Listerine is a popular over-the-counter oral antiseptic, commonly used as a mouthwash. While its exact composition has varied over time, the active ingredients typically include thymol, eucalyptol, menthol, and methyl salicylate. These compounds are known for their antimicrobial properties, which help to kill bacteria and reduce plaque and gingivitis. The effectiveness of Listerine as an oral antiseptic has been supported by various studies, showing a reduction in plaque formation and gingivitis compared to placebo. Additionally, some studies have suggested potential benefits in reducing bad breath and promoting oral health. Listerine is widely studied due to its accessibility and potential efficacy in maintaining oral hygiene. The combination of active ingredients in Listerine has been shown to be effective against a broad range of bacteria commonly found in the mouth, contributing to its popularity as an oral care product.'
Listerine: hydroalcohol solution containing thymol, menthol, eucalyptol, methyl salicylate & alcohol [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]
| ID Source | ID |
|---|---|
| PubMed CID | 114959 |
| MeSH ID | M0160819 |
| Synonym |
|---|
| listerine |
| phenol, 5-methyl-2-(1-methylethyl)-, mixt. with 5-methyl-2-(1-methylethyl)cyclohexanol and 1,3,3-trimethyl-2-oxabicyclo(2.2.2)octane |
| 51273-66-6 |
| 5-methyl-2-propan-2-ylcyclohexan-1-ol;5-methyl-2-propan-2-ylphenol;1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane |
Listerine has proven its ability to reduce plaque and gingivitis in a moderate way. Listerine retard the development of plaque by 45 to 56% and to reduce existing plaque by 39 to 48%.
| Excerpt | Reference | Relevance |
|---|---|---|
| "Listerine has proven its ability to reduce plaque and gingivitis in a moderate way." | ( [Chemical control of plaque: comparative review]. Marechal, M, 1991) | 1 |
| "Listerine has been reported to retard the development of plaque by 45 to 56% and to reduce existing plaque by 39 to 48%." | ( Microbiological effects of mouthrinses containing antimicrobials. Walker, CB, 1988) | 1 |
| Excerpt | Reference | Relevance |
|---|---|---|
| "Treatment with Listerine and CHX from d 3 reduced biomass but not viability." | ( A fluorescence assay to determine the viable biomass of microcosm dental plaque biofilms. Angker, L; Coleman, MJ; Filoche, SK; Sissons, CH, 2007) | 0.68 |
| Excerpt | Reference | Relevance |
|---|---|---|
| " Nonalcoholic ingredients of this mouthwash are phenolic compounds (eucalyptol, menthol, and thymol), and large-volume mouthwash ingestion will produce exposure in the reported toxic range of these ingredients." | ( Fatal large-volume mouthwash ingestion in an adult: a review and the possible role of phenolic compound toxicity. Dinovo, E; Hinds, RL; Renner, SW; Soo Hoo, GW, ) | 0.13 |
| " These compounds, in addition to alcohol, may account for the adverse effects associated with massive mouthwash ingestion." | ( Fatal large-volume mouthwash ingestion in an adult: a review and the possible role of phenolic compound toxicity. Dinovo, E; Hinds, RL; Renner, SW; Soo Hoo, GW, ) | 0.13 |
| Excerpt | Reference | Relevance |
|---|---|---|
| "The aim of the present study was to compare antimicrobial effects of essential oils alone and in combination with chlorhexidine digluconate against planktonic and biofilm cultures of Streptococcus mutans and Lactobacillus plantarum." | ( Antimicrobial effects of essential oils in combination with chlorhexidine digluconate. Filoche, SK; Sissons, CH; Soma, K, 2005) | 0.33 |
| Excerpt | Reference | Relevance |
|---|---|---|
| "Nitric Oxide (NO) bioavailability is essential for vascular health." | ( A stepwise reduction in plasma and salivary nitrite with increasing strengths of mouthwash following a dietary nitrate load. Allen, JD; Smoliga, JM; Stabler, T; Tarzia, B; Van Bruggen, M; Woessner, M, 2016) | 0.43 |
| Excerpt | Relevance | Reference |
|---|---|---|
| " Dosing for each of the test mouthrinses was based on the manufacturers' label directions." | ( Comparative antiplaque effectiveness of an essential oil and an amine fluoride/stannous fluoride mouthrinse. Barnett, ML; Bernimoulin, JP; Riep, BG, 1999) | 0.3 |
| " Chlorohexidine dosage forms Corsodyl and Eludril were used for this purpose." | ( [The clinico-microbiological evaluation of the efficacy of using new drug forms of chlorhexidine--Corsodyl and Eludril--for the prevention of infectious complications in operations for endosseous implantation]. Biziaev, AF; Chuvilkin, VI; Ivanov, SIu; Kuznetsov, EA; Romanenko, NV; Tsarev, VN, 2000) | 0.31 |
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 13 (5.80) | 18.7374 |
| 1990's | 62 (27.68) | 18.2507 |
| 2000's | 70 (31.25) | 29.6817 |
| 2010's | 73 (32.59) | 24.3611 |
| 2020's | 6 (2.68) | 2.80 |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
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.
| This Compound (63.74) All Compounds (24.57) |
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 100 (39.68%) | 5.53% |
| Reviews | 23 (9.13%) | 6.00% |
| Case Studies | 9 (3.57%) | 4.05% |
| Observational | 0 (0.00%) | 0.25% |
| Other | 120 (47.62%) | 84.16% |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts. [NCT01236950] | 90 participants (Actual) | Interventional | 2007-04-30 | Completed | |||
| The Effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate (MI Varnish) and 5% Sodium Fluoride Plus Xylitol (PreviDent Varnish) on Non Cavitated Interproximal Lesions. Randomised Clinical Trial [NCT03925740] | Phase 4 | 90 participants (Anticipated) | Interventional | 2019-01-01 | Active, not recruiting | ||
| Remineralization of Molar Incisor Hypomineralization (MIH) With a Hydroxyapatite Toothpaste - an in Situ Study [NCT05485662] | 15 participants (Anticipated) | Interventional | 2022-09-06 | Recruiting | |||
| Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse [NCT04719208] | 60 participants (Anticipated) | Interventional | 2020-10-06 | Active, not recruiting | |||
| Randomized, Examiner Blind, Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After 3 Weeks Use [NCT04050722] | Phase 4 | 130 participants (Actual) | Interventional | 2019-10-07 | Completed | ||
| Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation of an Essential Oils Mouthrinse and Dental Floss. [NCT01236963] | 60 participants (Actual) | Interventional | 2007-09-30 | Completed | |||
| Effect of a Triclosan Containing Dentifrice on Oral Bacteria and Postoperative Complications Following Third Molar Surgery [NCT01292343] | 141 participants (Actual) | Interventional | 2008-02-29 | Completed | |||
| An 8-Week Clinical Study to Evaluate the Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Non-surgical Periodontal Treatment: Randomized Clinical Trial [NCT02461030] | Phase 4 | 60 participants (Actual) | Interventional | 2014-08-31 | Completed | ||
| Effectiveness of Different Fluoride Varnishes on Salivary Bacteria Levels in Children With Early Childhood Caries [NCT03625310] | 88 participants (Actual) | Interventional | 2016-11-30 | Completed | |||
| Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model [NCT03383783] | Phase 3 | 28 participants (Actual) | Interventional | 2017-12-19 | Completed | ||
| Evaluation of Remineralization Potential of Preventive Regimens Containing Herbal-based Compared to Fluoride-based Toothpastes in High Caries Risk Patients With Initial Carious Lesions: Randomized Clinical Trial [NCT04446390] | 32 participants (Actual) | Interventional | 2021-01-01 | Active, not recruiting | |||
| Assessment of a Potassium Oxalate-Containing Formulation for the Relief of Dentinal Hypersensitivity [NCT01345292] | 226 participants (Actual) | Interventional | 2011-04-30 | Completed | |||
| 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) | Interventional | 2017-11-18 | Completed | |||
| Four Weeks Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis [NCT02065414] | Phase 4 | 260 participants (Actual) | Interventional | 2014-03-31 | Completed | ||
| Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (A Randomized Clinical Trial) [NCT03554980] | Phase 4 | 46 participants (Anticipated) | Interventional | 2018-12-01 | Not yet recruiting | ||
| A Method Development Clinical Study Investigating the Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity [NCT03238352] | Phase 2 | 89 participants (Actual) | Interventional | 2017-08-07 | Completed | ||
| Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial [NCT03557996] | Phase 4 | 42 participants (Anticipated) | Interventional | 2018-12-01 | Not yet recruiting | ||
| The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride [NCT04577716] | 102 participants (Actual) | Observational | 2021-04-01 | Active, not recruiting | |||
| 18F Sodium Fluoride PET/CT in Acute Aortic Syndrome [NCT03647566] | 76 participants (Actual) | Observational | 2018-10-01 | Completed | |||
| "Immediate And Sustained Treatment Response Of Commercially Available BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In Dentin Hypersensitivity - A Randomized Clinical Trial" [NCT04249336] | Phase 3 | 140 participants (Actual) | Interventional | 2019-09-27 | Completed | ||
| Clinical Study to Evaluate the Effectiveness of a Cognitive Behavioral Intervention (CBI) Adjunctive to a Smart Powered Toothbrush on the Oral Health of Adolescents [NCT05782348] | 150 participants (Anticipated) | Interventional | 2023-02-06 | Recruiting | |||
| Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis: a 3 Months Randomized Parallel Clinical Trial [NCT05868200] | Phase 3 | 80 participants (Actual) | Interventional | 2022-02-12 | Completed | ||
| Clinical Effectiveness of Silver Diamine Fluoride on Arresting Caries Lesions in Children [NCT05872542] | Phase 4 | 60 participants (Anticipated) | Interventional | 2023-06-01 | Recruiting | ||
