12027-02039.27

[back to top]

Mean Cold Air Stimulus VAS Score at Week 6

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01133379)
Timeframe: 6 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)26.61
12027-01925.40
12027-02026.28

[back to top]

Mean Tactile Sensitivity Score at Week 1

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. (NCT01133379)
Timeframe: 1 Week

Interventiongrams (Least Squares Mean)
12027-021 (Vehicle Control)15.99
12027-01915.04
12027-02015.03

[back to top]

Mean Tactile Sensitivity Score at Week 2

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. (NCT01133379)
Timeframe: 2 Weeks

Interventiongrams (Least Squares Mean)
12027-021 (Vehicle Control)22.27
12027-01922.59
12027-02018.28

[back to top]

Mean Tactile Sensitivity Score at Week 4

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. (NCT01133379)
Timeframe: 4 Weeks

Interventiongrams (Least Squares Mean)
12027-021 (Vehicle Control)30.58
12027-01931.69
12027-02025.66

[back to top]

Mean Cold Air Stimulus VAS Score at Week 2

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01133379)
Timeframe: 2 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)40.56
12027-01937.95
12027-02036.90

[back to top]

Mean Cold Air Stimulus VAS Score at Week 1

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01133379)
Timeframe: 1 Week

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)44.18
12027-01941.72
12027-02040.30

[back to top]

Global Subjective VAS Score at Week 2

"At Week 2, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT01133379)
Timeframe: 2 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)44.12
12027-01937.93
12027-02038.02

[back to top]

Global Subjective VAS Score at Week 1

"At Week 1, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last week when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT01133379)
Timeframe: 1 Week

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)47.54
12027-01948.51
12027-02047.28

[back to top]

Mean Cold Air Stimulus VAS Score at Week 4

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01133379)
Timeframe: 4 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
12027-021 (Vehicle Control)31.92
12027-01931.87
12027-02030.63

[back to top]

Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-01996.23.800
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Tongue at Screening

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-01996.23.800
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Tongue at Day 5

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Tongue at Day 3

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Tongue at Day 25

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-02096.23.800
19292-116-A Control (Listerine®)96.33.700

[back to top]

Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)96.33.700

[back to top]

Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment

,,
InterventionPercentage of Participants (Number)
Buccal MucosaLabial MucosaSublingual MucosaMucobuccal FoldGingivaTongueHard/Soft PalateUvula/OropharynxTeethDental Restorations
12027-0190000000000
12027-020000003.70000
19292-116-A Control (Listerine®)000003.70000

[back to top]

Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 1 - Post-treatment

,,
InterventionPercentage of Participants (Number)
Buccal MucosaLabial MucosaSublingual MucosaMucobuccal FoldGingivaTongueHard/Soft PalateUvula/OropharynxTeethDental Restorations
12027-0190000000000
12027-0203.800007.70000
19292-116-A Control (Listerine®)0000018.50000

[back to top]

Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 24 - Post-treatment

,,
InterventionPercentage of Participants (Number)
Buccal MucosaLabial MucosaSublingual MucosaMucobuccal FoldGingivaTongueHard/Soft PalateUvula/OropharynxTeethDental Restorations
12027-0190000000000
12027-020000004.30000
19292-116-A Control (Listerine®)0000015.40000

[back to top]

Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 24 - Pretreatment

,,
InterventionPercentage of Participants (Number)
Buccal MucosaLabial MucosaSublingual MucosaMucobuccal FoldGingivaTongueHard/Soft PalateUvula/OropharynxTeethDental Restorations
12027-0190000000000
12027-020000004.30000
19292-116-A Control (Listerine®)3.700003.70000

[back to top]

Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 25

,,
InterventionPercentage of Participants (Number)
Buccal MucosaLabial MucosaSublingual MucosaMucobuccal FoldGingivaTongueHard/Soft PalateUvula/OropharynxTeethDental Restorations
12027-0190000000000
12027-020000004.30000
19292-116-A Control (Listerine®)0000000000

[back to top]

Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 3

,,
InterventionPercentage of Participants (Number)
Buccal MucosaLabial MucosaSublingual MucosaMucobuccal FoldGingivaTongueHard/Soft PalateUvula/OropharynxTeethDental Restorations
12027-0190000000000
12027-0203.800003.80000
19292-116-A Control (Listerine®)0000025.90000

[back to top]

Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 5

,,
InterventionPercentage of Participants (Number)
Buccal MucosaLabial MucosaSublingual MucosaMucobuccal FoldGingivaTongueHard/Soft PalateUvula/OropharynxTeethDental Restorations
12027-0190000000000
12027-0204.000004.00000
19292-116-A Control (Listerine®)0000022.20000

[back to top]

Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening

Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Screening

,,
InterventionPercentage of Participants (Number)
Buccal MucosaLabial MucosaSublingual MucosaMucobuccal FoldGingivaTongueHard/Soft PalateUvula/OropharynxTeethDental Restorations
12027-0190003.803.80000
12027-02000003.73.70000
19292-116-A Control (Listerine®)0000000000

[back to top]

Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-02096.23.800
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)96.303.70

[back to top]

Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-02096.23.800
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-02096.04.000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Gingiva at Day 25

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Gingiva at Day 3

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Gingiva at Day 5

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Gingiva at Screening

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment

The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment

,,
InterventionPercentage of Participants (Number)
NoneMildModerateSevere
12027-019100000
12027-020100000
19292-116-A Control (Listerine®)100000

[back to top]

Mean Tactile Sensitivity Score at Week 4

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 4 weeks

Interventiongrams of force (Least Squares Mean)
Negative Control (Crest Regular Toothpaste)10.39
Positive Control (Sensodyne Toothpaste)21.83
12027-027 (1.40% Potassium Oxalate Mouth Rinse)18.72

[back to top]

Mean Tactile Sensitivity Score at Week 2

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 2 weeks

Interventiongrams of force (Least Squares Mean)
Negative Control (Crest Regular Toothpaste)10.10
Positive Control (Sensodyne Toothpaste)13.16
12027-027 (1.40% Potassium Oxalate Mouth Rinse)12.51

[back to top]

Mean Cold Air Stimulus VAS Score at Week 4

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 4 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Negative Control (Crest Regular Toothpaste)39.54
Positive Control (Sensodyne Toothpaste)28.36
12027-027 (1.40% Potassium Oxalate Mouth Rinse)29.30

[back to top]

Mean Cold Air Stimulus VAS Score at Week 2

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 2 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Negative Control (Crest Regular Toothpaste)43.65
Positive Control (Sensodyne Toothpaste)38.74
12027-027 (1.40% Potassium Oxalate Mouth Rinse)40.22

[back to top]

Global Subjective VAS Score at Week 4

"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT01345292)
Timeframe: 4 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Negative Control (Crest Regular Toothpaste)41.32
Positive Control (Sensodyne Toothpaste)32.79
12027-027 (1.40% Potassium Oxalate Mouth Rinse)35.19

[back to top]

Global Subjective VAS Score at Week 2

"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT01345292)
Timeframe: 2 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Negative Control (Crest Regular Toothpaste)44.94
Positive Control (Sensodyne Toothpaste)43.68
12027-027 (1.40% Potassium Oxalate Mouth Rinse)43.64

[back to top]

Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2

Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 2 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Negative Control (Crest Regular Toothpaste)41.59
Positive Control (Sensodyne Toothpaste)39.52
12027-027 (1.40% Potassium Oxalate Mouth Rinse)37.16

[back to top]

Mean Tactile Sensitivity VAS Score at Week 4

Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 4 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Negative Control (Crest Regular Toothpaste)39.49
Positive Control (Sensodyne Toothpaste)30.94
12027-027 (1.40% Potassium Oxalate Mouth Rinse)29.32

[back to top]

Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy

F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer. (NCT01541358)
Timeframe: an estimated average of 2 hours

Interventionlesions detected by F18 NaF (Number)
Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)1

[back to top]

Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy

"Specificity is the ability of a test to correctly determine the absence of disease (true negative). This study determined how accurately F18 NaF PET/CT performed at detecting the absence of disease.~The calculation for specificity is TN / (TN + FP), where:~TN = the participant was a true negative (the lesion was not detected on F18 NaF PET/CT and the patient does not have the disease) FP = the participant was a false positive (the lesion was falsely detected on the F18 NaF PET/CT and the patient does not have the disease) The result is expressed as a percentage." (NCT01541358)
Timeframe: an estimated average of 2 hours

Interventionpercentage of specificity (Number)
Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)100

[back to top]

Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy

"Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate). This study determined how many lesions were detected by F18 NaF PET/CT compared to the known results. The calculation for sensitivity is TP / (TP+FN), where:~TP = true positive (the lesion was accurately detected on both F18 NaF and comparison study) FN = false negative (the lesion was not detected on the PET/CT but was detected on the comparison study)~The result is expressed as the percentage of confirmed lesions across all participants that were also detected by F18 NaF PET/CT." (NCT01541358)
Timeframe: an estimated average of 2 hours

Interventionpercentage of sensitivity (Number)
Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)14

[back to top]

Gestational Age (Weeks)

log[42.9-gestational age] (NCT01549587)
Timeframe: At delivery

Interventionlog weeks (Least Squares Mean)
Regular Oral Hygiene1.3988
Advanced Oral Hygiene Plus Counseling1.3271

[back to top]

Neonate Birth Weight (Grams)

(NCT01549587)
Timeframe: At delivery

Interventiongrams (Least Squares Mean)
Regular Oral Hygiene3095.97
Advanced Oral Hygiene Plus Counseling3167.80

[back to top]

Preterm Birth (Gestational Age < 37 Weeks)

(NCT01549587)
Timeframe: At delivery

InterventionParticipants (Count of Participants)
Regular Oral Hygiene32
Advanced Oral Hygiene Plus Counseling21

[back to top]

Change From Baseline in Löe-Silness Gingivitis Index

"Score Criteria 0 Normal gingiva.~Mild inflammation - slight change in color, slight edema. No bleeding on probing.~Moderate inflammation - redness, edema, and glazing. Bleeding on probing.~Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding." (NCT01549587)
Timeframe: 1 month

Interventionscore on a scale (Least Squares Mean)
Regular Oral Hygiene0.112
Advanced Oral Hygiene Plus Counseling0.125

[back to top]

Change From Baseline in Löe-Silness Gingivitis Index

"Score Criteria 0 Normal gingiva.~Mild inflammation - slight change in color, slight edema. No bleeding on probing.~Moderate inflammation - redness, edema, and glazing. Bleeding on probing.~Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding." (NCT01549587)
Timeframe: 2 months

Interventionscore on a scale (Least Squares Mean)
Regular Oral Hygiene0.124
Advanced Oral Hygiene Plus Counseling0.137

[back to top]

Change From Baseline in Löe-Silness Gingivitis Index

"Score Criteria 0 Normal gingiva.~Mild inflammation - slight change in color, slight edema. No bleeding on probing.~Moderate inflammation - redness, edema, and glazing. Bleeding on probing.~Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding." (NCT01549587)
Timeframe: 3 months

Interventionscore on a scale (Least Squares Mean)
Regular Oral Hygiene0.141
Advanced Oral Hygiene Plus Counseling0.154

[back to top]

Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.

SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14

Intervention% SMH (Least Squares Mean)
Experimental Dentifrice 0.5g, 2 Minutes Brushing Group30.75
Experimental Dentifrice 0.5g, 45 Seconds Brushing Group25.05

[back to top]

Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.

SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14

Intervention% SMH (Least Squares Mean)
Experimental Dentifrice 0.5g, 2 Minutes Brushing Group30.75
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group41.61

[back to top]

Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.

SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14

Intervention% SMH (Least Squares Mean)
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group41.61
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group34.66

[back to top]

Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.

SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14

Intervention% SMH (Least Squares Mean)
Experimental Dentifrice 0.5g, 45 Seconds Brushing Group25.05
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group34.66

[back to top]

Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.

EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14

Interventionμg×F/cm2 (Least Squares Mean)
Experimental Dentifrice 0.5g, 2 Minutes Brushing Group1603.63
Experimental Dentifrice 0.5g, 45 Seconds Brushing Group1337.72

[back to top]

Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.

EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14

Interventionmicrograms (μg)×F/centimeters(cm)2 (Least Squares Mean)
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group2426.51
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group1912.51

[back to top]

Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.

EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14

Interventionμg×F/cm2 (Least Squares Mean)
Experimental Dentifrice 0.5g, 2 Minutes Brushing Group1603.63
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group2426.51

[back to top]

Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.

EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14

Interventionμg×F/cm2 (Least Squares Mean)
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group2426.51
Contol Group1132.18

[back to top]

Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.

EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14

Interventionμg×F/cm2 (Least Squares Mean)
Experimental Dentifrice 0.5g, 45 Seconds Brushing Group1337.72
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group1912.51

[back to top]

Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.

SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14

Intervention% SMH (Least Squares Mean)
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group41.61
Contol Group26.23

[back to top]

Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment

"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity." (NCT01592851)
Timeframe: Baseline to immediately post treatment administration

InterventionForce (grams) (Mean)
SnF Dentifrice5.8
NaMFP Dentifrice1.9

[back to top]

Change From Baseline in Tactile Pain Threshold Score at Day 14

"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity" (NCT01592851)
Timeframe: Baseline to Day 14

InterventionForce (grams) (Mean)
SnF Dentifrice22.9
NaMFP Dentifrice3.5

[back to top]

Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14

Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. (NCT01592851)
Timeframe: Baseline to Day 14

InterventionScore on a scale (Mean)
SnF Dentifrice-1.20
NaMFP Dentifrice-0.37

[back to top]

Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3

Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. (NCT01592851)
Timeframe: Baseline to Day 3

InterventionScore on a scale (Mean)
SnF Dentifrice-0.70
NaMFP Dentifrice-0.25

[back to top]

Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment

Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. (NCT01592851)
Timeframe: Baseline to immediately post treatment administration

InterventionScore on a scale (Mean)
SnF Dentifrice-0.40
NaMFP Dentifrice-0.14

[back to top]

Change From Baseline in Tactile Pain Threshold Score at Day 3

"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity." (NCT01592851)
Timeframe: Baseline to Day 3

InterventionForce (grams) (Mean)
SnF Dentifrice9.8
NaMFP Dentifrice3.0

[back to top]

Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8

"Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated.~sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached." (NCT01592864)
Timeframe: Baseline to 8 weeks post administration of study treatment

Interventiongrams (Mean)
SnF Dentifrice21.3
NaMFP Dentifrice4.2

[back to top]

Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4

Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated (NCT01592864)
Timeframe: Baseline to 4 weeks post administration of study treatment

Interventiongrams (Mean)
SnF Dentifrice11.2
NaMFP Dentifrice1.5

[back to top]

Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4

Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. (NCT01592864)
Timeframe: Baseline to 4 weeks post administration of study treatment

InterventionScore on a scale (Mean)
SnF Dentifrice-0.7
NaMFP Dentifrice-0.2

[back to top]

Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8

Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. (NCT01592864)
Timeframe: Baseline to 8 weeks post administration of study treatment

InterventionScore on a scale (Mean)
SnF Dentifrice-0.9
NaMFP Dentifrice-0.5

[back to top]

Percent Net Acid Resistance (%NAR) of Enamel Specimens

Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100. (NCT01607411)
Timeframe: Baseline to 4 hours

Intervention%NAR (Mean)
NaF Toothpaste (1426 Ppm F)-19.72
NaF Toothpaste (1000 Ppm F)-19.52
NaF Toothpaste (500 Ppm F)-25.82
Placebo Toothpaste (0 Ppm F)-54.38

[back to top]

Enamel Fluoride Uptake

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel. (NCT01607411)
Timeframe: Baseline to 4 hours

Interventionμg*F/cm^2 (Mean)
NaF Toothpaste (1426 Ppm F)1.76
NaF Toothpaste (1000 Ppm F)1.77
NaF Toothpaste (500 Ppm F)1.47
Placebo Toothpaste (0 Ppm F)0.98

[back to top]

%SMHR of Enamel Specimens Exposed to Test Treatments

Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. (NCT01607411)
Timeframe: Baseline to 4 hours

Intervention%SMHR (Mean)
NaF Toothpaste (1426 Ppm F)30.72
NaF Toothpaste (1000 Ppm F)29.49
NaF Toothpaste (500 Ppm F)28.29

[back to top]

Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice

Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. (NCT01607411)
Timeframe: Baseline to 4 hours

Intervention%SMHR (Mean)
NaF Toothpaste (1426 Ppm F)30.72
NaF Toothpaste (1000 Ppm F)29.49
NaF Toothpaste (500 Ppm F)28.29
Placebo Toothpaste (0 Ppm F)25.13

[back to top]

Extended Sensitivity Relief. Tactile Sensitivity.

"Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with yes response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination." (NCT01610167)
Timeframe: 28 days (+/- 2 days) post treatment.

Interventiongrams (Mean)
NUPRO Sensodyne Prophy Paste w/ Novamin10.19
NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.11.07
NUPRO(r) Classic Prophy Paste1.15

[back to top]

Immediate Sensitivity Relief. Air Blast Sensitivity.

Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment. (NCT01610167)
Timeframe: Immediately after treatment.

Interventionunits on a scale (Mean)
NUPRO Sensodyne Prophy Paste w/ Novamin-0.87
NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.-0.86
NUPRO(r) Classic Prophy Paste0.00

[back to top]

Immediate Sensitivity Relief. Tactile Sensitivity.

"Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a yes response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment." (NCT01610167)
Timeframe: Immediately after treatment.

Interventiongrams (Mean)
NUPRO Sensodyne Prophy Paste w/ Novamin12.36
NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.10.46
NUPRO(r) Classic Prophy Paste0.60

[back to top]

Adverse Events.

Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste). (NCT01610167)
Timeframe: Immediately after treatment to 28 days (+/- 2 days) post treatment.

InterventionNumber of adverse events. (Number)
NUPRO Sensodyne Prophy Paste w/ Novamin0
NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.0
NUPRO(r) Classic Prophy Paste0

[back to top]

Extended Sensitivity Relief. Air Blast Sensitivity.

Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. (NCT01610167)
Timeframe: 28 days (+/- 2 days) post treatment.

Interventionunits on a scale (Mean)
NUPRO Sensodyne Prophy Paste w/ Novamin-0.94
NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.-0.95
NUPRO(r) Classic Prophy Paste0.03

[back to top]

Enamel Fluoride Uptake (Corrected Data)

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data. (NCT01641237)
Timeframe: Baseline to 4 hours

Interventionmicrograms*F/centimeters^2 (Mean)
NaF Dentifrice (1426 ppmF)3.13
NaF Dentifrice (1150 ppmF)3.07
NaF Dentifrice (250 ppmF)2.09
Placebo Dentifrice (0 ppmF)1.47

[back to top]

Percentage Relative Erosion Resistance

Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100. (NCT01641237)
Timeframe: Baseline to 4 hours

Intervention% Relative Erosion Resistance (Mean)
NaF Dentifrice (1426 ppmF)-38.83
NaF Dentifrice (1150 ppmF)-39.75
NaF Dentifrice (250 ppmF)-50.40
Placebo Dentifrice (0 ppmF)-71.21

[back to top]

Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship

SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01641237)
Timeframe: Baseline to 4 hours

Intervention%SMHR (Mean)
NaF Dentifrice (1426 ppmF)30.89
NaF Dentifrice (1150 ppmF)28.71
NaF Dentifrice (250 ppmF)25.28
Placebo Dentifrice (0 ppmF)21.03

[back to top]

%SMHR

SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01641237)
Timeframe: Baseline to 4 hours

Intervention%SMHR (Mean)
NaF Dentifrice (1426 ppmF)30.9
NaF Dentifrice (1150 ppmF)28.7
NaF Dentifrice (250 ppmF)25.3
Placebo Dentifrice (0 ppmF)21.0

[back to top]

Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure

SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome. (NCT01657903)
Timeframe: Baseline, 4 hours post treatment in each treatment period

InterventionPercentage SMH (Least Squares Mean)
NaF/KNO3 Toothpaste 132.24
NaF/KNO3 Toothpaste 232.32
NaF/KNO3 Toothpaste 334.53
No Fluoride/KNO3 Toothpaste22.87

[back to top]

SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure

SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome. (NCT01657903)
Timeframe: Baseline, 2 hours post treatment in each treatment period

InterventionPercentage SMH (Least Squares Mean)
NaF/KNO3 Toothpaste 128.96
NaF/KNO3 Toothpaste 228.92
NaF/KNO3 Toothpaste 328.30
No Fluoride/KNO3 Toothpaste17.90

[back to top]

RER of Enamel Specimens Post 2 Hours of Treatment Exposure

Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel. (NCT01657903)
Timeframe: Baseline, 2 hours post treatment in each treatment period

Intervention% RER (Least Squares Mean)
NaF/KNO3 Toothpaste 1-43.76
NaF/KNO3 Toothpaste 2-43.33
NaF/KNO3 Toothpaste 3-41.88
No Fluoride/KNO3 Toothpaste-85.88

[back to top]

Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure

Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel. (NCT01657903)
Timeframe: Baseline, 4 hours post treatment in each treatment period

InterventionPercentage RER (Least Squares Mean)
NaF/KNO3 Toothpaste 1-36.66
NaF/KNO3 Toothpaste 2-36.53
NaF/KNO3 Toothpaste 3-36.98
No Fluoride/KNO3 Toothpaste-77.82

[back to top]

% Acid Resistance Score Per Each of Five Arms

% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization. (NCT01665911)
Timeframe: Three Weeks per each of five arms

Interventionpercent (Least Squares Mean)
0 mg fluoride in 200 ml milk1.5 mg fluoride in 100 ml milk1.5 mg fluoride in 200 ml milk3.0 mg fluoride in 100 ml milk3.0 mg fluoride in 200 ml milk
All Participants-3.42.6-0.25.46.0

[back to top]

Enamel Fluoride Uptake Per Each of Five Arms

Enamel fluoride uptake is a measure of fluoridation of a caries lesion (NCT01665911)
Timeframe: Three Weeks per each of five arms

Interventionmicrogram fluoride per square cm (Least Squares Mean)
0 mg fluoride in 200 ml milk1.5 mg fluoride in 100 ml milk1.5 mg fluoride in 200 ml milk3.0 mg fluoride in 100 ml milk3.0 mg fluoride in 200 ml milk
All Participants1.22.42.123.092.67

[back to top]

% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms

"surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:~SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening)." (NCT01665911)
Timeframe: Three Weeks per each of five arms

Interventionpercent (Least Squares Mean)
0 mg fluoride in 200 ml milk1.5 mg fluoride in 100 ml milk1.5 mg fluoride in 200 ml milk3.0 mg fluoride in 100 ml milk3.0 mg fluoride in 200 ml milk
All Participants202422.526.725.4

[back to top]

Long-term Sensitivity Relief (Self-Assessment)

"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: 28 days post-prophylaxis treatment.

