Page last updated: 2024-11-06

fluorophosphate

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

Description

Fluorophosphates are a class of chemical compounds containing both fluorine and phosphate groups. They are commonly found in various applications, including:
- **Inorganic Chemistry:** Fluorophosphates serve as precursors in the synthesis of other inorganic materials like metal fluorides. They can also act as ligands in coordination chemistry, forming complex compounds with transition metals.
- **Biochemistry:** Fluorophosphates have been investigated for their potential biological activity. Some studies suggest that fluorophosphates can inhibit certain enzymes by binding to active sites. They have also been explored as potential antiviral agents.
- **Materials Science:** Fluorophosphates are used in the production of glasses and ceramics, where they contribute to improved properties like durability and resistance to chemical attack.
- **Environmental Science:** Fluorophosphates can be found in various environmental compartments, including water and soil. They are often a result of industrial activities and can impact ecosystem health.
- **Pharmaceuticals:** Some fluorophosphates have been investigated as potential therapeutic agents for various conditions, including cancer. Their ability to interact with biological systems and enzymes makes them attractive candidates for drug development.
The specific synthesis, effects, and importance of a particular fluorophosphate compound depend heavily on its structure and composition. Therefore, a more detailed analysis would require specifying the exact fluorophosphate in question.'

fluorophosphate: inhibits Phosphorylas phosphatase irreversibly; RN given refers to parent cpd [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID65241
CHEBI ID42699
MeSH IDM0060392

Synonyms (23)

Synonym
fluoro-phosphite ion
fluoridotrioxidophosphate(2-)
fluorophosphate
[pfo3](2-)
15181-43-8
fluoridophosphate
CHEBI:42699 ,
phosphorofluoridate
monofluorophosphate ion
DB02348
monofluorophostae (po3f2-)
fluorophosphate ion (pfo32-)
fluorotrioxophosphate(2-)
fluorophosphate (fpo32-)
monofluorophosphate(2-)
unii-4964uz79mi
4964uz79mi ,
AB01563168_01
AB01563168_02
DTXSID90164882
Q21099556
fluoro-dioxido-oxo-lambda5-phosphane
(pfo3)(2-)

Research Excerpts

Toxicity

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. The toxic substance Na2PO3F (sodium monofluorophosphate) was administered intragastrically.

ExcerptReferenceRelevance
"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
)
0.64
"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
)
0.73
" 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
)
0.87
" 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
" 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

Pharmacokinetics

ExcerptReferenceRelevance
"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
)
0.76
" 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
)
0.52
" 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

Compound-Compound Interactions

ExcerptReferenceRelevance
" 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
)
0.86
"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
)
1.08
"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

Bioavailability

This paper reports a reassessment of the bioavailability of fluoride from monofluorophosphate (MFP, CAS 10163-15-2) Bioavailability of F from four dentifrices with either aminefluoride (AMF) or monof Luphosphate was compared with that of NaF.

ExcerptReferenceRelevance
"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
" 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
)
0.57
"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
)
0.53
" 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
)
0.54
" 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,
)
0.36
"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
)
0.77
" 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
)
0.72
" 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
)
0.51
" 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
)
0.51
" 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
)
0.69
"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
)
0.7
"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
)
0.75
"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
)
0.54
" 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
)
0.54
"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
)
0.54
"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
)
0.75
"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
)
0.76
" 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
" 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
" 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

Dosage Studied

Sodium monofluorophosphate (MFP) was compared to that of a benchmark commercial toothpaste containing 2% potassium ion, dosed as 3.0% arginine, calcium carbonate, and 1450 ppm fluoride. The study evaluated the dose-response relationship between four increasing levels of fluoride from 1000 to 2500 ppm F as sodium monoflourophosphate and three-year dental caries increments.

ExcerptRelevanceReference
" 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
"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
)
0.49
" 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
" 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
)
0.52
"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
" 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
)
0.85
" 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
" 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
)
0.51
" 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
" 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
" 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
" 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
"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
"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
"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
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (2)

ClassDescription
phosphoric acid derivative
fluorine molecular entity
[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]

Research

Studies (1,335)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990801 (60.00)18.7374
1990's153 (11.46)18.2507
2000's102 (7.64)29.6817
2010's276 (20.67)24.3611
2020's3 (0.22)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 52.47