| Pilot Study -- Oral Microbiome and Dental Plaque Control With Livionex(R) in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT) [NCT02617407] | Phase 4 | 75 participants (Anticipated) | Interventional | 2016-08-02 | Recruiting | ||
| PET Imaging as a Biomarker of Systemic Treatment Response for Men With Metastatic Castration-Resistant Prostate Cancer [NCT02169063] | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn | |||
| Different Concentrations of Potassium Nitrate in In-office Tooth Bleaching Sensitivity: a Randomized Clinical Trial [NCT03323372] | Phase 2 | 56 participants (Actual) | Interventional | 2016-12-21 | Completed | ||
| "Combined One Stop Shop NaF/FDG PET/MRI Evaluation of Response to Xofigo® in mCRPC Patients: A Pilot Study" [NCT02429804] | Phase 1 | 4 participants (Actual) | Interventional | 2015-04-30 | Terminated(stopped due to Accrual factor) | ||
| Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families. A Controlled and Randomized Clinical Trial. [NCT03642353] | Phase 4 | 40 participants (Actual) | Interventional | 2016-01-30 | Completed | ||
| Essential Oils With and Without Alcohol: in Vivo Antibacterial Effect [NCT03146390] | Phase 4 | 20 participants (Anticipated) | Interventional | 2017-05-02 | Recruiting | ||
| 18F-Sodium Fluoride (18F-NaF) PET-CT Imaging to Identify Vulnerable Plaques in Patients With Diabetes [NCT03530176] | 98 participants (Actual) | Interventional | 2015-01-01 | Completed | |||
| A Prospective, Open Label, Randomized Control Trial to Study the Effect of Different Remineralizing Agents on White Spot Lesions and Dental Plaque During Orthodontic Retention [NCT04788550] | 30 participants (Anticipated) | Interventional | 2021-03-17 | Recruiting | |||
| Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health [NCT02999230] | 170 participants (Actual) | Interventional | 2017-02-22 | Active, not recruiting | |||
| Cost Effectiveness of Sodium Fluoride Varnish Application in Prevention of Dental Caries in School Children Between Age of 6 and 7 Years [NCT03571815] | 328 participants (Actual) | Interventional | 2015-01-02 | Completed | |||
| Non-invasive Detection of Bicuspid Aortic Valve-Related Thoracic Aortopathy [NCT04083118] | 95 participants (Actual) | Observational | 2019-04-01 | Completed | |||
| Comparison of Clinpro™ 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste, Clinpro™ Tooth Crème, and MI-Paste Plus for the Prevention and Reduction of White Spot Lesions in Orthodontic Treatment [NCT03440996] | 90 participants (Actual) | Interventional | 2011-01-14 | Completed | |||
| Comparative Evaluation of Remineralizing Efficacy of Fluoride Varnish and Its Combination Varnishes on White Spot Lesions in Children With ECC: A Randomized Clinical Trial [NCT03360266] | 60 participants (Actual) | Interventional | 2016-03-21 | Completed | |||
| Comparison of the Remineralization Potential of an Optimized Fluoride Dentifrice With a Control Fluoride Dentifrice Using an in Situ Caries Model [NCT06010732] | Phase 3 | 65 participants (Anticipated) | Interventional | 2023-10-02 | Recruiting | ||
| Twelve Week Safety/Clinical/Microbiological Efficacy of Experimental Mouthwashes [NCT05121909] | Phase 4 | 274 participants (Actual) | Interventional | 2021-11-15 | Completed | ||
| Effect of Dissolving Xylitol Chewable Tablets Versus Xylitol Chewing Gum on Salivary pH and Bacterial Count in Geriatric Bedridden Patients : Randomized Clinical Trial [NCT03877705] | Early Phase 1 | 98 participants (Anticipated) | Interventional | 2019-09-01 | Not yet recruiting | ||
| Effect of Low-level Light Therapy Associated With Potassium Nitrate in the Control of Post-bleaching Dental Sensitivity: a Randomized, Double-blind, Split-mouth, Controlled Trial [NCT03434782] | Phase 1 | 50 participants (Actual) | Interventional | 2017-04-24 | Completed | ||
| Clinical Efficacy of Giomer Versus Sodium Fluoride Varnish for Management of Hypersensitivity: Randomized Control Trail [NCT03818945] | Phase 4 | 104 participants (Anticipated) | Interventional | 2019-03-01 | Recruiting | ||
| Retention of Fluoride Formed on Enamel by Fluoride Gel or Varnish Application and Its Release to Dental Biofilm Fluid - in Vivo Study [NCT02486458] | Early Phase 1 | 62 participants (Actual) | Interventional | 2015-04-30 | Completed | ||
| Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Patients Affected by Spondyloarthritis [NCT02869100] | 26 participants (Actual) | Interventional | 2013-01-31 | Completed | |||
| "Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath; Randomized Clinical Trial, Double-blind Cross-sectional Study" [NCT04279106] | 36 participants (Actual) | Interventional | 2018-09-03 | Completed | |||
| Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth [NCT01881100] | 81 participants (Actual) | Interventional | 2011-01-31 | Completed | |||
| Effect of Weekly Professional Oral Care, During 12 Months, on the Composition of the Oral Flora and Related Variables in Dependent Elderly Residents [NCT02627469] | 68 participants (Actual) | Interventional | 2007-08-31 | Completed | |||
| Safety and Clinical Efficacy of Mouth Rinses in Type 1 and Type 2 Diabetics: Effect on Oral Soft Tissue, Plaque and Gingivitis [NCT04449952] | Phase 4 | 154 participants (Actual) | Interventional | 2019-12-02 | Completed | ||
| Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases [NCT00375830] | Phase 2 | 114 participants (Actual) | Interventional | 2006-01-31 | Completed | ||
| Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash. [NCT02267239] | Phase 4 | 15 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting | ||
| Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study [NCT03353103] | Phase 2 | 20 participants (Anticipated) | Interventional | 2018-09-03 | Recruiting | ||
| Evaluation of Mechanical-chemical Gingival Therapy in Diabetic, Obese or Diabese Subjects: Quantitative and Qualitative Analysis of Local and General Aspects. [NCT02123563] | Phase 4 | 240 participants (Actual) | Interventional | 2012-06-30 | Completed | ||
| Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth: a Randomised Clinical Trial. [NCT02124655] | Phase 4 | 15 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| EFFECTIVENESS OF A HOMECARE DESENSITIZER FOR PATIENTS WITH DENTIN HYPERSENSITIVITY [NCT02128633] | Phase 2/Phase 3 | 126 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| The Role of Detergents in the Pathogenesis of Eosinophilic Esophagitis [NCT05482256] | 12 participants (Actual) | Interventional | 2022-09-12 | Active, not recruiting | |||
| Comparison of the Clinical Efficacy From the Retention Phase of Fluoride Delivery of Fluoride Toothpastes Using an in Situ Caries Model [NCT00708123] | Phase 3 | 60 participants (Actual) | Interventional | 2007-11-30 | Completed | ||
| SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial [NCT04802408] | Phase 2/Phase 3 | 200 participants (Anticipated) | Interventional | 2021-10-01 | Recruiting | ||
| Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study [NCT00723515] | Phase 4 | 45 participants (Actual) | Interventional | 2007-02-28 | Completed | ||
| Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model [NCT06140758] | 12 participants (Anticipated) | Interventional | 2023-07-31 | Active, not recruiting | |||
| A Randomized Clinical Trial to Investigate Salivary Flow and pH Following Use of Essential-Oil Containing Mouthwashes [NCT06136455] | Phase 4 | 164 participants (Anticipated) | Interventional | 2023-11-13 | Not yet recruiting | ||
| Effect of Antiseptic Mouthwash/Gargling Solutions and Pre-procedural Rinse on SARS-CoV-2 Load (COVID-19) [NCT04409873] | Phase 2 | 54 participants (Actual) | Interventional | 2021-03-31 | Terminated(stopped due to The funder decided not to continue funding, causing enrollment to cease prematurely and curtailing originally planned analyses. Participants with any samples collected after the baseline pre-rinse samples were included in the analysis.) | ||
| A Randomized, Controlled Clinical Study to Evaluate the Efficacy of a Range of Dental/Denture Products for Improved Oral Health, Compared to Existing Oral Hygiene, in a Population of Partial Denture Wearers With Generalized Mild-moderate Plaque-induced Gi [NCT04290624] | Phase 4 | 58 participants (Actual) | Interventional | 2020-10-14 | Completed | ||
| Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial [NCT05791669] | Phase 3 | 45 participants (Actual) | Interventional | 2021-08-01 | Completed | ||
| Assessment of Symptomatic and Asymptomatic Carotid Plaques Using Hybrid Imaging 18F-sodium Fluoride PET/MR [NCT02726984] | 15 participants (Actual) | Interventional | 2016-01-15 | Completed | |||
| Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ. A Randomized Clinical Trial [NCT02946814] | Phase 4 | 20 participants (Anticipated) | Interventional | 2016-10-31 | Not yet recruiting | ||
| Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus [NCT04748783] | Phase 2 | 2 participants (Actual) | Interventional | 2021-03-26 | Terminated(stopped due to Funding withdrawn) | ||
| Validation of Imaging-Based Biomarkers of Treatment Response in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide [NCT02677376] | 7 participants (Actual) | Observational | 2016-06-27 | Completed | |||
| Effectiveness of the Use of Desensitizing Dentifrices Based on Nanocrystals of Hydroxyapatite / 5% Potassium Nitrate / 1450ppm Sodium Monofluorophosphate and Potassium Nitrate 5% / 1426ppm Sodium Floride in the Treatment of Dentine Hypersensitivity. Test [NCT04156152] | 32 participants (Anticipated) | Interventional | 2020-04-10 | Not yet recruiting | |||
| Clinical and Microbiological Effects of Three Different Mouth Rinses Made of Sodium Fluoride, Guava Leaves Extract or Pomegranate Peel Extract on Dental Plaque in Children [NCT06013735] | 40 participants (Actual) | Interventional | 2020-02-17 | Completed | |||
| A Randomized Multi-treatment/Controlled Double-blinded Study to Evaluate the Efficacy of a Naturally-derived Mouthrinse in the Treatment of Gingival Inflammation. [NCT00885599] | Phase 1/Phase 2 | 94 participants (Actual) | Interventional | 2009-06-30 | Completed | ||