Interventionunits on a scale (Mean)
Group A0.60
Group B0.50
Group C0.72

[back to top]

Post-prophylaxis Sensitivity Relief (Self-Assessment)

"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Immediately following post-prophylaxis treatment.

Interventionunits on a scale (Mean)
Group A1.00
Group B0.90
Group C1.09

[back to top]

Sensitivity Relief (Self-Assessment)

"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity prior to the baseline assessments.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Pre-Treatment

Interventionunits on a scale (Mean)
Group A0.82
Group B0.67
Group C0.76

[back to top]

Post- Scaling Sensitivity Relief (Self-Assessment)

"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Post-scaling procedure,immediate

Interventionunits on a scale (Mean)
Group A1.31
Group B0.98
Group C1.28

[back to top]

Long-term Sensitivity Relief (Tactile Sensitivity)

"Assessment of sensitivity score via tactile measurements long term after treatment.~Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: 28 days (+/- 2 days) post treatment.

Interventiongrams (Mean)
Group A19.89
Group B16.51
Group C12.07

[back to top]

Baseline Pre-Prophy Assessment (Air Blast Sensitivity)

"Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Pre-treatment measurement

Interventionunits on a scale (Mean)
Group A1.72
Group B1.70
Group C1.65

[back to top]

Baseline Pre-Prophy Assessment (Tactile Sensitivity)

"Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Pre-treatment measurement

Interventiongrams (Mean)
Group A10.56
Group B10.00
Group C10.98

[back to top]

Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)

"Assessment of sensitivity score via air blast measurements immediately after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Immediately after treatment .

Interventionunits on a scale (Mean)
Group A0.88
Group B0.97
Group C1.72

[back to top]

Immediate Sensitivity Relief (Tactile Sensitivity)

"Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Immediately after treatment .

Interventiongrams (Mean)
Group A19.61
Group B16.67
Group C12.01

[back to top]

Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)

"Assessment of sensitivity score Schiff air blast measurements long term after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: 28 days (+/- 2 days) post treatment.

Interventionunits on a scale (Mean)
Group A0.87
Group B1.11
Group C1.67

[back to top]

Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8

Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. (NCT01691560)
Timeframe: Baseline to 8 weeks post administration of study treatment

Interventiongrams (Mean)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate10.15
Sodium Monofluorophosphate5.88
Sodium Fluoride4.39
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate11.97

[back to top]

Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4

Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. (NCT01691560)
Timeframe: Baseline to 4 weeks post administration of study treatment

Interventiongrams (Mean)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate7.31
Sodium Monofluorophosphate6.32
Sodium Fluoride4.09
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate3.64

[back to top]

Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4

Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain). (NCT01691560)
Timeframe: Baseline to 4 weeks post administration of study treatment

InterventionScore on a scale (Least Squares Mean)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate-1.22
Sodium Monofluorophosphate-1.07
Sodium Fluoride-1.35
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate-1.25

[back to top]

Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8

Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. (NCT01691560)
Timeframe: Baseline to 8 weeks post administration of study treatment

InterventionScore on a scale (Least Squares Mean)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate-0.55
Sodium Monofluorophosphate-0.43
Sodium Fluoride-0.43
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate-0.92

[back to top]

Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4

Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. (NCT01691560)
Timeframe: Baseline to 4 weeks post administration of study treatment

InterventionScore on a scale (Least Squares Mean)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate-0.36
Sodium Monofluorophosphate-0.43
Sodium Fluoride-0.40
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate-0.45

[back to top]

Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8

Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain). (NCT01691560)
Timeframe: Baseline to 8 weeks post administration of study treatment

InterventionScore on a scale (Least Squares Mean)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate-1.76
Sodium Monofluorophosphate-1.22
Sodium Fluoride-1.31
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate-2.06

[back to top]

Mean Cold Air Stimulus VAS Score at Week 2

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01727258)
Timeframe: 2 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Colgate Regular45.41
Sensodyne Toothpaste32.89
Potassium Oxalate Mouthrinse37.15

[back to top]

Mean Tactile Sensitivity VAS Score at Week 4

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01727258)
Timeframe: 4 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Colgate Regular38.38
Sensodyne Toothpaste26.40
Potassium Oxalate Mouthrinse31.45

[back to top]

Mean Cold Air Stimulus VAS Score at Week 4

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01727258)
Timeframe: 4 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Colgate Regular42.03
Sensodyne Toothpaste24.56
Potassium Oxalate Mouthrinse30.10

[back to top]

Mean Tactile Sensitivity Score at Week 2

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01727258)
Timeframe: 2 weeks

Interventiongrams of force (Least Squares Mean)
Colgate Regular11.09
Sensodyne Toothpaste17.00
Potassium Oxalate Mouthrinse17.18

[back to top]

Mean Tactile Sensitivity VAS Score at Week 2

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01727258)
Timeframe: 2 weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Colgate Regular43.80
Sensodyne Toothpaste36.95
Potassium Oxalate Mouthrinse37.08

[back to top]

Mean Tactile Sensitivity Score at Week 4

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01727258)
Timeframe: 4 weeks

Interventiongrams of force (Least Squares Mean)
Colgate Regular11.21
Sensodyne Toothpaste23.81
Potassium Oxalate Mouthrinse22.07

[back to top]

Validation of SFE Imaging for Lesion Size Assessment: SFE Imaging vs. Radiographic Imaging

"Categorical lesion depth (E1, E2, D1, D2) is measured using SFE imaging. The results are compared to the assessment of categorical lesion depth using radiographic imaging (state of the art method). Outcomes are defined as follows: 1) positive (if SFE imaging gave the same result as the radiograph analysis), 2) negative (if SFE imaging gave a different result as the radiograph analysis) and 3) failure (if lesion depth could not be assessed using SFE imaging).~Categorical lesion depth: E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin)." (NCT01796106)
Timeframe: 0, 12 and 24 months

InterventionLesions (Count of Units)
Baseline72235406Baseline7223540512 months7223540512 months7223540624 months7223540524 months72235406
PositiveNegativeFailure
Resin Infiltration1
Fluoride Varnish & Oral Hygiene Instruction2
Resin Infiltration3
Fluoride Varnish & Oral Hygiene Instruction3
Resin Infiltration0
Fluoride Varnish & Oral Hygiene Instruction0

[back to top]

Time to Progression

Summarized via the Kaplan-Meier (K-M) survivorship estimate. (NCT01812668)
Timeframe: From date of registration to date of first documented disease progression, or death from any cause, assessed up to 1 year

Interventionmonths (Median)
Treatment (Cabozantinib-s-malate)4.1

[back to top]

Number of Participants With Indicated Toxicities Grade 3 or Higher

Type of toxicities graded per National Cancer Institute (NCI) CTCAE version 4.0 Summarized via their frequency distribution and point estimate of the proportion. (NCT01812668)
Timeframe: Up to 4 weeks post-treatment, about 2 years on average.

InterventionParticipants (Count of Participants)
Parkinson like syndromeUTIanemiadecreased ALCdecreased plateletdehydrationdiarrheafatiguefoot blistershyperglycemiahypertensionhypophosphatemiaincreased ASTmandibular abscessmucositispleurisypneumoniaurinary retentionweight loss
Treatment (Cabozantinib-s-malate)11221113121121111112

[back to top]

PET Response Based on the RECIST Criteria 1.1

Summarized via their frequency distribution, point estimate of the proportion, and the Wilson type 80% CI. (NCT01812668)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Treatment (Cabozantinib-s-malate)19

[back to top]

Number of Participants With Indicated Clinical Response Based on the RECIST Criteria 1.1

Number of Participants with Indicated Clinical response based on the RECIST criteria 1.1 summarized via their frequency distribution. (NCT01812668)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Treatment (Cabozantinib-s-malate)6

[back to top]

PSA Response Based on the RECIST Criteria 1.1

Summarized via their frequency distribution, point estimate of the proportion, and the Wilson type 80% CI. (NCT01812668)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Treatment (Cabozantinib-s-malate)8

[back to top]

Change in PET Standard Uptake Value SUV Levels Pre-treatment to Post-treatment.

Change in PET standard uptake value SUV levels (each value measured in g/ml). (post-treatment - pre-treatment)/pre-treatment x 100 , therefore, measured in percentage change from baseline. (NCT01812668)
Timeframe: Baseline to 4 weeks

Interventionpercentage change from baseline (Median)
Treatment (Cabozantinib-s-malate)-56

[back to top] [back to top]

Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700

The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment. (NCT01816048)
Timeframe: Up to 12 months

Interventionparticipants (Number)
TAK-7008

[back to top]

Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)

The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF (NCT01827670)
Timeframe: Baseline-Week 4

,
InterventionScore on a Scale (Mean)
VAS Score at BaselineVAS Score at week 4
Control Dentrifice (0.76% Sodium Monofluorophosphate)58.4050.32
Test Dentrifice (0.454% Stannous Fluoride)58.2638.09

[back to top]

Mean Change From Baseline in Tactile Sensitivity

"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached." (NCT01827670)
Timeframe: Baseline-Week 4

,
InterventionGrams (Mean)
Tactile Thresold (g) at BaselineTactile Thresold (g) at Week 4
Control Dentrifice (0.76% Sodium Monofluorophosphate)10.115.8
Test Dentrifice (0.454% Stannous Fluoride Dentifrice)10.424.6

[back to top]

Mean Change From Baseline in Tactile Sensitivity

"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached." (NCT01827670)
Timeframe: Baseline-Week 8

,
InterventionGrams (Mean)
Tactile Threshold at Baseline (g)Tactile Threshold at Week 8 (g)
Control Dentrifice (0.76% Sodium Monofluorophosphate)10.114.6
Test Dentrifice (0.454% Stannous Fluoride)10.441.6

[back to top]

Mean Change From Baseline in Schiff Sensitivity Score

"The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).~Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation" (NCT01827670)
Timeframe: Baseline-Week 4

,
InterventionScore on a Scale (Mean)
Schiff Sensitivity Score at BaselineSchiff Sensitivity Score at Week 4
Control Dentrifice (0.76% Sodium Monofluorophosphate)2.262.10
Test Dentrifice (0.454% Stannous Fluoride)2.251.27

[back to top]

Mean Change From Baseline in Schiff Sensitivity Score

"The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).~Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation" (NCT01827670)
Timeframe: Baseline-Week 8

,
InterventionScore on a scale (Mean)
Schiff Sensitivity Score at BaselineSchiff Sensitivity Score at Week 8
Control Dentrifice (0.76% Sodium Monofluorophosphate)2.262.09
Test Dentrifice (0.454% Stannous Fluoride)2.250.78

[back to top]

Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)

The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF (NCT01827670)
Timeframe: Baseline - Week 8

,
InterventionScore on a Scale (Mean)
VAS Score at BaselineVAS Score at Week 8
Control Dentrifice (0.76% Sodium Monofluorophosphate)58.4043.94
Test Dentrifice (0.454% Stannous Fluoride)58.2622.17

[back to top]

Mean Change From Baseline in Schiff Sensitivity Score at Week 8

Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. (NCT01831817)
Timeframe: Baseline and 8 weeks post administration of study treatment

,,,
InterventionScore on a Scale (Mean)
BaselineWeek 8Mean change from baseline at Week 8
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate2.411.56-0.85
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate2.401.60-0.81
Sodium Fluoride2.382.440.07
Sodium Monofluorophosphate2.402.410.01

[back to top]

Median Change From Baseline in Tactile Sensitivity at Week 8

Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT01831817)
Timeframe: Baseline and 8 weeks post administration of study treatment

,,,
Interventiongrams (Median)
BaselineWeek 8Median change from baseline at Week 8
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate10.0015.005.00
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate10.0015.005.00
Sodium Fluoride10.0010.000.00
Sodium Monofluorophosphate10.0010.000.00

[back to top]

Median Change From Baseline in Tactile Sensitivity at Week 4

Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT01831817)
Timeframe: Baseline and 4 weeks post administration of study treatment

,,,
Interventiongrams (Median)
BaselineWeek 4Median change from baseline at Week 4
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate10.0010.000.00
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate10.0010.000.00
Sodium Fluoride10.0010.000.00
Sodium Monofluorophosphate10.0010.000.00

[back to top]

Mean Change From Baseline in Visual Rating Scale Score at Week 8

"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain." (NCT01831817)
Timeframe: Baseline and 8 weeks post administration of study treatment

,,,
InterventionScore on a scale (Mean)
BaselineWeek 8Mean change from baseline at Week 8
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate6.694.46-2.24
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate6.714.65-2.06
Sodium Fluoride6.926.07-0.86
Sodium Monofluorophosphate6.415.70-0.71

[back to top]

Mean Change From Baseline in Visual Rating Scale Score at Week 4

"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain." (NCT01831817)
Timeframe: Baseline and 4 weeks post administration of study treatment

,,,
InterventionScore on a scale (Mean)
BaselineWeek 4Mean change from baseline at Week 4
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate6.695.72-0.97
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate6.665.45-1.20
Sodium Fluoride6.926.38-0.54
Sodium Monofluorophosphate6.415.39-1.03

[back to top]

Mean Change From Baseline in Schiff Sensitivity Score at Week 4

Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. (NCT01831817)
Timeframe: Baseline and 4 weeks post administration of study treatment

,,,
InterventionScore on a scale (Mean)
BaselineWeek 4Mean change from baseline at Week 4
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate2.411.94-0.47
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate2.391.83-0.56
Sodium Fluoride2.382.31-0.07
Sodium Monofluorophosphate2.402.31-0.09

[back to top]

Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4

DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. (NCT01831817)
Timeframe: Baseline and 4 weeks post administration of study treatment

,,,
InterventionScore on a scale (Mean)
BaselineMean change from baseline at Week 4
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate132.55-4.39
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate136.53-3.91
Sodium Fluoride133.89-7.50
Sodium Monofluorophosphate121.09-3.80

[back to top]

Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8

DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. (NCT01831817)
Timeframe: Baseline and 8 weeks post administration of study treatment

,,,
InterventionScore on a scale (Mean)
BaselineChange from baseline at Week 8
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate132.55-7.97
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate134.33-6.43
Sodium Fluoride133.89-10.86
Sodium Monofluorophosphate120.09-3.88

[back to top]

Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade

"The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces.~For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the D and F portions of DFT, respectively." (NCT01901250)
Timeframe: baseline and middle of 2nd grade

InterventionNumber of surfaces (Mean)
Xylitol GB0.38
Fiber GB0.48

[back to top]

Overall Interproximal MLSI at Week 3

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 3 post treatment administration

InterventionScore on a Scale (Mean)
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.66
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.87

[back to top]

Overall Interproximal MLSI at Week 6

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 6 post treatment administration

InterventionScore on a Scale (Mean)
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash1.44
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash1.87

[back to top]

Modified Lobene Stain Index (MLSI) at Week 6

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 6 post treatment administration

InterventionScore on a Scale (Mean)
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.97
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash1.22

[back to top]

Overall Facial MLSI at Week 6

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 6 post treatment administration

InterventionScore on a Scale (Mean)
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.67
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.96

[back to top]

Overall Gingival and Interproximal MLSI at Week 3

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 3 post treatment administration

InterventionScore on a Scale (Mean)
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.56
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.73

[back to top]

Overall Facial MLSI at Week 3

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 3 post treatment administration

InterventionScore on a Scale (Mean)
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.27
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.41

[back to top]

Overall Gingival and Interproximal MLSI at Week 6

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 6 post treatment administration

InterventionScore on a Scale (Mean)
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash1.18
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash1.52

[back to top]

Overall MLSI at Week 3

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 3 post treatment administration

InterventionScore on a Scale (Mean)
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.46
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash0.59

[back to top]

Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.

Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease. (NCT01967862)
Timeframe: Up to 12 months

InterventionParticipants (Count of Participants)
Positive CT ScanPositive Bone ScanPositive MRIPositive PET
Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT)001217

[back to top]

Mean Cold Air Stimulus VAS Score at Week 2

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT02113579)
Timeframe: 2 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Placebo Control48.04
12027-03340.37

[back to top]

Mean Cold Air Stimulus VAS Score at Week 4

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT02113579)
Timeframe: 4 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Placebo Control40.04
12027-03325.76

[back to top]

Mean Tactile Sensitivity Score at Week 2

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. (NCT02113579)
Timeframe: 2 Weeks

Interventiongrams (Least Squares Mean)
Placebo Control12.72
12027-03317.42

[back to top]

Mean Tactile Sensitivity Score at Week 4

Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. (NCT02113579)
Timeframe: 4 Weeks

Interventiongrams (Least Squares Mean)
Placebo Control15.29
12027-03328.74

[back to top]

Mean Tactile Sensitivity VAS Score at Week 4

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT02113579)
Timeframe: 4 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Placebo Control38.24
12027-03326.72

[back to top]

Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score. (NCT02113579)
Timeframe: 4 Weeks

Interventionpercentage of participants (Number)
Placebo Control44.6
12027-03369.3

[back to top]

Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2

Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score. (NCT02113579)
Timeframe: 2 Weeks

Interventionpercentage of participants (Number)
Placebo Control30.6
12027-03346.0

[back to top]

Mean Tactile Sensitivity VAS Score at Week 2

Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT02113579)
Timeframe: 2 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Placebo Control44.39
12027-03337.72

[back to top]

Global Subjective VAS Score at Week 2

"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT02113579)
Timeframe: 2 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Placebo Control45.33
12027-03342.09

[back to top]

Global Subjective VAS Score at Week 4

"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT02113579)
Timeframe: 4 Weeks

Interventionunits on a scale (mm) (Least Squares Mean)
Placebo Control39.00
12027-03331.39

[back to top]

Time to Disease Progression

Months from the start of endocrine therapy to the time the patient is first recorded as having disease progression, (NCT02149173)
Timeframe: from start of therapy up to 20 years

Interventionmonths (Median)
FES With Potential ER Modulating Therapy (Vorinostat)2
FES With Potential ER Blocking Therapy5.6

[back to top]

Proportion of Patients Experienced a Threshold in Percentage Change, or Surpassed a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)

The number of patients showing a 20% increase in FES SULgmean compared to baseline at either 2 or 8 weeks using a 90% Wilson score binomial confidence interval. (NCT02149173)
Timeframe: from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

InterventionProportion of participants (Number)
FES With Potential ER Modulating Therapy (Vorinostat)0
FES With Potential ER Blocking Therapy0

[back to top]

Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV), Assessed by a One-sample Test of the Percent Change in FES SUV

Uptake was quantified using lean body mass adjusted SUV (SULmean). The geometric mean was calculated for up to 3 lesions per patient. Systematic change in FES SULgmean between baseline and a second FES scan at approximately 2 or 8 weeks and a third FES scan was at approximately 8 weeks measured using a sign test where the median change is zero. (NCT02149173)
Timeframe: from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

Interventionpercentage of change in SULgmean (Median)
FES-imaging After 2 Wks of ER Modulating (Vorinostat) Therapy8.7
FES-imaging After 8 Wks of ER Modulating (Vorinostat) Therapy1.9
FES-imaging After 2-8 Weeks of ER Blocking Therapy-60.3

[back to top]

F-18 16 Alpha-fluoroestradiol (FES) Uptake

Quantitative and qualitative measures of FES uptake for each disease site, a set of 1.5 cm diameter regions on three adjacent planes with the highest lesion FES uptake will be drawn to determine maximal FES uptake. Up to 10 sites seen on the static torso survey will be quantified. Lesions will qualitatively determined to be visible or not visible. (NCT02149173)
Timeframe: from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)

Interventionnumber of ER+ lesions (Count of Units)
Quantitative Uptake281
Qualitative Uptake243

[back to top]

Gingivitis Scores

Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02193165)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Regimen 11.40
Regimen 21.40
Regimen 3 - Control Group1.44

[back to top]

Gingivitis Scores

Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02193165)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Regimen 11.03
Regimen 21.21
Regimen 3 - Control Group1.46

[back to top]

Gingivitis Scores

Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02193165)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Regimen 11.19
Regimen 21.30
Regimen 3 - Control Group1.44

[back to top]

Dental Plaque Scores

Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02193165)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Regimen 12.42
Regimen 22.59
Regimen 3 - Control Group3.38

[back to top]

Dental Plaque Scores

Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02193165)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Regimen 12.78
Regimen 22.79
Regimen 3 - Control Group3.34

[back to top]

Dental Plaque Scores

Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02193165)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Regimen 13.33
Regimen 23.19
Regimen 3 - Control Group3.31

[back to top]

Percentage Comparative Acid Resistance (% CAR)

Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge. (NCT02195583)
Timeframe: Baseline to 4 hours

InterventionPercentage of CAR (Least Squares Mean)
Sodium Fluoride (1426 Ppm)45.00
Sodium Fluoride (1150 Ppm)45.23
Sodium Fluoride (250 Ppm)45.44
Sodium Fluoride (1426 Ppm) + Zinc Base A40.29
Sodium Fluoride (1426 Ppm) + Zinc Base B42.21
Sodium Fluoride (0 Ppm)75.41

[back to top]

Enamel Fluoride Uptake

The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2). (NCT02195583)
Timeframe: Baseline to 4 hours

Interventionmicrogram per square centimeter(μg/cm^2) (Least Squares Mean)
Sodium Fluoride (1426 Ppm)2.94
Sodium Fluoride (1150 Ppm)2.70
Sodium Fluoride (250 Ppm)1.85
Sodium Fluoride (1426 Ppm) + Zinc Base A2.62
Sodium Fluoride (1426 Ppm) + Zinc Base B2.37
Sodium Fluoride (0 Ppm)0.98

[back to top]

Percentage Surface Microhardness Recovery (% SMHR)

Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization. (NCT02195583)
Timeframe: Baseline to 4 hours

InterventionPercentage of SMHR (Least Squares Mean)
Sodium Fluoride (1426 Ppm)32.49
Sodium Fluoride (1150 Ppm)31.81
Sodium Fluoride (250 Ppm)27.56
Sodium Fluoride (1426 Ppm) + Zinc Base A22.62
Sodium Fluoride (1426 Ppm) + Zinc Base B23.22
Sodium Fluoride (0 Ppm)24.78

[back to top]

Percentage Net Acid Resistance (% NAR)

Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge. (NCT02195583)
Timeframe: Baseline to 4 hours

InterventionPercentage of NAR (Least Squares Mean)
Sodium Fluoride (1426 Ppm)-12.54
Sodium Fluoride (1150 Ppm)-13.45
Sodium Fluoride (250 Ppm)-17.81
Sodium Fluoride (1426 Ppm) + Zinc Base A-17.60
Sodium Fluoride (1426 Ppm) + Zinc Base B-18.98
Sodium Fluoride (0 Ppm)-50.60

[back to top]

Number of Gingival Bleeding Sites at 24 Weeks

The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed (NCT02207400)
Timeframe: 24 weeks

InterventionNumber of bleeding sites (Mean)
Sodium Bicarbonate and Sodium Fluoride Dentifrice13.24
Sodium Fluoride Dentifrice24.90

[back to top]

Modified Gingival Index (MGI)) at 6 and 12 Weeks.

MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration (NCT02207400)
Timeframe: 6 and 12 weeks

,
InterventionUnits on a scale (Mean)
MGI at 6 weeksMGI at 12 weeks
Sodium Bicarbonate and Sodium Fluoride Dentifrice1.501.50
Sodium Fluoride Dentifrice1.961.94

[back to top]

Number of Gingival Bleeding Sites at 6 and 12 Weeks

BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed (NCT02207400)
Timeframe: Baseline, 6 and 12 weeks

,
InterventionNumber of bleeding sites (Mean)
Number of Bleeding Sites at BaselineNumber of Bleeding Sites at 6 weeksNumber of Bleeding Sites at 12 weeks
Sodium Bicarbonate and Sodium Fluoride Dentifrice29.7612.2615.73
Sodium Fluoride Dentifrice29.0523.2323.86

[back to top]

Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.

The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth. (NCT02207400)
Timeframe: 6, 12 and 24 weeks

,
InterventionUnits on a scale (Mean)
Overall Plaque Score at 6 weeksOverall Plaque Score at 12 weeksOverall Plaque Score at 24 weeksInterproximal Plaque Score at 6 weeksInterproximal Plaque Score at 12 weeksInterproximal Plaque Score at 24 weeks
Sodium Bicarbonate and Sodium Fluoride Dentifrice2.562.542.472.782.762.71
Sodium Fluoride Dentifrice3.012.902.923.193.103.11

[back to top]

Bleeding Index (BI) at 6, 12 and 24 Weeks

BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed (NCT02207400)
Timeframe: 6, 12 and 24 weeks

,
InterventionUnits on a Scale (Mean)
BI Score Score at 6 weeksBI Score Score at 12 weeksBI Score Score at 24 weeks
Sodium Bicarbonate and Sodium Fluoride Dentifrice0.150.190.17
Sodium Fluoride Dentifrice0.300.280.31

[back to top]

Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks

Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours). (NCT02207400)
Timeframe: Baseline, 6, 12, 24 and 32 weeks

,
Interventioncolony forming units per sample (Mean)
Staph Count at Baseline (n=24, 26)Steph Count at 6 weeks (n=24, 26)Steph Count at 12 weeks (n=24, 26)Steph Count at 24 weeks (n=23, 25)Steph Count at 32 weeks (n=21, 21)Yeast Count at Baseline (n=24, 26)Yeast Count at 6 weeks (n=23, 26)Yeast Count at 12 weeks (n=24, 25)Yeast Count at 24 weeks (n=17, 22)Yeast Count at 32 weeks (n= 14, 14)Coliform count at Baseline (n= 24, 26)Coliform count at 6 weeks (n= 24, 26)Coliform count at 12 weeks (n= 24, 26)Coliform count at 24 weeks (n=23, 25)Coliform count at 32 weeks (n=21, 21)E. Coli count at Baseline (n=24, 26)E. Coli count at 6 weeks (n=24, 26)E. Coli count at 12 weeks (n=24, 26)E. Coli count at 24 weeks (n=23, 25)E. Coli count at 32 weeks (n=21, 21)
Sodium Bicarbonate and Sodium Fluoride Dentifrice0.20.11.80.60.2203.4287.3668.91479.62743.53.92.610.98.110.900.10.10.30.6
Sodium Fluoride Dentifrice0.203.20.20.1647.8784.3411.31522.31206.43.85.726.912.617.80000.20

[back to top]

Modified Gingival Index (MGI) at 24 Weeks

MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration (NCT02207400)
Timeframe: 24 weeks

InterventionUnits on a scale (Mean)
Sodium Bicarbonate and Sodium Fluoride Dentifrice1.26
Sodium Fluoride Dentifrice1.93

[back to top]

Bleeding Index at 6, 12 and 24 Weeks

The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed (NCT02207907)
Timeframe: Baseline, 6, 12 and 24 weeks

,
InterventionUnits on a Scale (Mean)
Bleeding Index Score at BaselineBleeding Index Score after 6 weeksBleeding Index Score after 12 weeksBleeding Index Score after 24 weeks
0% Sodium Bicarbonate Dentrifice0.470.410.350.37
Sodium Bicarbonate Dentrifice0.450.250.210.19

[back to top]

Modified Gingival Index (MGI) at 6 and 12 Weeks.

MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration (NCT02207907)
Timeframe: Baseline, 6 and 12 weeks

,
InterventionUnits on a scale (Mean)
Modified Gingival Index at BaselineModified Gingival Index after 6 weeksModified Gingival Index after 12 weeks
0% Sodium Bicarbonate Dentrifice2.542.452.40
Sodium Bicarbonate Dentrifice2.532.282.24

[back to top]

Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.

The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth (NCT02207907)
Timeframe: Baseline, 6,12 and 24 weeks

,
InterventionUnits on a scale (Mean)
Overall Plaque Score at BaselineOverall Plaque Score after 6 weeksOverall Plaque Score after 12 weeksOverall Plaque Score after 24 weeksInterproximal Plaque Score at BaselineInterproximal Plaque Score after 6 weeksInterproximal Plaque Score after 12 weeksInterproximal Plaque Score after 24 weeks
0% Sodium Bicarbonate Dentrifice3.002.982.922.953.083.053.013.03
Sodium Bicarbonate Dentrifice3.042.652.552.523.122.732.642.61

[back to top]

Number of Gingival Bleeding Sites at 6 and 12 Weeks.

Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. (NCT02207907)
Timeframe: Baseline, 6 and 12 weeks

,
Interventionnumber of gingival bleeding sites (Mean)
Number of Bleeding Sites at BaselineNumber of Bleeding Sites after 6 weeksNumber of Bleeding sites after 12 weeks
0% Sodium Bicarbonate45.8440.2734.23
Sodium Bicarbonate Dentrifice45.1325.4020.83

[back to top]

Number of Gingival Bleeding Sites at 24 Weeks

Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. (NCT02207907)
Timeframe: Baseline, 24 weeks

,
Interventionnumber of gingival bleeding sites (Mean)
Number of Bleeding Sites at BaselineNumber of Bleeding sites after 24 weeks
0% Sodium Bicarbonate Dentrifice45.8436.39
Sodium Bicarbonate Dentrifice45.1318.67

[back to top]

Modified Gingival Index (MGI) at 24 Weeks

The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration (NCT02207907)
Timeframe: Baseline, 24 weeks

,
InterventionUnits on a scale (Mean)
Modified Gingival Index at BaselineModified Gingival Index after 24 weeks
0% Sodium Bicarbonate Dentrifice2.542.43
Sodium Bicarbonate Dentrifice2.532.23

[back to top]

Change From Baseline Visual Analog Scale

Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. (NCT02221349)
Timeframe: 60 days

InterventionUnits on a scale (Mean)
Oxalate Liquid & Gel Plus SnF2 Paste-29.82
Oxalate Liquid & Gel Plus NaF Paste-24.67

[back to top]

Change From Baseline Air Challenge

The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure. (NCT02221349)
Timeframe: 60 days

InterventionUnits on a scale (Mean)
Oxalate Liquid & Gel Plus SnF2 Paste-1.643
Oxalate Liquid & Gel Plus NaF Paste-1.500

[back to top]

Mean Change From Baseline in Schiff Sensitivity Score at Week 4

The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity. (NCT02226562)
Timeframe: Baseline to 4 week

InterventionScores on scale (Mean)
Dentifrice Plus Oral Rinse-0.94
Dentifrice Alone-0.31

[back to top]

Mean Change From Baseline in Tactile Threshold at Week 4

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT02226562)
Timeframe: Baseline to 4 week

InterventionGram (g) (Mean)
Dentifrice Plus Oral Rinse14.11
Dentifrice Alone0.74

[back to top]

Mean Change From Baseline in Tactile Threshold at Week 8

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT02226562)
Timeframe: Baseline to 8 week

InterventionGram(g) (Mean)
Dentifrice Plus Oral Rinse31.32
Dentifrice Alone3.74

[back to top]

Mean Change From Baseline in Schiff Sensitivity Score at Week 8

The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity. (NCT02226562)
Timeframe: Baseline to 8 week

InterventionScore on scale (Least Squares Mean)
Dentifrice Plus Oral Rinse-1.47
Dentifrice Alone-0.37

[back to top]

Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8

Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. (NCT02226562)
Timeframe: Baseline to 8 week

InterventionScore on scale (Mean)
Dentifrice Plus Oral Rinse-3.05
Dentifrice Alone-1.05

[back to top]

Mean Change From Baseline in VRS at Week 4

Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. (NCT02226562)
Timeframe: Baseline to 4 week

InterventionScore on scale (Mean)
Dentifrice Plus Oral Rinse-1.64
Dentifrice Alone-0.86

[back to top]

Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery

The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery (NCT02319668)
Timeframe: Up to 7 days post implant surgery

Interventionlog (10) CFE × Day (Mean)
Test and Reference Product8.57
Reference Product8.37

[back to top]

Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis

Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol. Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery. After 30 minutes, the settle plates lids were replaced. This was repeated during the dental prophylaxis procedure using 5 fresh settle plates. All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days. The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation (NCT02319668)
Timeframe: At Baseline

,
Interventionlog (10) CFU/mL (Mean)
Pre prophylaxisPost prophylaxis
Reference Product0.911.33
Test and Reference Product0.941.31

[back to top]

Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7)

The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. (NCT02319668)
Timeframe: At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7

,
Interventionlog (10) CFE (Mean)
At Day 0 (pre rinse), (n=19,19)At Day 0 (pre implant), (n=19, 18)At Day 0 (mid implant), (n=19, 18)At Day 0 (post implant), (n=19,18)At Day 1 (n=19, 17)At Day 7 (n=19, 17)
Reference Product7.748.017.847.817.067.38
Test and Reference Products7.557.657.587.587.447.72

[back to top]

Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery

The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant. (NCT02319668)
Timeframe: At Day 3

Interventionlog(10) colony forming equivalents (CFE) (Mean)
Test and Reference Product7.63
Reference Product7.43

[back to top]

International Caries Detection and Assessment System (ICDAS II) - Number of Molars With ICDAS Score of 3 or More - ICDAS Score 3, Cavity -

"Difference in number of lesion changes into ICDAS score 3 (signifying a cavity) between matched case and control teeth (within patient) from baseline to 6 months and baseline to 12 months.~The International Caries Detection and Assessment System (ICDAS) is a visual assessment of the caries levels. The ICDAS score ranges from 0 to 6, with score 0 meaning no demineralization at all, score 3 means a first physical loss of enamel, and score 6 means a huge cavity." (NCT02357979)
Timeframe: 1 year

Interventionright or left second molar (Count of Units)
Laser & Fluoride0
Fluoride Alone13

[back to top]

Change in ICDAS Scores - International Caries Detection and Assessment System (ICDAS II) -

"Differences in change in ICDAS scores between matched case and control teeth (within patient) from baseline to 6 months and baseline to 12 months.~The International Caries Detection and Assessment System (ICDAS) is a visual assessment of the caries levels. The ICDAS score ranges from 0 to 6, with the score 0 meaning no demineralization at all, score 3 means a first physical loss of enamel, and score 6 means a huge cavity." (NCT02357979)
Timeframe: 1 year

,
Interventionright or left molar (Count of Units)
ICDAS score change -1ICDAS score change 0ICDAS score change +1ICDAS score change +2
Fluoride Alone0132810
Laser & Fluoride434121

[back to top]

Number of New Tooth Root Caries Lesions

the number of new tooth root caries lesions, i.e. tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination (NCT02360124)
Timeframe: 30 months

Interventionnew carious root surfaces (Mean)
Control1.1
Silver Diammine Fluoride0.43
Silver Diammine Fluoride and KI0.56

[back to top]

Proportion of Inactive Root Caries Lesions

the proportion of active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination will be calculated. The calculation is to divide the number of caries lesions that have changed status from active to inactive (assessed in clinical examination) by the number of active caries lesions found at baseline (NCT02360124)
Timeframe: 30 months

Interventionpercentage of inactive root caries (Number)
Control45.0
Silver Diammine Fluoride90.0
Silver Diammine Fluoride and KI92.5

[back to top]

Gingivitis Scores

Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02360995)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Total Toothpaste1.38
Toothpaste + Mouthwash1.35
Control Group1.41

[back to top]

Dental Plaque Scores

Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02360995)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Total Toothpaste3.42
Toothpaste + Mouthwash3.69
Control Group3.73

[back to top]

Gingivitis Scores

Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02360995)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Total Toothpaste1.05
Toothpaste + Mouthwash1.15
Control Group1.24

[back to top]

Gingivitis Scores

Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02360995)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Total Toothpaste1.15
Toothpaste + Mouthwash1.20
Control Group1.30

[back to top]

Dental Plaque Scores

Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02360995)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Total Toothpaste3.91
Toothpaste + Mouthwash3.86
Control Group3.84

[back to top]

Dental Plaque Scores

Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02360995)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Total Toothpaste1.05
Toothpaste + Mouthwash1.15
Control Group1.24

[back to top]

Dental Plaque Scores

Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02366689)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Toothpaste1.84
Toothpaste + Mouthwash1.86
Fluoride Only Toothpaste + Mouthwash2.37

[back to top]

Dental Plaque Scores

Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02366689)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Toothpaste3.33
Toothpaste + Mouthwash3.22
Fluoride Only Toothpaste + Mouthwash3.34

[back to top]

Gingivitis Scores

Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02366689)
Timeframe: 3 months

Interventionunits on a scale (Mean)
Toothpaste1.48
Toothpaste + Mouthwash1.65
Fluoride Only Toothpaste + Mouthwash1.89

[back to top]

Gingivitis Scores

Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02366689)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Toothpaste1.17
Toothpaste + Mouthwash1.18
Fluoride Only Toothpaste + Mouthwash1.85

[back to top]

Gingivitis Scores

Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02366689)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Toothpaste2.18
Toothpaste + Mouthwash2.17
Fluoride Only Toothpaste + Mouthwash2.22

[back to top]

Dental Plaque Scores

Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02366689)
Timeframe: 3 months

Interventionunits on a scale (Mean)
Toothpaste2.26
Toothpaste + Mouthwash2.42
Fluoride Only Toothpaste + Mouthwash2.66

[back to top]

Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8

"Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth." (NCT02371616)
Timeframe: At Baseline and Week 8

,
Interventionscore on a scale (Mean)
At BaselineAt Week 8Change from baseline at Week 8
Comparator Dentifrice55.8930.51-25.16
Test Dentifrice53.0531.62-21.50

[back to top]

Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4

"Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth." (NCT02371616)
Timeframe: At Baseline and Week 4

,
Interventionscore on a scale (Mean)
At Week 4Change from baseline at Week 4
Comparator Dentifrice40.60-15.24
Test Dentifrice40.71-12.12

[back to top]

Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8

Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. (NCT02371616)
Timeframe: At Baseline, Week 4 and Week 8

,
Interventionscore on a scale (Mean)
At BaselineAt Week 4Change from baseline at Week 4At Week 8Change from baseline at Week 8
Comparator Dentifrice2.682.11-0.571.58-1.09
Test Dentifrice2.722.13-0.591.65-1.08

[back to top]

Change From Baseline in Tactile Threshold at Week 4 and Week 8

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth. (NCT02371616)
Timeframe: At Baseline, Week 4 and Week 8

,
Interventiongram (g) (Mean)
At BaselineAt Week 4Change from baseline at Week 4At Week 8Change from baseline at Week 8
Comparator Dentifrice12.1823.6111.4233.5821.42
Test Dentifrice12.7925.4512.7232.8820.10

[back to top]

Enamel Fluoride Uptake

The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2). (NCT02399163)
Timeframe: Baseline to 14 days

Interventionmicrogram per square centimeter(μg/cm^2) (Mean)
Placebo Dentifrice/Fluoride Rinse7.22
Placebo Dentifrice/No Rinse1.60
Fluoride Dentifrice/No Rinse8.01
Fluoride Dentifrice/Fluoride Rinse9.97