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 Index52.47 (24.57)
Research Supply Index7.42 (2.92)
Research Growth Index4.63 (4.65)
Search Engine Demand Index88.70 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (52.47)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials217 (14.94%)5.53%
Reviews46 (3.17%)6.00%
Case Studies5 (0.34%)4.05%
Observational1 (0.07%)0.25%
Other1,183 (81.47%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (44)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02705716]409 participants (Actual)Interventional2016-03-01Completed
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 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice [NCT04123665]Phase 398 participants (Actual)Interventional2013-05-28Completed
A Proof of Principal Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices [NCT03160703]220 participants (Actual)Interventional2017-07-10Completed
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
The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial [NCT02598414]Phase 2/Phase 3102 participants (Anticipated)Interventional2015-11-30Recruiting
A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice [NCT02750943]253 participants (Actual)Interventional2015-11-01Completed
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
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
A Clinical Study Investigating the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population. [NCT02937636]128 participants (Actual)Interventional2017-09-19Completed
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
Assessment of Dentine Tubule Occlusion in a Modified in Situ Model [NCT02768194]26 participants (Actual)Interventional2016-07-06Completed
Clinical Study to Compare Dental Plaque Control [NCT00758394]Phase 329 participants (Actual)Interventional2007-09-30Completed
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
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
Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model [NCT01005966]Phase 365 participants (Actual)Interventional2008-11-30Completed
Assessing Three Oral Care Regimen on Plaque, Gingivitis, and Tooth Whitening [NCT02940821]142 participants (Actual)Interventional2016-05-30Completed
Compare Anti-inflammatory Dentifrices [NCT00762528]Phase 449 participants (Actual)Interventional2009-02-28Completed
Evaluate Clinical Research From Commerical Oral Care Products [NCT00759187]Phase 325 participants (Actual)Interventional2008-01-31Completed
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
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
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02731833]Phase 4229 participants (Actual)Interventional2016-04-01Completed
Firefly ANKLE Sprain Study [NCT02307955]Phase 224 participants (Actual)Interventional2014-09-30Completed
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
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02924350]205 participants (Actual)Interventional2016-11-07Completed
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
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 Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity [NCT02923895]Phase 4197 participants (Actual)Interventional2016-10-11Completed
Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue (ISB) and Indocyanine Green Dyes (ICG) With Fluorescence Imaging [NCT02068820]200 participants (Actual)Interventional2012-09-30Completed
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
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
Evaluate Inflammation Caused by Gingivitis in Adults [NCT00941668]Phase 449 participants (Actual)Interventional2007-01-31Completed
Phase 2 Multi-Center Randomized Controlled Feasibility Study of IS-002 in Subjects Undergoing Robotic-Assisted Radical Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescence Imaging [NCT05946603]Phase 260 participants (Anticipated)Interventional2023-06-16Recruiting
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
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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00758394 (1) [back to overview]Dental Plaque Index
NCT00759031 (1) [back to overview]Gingival Margin Plaque Index
NCT00759187 (1) [back to overview]Dental Plaque Index
NCT00762528 (8) [back to overview]Interleukin-6 (IL-6)
NCT00762528 (8) [back to overview]Nuclear Factor Kappa B Ligand (RANK-L)
NCT00762528 (8) [back to overview]Prostaglandin E2 (PGE2)
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]Bleeding on Probing (BOP)
NCT00762528 (8) [back to overview]8-iso-prostaglandinF2α (8-iso-PGF2α)
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
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]Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)
NCT01005966 (3) [back to overview]Change From Baseline in Enamel Fluoride Uptake Potential
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 at Day 14
NCT01592851 (6) [back to overview]Change From Baseline in Tactile Pain Threshold Score at Day 3
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 Immediately Post-treatment
NCT01592864 (4) [back to overview]Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
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
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 Tactile Sensitivity Pain Response (g) at Week 8
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 Response on a Visual Rating Scale (VRS) at Week 4
NCT01691560 (6) [back to overview]Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
NCT01691560 (6) [back to overview]Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
NCT01827670 (6) [back to overview]Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)
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
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 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]Mean Change From Baseline in Visual Rating Scale Score at Week 4
NCT01831817 (8) [back to overview]Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8
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 Schiff Sensitivity Score at Week 4
NCT02068820 (3) [back to overview]Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).
NCT02068820 (3) [back to overview]Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.
NCT02068820 (3) [back to overview]Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.
NCT02371616 (4) [back to overview]Change From Baseline in Tactile Threshold at Week 4 and 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 Visual Analogue Score (VAS) at Week 8
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
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
NCT02612064 (3) [back to overview]Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3
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
NCT02731833 (4) [back to overview]Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
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
NCT02750943 (5) [back to overview]Number of Bleeding Sites at Week 12
NCT02750943 (5) [back to overview]Bleeding Index (BI) at Week 4 and Week 12
NCT02750943 (5) [back to overview]Modified Gingival Index (MGI) at Week 4 and 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]Number of Bleeding Sites at Week 4
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
NCT02768194 (2) [back to overview]Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
NCT02768194 (2) [back to overview]Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
NCT02773758 (3) [back to overview]Change From Baseline in Schiff Sensitivity Score at Day 14
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
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 Schiff Sensitivity Score at Week 8
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 4
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 on Day 3
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 Tactile Threshold on Day 3
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
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)
NCT02937636 (4) [back to overview]Mean Bleeding Index (BI)
NCT02937636 (4) [back to overview]Mean Modified Gingival Index (MGI)
NCT02937636 (4) [back to overview]Mean Plaque Index (PI) (Overall and Interproximal)
NCT02937636 (4) [back to overview]Number of Bleeding Sites
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
NCT03160703 (1) [back to overview]Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4
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
NCT03965039 (12) [back to overview]Tactile Threshold
NCT03965039 (12) [back to overview]Tactile Threshold
NCT03965039 (12) [back to overview]Air Challenge
NCT03965039 (12) [back to overview]Baseline Air Challenge
NCT03965039 (12) [back to overview]Tactile Threshold
NCT03965039 (12) [back to overview]Air Challenge
NCT03965039 (12) [back to overview]Tactile Threshold
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]Air Challenge
NCT03965039 (12) [back to overview]Baseline Yeaple Probe
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 Low 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 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 High 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]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

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).

Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence. (NCT02068820)
Timeframe: through 6 weeks post-operative

,,
Interventionnodes (Number)
Sentinel NodesPelvic Nodes OnlyAorticInfrarenal
Both IHC and H&E16200
H&E Only31361410
IHC Only16110

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Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.

"The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients.~NPV = 140/141=99.3%" (NCT02068820)
Timeframe: through 6 weeks post-operative

,
InterventionParticipants (Count of Participants)
Metastatic DiseaseNon Metastatic Disease
ICG Negative1140
ICG Positive390

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Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.

(NCT02068820)
Timeframe: through 6 weeks post-operative

Interventionnodes (Mean)
ISB Dye, Standard White Light1.25
ICG Dye, FireFly Fluorescence Imaging2.03

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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