| Assessment of Effect of an Experimental Pregabalin Gel in Reducing Post-operative Tooth Sensitivity Surgery Caused by Bleaching With 35% Hydrogen Peroxide [NCT06180707] | Phase 3 | 75 participants (Anticipated) | Interventional | 2024-01-05 | Not yet recruiting | ||
| A Randomized, Controlled, Examiner-Blind Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% w/w Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks [NCT06143670] | 160 participants (Anticipated) | Interventional | 2023-11-29 | Recruiting | |||
| Assessment of the Oral Tissue Tolerance of a Potassium Oxalate Containing Mouthrinse [NCT01009554] | 96 participants (Actual) | Interventional | 2009-10-31 | Completed | |||
| Clinical Study to Compare Dental Plaque Control [NCT00758394] | Phase 3 | 29 participants (Actual) | Interventional | 2007-09-30 | Completed | ||
| The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration [NCT05758662] | 180 participants (Anticipated) | Observational | 2023-04-30 | Not yet recruiting | |||
| Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars [NCT02592278] | Phase 4 | 180 participants (Actual) | Interventional | 2015-03-31 | Completed | ||
| An Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body PET Scans in Patients for Whom 99m Tc MDP Bone Scans Would Normally be Indicated. [NCT00922519] | 9,999 participants (Anticipated) | Observational | 2009-06-30 | Recruiting | |||
| The Plaque- and Gingivitis Inhibiting Capacity of a Commercially Available Mouthwash Containing Essential Oils and Ethyl Lauroyl Arginate: A Parallel, Split-mouth, Double Blind, Randomized, Placebo-controlled Clinical Study [NCT02884817] | Phase 4 | 59 participants (Actual) | Interventional | 2015-09-30 | Completed | ||
| Phase 2 Clinical Study of a Day Long Effect of SmellX Palatal Patch Containing A Herbal Formula on Malodor [NCT01388023] | Phase 2 | 60 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial [NCT05761041] | Phase 3 | 140 participants (Actual) | Interventional | 2022-03-28 | Completed | ||
| Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis [NCT04750005] | Phase 4 | 209 participants (Actual) | Interventional | 2020-10-23 | Completed | ||
| 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 3 | 50 participants (Anticipated) | Interventional | 2015-12-31 | Recruiting | ||
| Investigation of Dental Plaque and Gingival Index [NCT00759031] | Phase 3 | 19 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
| 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) | Interventional | 2016-04-30 | Completed | |||
| Phase II Trial of Radium-223 in Biochemically Recurrent Prostate Cancer [NCT04206319] | Phase 2 | 26 participants (Anticipated) | Interventional | 2020-09-22 | Recruiting | ||
| F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study [NCT00956163] | Early Phase 1 | 50 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer [NCT01541358] | 2 participants (Actual) | Interventional | 2012-05-31 | Terminated(stopped due to Low accrual and no funding) | |||
| A Randomised Controlled Trial Investigating a Comparison of Fluoride Varnish vs Self-Etching Dentine Bonding Agent in the Reduction of Cervical Dentine Sensitivity in Patients Attending a General Dental Practice in West Sussex, UK. [NCT02919202] | 26 participants (Actual) | Interventional | 2016-10-26 | Completed | |||
| Glass Ionomer Sealant Versus Fluoride Varnish Application to Prevent Occlusal Caries Among Preschool Children - a Randomized Controlled Trial [NCT04163354] | 348 participants (Anticipated) | Interventional | 2018-04-11 | Enrolling by invitation | |||
| A Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell Cancer [NCT04981509] | Phase 2 | 65 participants (Anticipated) | Interventional | 2022-06-10 | Recruiting | ||
| A Randomized Crossover Study to Evaluate the Efficacy of Antibacterial Mouthwash in Preventing Pharyngeal Gonorrhea Among a High Risk Population [NCT04966507] | Phase 2 | 100 participants (Anticipated) | Interventional | 2022-02-17 | Recruiting | ||
| The Influence of Periodontal Treatment on Gingival Inflammatory Response of the Type II Diabetic Patient [NCT01881074] | 74 participants (Actual) | Observational | 2012-06-30 | Completed | |||
| 18F- Sodium Fluoride PET Imaging as a Replacement for Bone Scintigraphy [NCT01930812] | Phase 3 | 286 participants (Actual) | Interventional | 2014-07-31 | Completed | ||
| Cariostatic and Remineralizing Effects of Three Different Dental Varnishes (A Clinical Trial) [NCT04887389] | Phase 4 | 115 participants (Anticipated) | Interventional | 2021-08-01 | Active, not recruiting | ||
| Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth: a Randomized Crossover Clinical Trial [NCT02894593] | 21 participants (Actual) | Interventional | 2015-01-31 | Completed | |||
| The Effect of Toothpaste Containing Aloe Vera on Clinical and Microbiological Out Comes With Measuring IL_1 β in Gingival Crevicular Fluid: a Randomized Controlled Crossover Clinical Trial [NCT04662385] | Phase 2 | 24 participants (Actual) | Interventional | 2020-03-13 | Completed | ||
| Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Fissure Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children : A Randomized Clinical Trial ( Part 1) [NCT04603573] | 91 participants (Anticipated) | Interventional | 2021-07-10 | Recruiting | |||
| Clinical Evaluation of the Effectiveness of Immediate Relief Obtained With Desensitizing Creams - A Controlled, Randomized, Triple Masked, Split-Mouth Clinical Trial [NCT02018783] | 138 participants (Actual) | Interventional | 2013-04-30 | Completed | |||
| The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Appliance Orthodontic Treatment: a Randomized Clinical Trial [NCT05940701] | 65 participants (Actual) | Interventional | 2023-01-15 | Active, not recruiting | |||
| Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples [NCT05138978] | Phase 2 | 34 participants (Actual) | Interventional | 2017-10-06 | Completed | ||
| Sodium Fluoride, Chlorhexidine and Vancomycin Effect in the Inhibition of Mutans Streptococci in Children With Dental Caries: a Randomized, Double-Blind Clinical Trial [NCT00612469] | 69 participants (Actual) | Interventional | 2005-10-31 | Completed | |||
| A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as a Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor, in Men With Castration-Resistant Prostate Cancer and Bone Metastases (BMS #180-279) [NCT00936975] | Phase 2 | 18 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
| Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model [NCT01005966] | Phase 3 | 65 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
| Determination of the Oral Irritation and Sensitization Potential of Two Experimental Potassium Oxalate Containing Mouthrinses [NCT01156376] | 80 participants (Actual) | Interventional | 2010-06-30 | Completed | |||
| Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma [NCT02876991] | 110 participants (Anticipated) | Interventional | 2016-02-29 | Recruiting | |||
| Preventing Early Childhood Caries With Silver Diamine Fluoride - a Randomised Clinical Trial [NCT04075474] | Phase 2 | 730 participants (Anticipated) | Interventional | 2020-10-27 | Recruiting | ||
| Evaluation of Remineralizing Efficacy of Grape Seed Extract Oil Versus Fluoride Mouthwash in Management of Post-Orthodontic White Spot Lesions: Randomized Clinical Trial [NCT04357093] | 40 participants (Anticipated) | Interventional | 2021-02-28 | Not yet recruiting | |||
| Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus [NCT02874963] | 160 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting | |||
| A Randomized Controlled Clinical Trial to Evaluate Late First to Mid-Second Trimester Introduction of Advanced Daily Oral Hygiene on Gingivitis and Maternity Outcomes [NCT01549587] | 746 participants (Actual) | Interventional | 2012-02-29 | Completed | |||
| Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions Among a Group of Egyptian Children : A Randomized Clinical Trial [NCT05064137] | 30 participants (Anticipated) | Interventional | 2022-03-31 | Not yet recruiting | |||
| 18F-fluoride (18F-NaF) Positron Emission Tomography (PET) for Identification of Ruptured and High-Risk Coronary Atherosclerotic Plaques [NCT02607748] | Phase 4 | 41 participants (Actual) | Interventional | 2015-11-13 | Completed | ||
| Efficacy of Green and White Tea Extract Mouthwashes in the Management of Plaque-induced Gingivitis: A Clinical and Biochemical Study [NCT05861206] | 112 participants (Actual) | Interventional | 2020-09-01 | Completed | |||
| Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions: A Randomized, Double-blind Clinical Trial. [NCT04642001] | 24 participants (Actual) | Interventional | 2019-08-07 | Completed | |||
| Plaque Removal Efficacy of Four Dentifrices in a Single Brushing Model [NCT03285984] | 56 participants (Actual) | Interventional | 2012-03-27 | Completed | |||
| [NCT02384044] | 30 participants (Actual) | Interventional | 2015-02-28 | Completed | |||
| Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients [NCT05527483] | 40 participants (Anticipated) | Observational | 2022-04-21 | Recruiting | |||
| Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis [NCT04696536] | Phase 4 | 149 participants (Actual) | Interventional | 2018-09-26 | Completed | ||
| Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth. A Randomized Clinical Trial [NCT02946801] | Phase 4 | 20 participants (Anticipated) | Interventional | 2016-11-30 | Not yet recruiting | ||
| Twelve Week Safety, Clinical, and Microbiological Efficacy of Experimental Zinc Containing Mouth Rinses [NCT05526586] | Phase 4 | 192 participants (Actual) | Interventional | 2022-08-31 | Completed | ||
| Antimicrobial Effect of Tropolone Containing Versus Tropolone Free Mouthwash - Randomized Clinical Trail [NCT03384537] | Early Phase 1 | 30 participants (Anticipated) | Interventional | 2025-06-01 | Recruiting | ||