[back to top]

Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14

Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample. (NCT02399163)
Timeframe: Baseline to Day14

Interventionmicrogram per mililitre(μg/mL ) (Mean)
Placebo Dentifrice/Fluoride Rinse0.06
Placebo Dentifrice/No Rinse-0.01
Fluoride Dentifrice/No Rinse0.00
Fluoride Dentifrice/Fluoride Rinse0.06

[back to top]

Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse

SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100. (NCT02399163)
Timeframe: Baseline to 14 days

Intervention% SMHR (Mean)
Placebo Dentifrice/Fluoride Rinse24.48
Placebo Dentifrice/No Rinse8.09

[back to top]

Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse

SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100. (NCT02399163)
Timeframe: Baseline to 14 days

Intervention% SMHR (Mean)
Placebo Dentifrice/Fluoride Rinse24.48
Placebo Dentifrice/No Rinse8.09
Fluoride Dentifrice/No Rinse28.36
Fluoride Dentifrice/Fluoride Rinse30.01

[back to top]

Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14

Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample. (NCT02399163)
Timeframe: Baseline up to Day 14

Interventionμg/mL (Mean)
Placebo Dentifrice/Fluoride Rinse13.08
Placebo Dentifrice/No Rinse0.05
Fluoride Dentifrice/No Rinse8.62
Fluoride Dentifrice/Fluoride Rinse13.81

[back to top]

Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)

"The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering <50% of the area, 2 = decalcification covering > 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Thus, for each tooth the value can range between 0 and 12.~16 teeth per subject were evaluated, for each subject the value of each tooth was added - thus the range per one subject can be between 0 and 192.~A mean over all participants in one group was calculated. A higher score means a worse outcome." (NCT02424097)
Timeframe: Baseline and 12-months

Interventionunits on a scale (Mean)
MI Paste & MI Varnish40.2
Standard of Care41.3

[back to top]

Change in International Caries Detection and Assessment System (ICDAS II) to Score for Smooth Surfaces White Spot Lesions (WSL)

"The International Caries Detection and Assessment System (ICDAS II) is a standardized method of caries lesion assessment.The score is based on apparent lesion severity, with scores from 0 to 6.The buccal surface of each tooth was divided into 4 quadrants, and for each quadrant a score was assigned with ICDAS scores: 0 = sound, 1 = first visual change in enamel, after air drying, 2 = distinct demineralization visual change in enamel, 3 = localized enamel breakdown due to caries with no visible dentin, 4 = surface with underlying dark shadow from dentin with or without enamel breakdown, 5 = distinct cavity with visible dentin, 6 = extensive cavity with visible dentin.~The ICDAS scores were calculated as the sum of the highest ICDAS scores assigned to each examined tooth per subject. 16 teeth per subject were evaluated, thus, for each subject the value can range between 0 and 96.~A mean over all participants in one group was calculated. A higher score means a worse outcome." (NCT02424097)
Timeframe: Baseline and 12-months

Interventionscore on a scale (Mean)
MI Paste & MI Varnish22.3
Standard of Care22.6

[back to top]

Ability of 18F-FSPG PET/CT to Discriminate Benign From Malignant Nodules

"Sensitivity, specificity, overall accuracy and receiver operating characteristic (ROC) curves will be generated and compared for both 18F-FDG and 18F-FSPG tests.~Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among analyzed patients. Area under the curve(AUC) is the area under the ROC curve, which is the plot of sensitivity by 1-specificity." (NCT02448225)
Timeframe: Up to 2 years

Interventionproportion, range 0 to 1, higher better (Number)
FDG sensitivity(low and high)FDG specificityFDG accuracyFDG AUC(area under curve)ESPG sensitivity(low and high)ESPG specificity(low and high)ESPG accuracyESPG AUC
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)0.7060.7780.7310.8170.8240.6670.7690.843

[back to top]

CD44 and xC- Expression Levels in Tissue Samples(0-3)

The level of expression of xCT and CD44 proteins in the cytoplasmic membrane of tumor cells were examined by an experienced pathologist who was blinded to any patient and imaging information. The percentage of tumor cells positive for the marker and the intensity of staining were evaluated, the latter using a scale of 0 (none), 1+ (weak), 2+ (intermediate), and 3+ (strong) with a sample being reported as positive if greater than 10% of the tumor cells in the sample were positively stained with any intensity. (NCT02448225)
Timeframe: Up to 2 years

InterventionIHC score, range 0 and above (Mean)
CD44xCT
Some Cancer Patients2.61

[back to top]

Ability of 18F-FSPG PET/CT to Stage of Lung Cancer (Metastatic or Not)

"Sensitivity, specificity, overall accuracy and ROC curves will be generated and compared for both 18F-FDG and 18F-FSPG tests. Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of the biodistribution characteristics of 18F-FDG and 18F-FSPG tests.~Sensitivity is the proportion of High(positive) among cancer patients. Specificity is the proportion of low(negative) among benign tumors. Accuracy is the proportion of correctly diagnosed among all patients. Area under the curve(AUC) is the area under the ROC curve." (NCT02448225)
Timeframe: Up to 2 years

Interventionproportion, range 0-1, higher better (Number)
FDG sensitivityFDG specificityFDG accuracyFDG AUCFSPG sensitivityFSPG specificityFSPG accuracyFSPG AUC
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)0.80.8570.8240.8710.20.2860.2350.8

[back to top]

Uptake of 18F-FSPG (Expressed in Maximal Standardized Uptake Value [SUV] Within the Tumor)

Maximum standardized uptake values (SUVmax) were normalized to lean body mass and measured with a 1 cm diameter round region of interest over the area of greatest uptake in the lesion being measured. (NCT02448225)
Timeframe: Up to 2 years

InterventionMaximum standardized uptake values (SUVm (Mean)
Benign Patients0.8
Cancer Patients3.9

[back to top]

Change From Baseline Visual Analog Scale

Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. (NCT02513212)
Timeframe: 30 days

InterventionUnits on a scale (Mean)
Oxalate Liquid, SnF2 Paste, Manual Toothbrush-11.000
Oxalate Liquid, SnF2 Paste, Power Toothbrush-28.500

[back to top]

Change From Baseline Air Challenge

The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure. (NCT02513212)
Timeframe: 30 days

InterventionUnits on a scale (Mean)
Oxalate Liquid, SnF2 Paste, Manual Toothbrush-0.409
Oxalate Liquid, SnF2 Paste, Power Toothbrush-0.917

[back to top]

Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge

Saliva stored at 0 - 20°C was used for determining calcium concentration (NCT02533466)
Timeframe: Baseline, 7 hours post dietary acid challenge

Interventionppm (Mean)
Test Product4.38
Reference Product0.00

[back to top]

Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge

Saliva stored at 0 - 20°C was used for determining calcium concentration (NCT02533466)
Timeframe: Baseline, 30 mins post dietary acid challenge

Interventionppm (Mean)
Test Product-12.81
Reference Product-16.29

[back to top]

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.

"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable" (NCT02533466)
Timeframe: Baseline, 2 hours post acid challenge

InterventionScores on grading scale (Median)
Test Product3.83
Reference Product2.33

[back to top]

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge

"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable" (NCT02533466)
Timeframe: Baseline, 4 hours post acid challenge

InterventionScores on grading scale (Median)
Test Product3.17
Reference Product1.08

[back to top]

Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge

Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high. (NCT02533466)
Timeframe: Baseline, 30 mins post dietary acid challenge

Interventionscores on a scale (Mean)
Test Product-1.81
Reference Product-1.50

[back to top]

Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge

Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high. (NCT02533466)
Timeframe: Baseline, 7 hours post dietary acid challenge

Interventionscores on a scale (Mean)
Test Product-0.25
Reference Product-0.36

[back to top]

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge

"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable" (NCT02533466)
Timeframe: Baseline, 7 hours post acid challenge

InterventionScores on grading scale (Median)
Test Product2.58
Reference Product0.75

[back to top]

Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge

Saliva stored at 0 - 20°C was used for determining pH (NCT02533466)
Timeframe: Baseline, 7 hours post dietary acid challenge

InterventionpH units (Mean)
Test Product0.00
Reference Product0.16

[back to top]

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge

"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable" (NCT02533466)
Timeframe: Baseline, 30 minutes post dietary acid challenge

InterventionScores on grading scale (Median)
Test Product3.75
Reference Product3.17

[back to top]

Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge

Saliva stored at 0 - 20°C was used for determining pH (NCT02533466)
Timeframe: Baseline, 30 mins post dietary acid challenge

InterventionpH units (Mean)
Test Product-0.71
Reference Product-0.51

[back to top]

Dental Caries Activity

Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change (NCT02536040)
Timeframe: 14-21 days

InterventionProportion of arrested caries lesions (Mean)
38% Diamine Silver Fluoride.72
Water.05

[back to top]

Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. (NCT02542943)
Timeframe: Baseline, Week 8

,,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 8
Experimental Oral Rinse 22.56-0.66
Experimental Oral Rinse12.54-0.86
Placebo Oral Rinse2.55-0.73

[back to top]

Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. (NCT02542943)
Timeframe: Baseline, Week 4

,,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 4
Experimental Oral Rinse 12.54-0.63
Experimental Oral Rinse 22.56-0.56
Placebo Oral Rinse2.55-0.57

[back to top]

Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. (NCT02542943)
Timeframe: Baseline, Week 8

,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 8
Experimental Oral Rinse 22.56-0.66
Experimental Oral Rinse12.54-0.86

[back to top]

Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values. (NCT02542943)
Timeframe: Baseline, Week 8

,,
Interventiong (Median)
At BaselineChange from Baseline at Week 8
Experimental Oral Rinse 210.005.00
Experimental Oral Rinse110.007.50
Placebo Oral Rinse10.005.00

[back to top]

Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4

"Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). A reduction in the score is indicative of an improvement in sensitivity." (NCT02542943)
Timeframe: Baseline, Week 4

,,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 4
Experimental Oral Rinse 26.32-1.29
Experimental Oral Rinse16.22-1.60
Placebo Oral Rinse6.19-1.45

[back to top]

Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8

"Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). A reduction in the score is indicative of an improvement in sensitivity." (NCT02542943)
Timeframe: Baseline, Week 8

,,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 8
Experimental Oral Rinse 26.32-2.07
Experimental Oral Rinse16.22-2.25
Placebo Oral Rinse6.19-2.15

[back to top]

Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values. (NCT02542943)
Timeframe: Baseline, Week 4

,,
Interventiong (Median)
At BaselineChange from Baseline at Week 4
Experimental Oral Rinse 210.000.00
Experimental Oral Rinse110.005.00
Placebo Oral Rinse10.005.00

[back to top]

Change in Salivary Streptococcus Mutans Levels After 30 Second Oral Rinse Time (Chlorhexidine Gluconate, Sodium Fluoride, or Deionized Water) or 2 Minute Chew Time (Paraffin Wax Chewing Gum)

"Oral salivary sample obtained and plated on MSB (mitis salivarius-bacitracin) agar petri dish to determine Streptococcus mutans (S. mutans) levels.~Values in each row in the Outcome Measure Data Table represent percentage change (increase denoted by positive number, decrease denoted by negative number) in S. mutans colonies from baseline (pre rinse/chew) sample for a single participant within that particular Arm/Group. Row titles have been arbitrarily identified as 'First Participant', 'Second Participant', 'Third Participant' and 'Fourth Participant.' No values are shown for 'Third Participant' and 'Fourth Participant' for the Chlorhexidine gluconate (0.12%) and Deionized water Arm/Group since only 2 participants were enrolled within each group. One result is obtained from each pre and post sample combination (percentage change)." (NCT02598778)
Timeframe: Sample obtained at baseline (pre rinse/chew) and immediately after treatment (post rinse/chew). Timed for 30 seconds (oral rinses) or 2 minutes (chewing gum)

,
InterventionPercentage change in S. mutans colonies (Number)
First ParticipantSecond ParticipantThird ParticipantFourth Participant
Paraffin Wax Chewing Gum (Sugar-free)53.1388.89161.54176.26
Sodium Fluoride (0.05%)-75-100-100-100

[back to top]

Change in Salivary Streptococcus Mutans Levels After 30 Second Oral Rinse Time (Chlorhexidine Gluconate, Sodium Fluoride, or Deionized Water) or 2 Minute Chew Time (Paraffin Wax Chewing Gum)

"Oral salivary sample obtained and plated on MSB (mitis salivarius-bacitracin) agar petri dish to determine Streptococcus mutans (S. mutans) levels.~Values in each row in the Outcome Measure Data Table represent percentage change (increase denoted by positive number, decrease denoted by negative number) in S. mutans colonies from baseline (pre rinse/chew) sample for a single participant within that particular Arm/Group. Row titles have been arbitrarily identified as 'First Participant', 'Second Participant', 'Third Participant' and 'Fourth Participant.' No values are shown for 'Third Participant' and 'Fourth Participant' for the Chlorhexidine gluconate (0.12%) and Deionized water Arm/Group since only 2 participants were enrolled within each group. One result is obtained from each pre and post sample combination (percentage change)." (NCT02598778)
Timeframe: Sample obtained at baseline (pre rinse/chew) and immediately after treatment (post rinse/chew). Timed for 30 seconds (oral rinses) or 2 minutes (chewing gum)

,
InterventionPercentage change in S. mutans colonies (Number)
First ParticipantSecond Participant
Chlorhexidine Gluconate (0.12%)-100-100
Deionized Water-39.29-46.15

[back to top]

Time of Treatment Procedures (Duration of Time in Minutes)

(NCT02601833)
Timeframe: Baseline

InterventionTime in Minutes (Mean)
Silver Diamine Fluoride5
Conventional Caries Management30

[back to top]

Costs of Treatment (Dollars)

Cost of one application of SDF and one 1-2 surface conventional restoration. Cost was calculated by taking the average Medicaid reimbursement across all U.S. states. (NCT02601833)
Timeframe: Baseline

InterventionDollars (Mean)
Silver Diamine Fluoride20.62
Conventional Caries Management79.68

[back to top]

Caries Arrest of Teeth in the SDF Group Measured by Change in Size

"Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure.~Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment." (NCT02601833)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Silver Diamine Fluoride10

[back to top]

Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT02612064)
Timeframe: Baseline, 60 seconds post first treatment, Day 3

,
Interventiong (Mean)
Change from Baseline to Day 0, Post-TreatmentChange from Baseline to Day 3
Sodium Monofluorophosphate4.7412.77
Stannous Fluoride8.8315.09

[back to top]

Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. (NCT02612064)
Timeframe: Baseline to 60 seconds post first treatment

Interventionscore on a scale (Mean)
Stannous Fluoride-0.41
Sodium Monofluorophosphate-0.31

[back to top]

Change From Baseline in Schiff Sensitivity Score on Day 3

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. (NCT02612064)
Timeframe: Baseline to 3 days

InterventionScore on a scale (Mean)
Stannous Fluoride-0.96
Sodium Monofluorophosphate-0.77

[back to top]

Did Participants Notice a Difference in the Areas Noted?

Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. (NCT02613117)
Timeframe: Up to 8 weeks

InterventionParticipants (Count of Participants)
Hot/Cold72150926Hot/Cold72150927Sweet/Sour72150927Sweet/Sour72150926Hard/Soft72150926Hard/Soft72150927Cold Air72150927Cold Air72150926Other72150927Other72150926
YesNo
Potassium Oxalate Gel42
Oxalate Liquid, SnF2 Paste30
Potassium Oxalate Gel14
Oxalate Liquid, SnF2 Paste14
Potassium Oxalate Gel19
Potassium Oxalate Gel37
Potassium Oxalate Gel7
Oxalate Liquid, SnF2 Paste13
Potassium Oxalate Gel49
Oxalate Liquid, SnF2 Paste31
Oxalate Liquid, SnF2 Paste18
Potassium Oxalate Gel28
Oxalate Liquid, SnF2 Paste26
Potassium Oxalate Gel8
Oxalate Liquid, SnF2 Paste9
Potassium Oxalate Gel48
Oxalate Liquid, SnF2 Paste35

[back to top]

Root Caries Activity

Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method. (NCT02647203)
Timeframe: After 2 years of follow up

InterventionPercentage of active lesions (2-years) (Mean)
High Fluoride Toothpaste3.72
Standard Fluoride Toothpaste40.52

[back to top] [back to top]

Change From Baseline in Schiff Sensitivity Score on Day 14

Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. (NCT02705716)
Timeframe: Baseline, Day 14

Interventionscore on a scale (Mean)
Test Dentifrice-1.01
Control Dentifrice-0.88

[back to top]

Change From Baseline in Schiff Sensitivity Score on Day 7

Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. (NCT02705716)
Timeframe: Baseline, Day 7

Interventionscore on a scale (Mean)
Test Dentifrice-0.49
Control Dentifrice-0.54

[back to top]

Change From Baseline in Tactile Threshold on Day 7 and 14

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. (NCT02705716)
Timeframe: Baseline, Day 7 and Day 14

,
Interventiong (Mean)
Change from baseline on Day 7(n=70,69)Change from baseline on Day 14(n=68,68)
Control Dentifrice10.2918.90
Test Dentifrice11.2118.24

[back to top]

Caries Activity Assessment According to Nyvad Criteria

"Caries activity assessment according to Nyvad criteria, number of participants still have active lesions overall study.~This assessment includes two clinical judgment inserts: active lesion or inactive lesion basing on visual-tactile surface characteristics of the caries lesions such as integrity, texture, translucency/opacity, lesion location, and surface color.~During the study, an alteration from active lesion to in active lesion means an improvement." (NCT02724592)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Intervention6
Control21

[back to top]

ICDAS Classification Index

"Number of patients who have improvement on the ICDAS classification index (International Caries Detection and Assessment System), changes from Baseline to 6-months recall.~This carries clinical index range from 0 to 6. The values mean:~0 No evidence of caries~Initial caries~Distinct visual change in enamel~Localised enamel breakdown due to caries with no visible dentine~Underlying dark shadow from dentine~Distinct cavity with visible dentine~Extensive distinct cavity with visible dentine. During the study, a change from level to lower level number (e.g. from 2 to 1) in patients means that the carious lesion is regressed." (NCT02724592)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Intervention9
Control2

[back to top]

Visual Analog Scale of Lesion Progression (VAS)

Visual Analog Scale of lesion progression (VAS), Effect via t test between Baseline and 6-months recall VAS values range from -100 % to +100 %. The value of -100 means that the carious lesion is strongly remineralising, the value of 0 means that the lesion is arrested, and the value of +100 means that the lesion is strongly progressing. (NCT02724592)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Intervention88.0
Control49.1

[back to top]

Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device.

"Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER Light Amplification by Stimulated Emission of Radiation fluorescence readings by Diagnodent® device.~Diagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity.~Effect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression." (NCT02724592)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Intervention18.6
Control1.1

[back to top]

Change From Baseline in Schiff Sensitivity Score on Day 3

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. (NCT02731833)
Timeframe: Baseline to Day 3

InterventionScore on a scale (Mean)
Stannous Fluoride-0.40
Sodium Monofluorophosphate0.00

[back to top]

Change From Baseline in Tactile Threshold Post First Treatment by Direct Application

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. (NCT02731833)
Timeframe: Baseline to 60 seconds post first treatment

Interventiong (Mean)
Stannous Fluoride1.71
Sodium Monofluorophosphate0.18

[back to top]

Change From Baseline in Tactile Threshold on Day 3

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. (NCT02731833)
Timeframe: Baseline to Day 3

Interventiong (Mean)
Stannous Fluoride3.69
Sodium Monofluorophosphate0.09

[back to top]

Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. (NCT02731833)
Timeframe: Baseline to 60 seconds post first treatment

InterventionScore on a scale (Mean)
Stannous Fluoride-0.17
Sodium Monofluorophosphate-0.02

[back to top]

Bleeding Index (BI) at Week 4 and Week 12

BI was assessed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed (NCT02750943)
Timeframe: Week 4, Week 12

,
Interventionscore on a scale (Least Squares Mean)
BI at Week 4 (n=121, 122)BI at Week 12 (n=119, 119)
Sodium Monofluorophosphate0.440.43
Stannous Fluoride0.290.27

[back to top]

Number of Bleeding Sites at Week 4

Number of bleeding sites was measured as BI via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2. (NCT02750943)
Timeframe: Week 4

Interventionnumber of bleeding sites (Least Squares Mean)
Stannous Fluoride45.44
Sodium Monofluorophosphate68.30

[back to top]

Number of Bleeding Sites at Week 12

Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2. (NCT02750943)
Timeframe: Week 12

Interventionnumber of bleeding sites (Least Squares Mean)
Stannous Fluoride42.02
Sodium Monofluorophosphate67.36

[back to top]

Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12

Visible blood in expectorate for each participant was classified as (i) Present (Trace or Substantial) (ii) Absent. The number of participants with blood 'Present' (Trace or Substantial) or 'absent' in expectorate was analyzed. (NCT02750943)
Timeframe: Week 4, Week 12

,
Interventionnumber of participants (Number)
At Week 4, Visible blood= PresentAt Week 4, Visible blood= TraceAt Week 4, Visible blood= SubstantialAt Week 4, Visible blood= AbsentAt Week 12, Visible blood= PresentAt Week 12, Visible blood= TraceAt Week 12, Visible blood= SubstantialAt Week 12, Visible blood= Absent
Sodium Monofluorophosphate8931583478136541
Stannous Fluoride9235573072185447

[back to top]

Modified Gingival Index (MGI) at Week 4 and Week 12

MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. (NCT02750943)
Timeframe: Week 4, Week 12

,
Interventionscore on a scale (Least Squares Mean)
MGI at Week 4MGI at Week 12
Sodium Monofluorophosphate2.402.47
Stannous Fluoride2.272.29

[back to top]

Change From Baseline in Tactile Threshold Post First Treatment by Direct Application

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT02751450)
Timeframe: Baseline to 60 seconds post first treatment

Interventiong (Mean)
Stannous Fluoride Dentifice19.49
Sodium Monofluorophosphate Dentifrice3.66

[back to top]

Change From Baseline in Tactile Threshold on Day 3

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT02751450)
Timeframe: Baseline to Day 3

Interventiong (Mean)
Stannous Fluoride35.47
Sodium Monofluorophosphate6.55

[back to top]

Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. (NCT02751450)
Timeframe: Baseline to 60 seconds post first treatment

InterventionScore on a Scale (Mean)
Stannous Fluoride Dentifice-0.89
Sodium Monofluorophosphate Dentifrice-0.17

[back to top]

Change From Baseline in Schiff Sensitivity Score on Day 3

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. (NCT02751450)
Timeframe: Baseline to Day 3

InterventionScore on a scale (Mean)
Stannous Fluoride-1.40
Sodium Monofluorophosphate-0.38

[back to top]

Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12

All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34). (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore ona Scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride142.41120.39-22.54

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4

All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a Scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride35.4832.64-2.40

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24

All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a scale (Mean)
At BaselineAt Week 24Change from Baseline at Week 24
Stannous Fluoride35.4827.03-8.45

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20

All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a scale (Mean)
At BaselineAt week 20Change from Baseline at Week 20
Stannous Fluoride35.4827.32-8.17

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16

All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore on a scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride35.4828.24-7.33

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12

All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a Scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride35.4828.79-6.86

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16

All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums? (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore on a scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride3.383.24-0.14

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20

All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums? (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride3.383.29-0.11

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24

All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums? (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a scale (Mean)
At BaselineAt Week 24Change from Baseline at Week 24
Stannous Fluoride3.383.24-0.15

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4

All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums? (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride3.383.24-0.14

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8

All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums? (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride3.383.32-0.04

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16

All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3 disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me fee damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy. (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore ona scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride16.2714.55-2.29

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12

All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy. (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride16.2714.64-1.83

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20

All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy. (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride16.2713.82-2.65

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4

All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy. (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride16.2715.66-0.64

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8

All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy. (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride16.2715.55-0.81

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12

All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations. (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride19.5516.31-3.19

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16

All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations. (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore on a Scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride19.5515.55-3.98

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20

All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations. (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a Scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride19.5515.50-3.94

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24

All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations. (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a Scale (Mean)
At BaselineAt Week 24Change from Baseline at Week 24
Stannous Fluoride19.5514.91-4.53

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4

All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations. (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride19.5518.24-1.21

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8

All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life? (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride6.565.12-1.43

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4

All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life? (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride6.565.88-0.64

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8

All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations. (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore ona scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride19.5516.86-2.75

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12

All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided. (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride53.1245.04-8.27

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16

All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided. (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore on a Scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride53.1242.59-10.45

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20

All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided. (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore ona scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride53.1241.89-11.48

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24

All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided. (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a scale (Mean)
At BaselineAt Week 24Change from Baseline at Week 24
Stannous Fluoride53.1241.67-11.71

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4

All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided. (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride53.1251.42-1.46

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8

All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided. (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride53.1246.43-6.80

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12

: All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life? (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride6.564.70-1.87

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16

All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life? (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore on a scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride6.564.42-2.12

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20

All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life? (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride6.564.29-2.32

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24

All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life? (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a scale (Mean)
At BaselineAt Week 24Change from Baseline at Week 24
Stannous Fluoride6.564.29-2.32

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12

All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride17.9915.60-2.64

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16

All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore ona Scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride17.9914.44-3.62

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20

All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride17.9913.79-4.33

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24

All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a scale (Mean)
At BaselineAt week 24Change from Baseline at Week 24
Stannous Fluoride17.9913.88-4.24

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4

All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a Scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride17.9917.30-0.57

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24

All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy. (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a scale (Mean)
At BaselineAt Week 24Change from Baseline at Week 24
Stannous Fluoride16.2713.71-2.76

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8

All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride17.9916.32-1.67

[back to top]

Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8

All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride5.934.51-1.45

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24

All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a scale (Mean)
At BaselineAt Week 24Change from baseline at Week 24
Stannous Fluoride4.953.36-1.56

[back to top]

Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 - Question (Q) No. 7 At Week 4

All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride5.784.85-0.88

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4

All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride4.954.46-0.43

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20

All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride5.783.67-2.06

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8

All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride4.954.29-0.67

[back to top]

Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16

All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34). (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore ona Scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride142.41115.36-27.68

[back to top]

Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20

All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34). (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a Scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride142.41112.32-30.58

[back to top]

Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24

All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34). (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a Scale (Mean)
At BaselineAt Week 24Change from Baseline at Week 24
Stannous Fluoride142.41111.20-31.70

[back to top]

Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4

All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34). (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a Scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride142.41135.24-6.28

[back to top]

Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8

All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34). (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a Scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride142.41126.58-16.33

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12

All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride5.784.01-1.73

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16

All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore on a scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride5.783.74-1.98

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24

All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a scale (Mean)
At BaselineAt Week 24Change from Baseline at Week 24
Stannous Fluoride5.783.52-2.21

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8

All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride5.784.49-1.26

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12

All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride5.933.99-1.94

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16

All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore on a scale (Mean)
At BaselineAt Week 16Change from Baseline at Week 16
Stannous Fluoride5.933.55-2.35

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24

All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 24

InterventionScore on a Scale (Mean)
At BaselineAt Week 24Change from Baseline at Week 24
Stannous Fluoride5.933.41-2.48

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4

All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 4

InterventionScore on a scale (Mean)
At BaselineAt Week 4Change from Baseline at Week 4
Stannous Fluoride5.934.69-1.22

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20

All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride5.933.70-2.20

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12

All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride4.953.56-1.39

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16

All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 16

InterventionScore on a scale (Mean)
At BaselineAt Week 16Change from baseline at Week 16
Stannous Fluoride4.953.47-1.47

[back to top]

Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20

All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life. (NCT02752958)
Timeframe: At Baseline and Week 20

InterventionScore on a scale (Mean)
At BaselineAt Week 20Change from Baseline at Week 20
Stannous Fluoride4.953.76-1.17

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12

All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums? (NCT02752958)
Timeframe: At Baseline and Week 12

InterventionScore on a scale (Mean)
At BaselineAt Week 12Change from Baseline at Week 12
Stannous Fluoride3.383.27-0.12

[back to top]

Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8

All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth. (NCT02752958)
Timeframe: At Baseline and Week 8

InterventionScore on a scale (Mean)
At BaselineAt Week 8Change from Baseline at Week 8
Stannous Fluoride35.4831.42-4.30

[back to top]

Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4

Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain). A reduction in the score is indicative of an improvement in sensitivity. (NCT02753075)
Timeframe: Baseline, Week 4

,,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 4
Experimental Oral Rinse 16.88-1.57
Experimental Oral Rinse 26.96-1.84
Placebo Oral Rinse6.72-1.97

[back to top]

Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4

The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. (NCT02753075)
Timeframe: Baseline, Week 4

,,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 4
Experimental Oral Rinse 12.54-0.71
Experimental Oral Rinse 22.54-0.83
Placebo Oral Rinse2.54-0.85

[back to top]

Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8

The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. (NCT02753075)
Timeframe: Baseline, Week 8

,,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 8
Experimental Oral Rinse 12.53-1.19
Experimental Oral Rinse 22.55-1.29
Placebo Oral Rinse2.55-1.28

[back to top]

Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8

The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. (NCT02753075)
Timeframe: Baseline, Week 8

,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 8
Experimental Oral Rinse 12.53-1.19
Experimental Oral Rinse 22.55-1.29

[back to top]

Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values. (NCT02753075)
Timeframe: Baseline, Week 8

,,
Interventiong (Median)
At BaselineChange from Baseline at Week 8
Experimental Oral Rinse 110.0040.00
Experimental Oral Rinse 210.0040.00
Placebo Oral Rinse10.0040.00

[back to top]

Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values. (NCT02753075)
Timeframe: Baseline, Week 4

,,
Interventiong (Median)
At BaselineChange from Baseline at Week 4
Experimental Oral Rinse 110.0015.00
Experimental Oral Rinse 210.0010.00
Placebo Oral Rinse10.005.00

[back to top]

Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8

"Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). A reduction in the score is indicative of an improvement in sensitivity." (NCT02753075)
Timeframe: Baseline, Week 8

,,
Interventionscore on a scale (Mean)
At BaselineChange from Baseline at Week 8
Experimental Oral Rinse 16.92-2.63
Experimental Oral Rinse 26.92-2.73
Placebo Oral Rinse6.72-2.54

[back to top]

Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application

Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded (NCT02768194)
Timeframe: Baseline, Day 1, 4, and 10

,,
InterventionScore on a scale (Mean)
Day 1: Pre-dose (Baseline)Day 1: Post-dose (Post Baseline)Day 1: Change from BaselineDay 4: Pre-dose (Baseline)Day 4: Post-dose (Post Baseline)Day 4: Change from BaselineDay 10: Pre-dose (Baseline)Day 10: Post-dose (Post Baseline)Day 10: Change from Baseline
Negative Control4.303.86-0.444.233.98-0.254.363.74-0.62
Reference Product4.384.13-0.264.303.60-0.704.313.49-0.82
Test Product4.303.96-0.344.413.51-0.914.313.13-1.18

[back to top]

Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application

Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded (NCT02768194)
Timeframe: Baseline and Day 8

,,
InterventionScore on a scale (Mean)
Pre-dose (Baseline)Post-dose (Post Baseline)Change
Negative Control4.363.53-0.83
Reference Product4.323.42-0.90
Test Product4.383.43-0.95

[back to top]

Change From Baseline in Tactile Threshold at Day 7 and Day 14

A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth. (NCT02773758)
Timeframe: Baseline, Day 7 and Day 14

,
Interventiongram (g) (Mean)
At BaselineChange from Baseline at Day 7Change from Baseline at Day 14
Sodium Monofluorophosphate Dentifrice11.500.860.86
Stannous Fluoride Dentifrice11.835.9215.21

[back to top]

Change From Baseline in Schiff Sensitivity Score at Day 7

Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. (NCT02773758)
Timeframe: Baseline, Day 7

,
Interventionscore on a scale (Mean)
At BaselineChange from baseline at Week 7
Sodium Monofluorophosphate Dentifrice2.74-0.04
Stannous Fluoride Dentifrice2.70-0.74

[back to top]

Change From Baseline in Schiff Sensitivity Score at Day 14

Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. (NCT02773758)
Timeframe: Baseline, Day 14

,
Interventionscore on a scale (Mean)
At BaselineChange From Baseline at Day 14
Sodium Monofluorophosphate Dentifrice2.74-0.10
Stannous Fluoride Dentifrice2.70-1.38

[back to top]

Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. (NCT02832375)
Timeframe: Baseline, after single use (after 5 minutes) and on Day 3

,
Interventiong (Mean)
Change from baseline post treatmentChange from baseline on Day 3
Experimental: Stannous Fluoride(SnF)4.0115.25
Standard: Sodium Monofluorophosphate(SMFP)3.603.88

[back to top]

Change From Baseline in Schiff Sensitivity Score After Single Use

Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. (NCT02832375)
Timeframe: Baseline, after single use (after 5 minutes)

Interventionscore on a scale (Mean)
Experimental: Stannous Fluoride(SnF)-0.46
Standard: Sodium Monofluorophosphate(SMFP)-0.45

[back to top]

Change From Baseline in Schiff Sensitivity Score on Day 3

Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. (NCT02832375)
Timeframe: Baseline, Day 3

Interventionscore on a scale (Mean)
Experimental: Stannous Fluoride(SnF)-0.82
Control: Sodium Monofluorophosphate(SMFP)-0.39

[back to top]

Change From Baseline in Tactile Threshold at Week 4 and 8

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT02861664)
Timeframe: At Baseline, Week 4 and Week 8

,
Interventiong (Mean)
Change from baseline at Week 4Change from baseline at Week 8
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)4.98.4
Test Dentifrice: Stannous Fluoride (SnF2)4.810.4

[back to top]

Change From Baseline in Schiff Sensitivity Score at Week 8

The examiner assessed the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. (NCT02861664)
Timeframe: At Baseline and Week 8

Interventionscore on a scale (Mean)
Test Dentifrice: Stannous Fluoride (SnF2)-0.94
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)-0.33

[back to top]

Change From Baseline in Schiff Sensitivity Score at Week 4

The examiner assessed the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. (NCT02861664)
Timeframe: At Baseline and Week 4

Interventionscore on a scale (Mean)
Test Dentifrice: Stannous Fluoride (SnF2)-0.63
Negative Control Dentifrice: Sodium Monofluorophosphate (SMFP)-0.10

[back to top]

Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation

Patient's response to cold stimulus is recorded on a Visual Analog Scale of 0-100 with 0 signifying no pain and 100 signifying the worst possible pain (NCT02918617)
Timeframe: Baseline to 8 weeks

Interventionpercentage change from baseline (Mean)
Control Toothpaste Containing Novamin® Technology-48.14
Control Toothpaste Containing 1500 Ppm Fluoride as MFP-34.96
Test Toothpaste With Nano-HAP (High Concentration)-44.71
Test Toothpaste With Nano-HAP (Low Concentration)-31.95
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)-42.49
Control Toothpaste Without Nano-HAP-35.67
Test Toothpaste With Nano-HAP (Medium Concentration)-48.80
Test Cream With Nano-HAP (Higher Concentration)-34.90
Control Cream Without Nano-HAP-39.36

[back to top]

Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation

Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]). (NCT02918617)
Timeframe: Baseline to 8 weeks

Interventionpercentage change from baseline (Mean)
Control Toothpaste Containing Novamin® Technology-35.37
Control Toothpaste Containing 1500 Ppm Fluoride as MFP-30.18
Test Toothpaste With Nano-HAP (High Concentration)-39.81
Test Toothpaste With Nano-HAP (Low Concentration)-38.41
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)-35.03
Control Toothpaste Without Nano-HAP-34.07
Test Toothpaste With Nano-HAP (Medium Concentration)-46.21
Test Cream With Nano-HAP (Higher Concentration)-15.30
Control Cream Without Nano-HAP-25.57

[back to top]

Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation

Patient's response to an air stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]). (NCT02918617)
Timeframe: Baseline to 8 weeks

Interventionpercentage change from baseline (Mean)
Control Toothpaste Containing Novamin® Technology-35.14
Control Toothpaste Containing 1500 Ppm Fluoride as MFP-43.35
Test Toothpaste With Nano-HAP (High Concentration)-34.15
Test Toothpaste With Nano-HAP (Low Concentration)-38.63
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)-43.95
Control Toothpaste Without Nano-HAP-33.63
Test Toothpaste With Nano-HAP (Medium Concentration)-49.35
Test Cream With Nano-HAP (Higher Concentration)-17.47
Control Cream Without Nano-HAP-28.54

[back to top]

Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation

Patient's response to an air stimulus is recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain. (NCT02918617)
Timeframe: Baseline to 8 weeks

Interventionpercentage change from baseline (Mean)
Control Toothpaste Containing Novamin® Technology-51.44
Control Toothpaste Containing 1500 Ppm Fluoride as MFP-51.59
Test Toothpaste With Nano-HAP (High Concentration)-41.59
Test Toothpaste With Nano-HAP (Low Concentration)-38.64
Test Toothpaste With Nano-HAP and Potassium Nitrate (KNO3)-53.16
Control Toothpaste Without Nano-HAP-47.19
Test Toothpaste With Nano-HAP (Medium Concentration)-56.85
Test Cream With Nano-HAP (Higher Concentration)-38.99
Control Cream Without Nano-HAP-50.67

[back to top]

Change From Baseline in Tactile Threshold on Day 3

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 gram[g] to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. (NCT02923895)
Timeframe: Baseline and Day 3

,
Interventiong (Mean)
At BaselineAt Day 3Change from Baseline
Control Dentifrice13.5814.891.32
Test Dentifrice13.4039.2825.88

[back to top]

Change From Baseline in Tactile Threshold After a Single Use

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. (NCT02923895)
Timeframe: Baseline to 60 seconds post first treatment

,
Interventiong (Mean)
At Baseline (Day 0, Pre-treatment)Day 0, Post-treatmentChange from Baseline
Control Dentifrice13.5814.631.05
Test Dentifrice13.4022.479.07

[back to top]

Change From Baseline in Schiff Sensitivity Score After a Single Use

The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. The Schiff sensitivity score was calculated as the average of individual test teeth score. Change from baseline in Schiff sensitivity was calculated as participant level mean change from baseline of the 2 test teeth. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. (NCT02923895)
Timeframe: Baseline to 60 seconds post first treatment

,
InterventionScore on a scale (Mean)
At Baseline (Day 0, Pre-treatment)Day 0 (Post-treatment)Change from Baseline
Control Dentifrice2.492.40-0.09
Test Dentifrice2.441.76-0.68

[back to top]

Change From Baseline in Schiff Sensitivity Score on Day 3

The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. The Schiff sensitivity score was calculated as the average of individual test teeth score. Change from baseline in Schiff sensitivity was calculated as participant level mean change from baseline of the 2 test teeth. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. (NCT02923895)
Timeframe: Baseline and Day 3

,
InterventionScore on a scale (Mean)
At Baseline (Day 0, Pre-treatment)At Day 3Change from Baseline
Control Dentifrice2.492.37-0.13
Test Dentifrice2.441.01-1.44

[back to top]

Change From Baseline (Day 0 Pre-treatment) in Schiff Sensitivity Score on Day 0 (After 60 Seconds of Single Direct Application)

The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. (NCT02924350)
Timeframe: At Baseline (Day 0 pre-treatment) and after 60 seconds of single direct application on Day 0

Interventionscore on a scale (Mean)
Test Dentifrice Containing Stannous Fluoride-0.63
Control Dentifrice Containing Sodium Monofluorophosphate-0.38

[back to top]

Change From Baseline in Schiff Sensitivity Score on Day 3

The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. (NCT02924350)
Timeframe: Baseline, Day 3

Interventionscore on a scale (Mean)
Test Dentifrice Containing Stannous Fluoride-1.37
Control Dentifrice Containing Sodium Monofluorophosphate-0.45

[back to top]

Change From Baseline (Day 0 Pre-treatment) in Tactile Threshold on Day 0 (After 60 Seconds of Single Direct Application) and Day 3

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10gram (g) and raised in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses were recorded as the tactile threshold. Higher tactile threshold means less sensitive tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT02924350)
Timeframe: At Baseline (Day 0 pre-treatment), after 60 seconds of single direct application on Day 0 and Day 3

,
Interventiong (Mean)
Change from baseline on Day 0Change from baseline on Day 3
Control Dentifrice Containing Sodium Monofluorophosphate8.1410.45
Test Dentifrice Containing Stannous Fluoride15.1032.79

[back to top]

Number of Bleeding Sites

Number of bleeding sites were measured as BI via a single examiner using a color coded periodontal probe. The probe was gently inserted approximately 1 millimeter (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. (NCT02937636)
Timeframe: At Week 12

InterventionNumber of bleeding sites (Mean)
Test Product10.37
Reference Product20.92