| Mouth Rinses Efficacy on Salivary SARS-CoV-2 Viral Load: A Randomized Clinical Trial [NCT04721457] | Phase 4 | 90 participants (Actual) | Interventional | 2021-01-03 | Completed | ||
| Six Month Clinical Efficacy of Virtually Supervised Mouthwash and Interdental Brushes: Effect on Plaque, Gingivitis and Oral Microbiome [NCT05756673] | Phase 4 | 292 participants (Actual) | Interventional | 2023-02-09 | Completed | ||
| Randomized Clinical Trial to Evaluate the Efficacy of Nano-hydroxyapatite Combined With the Potassium Nitrate for the Treatment of Dental Sensitivity [NCT02895321] | Phase 4 | 35 participants (Anticipated) | Interventional | 2016-03-31 | Completed | ||
| Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children: A Randomized Clinical Trial(Part 2). [NCT04793256] | 91 participants (Anticipated) | Interventional | 2021-04-30 | Not yet recruiting | |||
| Efficacy of Salivary Bacteria and Post Brushing [NCT00981825] | Phase 3 | 22 participants (Actual) | Interventional | 2007-10-31 | Completed | ||
| Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa [NCT05596149] | 80 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting | |||
| Comparing Chlorhexidine Gluconate Rinse, Sodium Fluoride Rinse, Water Rinse, and Chewing Gum in Regard to Streptococcus Mutans Reduction [NCT02598778] | Phase 2 | 12 participants (Actual) | Interventional | 2015-11-01 | Terminated(stopped due to Study discontinued early due to time constraints and lack of selectivity in agar used in the identification of the target (Streptococcus mutans). Only 12 participants out of a planned 40 were enrolled.) | ||
| A Randomized, Crossover, Controlled, Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101 in Healthy Adult Subjects [NCT06182267] | Phase 1 | 30 participants (Anticipated) | Interventional | 2023-11-27 | Active, not recruiting | ||
| Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis [NCT05731778] | Phase 4 | 26 participants (Actual) | Interventional | 2018-12-22 | Completed | ||
| The Effect of Sodium Fluoride Application on the Prevention of Radiation Caries in Nasopharyngeal Carcinoma Patients: A Prospective, Open, Randomized Controlled Phase II Trial [NCT06174012] | Phase 2 | 135 participants (Anticipated) | Interventional | 2023-12-15 | Not yet recruiting | ||
| Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract [NCT05603650] | 200 participants (Anticipated) | Interventional | 2021-09-01 | Recruiting | |||
| Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Six-month Study in Italy [NCT05821712] | Phase 3 | 80 participants (Actual) | Interventional | 2021-03-08 | Completed | ||
| Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion [NCT01128972] | Phase 2 | 36 participants (Actual) | Interventional | 2009-08-31 | Completed | ||
| Effectiveness of Nano-hydroxyapetite Care Paste in Reducing Dentinhypersenstitivity: A Double Blind Randomized Control Trial [NCT02936830] | Phase 4 | 63 participants (Actual) | Interventional | 2016-10-31 | Completed | ||
| A Randomized, Controlled, Examiner-Blind Clinical Study Investigating the Effects of a Dentifrice Containing 67% Sodium Bicarbonate When Used Twice Daily for 12 Weeks on Gingivitis Treatment and Plaque Removal [NCT05654662] | 204 participants (Actual) | Interventional | 2023-02-20 | Completed | |||
| Compare the Clinical Efficacy of Prototype Toothpastes [NCT00926029] | Phase 3 | 98 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| A Randomized, Open-Label, Crossover, Controlled, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases of Malignant Tumors Compared With 99mTc⁃MDP-BS±SPECT [NCT05614518] | Phase 3 | 280 participants (Actual) | Interventional | 2021-03-29 | Completed | ||
| NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either an Antimicrotubule Directed Agent or Androgen Receptor (AR)-Directed Therapies [NCT01516866] | 58 participants (Actual) | Observational | 2011-11-30 | Completed | |||
| Effectiveness of Remineralization Agents on the Prevention of Dental Bleaching Induced Sensitivity [NCT04855279] | 64 participants (Actual) | Interventional | 2019-01-07 | Completed | |||
| The Effect of Fluoride Varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate, and Resin Infiltration in the Treatment of White Spot Lesions After Orthodontic Therapy: A Randomized Controlled Trial [NCT06051981] | Phase 4 | 88 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting | ||
| Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial. [NCT04731766] | 42 participants (Anticipated) | Interventional | 2021-11-01 | Not yet recruiting | |||
| Minimally Invasive Treatment Approach for Early Childhood Caries Using Silver Diammine Fluoride and Sodium Fluoride With Functionalized Tricalcium Phosphate and Their Effects on Oral Health Related Quality of Life: A Pragmatic Randomized Control Trial [NCT05772039] | Phase 4 | 72 participants (Anticipated) | Interventional | 2022-01-18 | Enrolling by invitation | ||
| Efficacy of Shoplaq® Disclosing Toothpaste in Removing Dental Plaque: A Randomized Controlled Clinical Trial. [NCT03287011] | 50 participants (Anticipated) | Interventional | 2017-09-11 | Recruiting | |||
| F-18 Sodium Fluoride PET/CT Guided Robotic Arm-assisted Pain Palliation in Chronic Nociceptive Low Backache [NCT05560165] | 30 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting | |||
| Determination of the Antiplaque/Antigingivitis Efficacy of Essential Oil Containing Mouthrinses In a Six-Month Study [NCT02980497] | 370 participants (Actual) | Interventional | 2013-09-30 | Completed | |||
| F18 NaF PET/CT and Whole Body and Axial MRI for the Detection of Metastases in Patients With Biochemical Recurrence of Prostate Cancer [NCT01967862] | 54 participants (Actual) | Interventional | 2013-12-31 | Completed | |||
| 21 Day Clinical Efficacy of Essential Oil Containing Mouth Rinses: Effect on Reducing Existing Gingivitis and Plaque [NCT02233998] | 158 participants (Actual) | Interventional | 2014-08-31 | Completed | |||
| A Randomized Controlled Trial on the Remineralization Agents Used for the Treatment of White Spot Lesions [NCT04827966] | 12 participants (Actual) | Interventional | 2022-09-01 | Terminated(stopped due to Funding issues) | |||
| The Effect of Light-cured Fluoride Varnish to Remineralize Post-orthodontic White Spot Lesions and Change the Oral Microbiome: a Double-blind, Split-mouth Randomized Clinical Trial [NCT04528134] | 120 participants (Anticipated) | Interventional | 2022-02-07 | Recruiting | |||
| Effect of Evolocumab on Coronary Artery Plaque Volume and Composition by Coronary CTA (CCTA) and Microcalcification by F18-NaF PET: A Phase 3 Study [NCT03689946] | Phase 3 | 55 participants (Actual) | Interventional | 2019-03-19 | Completed | ||
| Prospective Cohort Study: Efficacy of the Use of 38% Silver Diamine Fluoride and 5% Sodium Fluoride Varnish in Patients 4 to 12 Years for the Treatment of Caries and Its Association With Other Aspects of Relevance [NCT05638217] | 199 participants (Actual) | Observational | 2022-11-07 | Completed | |||
| Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse In Improving Oral Health in Orthodontic Patients [NCT01637948] | Phase 1 | 90 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| In-situ Evaluation of Anti-caries Technology [NCT01650493] | 29 participants (Actual) | Observational | 2012-06-30 | Completed | |||
| Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina [NCT01665248] | 20 participants (Actual) | Interventional | 2012-08-31 | Terminated | |||
| Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter Toothpastes Followed by Fluoride Mouthrinses [NCT05601154] | Early Phase 1 | 20 participants (Anticipated) | Interventional | 2023-03-23 | Enrolling by invitation | ||
| Assessment of the Effect of an Intervention (Periodontal Scaling + Mouthwash + Toothpaste) to Reduce the Load on Oral Bacterial Activity of Rheumatoid Arthritis: a Randomized Trial Nested in the Cohort ESPOIR [NCT01706874] | 92 participants (Actual) | Observational | 2012-11-20 | Completed | |||
| A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth [NCT01829334] | Phase 2 | 329 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity. [NCT01610167] | 151 participants (Actual) | Interventional | 2011-09-30 | Completed | |||
| Comparison Of The Caries-Protective Effect Of Fluoride Varnish (Duraphat®) With Treatment As Usual In Nursery School Attendees Receiving Preventive Oral Health Support Through The Childsmile Oral Health Improvement Programme: An RCT [NCT01674933] | Phase 4 | 1,610 participants (Anticipated) | Interventional | 2012-10-31 | Completed | ||
| Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes [NCT00708305] | Phase 3 | 65 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
| A Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients [NCT04410159] | Phase 2 | 20 participants (Actual) | Interventional | 2020-06-22 | Completed | ||
| The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation-A Randomized Controlled Clinical Trial in Klinik Pergigian, MMMC, Melaka [NCT03989427] | 30 participants (Actual) | Interventional | 2019-05-20 | Completed | |||
| Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses: Effect on Gingivitis and Plaque [NCT04921371] | Phase 1 | 157 participants (Actual) | Interventional | 2019-10-08 | Completed | ||
| Remineralization Effect of NaF, NaF With TCP, NaF With CPP-ACP, and NaF With CXP Varnishes on Newly Erupted First Permanent Molars: a Randomised Controlled Trial [NCT04124887] | 40 participants (Actual) | Interventional | 2017-02-03 | Completed | |||
| Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque, Gingivitis, and Microbiome [NCT05600231] | Phase 4 | 284 participants (Actual) | Interventional | 2022-04-18 | Completed | ||
| 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) | Interventional | 2020-07-14 | Completed | |||
| Open-label Clinical Trial on the Safety and Efficacy of 18F-sodium Fluoride (NaF) PET Imaging in Patients in Need of a Standard 99mTc Bone Scintigraphy [NCT04842071] | Phase 3 | 2,500 participants (Anticipated) | Interventional | 2008-01-01 | Recruiting | ||
| NUPRO Sensodyne Prophylaxis Paste With NovaMin for the Treatment of Dentin Hypersensitivity. [NCT01669785] | 139 participants (Actual) | Interventional | 2012-03-31 | Completed | |||
| Comparison of the Salivary Levels of Streptococcus Mutans in Pediatric Patients With Early Childhood Caries After the Application of Silver Diamine Fluoride or 5% Sodium Fluoride Varnish [NCT03089567] | Early Phase 1 | 0 participants (Actual) | Interventional | 2017-09-15 | Withdrawn(stopped due to Study was not conducted. No participants were enrolled) | ||
| Evaluation of the Efficacy of Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth [NCT04804423] | Phase 2/Phase 3 | 30 participants (Actual) | Interventional | 2020-01-13 | Completed | ||
| A Prospective Randomized Controlled Trial for Prevention of Enamel White Spot Lesions During Fixed Orthodontic Treatment [NCT04342858] | Phase 2 | 99 participants (Actual) | Interventional | 2017-09-15 | Active, not recruiting | ||
| An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy [NCT01665911] | 28 participants (Actual) | Interventional | 2012-08-31 | Completed | |||
| Two-Week Clinical Safety and Saliva Flow Quantification [NCT05645705] | Phase 4 | 270 participants (Actual) | Interventional | 2022-11-28 | Completed | ||
| A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model [NCT01657903] | 56 participants (Actual) | Interventional | 2011-11-30 | Completed | |||
| Clinical Investigation Examining the Anticaries Efficacy of Three Dentifrices (1.5% Arginine in a Calcium Base, 8.0% Arginine in a Calcium Base, and 0.32% Sodium Fluoride in a Silica Base): a Two-year Caries Clinical Study [NCT05560945] | Phase 3 | 6,000 participants (Actual) | Interventional | 2019-04-15 | Completed | ||
| A Randomized, Parallel Design Study to Assess the Effects of Three Interproximal Cleaning Modalities Versus a Manual Toothbrush Control on Gingivitis and Plaque Following a Period of Home Use [NCT02187016] | 290 participants (Actual) | Interventional | 2014-06-30 | Completed | |||
| A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms [NCT02207400] | Phase 2 | 246 participants (Actual) | Interventional | 2014-08-25 | Completed | ||
| A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity [NCT01831817] | Phase 2 | 140 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste [NCT02207907] | Phase 2 | 247 participants (Actual) | Interventional | 2014-08-31 | Completed | ||
| MI Varnish and MI Paste Plus in a Caries Prevention and Remineralization Study [NCT02424097] | Phase 4 | 40 participants (Actual) | Interventional | 2013-05-31 | Completed | ||
| The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ [NCT02195583] | 62 participants (Actual) | Interventional | 2014-06-30 | Completed | |||
| A Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity [NCT02371616] | 304 participants (Actual) | Interventional | 2014-09-29 | Completed | |||
| A Clinical Study to Evaluate the Efficacy of Pre-procedural and Pre-surgical Rinsing With an Antimicrobial Agent in Reducing Bacteria in Dental Aerosols and in the Oral Cavity [NCT02319668] | Phase 4 | 38 participants (Actual) | Interventional | 2015-02-01 | Completed | ||
| Exploring Caregivers' Experiences Related to the Use of a Smart Toothbrush by Children With Autism Spectrum Disorder [NCT05552144] | 17 participants (Actual) | Observational | 2022-08-24 | Completed | |||
| Twelve Week Safety and Clinical Efficacy of Experimental Mouth Rinses [NCT05120141] | Phase 4 | 300 participants (Actual) | Interventional | 2021-03-29 | Completed | ||
| Evaluation of Two Different Toothpastes for the Clinical Management of Extrinsic Stains: Randomized Clinical Trial. [NCT04904978] | 40 participants (Actual) | Interventional | 2021-05-28 | Completed | |||
| Study to Investigate the Initial Stages of Enamel Erosion in Vivo [NCT02533466] | 30 participants (Actual) | Interventional | 2015-10-01 | Completed | |||
| Ecological Effect of 8% Arginine Dentifrice on Oral Microbiota of Caries-Free and Caries-active Populations [NCT02988349] | 42 participants (Actual) | Interventional | 2013-10-31 | Completed | |||
| A Randomized, Examiner Blind, Crossover, in Situ Erosion Study to Investigate the Efficacy of an Experimental Dentifrice in Remineralization of Previously Softened Enamel Compared to a Placebo Dentifrice [NCT03296072] | Phase 3 | 62 participants (Actual) | Interventional | 2017-11-13 | Completed | ||
| Comparing Three Caries Prevention Products on Dentinal Hypersensitivity - A Pilot Study [NCT02136576] | 39 participants (Actual) | Interventional | 2014-05-31 | Completed | |||
| Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: A Randomized Clinical Trial [NCT04485299] | Phase 2/Phase 3 | 68 participants (Anticipated) | Interventional | 2020-10-31 | Not yet recruiting | ||
| Whitening Action of a Hydrogen Peroxide/Sodium Fluoride Containing Mouth Rinse: A 2 Week Randomized Controlled Trial [NCT02151058] | 227 participants (Actual) | Interventional | 2014-06-30 | Completed | |||
| A Comparison Between a Toothpaste With Micro Crystals of Hydroxyapatite and a Toothpaste With 1450 Ppm of Fluoride in the Home Remineralization of White Spot Lesions: a Clinical Trial. [NCT04908293] | 40 participants (Actual) | Interventional | 2021-05-28 | Completed | |||
| A Phase 2 Randomized, Double-blind, Active-controlled Multi-center Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices With 1.5%, 4.0% and 8.0% Arginine Each in Comparison With 0.24% Sodium Fluor [NCT04750902] | Phase 2 | 2,000 participants (Actual) | Interventional | 2021-01-21 | Active, not recruiting | ||
| Silver Diamine Fluoride: Novel Addition to the Prophylactic Bundle for Dental Management of Radiation-Induced Dental Caries in Oral and Pharyngeal Cancer Patients [NCT05403125] | 60 participants (Anticipated) | Interventional | 2022-06-01 | Not yet recruiting | |||
| A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene [NCT02221349] | 30 participants (Actual) | Interventional | 2014-08-31 | Completed | |||
| A Pharmacodynamic Study Using NaF PET/CT Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Metastatic Castrate Resistant Prostate Cancer to Bone [NCT01816048] | Phase 2 | 8 participants (Actual) | Interventional | 2013-05-31 | Terminated(stopped due to Study supporter (Takeda) ended study drug for prostate cancer; enrollment ended prematurely.) | ||
| Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Three Month Study [NCT04033575] | Phase 4 | 88 participants (Actual) | Interventional | 2019-03-06 | Completed | ||
| Non-invasive and Minimal Intervention in Dental Caries Management: Randomized Clinical Study [NCT04373356] | 30 participants (Anticipated) | Interventional | 2020-07-01 | Not yet recruiting | |||
| Effect of Sodium Fluoride at 1.1%, Associated or Not With the Low-level Light Therapy in the Prevention of Post-bleaching Sensitivity: a Randomized, Double-blind, Controlled Trial [NCT03044171] | Phase 1 | 25 participants (Actual) | Interventional | 2016-08-01 | Completed | ||
| Evaluation of the Response of Caries Lesions in Dentin After Application of Silver Diamine Fluoride Gel: A Case Series [NCT05395065] | 235 participants (Actual) | Observational | 2022-07-11 | Active, not recruiting | |||
| Effectiveness of Self-assembling Peptide (P11-4) and Nano-silver Fluoride Varnish in Management of Enamel White Spot Lesions in Young People (Randomized Controlled Clinical Trial) [NCT04929509] | 66 participants (Anticipated) | Interventional | 2020-12-05 | Recruiting | |||
| Compare the Clinical Efficacy of Prototype Toothpastes. [NCT00761930] | Phase 3 | 103 participants (Actual) | Interventional | 2008-03-31 | Completed | ||
| A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity [NCT01691560] | Phase 2 | 140 participants (Actual) | Interventional | 2012-08-31 | Completed | ||
| A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity [NCT02226562] | Phase 2 | 191 participants (Actual) | Interventional | 2014-09-02 | Completed | ||
| A Randomized Clinical Trial to Investigate Two-Week Clinical Safety, Changes in Salivary Flow and pH Following Use of an Anticavity Low pH Mouthwash [NCT06010758] | Phase 4 | 163 participants (Actual) | Interventional | 2023-07-17 | Completed | ||
| Effectiveness of Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth of Preschool Children: a 30-month Randomized Clinical Trial [NCT05084001] | Phase 2/Phase 3 | 769 participants (Anticipated) | Interventional | 2020-03-01 | Recruiting | ||
| Effect of 0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia Among Hospitalized Patients [NCT04403971] | 103 participants (Actual) | Interventional | 2020-05-25 | Completed | |||
| Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis With Subgingival Ultrasonic Instrumentation in Periodontitis Patients: A Randomized Clinical Study [NCT03468595] | 90 participants (Actual) | Interventional | 2016-03-31 | Completed | |||
| The Clinical Investigation of Colgate Total Toothpaste as Compared to Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis. (A Six Month Study) [NCT02080273] | Phase 4 | 135 participants (Actual) | Interventional | 2013-03-31 | Completed | ||
| Remineralization of Dentine Caries Using Nanosilver Fluoride and Casein Phosphopeptides-amorphous Calcium Phosphate (A Randomized Clinical Trial) [NCT04930458] | 135 participants (Anticipated) | Interventional | 2021-08-10 | Recruiting | |||
| A Study to Evaluate the Effect of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Digluconate Tooth Staining [NCT01962493] | Phase 4 | 160 participants (Actual) | Interventional | 2013-09-30 | Completed | ||