[back to top]

Mean Plaque Index (PI) (Overall and Interproximal)

The dental examiner used the PI to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.Overall PI score and interproximal PI score were calculated as the mean PI over all tooth sites and mean PI over interproximal sites (distal and mesial) respectively. (NCT02937636)
Timeframe: At Week 12

,
InterventionScore on Scale (Mean)
Mean Plaque Index (PI) (overall)Mean Plaque Index (PI) (interproximal)
Reference Product2.192.24
Test Product1.851.92

[back to top]

Mean Bleeding Index (BI)

The BI was performed by a single examiner using a color coded periodontal probe. The probe was inserted approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. This measure will be analyzed and summarized over all sites. (NCT02937636)
Timeframe: At Week 12

InterventionScore on Scale (Mean)
Test Product0.07
Reference Product0.15

[back to top]

Mean Modified Gingival Index (MGI)

The MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin).The scoring of MGI was performed by a single examiner. The MGI scoring system is as follows:0=absence of inflammation;1=mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit;2=mild inflammation; criteria as above but involving the entire marginal or papillar gingival units;3=moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit;4=severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. (NCT02937636)
Timeframe: At Week 12

InterventionScore On Scale (Mean)
Test Product1.62
Reference Product1.89

[back to top]

Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)

Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling. (NCT02953886)
Timeframe: One month

InterventionParticipants (Count of Participants)
Concerned with appearance of toothDesire for tooth to be filled
Silver Diamine Fluoride (SDF)118

[back to top]

Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions

Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application. (NCT02953886)
Timeframe: baseline, One month after SDF

Interventionbacterial count (Number)
BaselineOne month after SDF
Silver Diamine Fluoride (SDF)18900871959306

[back to top]

Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)

Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below. (NCT02953886)
Timeframe: One month

Interventioncervical lesions (Number)
SoftHard
Silver Diamine Fluoride (SDF)812

[back to top]

Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. (NCT03072719)
Timeframe: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14

,
Interventiongram (g) (Mean)
At BaselineAfter 5 minutes of brushingChange after 5 minutes of brushingOn Day 3Change from baseline on Day 3On Day 14Change from baseline on Day 14
Experimental Dentifrice10.816.55.718.47.525.314.6
Reference Dentifrice11.516.75.218.67.123.812.3

[back to top]

Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3

Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. (NCT03072719)
Timeframe: Baseline, post first brushing (after 5 minutes) and Day 3

,
Interventionscore on a scale (Mean)
After 5 minutes of brushingChange after 5 minutes of brushingOn Day 3Change from baseline on Day 3
Experimental Dentifrice1.73-0.781.63-0.88
Reference Dentifrice1.92-0.591.77-0.74

[back to top]

Change From Baseline in Schiff Sensitivity Score on Day 14

Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. (NCT03072719)
Timeframe: Baseline, Day 14

,
Interventionscore on a scale (Mean)
At BaselineAt Day 14Change from Baseline on Day 14
Experimental Dentifrice2.511.16-1.35
Reference Dentifrice2.511.35-1.16

[back to top]

Child Response to First Treatment

Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5. (NCT03082196)
Timeframe: After first treatment visit

Interventionunits on a scale (Mean)
Test Varnish2.3
Standard Varnish2.5

[back to top]

Child Response to Fifth Treatment

Facial Images Scale which measures the child's response using a series of five happy/sad faces from a very unhappy face (5) to a very happy face (1). The minimum value is 1 which corresponds to a very happy face and the maximum value is 5 which corresponds to a very unhappy face. The possible values of the scale are 1, 2, 3, 4, or 5. (NCT03082196)
Timeframe: After fifth treatment visit

Interventionunits on a scale (Mean)
Test Varnish2.2
Standard Varnish2.1

[back to top]

Dental Caries for All Primary Teeth Sound at Baseline

"The outcome will be the surface-level primary tooth caries increment (d2-4mfs) at two years post baseline that were sound at baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 4 or 5 surfaces of the tooth for up to 20 primary teeth that were sound at baseline, and has a range of 0 to 88. Higher values indicate a greater number of caries.~The measure records whether caries is present on any of the 5 surfaces of the primary molars or 4 surfaces of the other teeth." (NCT03082196)
Timeframe: 24 months

Interventionunits on a scale (Mean)
Test Varnish2.0
Standard Varnish2.7

[back to top]

Dental Caries for Primary Molars Sound at Baseline

The primary outcome will be the surface-level primary molar caries increment (d2-4mfs) at two years post baseline. Caries, as measured by d2-4mfs, is the total number of surfaces with decay into the enamel (2), dentin (3) or pulp (4), missing due to caries (m), or filled with amalgam, composite or other filling material (f). This scale records whether caries is detected in any of the 5 surfaces of the tooth for up to 8 primary molar teeth that were sound at baseline, and has a range of 0 to 40. Higher values indicate a greater number of caries. (NCT03082196)
Timeframe: 24 months

Interventionunits on a scale (Mean)
Test Varnish2.3
Standard Varnish3.3

[back to top]

Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of the allocated study dentifrice, after 4 weeks twice daily use. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT03160703)
Timeframe: Baseline and Week 4

,,,
InterventionScore on a scale (Mean)
BaselineWeek 4
Reference Dentifrice 1 (RDA~80)1.420.10
Reference Dentifrice 2 (RDA~120)1.380.16
Test Dentifrice 1 (RDA~58)1.380.08
Test Dentifrice 2 (RDA~77)1.430.05

[back to top]

Bacterial Count of Streptococus Mutans

Digital Colony Counter, Agar Diffusion test (NCT03186261)
Timeframe: 5 minutes on average between baseline and after application of the solution

,
InterventionCFU/ml log10 (Mean)
BaselineAfter solution application
Cavity Cleanser2.041.05
Nano Silver Fluoride Solution2.001.12

[back to top]

Change From Baseline in Tactile Threshold

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT03238352)
Timeframe: Week 8

,,
InterventionGrams (Mean)
Tactile threshold at baselineChange from baseline at Week 8
Negative Control (0.02% w/w Sodium Fluoride)10.2523.75
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)10.2311.59
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)10.3561.28

[back to top]

Change From Baseline in Schiff Sensitivity Score

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity. (NCT03238352)
Timeframe: Week 8

,,
InterventionScore on Scale (Mean)
Schiff score at baselineChange from baseline in Schiff score at Week 8
Negative Control (0.02% w/w Sodium Fluoride)2.68-0.75
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)2.52-0.64
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)2.59-1.94

[back to top]

Thermo-evaporative (Schiff Air Blast) Stimuli

Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome. (NCT03244618)
Timeframe: 4-weeks of product use (Day 28)

,
Interventionscore on a scale (Mean)
BaselineWeek 4
CSSP Toothpaste2.1881.268
Fluoride Toothpaste2.2461.811

[back to top]

Thermo-evaporative (Schiff Air Blast) Stimuli

Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity will be recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. (NCT03244618)
Timeframe: Day 29, 12 hours after product use has ceased

,
Interventionscore on a scale (Mean)
BaselineDay 29, 12hr after last product use
CSSP Toothpaste2.1881.044
Fluoride Toothpaste2.2461.713

[back to top]

Visual Analogue Scale

Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain). (NCT03244618)
Timeframe: Day 29, 12 hours after product use has ceased

,
Interventionscore on a scale (Mean)
BaselineDay 29, 12hr after last product use
CSSP Toothpaste48.127.2
Fluoride Toothpaste49.938.1

[back to top]

Visual Analogue Scale

Visual Analogue Scale values were recorded to give the outcome variable per subject at the same time asSchiff assessment. The VAS values were assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain). (NCT03244618)
Timeframe: 4-weeks of product use (Day 28)

,
Interventionscore on a scale (Mean)
BaselineWeek 4
CSSP Toothpaste48.131.1
Fluoride Toothpaste49.942.0

[back to top]

Tactile (Yeaple Probe) Stimuli

The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. (NCT03244618)
Timeframe: 4-weeks of product use (Day 28)

,
Interventionscore on a scale (Mean)
BaselineWeek 4
CSSP Toothpaste17.538.2
Fluoride Toothpaste16.627.5

[back to top]

Tactile (Yeaple Probe) Stimuli

The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. (NCT03244618)
Timeframe: Day 29, 12 hours after product use has ceased

,
Interventionscore on a scale (Mean)
BaselineDay 29, 12hr after last product use
CSSP Toothpaste17.541.5
Fluoride Toothpaste16.629.7

[back to top]

Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks

The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area. (NCT03285984)
Timeframe: Baseline to 4 Weeks

,,,
InterventionScore on a scale (Mean)
BaselinePost BaselineChange from Baseline after 4 weeks
Test Product 12.901.76-1.13
Test Product 22.921.78-1.14
Test Product 32.891.77-1.11
Test Product 42.861.96-0.90

[back to top]

Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks

The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area. (NCT03285984)
Timeframe: Baseline to 4 Weeks

,
InterventionScore on a scale (Mean)
BaselinePost BaselineChange from Baseline
Test Product 12.901.76-1.13
Test Product 42.861.96-0.90

[back to top]

% Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel)

The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = [(E1-R)/(E1-B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment

InterventionPercentage SMHR (Least Squares Mean)
Test Product29.67
Placebo Product21.98

[back to top]

% Relative Erosion Resistance (RER; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Inhibit Demineralization of Enamel)

The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment

InterventionPercentage RER (Least Squares Mean)
Test Product-23.65
Placebo Product-56.94

[back to top]

% RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)

The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment

InterventionPercentage RER (Least Squares Mean)
Test Product-23.65
Comparator Product-34.63

[back to top]

% SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)

The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as: %SMHR = [(E1-R)/(E1-B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment

InterventionPercentage SMHR (Least Squares Mean)
Test Product29.67
Comparator Product22.10

[back to top]

EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)

The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment

InterventionMicrogram fluoride per square centimeter (Least Squares Mean)
Test Product2.98
Comparator Product2.01

[back to top]

Enamel Fluoride Uptake (EFU; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Promote Fluoride Uptake in Enamel)

The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment

InterventionMicrogram fluoride per square centimeter (Least Squares Mean)
Test Product2.98
Placebo Product1.17

[back to top]

Change From Baseline in Tactile Threshold After 8 Weeks of Treatment

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT03310268)
Timeframe: Week 8

,,
InterventionGrams (Mean)
Tactile threshold at baselineTactile threshold at Week 8Change from baseline at Week 8
Negative Control (1400 Ppm Fluoride as SMFP)11.4236.4925.00
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])11.8033.9322.31
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])11.1328.5217.38

[back to top]

Change From Baseline in Schiff Sensitivity Score After 8 Weeks of Treatment

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity. (NCT03310268)
Timeframe: Baseline, Week 8

,,
InterventionScore on Scale (Mean)
Schiff score at baselineSchiff score at Week 8Change from baseline in Schiff score at Week 8
Negative Control (1400 Ppm Fluoride as SMFP)2.231.50-0.72
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])2.181.70-0.48
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])2.221.69-0.53

[back to top]

Net Acid Resistance (NAR)

"The %NAR will be calculated by the method of Corpron [Corpron et al., 1986]:~Net Acid Resistance = [(D1-D2) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure

Intervention% Net Acid Resistance (Mean)
Bovine Specimens 0 Ppm F-22.68
Bovine Specimens 250 Ppm F11.43
Bovine Specimens 500 Ppm F18.66
Bovine Specimens 1100 Ppm F31.79
Human Specimens 0 Ppm F-18.60
Human Specimens 250 Ppm F1.99
Human Specimens 500 Ppm F8.31
Human Specimens 1100 Ppm F16.87

[back to top]

Transverse Microradiography (TMR) - Lesion Depth - L

"Lesions will be analyzed after in situ demineralization and the following three parameters calculated:~Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]~Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)~Maximum mineral density at the surface-zone - SZmax" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure

InterventionMicrometers (Mean)
Bovine Specimens 0 Ppm F52.01
Bovine Specimens 250 Ppm F41.74
Bovine Specimens 500 Ppm F34.85
Bovine Specimens 1100 Ppm F27.31
Human Specimens 0 Ppm F60.73
Human Specimens 250 Ppm F42.12
Human Specimens 500 Ppm F37.38
Human Specimens 1100 Ppm F36.02

[back to top]

Transverse Microradiography (TMR) - Integrated Mineral Loss - ∆Z

"Lesions will be analyzed after in situ demineralization and the following three parameters calculated:~Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]~Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)~Maximum mineral density at the surface-zone - SZmax" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure

InterventionIntegrated Mineral Loss - ∆Z (Mean)
Bovine Specimens 0 Ppm F1240
Bovine Specimens 250 Ppm F902
Bovine Specimens 500 Ppm F664
Bovine Specimens 1100 Ppm F684
Human Specimens 0 Ppm F1526
Human Specimens 250 Ppm F912
Human Specimens 500 Ppm F901
Human Specimens 1100 Ppm F859

[back to top]

Comparative Acid Resistance (CAR)

"Using the data from the four centrally located enamel specimens, the equation used will compare explicitly the reduction in SMH brought by the first and second acid challenges:~Comparative Acid Resistance = [(D2-R) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure

Intervention% Comparative Acid Resistance (Mean)
Bovine Specimens 0 Ppm F36.42
Bovine Specimens 250 Ppm F19.20
Bovine Specimens 500 Ppm F22.16
Bovine Specimens 1100 Ppm F16.27
Human Specimens 0 Ppm F25.82
Human Specimens 250 Ppm F14.31
Human Specimens 500 Ppm F13.33
Human Specimens 1100 Ppm F9.71

[back to top]

Enamel Fluoride Uptake (EFU)

The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2. (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure

Interventionµg F/cm^2 (Mean)
Bovine Specimens 0 Ppm F0.96
Bovine Specimens 250 Ppm F2.25
Bovine Specimens 500 Ppm F2.69
Bovine Specimens 1100 Ppm F2.98
Human Specimens 0 Ppm F0.96
Human Specimens 250 Ppm F2.14
Human Specimens 500 Ppm F2.50
Human Specimens 1100 Ppm F2.73

[back to top]

Percentage Surface Microhardness Recovery (%SMH)

"The extent of remineralization will be calculated based on the method of [Gelhard et al., 1979].~SMH recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure." (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure

InterventionPercent Surface Microhardness Recovery (Mean)
Bovine Specimens 0 Ppm F13.96
Bovine Specimens 250 Ppm F30.59
Bovine Specimens 500 Ppm F40.74
Bovine Specimens 1100 Ppm F48.28
Human Specimens 0 Ppm F7.42
Human Specimens 250 Ppm F16.27
Human Specimens 500 Ppm F21.59
Human Specimens 1100 Ppm F26.75

[back to top]

Transverse Microradiography (TMR) - Maximum Mineral Density at the Surface-zone

"Lesions will be analyzed after in situ demineralization and the following three parameters calculated:~Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]~Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)~Maximum mineral density at the surface-zone - SZmax (arbitrary unit from TMR software)" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure

InterventionSZmax (Mean)
Bovine Specimens 0 Ppm F62.17
Bovine Specimens 250 Ppm F62.54
Bovine Specimens 500 Ppm F67.13
Bovine Specimens 1100 Ppm F65.93
Human Specimens 0 Ppm F61.22
Human Specimens 250 Ppm F62.99
Human Specimens 500 Ppm F61.38
Human Specimens 1100 Ppm F63.66

[back to top]

Change From Baseline Air Challenge

The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure. (NCT03405259)
Timeframe: Within 5 minutes after treatment was applied

InterventionUnits on a scale (Mean)
Super Seal® Desensitizer-0.55
Acclean® Fluoride Varnish-0.95

[back to top]

Change From Baseline Visual Analog Scale

Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline. (NCT03405259)
Timeframe: Within 5 minutes after treatment was applied

InterventionUnits on a scale (Mean)
Super Seal® Desensitizer-17.60
Acclean® Fluoride Varnish-19.55

[back to top]

Progression Free Survival

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology. (NCT03778294)
Timeframe: At 12 months after radiation therapy

Interventionproportion of successes (Number)
Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide)0.72

[back to top]

Overall Survival (OS)

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958). (NCT03778294)
Timeframe: Time from registration to death due to any cause, assessed up to 12 months

Interventionproportion of successes (Number)
Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide)0.54

[back to top]

Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28

Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement. (NCT03943095)
Timeframe: Day 28

InterventionNumber of Sensitive teeth (Mean)
Test Dentifrice1.0
Control Dentifrice2.1

[back to top]

Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14

Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement. (NCT03943095)
Timeframe: Day 14

InterventionNumber of Sensitive teeth (Mean)
Test Dentifrice1.7
Control Dentifrice2.8

[back to top]

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 7

InterventionGrams (Mean)
Test Dentifrice47.45
Control Dentifrice38.75

[back to top]

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 56

InterventionGrams (Mean)
Test Dentifrice79.71
Control Dentifrice64.80

[back to top]

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 3

InterventionGrams (Mean)
Test Dentifrice31.35
Control Dentifrice27.98

[back to top]

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 28

InterventionGrams (Mean)
Test Dentifrice71.67
Control Dentifrice57.94

[back to top]

Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7

Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement. (NCT03943095)
Timeframe: Day 7

InterventionNumber of Sensitive teeth (Mean)
Test Dentifrice2.2
Control Dentifrice3.2

[back to top]

Change From Baseline (Day 0) in Tactile Threshold on Day 56

Tactile sensitivity was assessed for eligible teeth using constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until tactile threshold for that visit is reached. The probe tip was placed perpendicular to facial surface of tooth and drawn slowly across exposed dentine. After each application, participant was asked whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gives two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20g;at all subsequent visits,80g.If no sensitivity was found at the upper limit, the tactile threshold was recorded as >20 g (Baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement. Adjusted mean change from baseline are derived from ANCOVA model which included treatment as factor and baseline tactile senstivity as covariate with change from baseline as dependent variable. (NCT03943095)
Timeframe: Baseline (Day 0), Day 56

InterventionGrams (Mean)
Test Dentifrice69.34
Control Dentifrice51.94

[back to top]

Change From Baseline in Schiff Sensitivity Score at Day 56

Evaporative air sensitivity was assessed on the facial surfaces of teeth by directing one second application of air from dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin and from a distance of approximately 1 cm. Participant response to stimulus was evaluated using Schiff sensitivity scale following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of stimulus. Score range 0-3;a decrease in Schiff sensitivity score indicates improvement. Adjusted mean change from baseline are derived from analysis of covariance (ANCOVA) model which included treatment as a factor and baseline Schiff sensitivity score as a covariate with change from baseline as dependent variable. (NCT03943095)
Timeframe: Baseline (Day 0), Day 56

InterventionScore on a scale (Mean)
Test Dentifrice-2.48
Control Dentifrice-2.17

[back to top]

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)

Tactile sensitivity was assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 gram (g) and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached.The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application,the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20 g;at all subsequent visits, 80 g.If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits).An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Baseline (Day 0)

InterventionGrams (Mean)
Test Dentifrice11.06
Control Dentifrice12.31

[back to top]

Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14

Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (>) 20 g (baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 14

InterventionGrams (Mean)
Test Dentifrice60.59
Control Dentifrice48.53

[back to top]

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 7

InterventionScore on a scale (Mean)
Test Dentifrice0.73
Control Dentifrice1.20

[back to top]

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 56

InterventionScore on a scale (Mean)
Test Dentifrice0.12
Control Dentifrice0.42

[back to top]

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 3

InterventionScore on a scale (Mean)
Test Dentifrice1.19
Control Dentifrice1.46

[back to top]

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 28

InterventionScore on a scale (Mean)
Test Dentifrice0.32
Control Dentifrice0.75

[back to top]

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 millimeter (mm) coronal to the gingival margin from a distance of approximately 1 centimeter (cm).Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus.0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus,considers stimulus to be painful, requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Baseline (Day 0)

InterventionScore on a scale (Mean)
Test Dentifrice2.61
Control Dentifrice2.60

[back to top]

Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)

Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement. (NCT03943095)
Timeframe: Baseline (Day 0)

InterventionNumber of sensitive teeth (Mean)
Test Dentifrice3.1
Control Dentifrice3.2

[back to top]

Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56

Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement. (NCT03943095)
Timeframe: Day 56

InterventionNumber of Sensitive teeth (Mean)
Test Dentifrice0.5
Control Dentifrice1.3

[back to top]

Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14

Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 0=Does not respond to air stimulation;1=Responds to air stimulus but does not request discontinuation of stimulus;2=Responds to air stimulus and requests discontinuation or moves from stimulus;3=Responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth. (NCT03943095)
Timeframe: Day 14