| The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ [NCT01641237] | Phase 3 | 72 participants (Actual) | Interventional | 2012-03-31 | Completed | ||
| Clinical Evaluation of Efficacy of Shield Force Plus Varnish Versus Sodium Fluoride on Cervical Dentin Hypersensitivity on Adult Patients: A Randomized Clinical Trial [NCT04484844] | Phase 2/Phase 3 | 68 participants (Anticipated) | Interventional | 2020-10-31 | Not yet recruiting | ||
| Effectiveness of Self-assembling Peptide (p11-4) in Conjunction With Fluoride Varnish in the Management of White Spot Lesions in Primary Teeth (Randomized Controlled Clinical Trial) [NCT05721586] | 24 participants (Actual) | Interventional | 2020-06-01 | Completed | |||
| A Real-World Evidence Study Evaluating Oral Health Related Quality of Life Following the Use of Antisensitivity Toothpaste for Dentine Hypersensitivity Management [NCT04964063] | 655 participants (Actual) | Interventional | 2021-08-31 | Completed | |||
| A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model [NCT01563172] | Phase 4 | 65 participants (Actual) | Interventional | 2009-01-01 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. (NCT00375830)
Timeframe: 30 days
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Sensitivity | Accuracy | |
| Cohort 2 Combined 18F-NaF-CT/18F-FDG-PET Scan | 95.7 | 87.6 |
| Cohort 2 WB-MRI & 99mTc-MDP Bone Scintigraphy | 91.6 | 83.0 |
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. (NCT00375830)
Timeframe: 30 days
| Intervention | percentage of particpants (Number) | |
|---|---|---|
| Sensitivity | Accuracy | |
| Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan | 96.2 | 89.8 |
| Cohort 2 - WB-MRI Scan | 81.4 | 74.7 |
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. (NCT00375830)
Timeframe: 30 days
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Sensitivity | Accuracy | |
| Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan | 95.7 | 87.6 |
| Cohort 2 - Whole Body Magnetic Resonance Imaging (WB-MRI) Scan | 83.3 | 76.0 |
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, participants with skeletal lesions were identified. The outcome is reported as the number of Cohort 3 participants for whom skeletal lesions were identified by each scan methodology, a number without dispersion. (NCT00375830)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort 3 - 99mTc-methyl Diphosphonate (MDP) Bone Scan | 37 |
| Cohort 3 - 18F-NaF / 18F-FDG PET/MRI | 45 |
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, the total number skeletal lesions identified in the participants was determined. The outcome is reported as the total number skeletal lesions identified by each scan methodology, a number without dispersion. (NCT00375830)
Timeframe: 30 days
| Intervention | lesions (Number) |
|---|---|
| Cohort 3 - 99mTc-methyl Diphosphonate (MDP) Bone Scan | 81 |
| Cohort 3 - 18F-NaF / 18F-FDG PET/MRI | 140 |
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant diagnosed with osseous (skeletal) metastases. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18-NaF PET/CT compared to 18F-FDG PET/CT, the same between both scans, or inferior for 18-NaF PET/CT compared to 18F-FDG PET/CT. The outcome result is represented as a number without dispersion. (NCT00375830)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| 18F-NaF > 18F-FDG | 18F-NaF = 18F-FDG | 18F-NaF < 18F-FDG | |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | 3 | 0 | 0 |
"The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF > 99mTc-MDP), the same between both scans (18F-NaF = 99mTc-MDP), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy (18F-NaF < 99mTc-MDP)." (NCT00375830)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| 18F-NaF > 99mTc-MDP | 18F-NaF = 99mTc-MDP | 18F-NaF < 99mTc-MDP | |
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | 10 | 0 | 0 |
"Sensitivity; positive predictive value (PPV); and accuracy for the detection of extraskeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI).~Sensitivity is a percentage that defines the proportion of true positive participants with the disease in a total group of participants.~PPV is the probability that participants with a positive screening test truly have the disease.~Accuracy is the proportion of true results (both true positives and true negatives) among the total number of cases examined.~Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity, PPV, and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection." (NCT00375830)
Timeframe: 30 days
| Intervention | percentage of particpants (Number) | ||
|---|---|---|---|
| Sensitivity | Positive predictive value | Accuracy | |
| Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan | 92.9 | 81.3 | 76.5 |
| Cohort 2 - Whole Body-MRI Scan | 92.9 | 86.7 | 82.4 |
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection. (NCT00375830)
Timeframe: 30 days
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Sensitivity | Accuracy | |
| Cohort 2 - 99mTc-MDP Bone Scintigraphy Scan | 64.6 | 65.9 |
| Cohort 2 Combined 18F-NaF-CT/18F-FDG-PET Scan | 96.2 | 89.8 |
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel. (NCT00708123)
Timeframe: Baseline to 14 days
| Intervention | µg*F/cm^2 (Least Squares Mean) |
|---|---|
| NaF/ Carbopol Toothpaste (1400 Ppm F) | 1283.13 |
| NaF Toothpaste (1350ppm F) | 1333.09 |
| NaF Toothpaste (250 Ppm F) | 680.20 |
| NaMFP/NaF Toothpaste (1450 Ppm F) | 1086.39 |
| Placebo Toothpaste (0 Ppm F) | 435.58 |
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100. (NCT00708123)
Timeframe: Baseline to 14 days
| Intervention | %SMHR (Least Squares Mean) |
|---|---|
| NaF/Carbopol Toothpaste (1400 Ppm F) | 33.54 |
| NaF Toothpaste (1350ppm F) | 35.23 |
| NaF Toothpaste (250 Ppm F) | 24.98 |
| NaMFP/NaF Toothpaste (1450 Ppm F) | 29.57 |
| Placebo Toothpaste (0 Ppm F) | 22.05 |
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100. (NCT00708123)
Timeframe: Baseline to 14 days
| Intervention | %SMHR (Least Squares Mean) |
|---|---|
| NaF/Carbopol Toothpaste (1400 Ppm F) | 33.54 |
| NaF Toothpaste (1350 Ppm F) | 35.23 |
| NaMFP/NaF Toothpaste (1450 Ppm F) | 29.57 |
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 2 hour post single application of study treatment
| Intervention | μg*F/g (Median) |
|---|---|
| NaF Toothpaste(1450ppmF) | 0.09 |
| NaF Toothpaste (1400ppmF) | 0.09 |
| NaMFP/NaF Toothpaste (1450ppmF) | 0.07 |
| Placebo Toothpaste (0ppmF) | 0.00 |
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 15 minutes post single application of study treatment
| Intervention | μg*F/g (Median) |
|---|---|
| NaF Toothpaste(1450ppmF) | 2.00 |
| NaF Toothpaste (1400ppmF) | 1.56 |
| NaMFP/NaF Toothpaste (1450ppmF) | 0.76 |
| Placebo Toothpaste (0ppmF) | 0.03 |
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 1 hour post single application of study treatment
| Intervention | μg*F/g (Median) |
|---|---|
| NaF Toothpaste(1450ppmF) | 0.20 |
| NaF Toothpaste (1400ppmF) | 0.22 |
| NaMFP/NaF Toothpaste (1450ppmF) | 0.12 |
| Placebo Toothpaste (0ppmF) | 0.01 |
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 30 minutes post single application of study treatment
| Intervention | μg*F/g (Median) |
|---|---|
| NaF Toothpaste(1450ppmF) | 0.71 |
| NaF Toothpaste (1400ppmF) | 0.72 |
| NaMFP/NaF Toothpaste (1450ppmF) | 0.28 |
| Placebo Toothpaste (0ppmF) | 0.02 |
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data. (NCT00708305)
Timeframe: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
| Intervention | ln(μg*F*minutes/cm^2) (Log Mean) |
|---|---|
| NaF Toothpaste(1450ppmF) | 0.54 |
| NaF Toothpaste (1400ppmF) | 0.54 |
| NaMFP/NaF Toothpaste (1450ppmF) | 0.05 |
| Placebo Toothpaste (0ppmF) | -0.90 |
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period. (NCT00708305)
Timeframe: Plaque samples were collected at baseline, 4 hours post single application of study treatment
| Intervention | μg*F/g (Median) |
|---|---|
| NaF Toothpaste(1450ppmF) | 0.04 |
| NaF Toothpaste (1400ppmF) | 0.04 |
| NaMFP/NaF Toothpaste (1450ppmF) | 0.02 |
| Placebo Toothpaste (0ppmF) | -0.01 |
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data. (NCT00708305)
Timeframe: Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
| Intervention | ln(μg*F*minutes/cm^2) (Least Squares Mean) |
|---|---|
| NaF Toothpaste(1450 Ppm F) | 0.54 |
| NaF Toothpaste (1400 Ppm F) | 0.54 |
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
| Intervention | Units on a scale (Mean) |
|---|---|
| Fluoride - A | 3.12 |
| Fluoride/Triclosan - B | 2.90 |
| Triclosan/Fluoride/Arginine | 2.92 |
| Triclosan/Fluoride/Cavistat | 2.94 |
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
| Intervention | Units on a scale (Mean) |
|---|---|
| Fluoride | 15.4 |
| Triclosan + Fluoride | 12.81 |
"Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored." (NCT00761930)
Timeframe: 6 weeks
| Intervention | Units on a scale (Mean) |
|---|---|
| A- Placebo Comparator | 0.942 |
| B - Active Comparator | 0.722 |
| C - Experimental Toothpaste | 0.705 |
Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100. (NCT00761930)
Timeframe: 6 weeks
| Intervention | Units on a scale (Mean) |
|---|---|
| A- Placebo Comparator | 0.325 |
| B - Active Comparator | 0.164 |
| C - Experimental Toothpaste | 0.141 |
Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored. (NCT00761930)
Timeframe: 6 weeks
| Intervention | Units on a scale (Mean) |
|---|---|
| A- Placebo Comparator | 2.273 |
| B - Active Comparator | 1.806 |
| C - Experimental Toothpaste | 2.041 |
Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT00926029)
Timeframe: 6 weeks
| Intervention | Units on a scale (Mean) |
|---|---|
| Placebo Control | 0.91 |
| Positive Control | 0.84 |
| Experimental | 1.77 |
Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT00926029)
Timeframe: 6 Weeks
| Intervention | Units on a scale (Mean) |
|---|---|
| Placebo Control | 0.63 |
| Positive Control | 0.51 |
| Experimental | 0.98 |
Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone (NCT00936975)
Timeframe: Baseline and 12 weeks
| Intervention | mL/min/mL (Mean) |
|---|---|
| 18F-Fluoride PET | 0.0 |
Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone (NCT00936975)
Timeframe: Baseline and 12 weeks
| Intervention | mL/min/mL (Mean) |
|---|---|
| 18F-Fluoride PET | -0.02 |
Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax (NCT00936975)
Timeframe: Baseline and 12 weeks
| Intervention | SUVmax (Mean) |
|---|---|
| 18F-Fluoride PET | -6.67 |
Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax (NCT00936975)
Timeframe: Baseline and 12 weeks
| Intervention | SUVmax (Mean) |
|---|---|
| 18F-Fluoride PET | 0.31 |
Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis. (NCT00936975)
Timeframe: Baseline and 12 weeks
| Intervention | mL/min/mL (Mean) |
|---|---|
| Overall | 0.01 |
Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant. (NCT00936975)
Timeframe: Baseline and 12 weeks
| Intervention | mL/min/mL (Mean) |
|---|---|
| Overall | -0.01 |
Total number of salivary bacterial colony forming units (lower number = less colonies present) (NCT00981825)
Timeframe: 4 hours
| Intervention | number of colony forming units (Mean) |
|---|---|
| Fluoride Toothpaste (Control) | 7.18 |
| Triclosan/Fluoride Toothpaste | 6.94 |
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
| Intervention | Percentage 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 |
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
| Intervention | micrograms (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 |
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
| Intervention | Percentage SMHR (Mean) |
|---|---|
| NaF Toothpaste (1426ppmF) | 38.05 |
| AmF Toothpaste (1400ppmF) | 41.06 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.526 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.920 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.408 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.463 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.427 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.776 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.451 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.994 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.596 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.716 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.586 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 1.106 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.063 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.058 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.329 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.386 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.349 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.621 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.394 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.791 |
Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event. (NCT01009554)
Timeframe: through 8 weeks
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Participants with ≥ one treatment-related AE | Sensitivity of teeth | |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.0 | 0.0 |
| Crest® Regular Toothpaste | 2.1 | 2.1 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.118 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.140 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.097 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.319 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.383 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.521 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.395 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.732 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.677 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 1.244 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.164 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.302 |
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.077 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | -0.117 |
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.123 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | -0.212 |
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.107 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | -0.107 |
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.875 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.882 |
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.805 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 1.040 |
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.909 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 1.035 |
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.013 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.054 |
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.071 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | -0.090 |
The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant. (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.158 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | -0.043 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.064 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.056 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.076 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.100 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.067 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.124 |
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.032 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.033 |
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.059 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.075 |
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.047 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.160 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.186 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.263 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.184 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.352 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.250 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.444 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.202 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.236 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.206 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.383 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area. (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.218 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.483 |
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.293 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.359 |
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.277 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.533 |
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.325 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.598 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.162 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.196 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.166 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.303 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected. (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.188 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.383 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.058 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.045 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.075 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.100 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.063 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.112 |
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.027 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.025 |
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.054 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.065 |
The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.042 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.144 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.180 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.252 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.180 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.358 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.241 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.438 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.192 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.224 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.205 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.379 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.210 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.475 |
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.282 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.344 |
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.279 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.541 |
The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.314 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.596 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.154 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.184 |
The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.181 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.375 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 4 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.132 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.112 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 6 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.160 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.215 |
The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain). (NCT01009554)
Timeframe: 8 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Crest® Regular Toothpaste | 0.143 |
| 11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse) | 0.258 |
SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period.