InterventionScore on a scale (Mean)
Test Dentifrice0.52
Control Dentifrice1.07

[back to top]

Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3

Number of eligible teeth were identified at screening with Schiff sensitivity score of >=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement. (NCT03943095)
Timeframe: Day 3

InterventionNumber of Sensitive Teeth (Mean)
Test Dentifrice3.6
Control Dentifrice3.6

[back to top]

Baseline Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. (NCT03965039)
Timeframe: Baseline

Interventionscore on a scale (Mean)
Marketed Stannous Fluoride Toothpaste2.45
Marketed Potassium Nitrate Toothpaste2.40
Marketed Sodium Monofluorophosphate Toothpaste2.52
Experimental Dipotassium Oxalate Toothpaste2.45

[back to top]

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluophosphate toothpaste (from week 8 to week 11). (NCT03965039)
Timeframe: 11 weeks

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste1.32
Marketed Potassium Nitrate Toothpaste1.40
Marketed Sodium Monofluorophosphate Toothpaste2.18
Experimental Dipotassium Oxalate Toothpaste1.32

[back to top]

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. (NCT03965039)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste0.96
Marketed Potassium Nitrate Toothpaste1.24
Marketed Sodium Monofluorophosphate Toothpaste2.22
Experimental Dipotassium Oxalate Toothpaste1.18

[back to top]

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. (NCT03965039)
Timeframe: 2 weeks

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste1.44
Marketed Potassium Nitrate Toothpaste1.78
Marketed Sodium Monofluorophosphate Toothpaste2.24
Experimental Dipotassium Oxalate Toothpaste1.61

[back to top]

Tactile Threshold

"Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluorophosphate toothpaste (from week 8 to week 11)." (NCT03965039)
Timeframe: 11 weeks

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste24.75
Marketed Potassium Nitrate Toothpaste21.92
Marketed Sodium Monofluorophosphate Toothpaste12.71
Experimental Dipotassium Oxalate Toothpaste24.85

[back to top]

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. (NCT03965039)
Timeframe: 4 weeks

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste1.17
Marketed Potassium Nitrate Toothpaste1.48
Marketed Sodium Monofluorophosphate Toothpaste2.26
Experimental Dipotassium Oxalate Toothpaste1.39

[back to top]

Air Challenge

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. (NCT03965039)
Timeframe: 3 days

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste1.93
Marketed Potassium Nitrate Toothpaste2.05
Marketed Sodium Monofluorophosphate Toothpaste2.36
Experimental Dipotassium Oxalate Toothpaste1.88

[back to top]

Baseline Yeaple Probe

"Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form." (NCT03965039)
Timeframe: Baseline

Interventionscore on a scale (Mean)
Marketed Stannous Fluoride Toothpaste10.33
Marketed Potassium Nitrate Toothpaste10.50
Marketed Sodium Monofluorophosphate Toothpaste11.00
Experimental Dipotassium Oxalate Toothpaste10.50

[back to top]

Tactile Threshold

"Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure." (NCT03965039)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste29.30
Marketed Potassium Nitrate Toothpaste27.45
Marketed Sodium Monofluorophosphate Toothpaste13.45
Experimental Dipotassium Oxalate Toothpaste28.49

[back to top]

Tactile Threshold

"Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure." (NCT03965039)
Timeframe: 4 weeks

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste26.76
Marketed Potassium Nitrate Toothpaste22.76
Marketed Sodium Monofluorophosphate Toothpaste13.93
Experimental Dipotassium Oxalate Toothpaste25.06

[back to top]

Tactile Threshold

"Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure." (NCT03965039)
Timeframe: 3 days

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste16.70
Marketed Potassium Nitrate Toothpaste13.74
Marketed Sodium Monofluorophosphate Toothpaste12.41
Experimental Dipotassium Oxalate Toothpaste15.90

[back to top]

Tactile Threshold

"Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a yes response is repeated. If a second yes is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive yes responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure." (NCT03965039)
Timeframe: 2 weeks

Interventionscore on a scale (Least Squares Mean)
Marketed Stannous Fluoride Toothpaste22.70
Marketed Potassium Nitrate Toothpaste18.57
Marketed Sodium Monofluorophosphate Toothpaste14.17
Experimental Dipotassium Oxalate Toothpaste21.61

[back to top]

Anterior Teeth Arrest Rates

Total number of anterior lesions arrested/total number of anterior lesions treated. (NCT04054635)
Timeframe: 8 months, 12 months, and 2 months

,,
Interventionpercentage of lesions arrested (Number)
Second visit (first follow-up)Third visit (second follow-up)
Regimen 183.097.9
Regimen 275.374.0
Regimen 385.099.2

[back to top]

Posterior Arrest Rates

Total number of posterior lesions arrested/total number of posterior lesions treated. (NCT04054635)
Timeframe: 8 months, 12 months, and 2 months

,,
Interventionpercentage of lesions arrested (Number)
Second visit (first follow-up)Third visit (second follow-up)
Regimen 179.293.1
Regimen 248.670.0
Regimen 363.595.2

[back to top]

Overall Arrest Rates

Total number of lesions arrested/total number of lesions treated (NCT04054635)
Timeframe: 8 months, 12 months, and 2 months

,,
Interventionpercentage of lesions arrested (Number)
Second visit (first follow-up)Third visit (second follow-up)
Regimen 181.395.8
Regimen 261.572.0
Regimen 378.198.0

[back to top]

Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks

MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High:>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring:0=absence of inflammation, 1=mild inflammation;slight change in color,little change in color;little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation;criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing,redness,edema,and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation;marked redness,edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion or ulceration. Lower scores indicate better results. (NCT04123665)
Timeframe: At Week 12 and Week 24

,
InterventionScore on scale (Mean)
At week 12 with baseline MGI <=2.00At week 24 with baseline MGI <=2.00
Control Sodium Monofluorophosphate Dentifrice1.741.60
Experimental Test Stannous Fluoride Dentifrice1.261.29

[back to top]

Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks

BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60[degrees(deg)] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7in each arch). 3scores were recorded buccally/labially,3scores lingually/palatally. All scorable teeth in one quadrant were probed first(app30seconds[sec])before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values(i.e.,0-2).BI score:0=no bleeding after30sec,1=bleeding upon probing after30sec,2=immediate bleeding observed. Lower scores indicate better results. (NCT04123665)
Timeframe: At Week 24

InterventionScore on scale (Mean)
Experimental Test Stannous Fluoride Dentifrice0.11
Control Sodium Monofluorophosphate Dentifrice0.19

[back to top]

Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks

BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth (7in each arch). 3 scores were recorded buccally/ labially, 3scores lingually/ palatally. All scorable teeth in one quadrant were probed first (app 30 sec) before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-2). BI score:0=no bleeding after 30 sec, 1=bleeding upon probing after 30 sec,2=immediate bleeding observed. Lower scores indicate better results. (NCT04123665)
Timeframe: At Week 12

InterventionScore on scale (Mean)
Experimental Test Stannous Fluoride Dentifrice0.11
Control Sodium Monofluorophosphate Dentifrice0.23

[back to top]

Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks

MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High:>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring:0=absence of inflammation, 1=mild inflammation;slight change in color,little change in color;little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation;criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing,redness,edema,and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation;marked redness,edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion or ulceration. Lower scores indicate better results. (NCT04123665)
Timeframe: At Week 12 and Week 24

,
InterventionScore on scale (Mean)
At week 12 with baseline MGI >2.00At week 24 with baseline MGI >2.00
Control Sodium Monofluorophosphate Dentifrice1.961.93
Experimental Test Stannous Fluoride Dentifrice1.541.57

[back to top]

Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks

BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High: >2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results. (NCT04123665)
Timeframe: At Week 12 and Week 24

,
InterventionScore on scale (Mean)
At week 12 with baseline MGI <=2.00At week 24 with baseline MGI <=2.00
Control Sodium Monofluorophosphate Dentifrice0.210.16
Experimental Test Stannous Fluoride Dentifrice0.110.10

[back to top]

Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks

BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High: >2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results. (NCT04123665)
Timeframe: At Week 12 and Week 24

,
InterventionScore on scale (Mean)
At week 12 with baseline MGI >2.00At week 24 with baseline MGI >2.00
Control Sodium Monofluorophosphate Dentifrice0.250.21
Experimental Test Stannous Fluoride Dentifrice0.110.12

[back to top]

Number of Bleeding Sites After 12 and 24 Weeks

Number of gingival bleeding sites were measured as part of bleeding index via a single examiner using a color-coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. For each participant, the scoring system used to measure bleeding sites is as follows: 0= no bleeding after 30 sec, 1= bleeding upon probing after 30 sec, 2= immediate bleeding observed. Lower bleeding sites indicate better results. (NCT04123665)
Timeframe: At Week 12 and Week 24

,
InterventionNumber of bleeding sites (Mean)
At week 12At week 24
Control Sodium Monofluorophosphate Dentifrice23.9220.19
Experimental Test Stannous Fluoride Dentifrice12.2612.69

[back to top]

Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks

Turesky Modification of Quigley Hein Plaque Index-to assess plaque on all gradable teeth. Participants rinsed the plaque in dye solution of 5milliliters(mL)of solution for 10 sec, then expectorated and rinsed with 10 mL of water for 10 sec and then expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-5). Disclosed plaque scored as:0=no plaque, 1=slight flecks of plaque at the cervical margin of the tooth,2=a thin continuous band of plaque (1mm or smaller) at the cervical margin of the tooth, 3=a band of plaque wider than 1mm but covering less than 1/3 of the area, 4=plaque covering at least 1/3 but less than 2/3 of the area,5=plaque covering 2/3 or more of the crown of the tooth. Lower scores indicate better results. (NCT04123665)
Timeframe: At Week 12 and Week 24

,
InterventionScore on scale (Mean)
Overall analysis at week 12Overall analysis at week 24Interproximal analysis at week 12Interproximal analysis at week 24
Control Sodium Monofluorophosphate Dentifrice2.902.833.053.00
Experimental Test Stannous Fluoride Dentifrice2.602.562.822.78

[back to top]

Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks

MGI- to assess visual symptoms of gingivitis on facial and lingual surfaces of each scorable tooth (7 in each arch). 2scores recorded buccally/labially, 2scores lingually/palatally. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-4). Scoring was performed using standard dental light:0=absence of inflammation,1=mild inflammation;slight change in color,little change in color; little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation; criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion,or ulceration. Lower scores indicate better results. (NCT04123665)
Timeframe: At Week 12 and Week 24

,
InterventionScore on scale (Mean)
At week 12At week 24
Control Sodium Monofluorophosphate Dentifrice1.871.78
Experimental Test Stannous Fluoride Dentifrice1.431.46

[back to top]

Observed Silver Tmax

Observed silver time to maximum serum concentration in hours (NCT04184271)
Timeframe: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours

Interventionhours (Mean)
38% Silver Diamine Fluoride5.3

[back to top]

Observed Fluoride Urinary Recovery

24 hour fluoride urinary recovery (in mg) (NCT04184271)
Timeframe: baseline to 24 hours

Interventionmg (Mean)
38% Silver Diamine Fluoride1.29

[back to top]

Observed Silver 24 Hour Urinary Concentration

Observed silver 24-hour urinary concentration in ng/mL (NCT04184271)
Timeframe: baseline to 24 hours

Interventionng/mL (Mean)
38% Silver Diamine Fluoride0.05

[back to top]

Observed Silver Baseline-Corrected Cmax

Observed silver baseline-corrected maximum serum concentration in ng/mL (NCT04184271)
Timeframe: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours

Interventionng/mL (Mean)
38% Silver Diamine Fluoride0.67

[back to top]

Observed Silver t1/2

Observed silver serum elimination half-life in hours (NCT04184271)
Timeframe: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours

Interventionhours (Mean)
38% Silver Diamine Fluoride46

[back to top]

Observed Silver Cmax

Observed silver maximum serum concentration in ng/mL (NCT04184271)
Timeframe: baseline, 30 minutes, and 1, 2, 3, 4, 6, 8, 12, and 24 hours

Interventionng/mL (Mean)
38% Silver Diamine Fluoride0.70

[back to top]

Average Serum Fluoride Concentrations

Overall average of measured serum fluoride concentrations at the various timepoints. (NCT04186663)
Timeframe: Collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

Interventionng/ml (Mean)
Advantage Arrest15

[back to top]

Apparent Oral Clearance of Silver (CL/F)

As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The apparent oral clearance of silver (CL/F) was an estimated parameter. (NCT04186663)
Timeframe: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

InterventionLiters/day (Mean)
Advantage Arrest498

[back to top]

Predicted Time to Peak Serum Silver Concentration (Tmax)

As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The predicted time to peak concentration was calculated using tmax = [ln(ka/k)]/(ka-k), where k = (CL/F)/(V/F). (NCT04186663)
Timeframe: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

Interventionhours (Mean)
Advantage Arrest5.1

[back to top]

Serum Silver Exposure (AUC)

Area under the curve of silver. As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The area under the curve was calculated using AUC = Dose/(CL/F). (NCT04186663)
Timeframe: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

Interventionng*day/mL (Mean)
Advantage Arrest149

[back to top]

Silver Half-life

As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The half-life of silver was calculated using half-life = ln(2)/k, where k = (CL/F)/(V/F). (NCT04186663)
Timeframe: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

Interventiondays (Mean)
Advantage Arrest5.9

[back to top]

Apparent Volume of Distribution of Silver (V/F)

As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The apparent volume of distribution (V/F) was an estimated parameter. (NCT04186663)
Timeframe: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

InterventionLiters/day (Mean)
Advantage Arrest2294

[back to top]

Predicted Peak Serum Silver Concentration (Cmax)

As only a single blood sample was obtained from each child, serum silver concentration versus time data were analyzed simultaneously using population pharmacokinetic analysis with nonlinear mixed effects modeling. The parameters estimated were the apparent volume of distribution (V/F) and apparent oral clearance (CL/F). The rate constant of absorption (ka) was fixed to 23.7 day-1. The predicted peak serum silver Cmax was calculated using Cmax = Dose/(V/F)*exp^(-k⋅tmax ), where k = (CL/F)/(V/F) and tmax = [ln(ka/k)]/(ka-k). (NCT04186663)
Timeframe: Based on data collected at 2, 4, 6, 24, 48, 96, and 168 hours post-SDF application

Interventionng/ml (Mean)
Advantage Arrest17.8

[back to top]

Area Under the Curve of Calcium Concentration in Saliva Overtime

Calcium concentration in unstimulated saliva collected at baseline (before mouthwash(es)), 16, 30, 61, 90 and 121 minutes after mouthwash(es) was expressed as the area under the curve of calcium concentration in saliva as a function of time (millimolar x min). (NCT04239872)
Timeframe: Baseline, 16, 30, 61, 90 and 121 minutes after a mouthwash(es)

Interventionmilimolar x minutes (Mean)
Fluoride Mouthwash176
Calcium Mouthwash Before Fluoride Mouthwash242

[back to top]

Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime

Calcium concentration in dental biofilm solids collected at baseline (before mouthwash(es)), 15, 60 and 120 minutes after mouthwash(es) was expressed as the area under the curve of calcium concentration in dental biofilm solids as a function of time. (NCT04239872)
Timeframe: Baseline, 15, 60 and 120 minutes after mouthwash(es)

Interventionmicrograms calcium x time/milligram prot (Geometric Mean)
Fluoride Mouthwash780
Calcium Mouthwash Before Fluoride Mouthwash1165

[back to top]

Calcium Concentration in Dental Biofilm Solids at Baseline

Dental biofilm was collected at baseline (before mouthwash(es)). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of calcium reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein. (NCT04239872)
Timeframe: Baseline

Interventionmicrograms calcium/miligram protein (Geometric Mean)
Fluoride Mouthwash5.74
Calcium Mouthwash Before Fluoride Mouthwash4.67

[back to top]

Calcium Concentration in Saliva at 121 Minutes

Unstimulated saliva was collected at 121 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). (NCT04239872)
Timeframe: 121-126 minutes after mouthwash(es)

Interventionmilimolar (Mean)
Fluoride Mouthwash1.60
Calcium Mouthwash Before Fluoride Mouthwash1.80

[back to top]

Calcium Concentration in Saliva at 16 Minutes

Unstimulated saliva was collected at 16 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). (NCT04239872)
Timeframe: 16-21 minutes after mouthwash(es)

Interventionmilimolar (Geometric Mean)
Fluoride Mouthwash1.14
Calcium Mouthwash Before Fluoride Mouthwash2.38

[back to top]

Fluoride Concentration in Dental Biofilm Solids at 60 Minutes

Dental biofilm will be collected 60 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of fluoride reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Fluoride concentration in the dental biofilm solids acid extract was measured using an ion-specific electrode adapted for microanalysis; protein concentration in the alkali extract was determined using the Lowry colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein. (NCT04239872)
Timeframe: 60 minutes after mouthwash(es)

Interventionmicrograms fluoride/miligram protein (Geometric Mean)
Fluoride Mouthwash0.23
Calcium Mouthwash Before Fluoride Mouthwash5.98

[back to top]

Calcium Concentration in Saliva at 30 Minutes

Unstimulated saliva was collected at 30 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). (NCT04239872)
Timeframe: 30-35 minutes after mouthwash(es)

Interventionmilimolar (Geometric Mean)
Fluoride Mouthwash1.12
Calcium Mouthwash Before Fluoride Mouthwash2.03

[back to top]

Calcium Concentration in Saliva at 61 Minutes

Unstimulated saliva was collected at 61 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). (NCT04239872)
Timeframe: 61-66 minutes after mouthwash(es)

Interventionmilimolar (Mean)
Fluoride Mouthwash1.62
Calcium Mouthwash Before Fluoride Mouthwash2.01

[back to top]

Fluoride Concentration in Dental Biofilm Solids at Baseline

Dental biofilm was collected at baseline (before mouthwash(es)). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of fluoride reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Fluoride concentration in the dental biofilm solids acid extract was measured using an ion-specific electrode adapted for microanalysis; protein concentration in the alkali extract was determined using the Lowry colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein. (NCT04239872)
Timeframe: Baseline

Interventionmicrograms fluoride/milligram protein (Geometric Mean)
Fluoride Mouthwash0.17
Calcium Mouthwash Before Fluoride Mouthwash0.13

[back to top]

Fluoride Concentration in Saliva at 16 Minutes

Unstimulated saliva was collected 16 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: 16-21 minutes after mouthwash(es)

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash4.60
Calcium Mouthwash Before Fluoride Mouthwash20.36

[back to top]

Fluoride Concentration in Saliva at 30 Minutes

Unstimulated saliva was collected 30 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: 30-35 minutes after mouthwash(es)

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash2.18
Calcium Mouthwash Before Fluoride Mouthwash17.05

[back to top]

Fluoride Concentration in Saliva at 61 Minutes

Unstimulated saliva was collected 61 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: 61-66 minutes after mouthwash(es)

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash1.07
Calcium Mouthwash Before Fluoride Mouthwash9.98

[back to top]

Fluoride Concentration in Saliva at 90 Minutes

Unstimulated saliva was collected 90 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: 90-95 minutes after mouthwash(es)

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash0.80
Calcium Mouthwash Before Fluoride Mouthwash7.66

[back to top]

Fluoride Concentration in Saliva at Baseline

Unstimulated saliva was collected at baseline (before mouthwash(es)), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: Baseline

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash0.14
Calcium Mouthwash Before Fluoride Mouthwash0.11

[back to top]

Fluoride Concentration in Saliva at 121 Minutes

Unstimulated saliva was collected 121 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: 121-126 minutes after mouthwash(es)

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash0.46
Calcium Mouthwash Before Fluoride Mouthwash3.71

[back to top]

Calcium Concentration in Dental Biofilm Solids at 60 Minutes

Dental biofilm was collected 60 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of calcium reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein. (NCT04239872)
Timeframe: 60 minutes after mouthwash(es)

Interventionmicrograms calcium/miligram protein (Geometric Mean)
Fluoride Mouthwash6.64
Calcium Mouthwash Before Fluoride Mouthwash12.4

[back to top]

Calcium Concentration in Saliva at 90 Minutes

Unstimulated saliva was collected at 90 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). (NCT04239872)
Timeframe: 90-95 minutes after mouthwash(es)

Interventionmilimolar (Geometric Mean)
Fluoride Mouthwash1.50
Calcium Mouthwash Before Fluoride Mouthwash1.74

[back to top]

Calcium Concentration in Saliva at Baseline

Unstimulated saliva was collected at baseline (before mouthwash(es)), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). (NCT04239872)
Timeframe: Baseline

Interventionmilimolar (Mean)
Fluoride Mouthwash1.57
Calcium Mouthwash Before Fluoride Mouthwash1.76

[back to top]

Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes

Dental biofilm was collected 120 minutes after mouthwash(es), and the fluid phase was separated using centrifugation. Fluoride concentration in the dental biofilm fluid was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: 120 minutes after mouthwash(es)

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash0.63
Calcium Mouthwash Before Fluoride Mouthwash2.58

[back to top]

Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes

Dental biofilm was collected 15 minutes after mouthwash(es), and the fluid phase was separated using centrifugation. Fluoride concentration in the dental biofilm fluid was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: 15 minutes after mouthwash(es)

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash15.27
Calcium Mouthwash Before Fluoride Mouthwash12.29

[back to top]

Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes

Dental biofilm was collected 60 minutes after mouthwash(es), and the fluid phase was separated using centrifugation. Fluoride concentration in the dental biofilm fluid was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: 60 minutes after mouthwash(es)

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash1.57
Calcium Mouthwash Before Fluoride Mouthwash4.07

[back to top]

Fluoride Concentration in Dental Biofilm Fluid at Baseline

Dental biofilm was collected at baseline (before mouthwash(es)), and the fluid phase was separated using centrifugation. Fluoride concentration in the dental biofilm fluid was measured using an ion-specific electrode adapted for microanalysis. (NCT04239872)
Timeframe: Baseline

Interventionparts per million (ppm) of fluoride (Geometric Mean)
Fluoride Mouthwash0.24
Calcium Mouthwash Before Fluoride Mouthwash0.22

[back to top]

Fluoride Concentration in Dental Biofilm Solids at 120 Minutes

Dental biofilm was collected 120 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of fluoride reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Fluoride concentration in the dental biofilm solids acid extract was measured using an ion-specific electrode adapted for microanalysis; protein concentration in the alkali extract was determined using the Lowry colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein. (NCT04239872)
Timeframe: 120 minutes after mouthwash(es)

Interventionmicrograms fluoride/miligram protein (Geometric Mean)
Fluoride Mouthwash0.18
Calcium Mouthwash Before Fluoride Mouthwash4.84

[back to top]

Fluoride Concentration in Dental Biofilm Solids at 15 Minutes

Dental biofilm was collected 15 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of fluoride reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Fluoride concentration in the dental biofilm solids acid extract was measured using an ion-specific electrode adapted for microanalysis; protein concentration in the alkali extract was determined using the Lowry colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein. (NCT04239872)
Timeframe: 15 minutes after mouthwash(es)

Interventionmicrograms fluoride/milligram protein (Geometric Mean)
Fluoride Mouthwash0.44
Calcium Mouthwash Before Fluoride Mouthwash5.30

[back to top]

Calcium Concentration in Dental Biofilm Solids at 15 Minutes

Dental biofilm was collected 15 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of calcium reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein. (NCT04239872)
Timeframe: 15 minutes after mouthwash(es)

Interventionmicrograms calcium/miligram protein (Geometric Mean)
Fluoride Mouthwash4.48
Calcium Mouthwash Before Fluoride Mouthwash8.88

[back to top]

Calcium Concentration in Dental Biofilm Solids at 120 Minutes

Dental biofilm was collected 120 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of calcium reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein. (NCT04239872)
Timeframe: 120 minutes after mouthwash(es)

Interventionmicrograms calcium/miligram protein (Geometric Mean)
Fluoride Mouthwash5.08
Calcium Mouthwash Before Fluoride Mouthwash9.66

[back to top]

Area Under the Curve of Fluoride Concentration in Saliva Overtime

Fluoride concentration in unstimulated saliva collected at baseline (before mouthwash(es)), 16, 30, 61, 90 and 121 minutes after mouthwash(es) was expressed as the area under the curve of fluoride concentration in saliva as a function of time. (NCT04239872)
Timeframe: Baseline, 16, 30, 61, 90 and 121 minutes after mouthwash(es)

Interventionparts per million x minutes (Geometric Mean)
Fluoride Mouthwash186
Calcium Mouthwash Before Fluoride Mouthwash1415

[back to top]

Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid Overtime

Fluoride concentration in dental biofilm fluid collected at baseline (before mouthwash(es)), 15, 60 and 120 minutes after mouthwash(es) was expressed as the area under the curve of fluoride concentration in dental biofilm fluid as a function of time (parts per million x min). (NCT04239872)
Timeframe: Baseline, 15, 60 and 120 minutes after mouthwash(es)

Interventionparts per million x minutes (Mean)
Fluoride Mouthwash841.6
Calcium Mouthwash Before Fluoride Mouthwash764.4

[back to top]

Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids Overtime

Fluoride concentration in dental biofilm solids collected at baseline (before mouthwash(es)), 15, 60 and 120 minutes after mouthwash(es) was expressed as the area under the curve of fluoride concentration in dental biofilm solids as a function of time (micrograms of fluoride x minutes/ milligram of proteins). (NCT04239872)
Timeframe: Baseline, 15, 60 and 120 minutes after mouthwash

Interventionmicrogram fluoride/milligram prot x min (Geometric Mean)
Fluoride Mouthwash37.85
Calcium Mouthwash Before Fluoride Mouthwash521.2

[back to top]

Percent Change in Mean Score of Pain Response From Baseline on Schiff Cold Air Sensitivity Scale Using Air Blast Stimulus

"SCHIFF cold air sensitivity scale was used to measure the intensity of pain due to dentin hypersensitivity using air blast stimulus. Patients' response of pain was assessed by the doctor according to following score range from; 0(no response of pain), 1 (pain response but no request of discontinuity of stimulus), 2(pain response with request of discontinuity of stimulus), 3(Immediate pain response for discontinuity of stimulus). Percent change in mean scores = ( one minute score-Baseline score) / Baseline score" (NCT04249336)
Timeframe: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

,,,
Interventionpercentage of change in mean scores (Mean)
1- minute5-minutesDay-3Week-4
BioMin F18272258
Colgate Sensitive Pro Relief45562455
Colgate Total15191022
Sensodyne Rapid Action37512545

[back to top]

Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Mechanical Stimulus

Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using mechanical stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score (NCT04249336)
Timeframe: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

,,,
Interventionpercentage of change in mean scores (Mean)
1-minute5-minutesDay-3Week-4
BioMin F25272859
Colgate Sensitive Pro Relief56613866
Colgate Total16201827
Sensodyne Rapid Action46513257

[back to top]

Percent Change in Mean Scores of Pain Response From Baseline on Visual Analog Scale Using Water Jet Stimulus

Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using Water Jet Stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score (NCT04249336)
Timeframe: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)

,,,
Interventionpercentage of change in mean scores (Mean)
1-minute5-minutesDay-3Week-4
BioMin F22273067
Colgate Sensitive Pro Relief52563457
Colgate Total18211829
Sensodyne Rapid Action46523255

[back to top]

Mean Oral Hygiene Index (OHI) at Week 6 and Week 12

OHI was calculated as sum score of mean CI and mean ODI. CI scoring:0=no calculus present,1=supragingival calculus covering not >1/3 of exposed tooth surface,2=supragingival calculus covering >1/3 but not >2/3 of exposed tooth surface/presence of individual flecks of subgingival calculus around cervical portion of tooth/both,3=supragingival calculus covering >2/3 of exposed tooth surface/continuous band of subgingival calculus around cervical portion of tooth/both. ODI scoring:0=no debris/stain present,1= supragingival calculus covering not >1/3 of exposed tooth surface,2=supragingival calculus covering>1/3 but not >2/3 of exposed tooth surface/presence of individual flecks of subgingival calculus around cervical portion of tooth/both,3=supragingival calculus covering >2/3 of exposed tooth surface/continuous band of subgingival calculus around cervical portion of tooth/ both. Thus, total OHI score range was 0 to 6. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12

,
InterventionScore on a scale (Mean)
Week 6Week 12
Intervention Group0.300.30
Non-intervention Group0.690.64

[back to top]

Mean Oral Debris Index (ODI) at Week 6 and Week 12

The extent of oral debris (defined as soft foreign matter on the surface of teeth) on each tooth surface was determined by running the side of a number 5 explorer (Shephard's crook) probe along the buccal, labial and lingual surfaces and noting the occlusal or incisal extent of the debris as it was removed from the tooth surface. The ODI was assessed on the facial and lingual surfaces of each scorable tooth. The ODI for each participant was calculated as the mean score of all tooth surfaces (facial/lingual).ODI scoring system included 4-point scale ranged from 0 to 3 where: 0=No debris or stain present, 1=Soft debris covering not > 1/3 of the tooth surface the presence of extrinsic stains without other debris regardless of surface area covered, 2= Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface, 3=Soft debris covering more than two thirds of the exposed tooth surface. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12

,
InterventionScore on a scale (Mean)
Week 6Week 12
Intervention Group0.220.20
Non-intervention Group0.500.46

[back to top]

Mean Number of Bleeding Sites (NBS) at Week 6 and Week 12

Number of gingival bleeding sites were measured during BI assessment. BI assesses the severity and number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted approximately 1 mm into the gingival sulcus (at approximately 60 degrees) and moved around the tooth, from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. Sites which showed signs of bleeding immediately on probing or within 30 seconds of probing were classified as a bleeding sites. (NCT04290624)
Timeframe: Week 6 and Week 12

,
InterventionNumber of sites (Mean)
Week 6Week 12
Intervention Group53.152.9
Non-intervention Group81.780.8

[back to top]

Mean Modified Gingival Index (MGI) at Week 6 and Week 12

The MGI focuses on the visual symptoms of gingivitis (redness, texture, edema). The MGI was assessed for the facial and lingual/palatal gingiva of all evaluable teeth, four sites per tooth (facial surface - papilla and margin; lingual/palatal surface - papilla and margin). The MGI scoring included 5-point scale ranged from 0 to 4, where 0=Absence of inflammation, 1=Mild inflammation: slight change in color, little change in texture of any portion of the marginal or papillary gingival unit, 2=Mild inflammation: criteria as (1) but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, 4=Severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12

,
InterventionScore on a scale (Mean)
Week 6Week 12
Intervention Group1.521.50
Non-intervention Group1.921.86

[back to top]

Mean Interproximal TPI at Week 6 and Week 12

Supra-gingival plaque was assessed on the facial and lingual/palatal surfaces of all scorable teeth, six sites per tooth using TPI which indicated plaque accumulation in the gingival area of the tooth. Each tooth surface was divided into 3 areas; three scores were recorded facially (mesiofacial, facial, distofacial) and three scores lingually (mesiolin-gual, lingual and distolingual) generating a total of six scores per tooth. The plaque was disclosed and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3=Band of plaque wider than 1 mm but covering < 1/3 of the tooth surface, 4=Plaque covering >= 1/3 but < 2/3 of the tooth surface, 5=Plaque covering >= 2/3 of the tooth surface. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12

,
InterventionScore on a scale (Mean)
Week 6Week 12
Intervention Group2.312.24
Non-intervention Group3.223.29

[back to top]

Mean Calculus Index (CI) at Week 6 and Week 12

The extent of calculus on each tooth surface (buccal and lingual) was determined by visual examination. Only definite deposits of hard calculus were recorded. The CI was assessed on the facial and lingual surfaces of each scorable tooth. The CI for each participant was calculated as the mean score of all tooth surfaces (facial/lingual). CI scoring included 4-point scale ranged from 0 to 3 where: 0=No calculus present, 1=Supragingival calculus covering not greater than (>) 1/3 of exposed tooth surface, 2=Supragingival calculus covering > 1/3 but not > 2/3 of exposed tooth surface or presence of individual flecks of Subgingival calculus around cervical portion of tooth or both, 3= supragingival calculus covering > 2/3 of exposed tooth surface or a continuous band of Subgingival calculus around cervical portion of tooth or both. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12

,
InterventionScore on a scale (Mean)
Week 6Week 12
Intervention Group0.080.10
Non-intervention Group0.190.18

[back to top]

Mean Bleeding Index (BI) at Week 12

The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted into the gingival crevice to a depth of approximately 1 millimeter [mm] and then run around the tooth (at approximately 60 degrees to the long axis of the tooth) gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Three scores were recorded bucally/labially (distal, body, mesial sites) and 3 scores lingually/palatally (distal, body, mesial sites). All scorable teeth in 1 quadrant were probed first (approximately 30 seconds) before recording the number of gingival units which bled. The BI scoring included 3-point scale ranged from 0 to 2, where 0=no bleeding, 1=bleeding within 30 seconds of probing, 2=bleeding immediately on probing. Sites with a score of 1 or 2 were classified as 'bleeding' sites. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 12

InterventionScore on a scale (Mean)
Intervention Group0.45
Non-intervention Group0.76

[back to top]

Mean BI at Week 6

The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted into the gingival crevice to a depth of approximately 1 mm and then run around the tooth (at approximately 60 degrees to the long axis of the tooth) gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Three scores were recorded bucally/labially (distal, body, mesial sites) and 3 scores lingually/palatally (distal, body, mesial sites). All scorable teeth in 1 quadrant were probed first (approximately 30 seconds) before recording the number of gingival units which bled. The BI scoring included 3-point scale ranged from 0 to 2, where 0=no bleeding, 1=bleeding within 30 seconds of probing, 2=bleeding immediately on probing. Sites with a score of 1 or 2 were classified as 'bleeding' sites. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6

InterventionScore on a scale (Mean)
Intervention Group0.45
Non-intervention Group0.76

[back to top]

Mean Partial Denture Cleanliness Index (PDCI) at Week 6 and 12

"The cleanliness of the partial denture was evaluated based on the modification of the Clinical Categorization of Denture Cleanliness Index. A suitable dental probe was used to gently scrape the surfaces of the RPD and the PDCI was scored. All surfaces of the RPD were assessed and the highest score applicable was recorded. PDCI scoring system included 5-point scale ranged from 0 to 4, where 0=No visible plaque; no matter adherent to the dental probe on light scraping, 1=No visible plaque; matter adherent to the dental probe on light scraping, 2=Deposits of plaque just visible on careful examination without need to confirm by scraping, 3=Deposits of plaque clearly visible, 4=Gross plaque deposits (velvet appearance). Higher score indicates worst outcome." (NCT04290624)
Timeframe: Week 6 and Week 12

,
InterventionScore on a scale (Mean)
Week 6Week 12
Intervention Group1.21.1
Non-intervention Group1.71.9

[back to top]

Mean Overall Turesky Plaque Index (TPI) at Week 6 and Week 12

Supra-gingival plaque was assessed on the facial and lingual/palatal surfaces of all scorable teeth, six sites per tooth using TPI which indicated plaque accumulation in the gingival area of the tooth. Each tooth surface was divided into 3 areas; three scores were recorded facially (mesiofacial, facial, distofacial) and three scores lingually (mesiolin-gual, lingual and distolingual) generating a total of six scores per tooth. The plaque was disclosed and scored on a 6-point scale ranged from 0 to 5 where: 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3=Band of plaque wider than 1 mm but covering less than (<) 1/3 of the tooth surface, 4=Plaque covering greater than or equal to (>=) 1/3 but < 2/3 of the tooth surface, 5=Plaque covering >= 2/3 of the tooth surface. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12

,
InterventionScore on a scale (Mean)
Week 6Week 12
Intervention Group2.122.07
Non-intervention Group2.973.02

[back to top]

Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months

"Treated MIH affected molars must fulfilled all criteria for success in order to be reported as success. Criteria of 'Successful' on treated MIH affected molars include~Absence of pain related to the treated tooth/teeth~Absence of tenderness to percussion (TTP)~No evidence of swelling of supporting soft tissue or presence of a sinus tract~Absence of enamel breakdown and caries along margin of restoration~Scale 0 and 1 for Schiff Cold Air Sensitivity Scale" (NCT04710927)
Timeframe: 6 month

Interventionnumber of Successful MIH affected molars (Number)
High Viscosity GIC (HVGIC)17
Silver Diamine Fluoride (SDF) + HVGIC18
Papain Based Gel + SDF + HVGIC17

[back to top]

Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months

"Treated MIH affected molars must fulfilled all criteria for success in order to be reported as successful. Criteria of 'Successful' on treated MIH affected molars include~Absence of pain related to the treated tooth/teeth~Absence of tenderness to percussion (TTP)~No evidence of swelling of supporting soft tissue or presence of a sinus tract~Absence of enamel breakdown and caries along margin of restoration~Scale 0 and 1 for Schiff Cold Air Sensitivity Scale" (NCT04710927)
Timeframe: 12 month

Interventionnumber of successful MIH affected molars (Number)
High Viscosity GIC (HVGIC)14
Silver Diamine Fluoride (SDF ) + HVGIC13
Papain Based Gel + SDF + HVGIC15

[back to top]

Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control)

Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20g and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses would be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. (NCT04950465)
Timeframe: Baseline, Week 4 and Week 8

,
Interventiongrams (Mean)
Week 4Week 8
Negative Control (Crest Cavity Protection Fresh Lime)7.4211.82
Positive Control (Sensodyne Repair and Protect)4.5911.05

[back to top]

Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)

Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participants were scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. (NCT04950465)
Timeframe: Baseline and Week 8

InterventionScore on a scale (Mean)
Test Dentifrice (Sensodyne Sensitivity & Gum)-0.98
Negative Control (Crest Cavity Protection Fresh Lime)-1.14

[back to top]

Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control)

Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20 gram (g) and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth were determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses were recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. (NCT04950465)
Timeframe: Baseline, Week 4 and 8

,
Interventiongrams (Mean)
Week 4Week 8
Negative Control (Crest Cavity Protection Fresh Lime)7.4211.82
Test Dentifrice (Sensodyne Sensitivity & Gum)9.2216.63

[back to top]

Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control)

Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. (NCT04950465)
Timeframe: Baseline, Week 4 and Week 8

,
Interventionscore on a scale (Mean)
Week 4Week 8
Negative Control (Crest Cavity Protection Fresh Lime)-0.75-1.14
Positive Control (Sensodyne Repair and Protect)-0.76-0.99

[back to top]

Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control)

Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value. (NCT04950465)
Timeframe: Baseline and Week 4

InterventionScore on a scale (Mean)
Test Dentifrice (Sensodyne Sensitivity & Gum)-0.79
Negative Control (Crest Cavity Protection Fresh Lime)-0.75

[back to top]

Antibacterial Effect in Active Dental Caries Lesions

"Measuring the percent change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected immediately before application of the intervention (baseline) and one month after the intervention application (1 month follow-up).~The CFU counts will be used to calculate the percentage change in bacterial prevalence which will be used for assessment and reporting results" (NCT05221749)
Timeframe: 1 month

,
InterventionCFU/mL (Median)
BaselineFollow-up
Nanosilver Fluoride (NSF)500005000
Silver Diamine Fluoride (SDF)7000020000

[back to top]

Changes in Modified Gingival Index (MGI)

"MGI uses a rating score between 0 and 4, with 0 indicating a tooth with healthy gums and 4 the most severe inflammation. MGI scores were determined by visual exam of the gingiva on 4 surfaces for each tooth present except for third molars, for a total of 28 teeth. The total number of teeth exhibiting inflammation affecting all portions of the gingival unit (Score ≥ 2) were noted at each visit. The total number of teeth affected was evaluated for each visit in the final analysis.~At baseline: Score range is (0-64) At 12 weeks: Score range is (0-32)" (NCT05258721)
Timeframe: Baseline and 12 weeks

Interventionscore on a scale (Median)
Baseline12 weeks
Treatment Group8.51.5

[back to top]

Changes in Bleeding On Probing (BOP)

Bleeding On Probing (BOP) will be recorded as a dichotomous variable (present/absent) during the periodontal examination. The percentage of sites that bleed will be calculated by dividing the number of sites with bleeding by the total number of sites. (NCT05258721)
Timeframe: Baseline and 12 weeks

Interventionpercentage of sites with bleeding (Median)
Baseline12 weeks
Treatment Group37.015.0

[back to top]

Changes in Plaque Index (PI)

"The PI was recorded on all teeth except for third molars. PI was recorded on 4 surfaces of each tooth. PI uses a rating score between 0 and 3, with 0 indicating no plaque in gingival area and 3 heavy accumulation of plaque. Total score is reported.~At baseline: Score range is 9 -157. At 12 weeks: Score range is 1 -147." (NCT05258721)
Timeframe: Baseline and 12 weeks

Interventionscore on a scale (Median)
Baseline12 weeks
Treatment Group22.08.0

[back to top]