| Intervention | Percent SMH (Least Squares Mean) |
|---|---|
| Test Dentifrice + Test MR | 42.14 |
| Test Dentifrice + Sterile Water Rinse | 38.02 |
| Reference Dentifrice + Sterile Water Rinse | 30.88 |
| Placebo Dentifrice + Sterile Water Rinse | 30.57 |
SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period
| Intervention | Percent SMH (Least Squares Mean) |
|---|---|
| Placebo Dentifrice + Test MR | 37.75 |
| Test Dentifrice + Test MR | 42.14 |
| Test Dentifrice + Sterile Water Rinse | 38.02 |
| Reference Dentifrice + Sterile Water Rinse | 30.88 |
| Placebo Dentifrice + Sterile Water Rinse | 30.57 |
SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period
| Intervention | Percent SMH (Least Squares Mean) |
|---|---|
| Test Dentifrice + Sterile Water Rinse | 38.02 |
| Reference Dentifrice + Sterile Water Rinse | 30.88 |
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period
| Intervention | Percent NER (Least Squares Mean) |
|---|---|
| Test Dentifrice + Test MR | -2.88 |
| Test Dentifrice + Sterile Water Rinse | -14.54 |
| Reference Dentifrice + Sterile Water Rinse | -29.48 |
| Placebo Dentifrice + Sterile Water Rinse | -40.05 |
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period
| Intervention | Percent NER (Least Squares Mean) |
|---|---|
| Test Dentifrice + Sterile Water Rinse | -2.88 |
| Reference Dentifrice + Sterile Water Rinse | -29.48 |
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel. (NCT01128972)
Timeframe: Baseline, 4 hours post treatment in each treatment period
| Intervention | Percent NER (Least Squares Mean) |
|---|---|
| Placebo Dentifrice + Test MR | -3.76 |
| Test Dentifrice + Test MR | -2.88 |
| Test Dentifrice + Sterile Water Rinse | -14.54 |
| Reference Dentifrice + Sterile Water Rinse | -29.48 |
| Placebo Dentifrice + Sterile Water Rinse | -40.05 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 96.3 | 3.7 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 96.2 | 3.8 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 96.3 | 3.7 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 96.2 | 3.8 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment
| Intervention | Percentage of Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Buccal Mucosa | Labial Mucosa | Sublingual Mucosa | Mucobuccal Fold | Gingiva | Tongue | Hard/Soft Palate | Uvula/Oropharynx | Teeth | Dental Restorations | |
| 12027-019 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 12027-020 | 0 | 0 | 0 | 0 | 0 | 3.7 | 0 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 0 | 0 | 0 | 0 | 0 | 3.7 | 0 | 0 | 0 | 0 |
Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 1 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Buccal Mucosa | Labial Mucosa | Sublingual Mucosa | Mucobuccal Fold | Gingiva | Tongue | Hard/Soft Palate | Uvula/Oropharynx | Teeth | Dental Restorations | |
| 12027-019 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 12027-020 | 3.8 | 0 | 0 | 0 | 0 | 7.7 | 0 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 0 | 0 | 0 | 0 | 0 | 18.5 | 0 | 0 | 0 | 0 |
Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 24 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Buccal Mucosa | Labial Mucosa | Sublingual Mucosa | Mucobuccal Fold | Gingiva | Tongue | Hard/Soft Palate | Uvula/Oropharynx | Teeth | Dental Restorations | |
| 12027-019 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 12027-020 | 0 | 0 | 0 | 0 | 0 | 4.3 | 0 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 0 | 0 | 0 | 0 | 0 | 15.4 | 0 | 0 | 0 | 0 |
Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 24 - Pretreatment
| Intervention | Percentage of Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Buccal Mucosa | Labial Mucosa | Sublingual Mucosa | Mucobuccal Fold | Gingiva | Tongue | Hard/Soft Palate | Uvula/Oropharynx | Teeth | Dental Restorations | |
| 12027-019 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 12027-020 | 0 | 0 | 0 | 0 | 0 | 4.3 | 0 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 3.7 | 0 | 0 | 0 | 0 | 3.7 | 0 | 0 | 0 | 0 |
Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 25
| Intervention | Percentage of Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Buccal Mucosa | Labial Mucosa | Sublingual Mucosa | Mucobuccal Fold | Gingiva | Tongue | Hard/Soft Palate | Uvula/Oropharynx | Teeth | Dental Restorations | |
| 12027-019 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 12027-020 | 0 | 0 | 0 | 0 | 0 | 4.3 | 0 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 3
| Intervention | Percentage of Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Buccal Mucosa | Labial Mucosa | Sublingual Mucosa | Mucobuccal Fold | Gingiva | Tongue | Hard/Soft Palate | Uvula/Oropharynx | Teeth | Dental Restorations | |
| 12027-019 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 12027-020 | 3.8 | 0 | 0 | 0 | 0 | 3.8 | 0 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 0 | 0 | 0 | 0 | 0 | 25.9 | 0 | 0 | 0 | 0 |
Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Day 5
| Intervention | Percentage of Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Buccal Mucosa | Labial Mucosa | Sublingual Mucosa | Mucobuccal Fold | Gingiva | Tongue | Hard/Soft Palate | Uvula/Oropharynx | Teeth | Dental Restorations | |
| 12027-019 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 12027-020 | 4.0 | 0 | 0 | 0 | 0 | 4.0 | 0 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 0 | 0 | 0 | 0 | 0 | 22.2 | 0 | 0 | 0 | 0 |
Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. (NCT01156376)
Timeframe: Screening
| Intervention | Percentage of Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Buccal Mucosa | Labial Mucosa | Sublingual Mucosa | Mucobuccal Fold | Gingiva | Tongue | Hard/Soft Palate | Uvula/Oropharynx | Teeth | Dental Restorations | |
| 12027-019 | 0 | 0 | 0 | 3.8 | 0 | 3.8 | 0 | 0 | 0 | 0 |
| 12027-020 | 0 | 0 | 0 | 0 | 3.7 | 3.7 | 0 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 96.2 | 3.8 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 96.3 | 0 | 3.7 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 96.2 | 3.8 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 96.0 | 4.0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Baseline/Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 1 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Post-treatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 24 - Pretreatment
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 25
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 3
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Day 5
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 100 | 0 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). (NCT01156376)
Timeframe: Screening
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| None | Mild | Moderate | Severe | |
| 12027-019 | 96.2 | 3.8 | 0 | 0 |
| 12027-020 | 100 | 0 | 0 | 0 |
| 19292-116-A Control (Listerine®) | 100 | 0 | 0 | 0 |
Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 4 weeks
| Intervention | units on a scale (mm) (Least Squares Mean) |
|---|---|
| Negative Control (Crest Regular Toothpaste) | 39.54 |
| Positive Control (Sensodyne Toothpaste) | 28.36 |
| 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | 29.30 |
"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT01345292)
Timeframe: 2 weeks
| Intervention | units on a scale (mm) (Least Squares Mean) |
|---|---|
| Negative Control (Crest Regular Toothpaste) | 44.94 |
| Positive Control (Sensodyne Toothpaste) | 43.68 |
| 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | 43.64 |
"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm." (NCT01345292)
Timeframe: 4 weeks
| Intervention | units on a scale (mm) (Least Squares Mean) |
|---|---|
| Negative Control (Crest Regular Toothpaste) | 41.32 |
| Positive Control (Sensodyne Toothpaste) | 32.79 |
| 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | 35.19 |
Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 2 weeks
| Intervention | units on a scale (mm) (Least Squares Mean) |
|---|---|
| Negative Control (Crest Regular Toothpaste) | 43.65 |
| Positive Control (Sensodyne Toothpaste) | 38.74 |
| 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | 40.22 |
Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 2 weeks
| Intervention | grams of force (Least Squares Mean) |
|---|---|
| Negative Control (Crest Regular Toothpaste) | 10.10 |
| Positive Control (Sensodyne Toothpaste) | 13.16 |
| 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | 12.51 |
Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 4 weeks
| Intervention | grams of force (Least Squares Mean) |
|---|---|
| Negative Control (Crest Regular Toothpaste) | 10.39 |
| Positive Control (Sensodyne Toothpaste) | 21.83 |
| 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | 18.72 |
Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 4 weeks
| Intervention | units on a scale (mm) (Least Squares Mean) |
|---|---|
| Negative Control (Crest Regular Toothpaste) | 39.49 |
| Positive Control (Sensodyne Toothpaste) | 30.94 |
| 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | 29.32 |
Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. (NCT01345292)
Timeframe: 2 weeks
| Intervention | units on a scale (mm) (Least Squares Mean) |
|---|---|
| Negative Control (Crest Regular Toothpaste) | 41.59 |
| Positive Control (Sensodyne Toothpaste) | 39.52 |
| 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | 37.16 |
"Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate). This study determined how many lesions were detected by F18 NaF PET/CT compared to the known results. The calculation for sensitivity is TP / (TP+FN), where:~TP = true positive (the lesion was accurately detected on both F18 NaF and comparison study) FN = false negative (the lesion was not detected on the PET/CT but was detected on the comparison study)~The result is expressed as the percentage of confirmed lesions across all participants that were also detected by F18 NaF PET/CT." (NCT01541358)
Timeframe: an estimated average of 2 hours
| Intervention | percentage of sensitivity (Number) |
|---|---|
| Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) | 14 |
F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer. (NCT01541358)
Timeframe: an estimated average of 2 hours
| Intervention | lesions detected by F18 NaF (Number) |
|---|---|
| Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) | 1 |
"Specificity is the ability of a test to correctly determine the absence of disease (true negative). This study determined how accurately F18 NaF PET/CT performed at detecting the absence of disease.~The calculation for specificity is TN / (TN + FP), where:~TN = the participant was a true negative (the lesion was not detected on F18 NaF PET/CT and the patient does not have the disease) FP = the participant was a false positive (the lesion was falsely detected on the F18 NaF PET/CT and the patient does not have the disease) The result is expressed as a percentage." (NCT01541358)
Timeframe: an estimated average of 2 hours
| Intervention | percentage of specificity (Number) |
|---|---|
| Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) | 100 |
(NCT01549587)
Timeframe: At delivery
| Intervention | grams (Least Squares Mean) |
|---|---|
| Regular Oral Hygiene | 3095.97 |
| Advanced Oral Hygiene Plus Counseling | 3167.80 |
(NCT01549587)
Timeframe: At delivery
| Intervention | Participants (Count of Participants) |
|---|---|
| Regular Oral Hygiene | 32 |
| Advanced Oral Hygiene Plus Counseling | 21 |
"Score Criteria 0 Normal gingiva.~Mild inflammation - slight change in color, slight edema. No bleeding on probing.~Moderate inflammation - redness, edema, and glazing. Bleeding on probing.~Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding." (NCT01549587)
Timeframe: 1 month
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Regular Oral Hygiene | 0.112 |
| Advanced Oral Hygiene Plus Counseling | 0.125 |
"Score Criteria 0 Normal gingiva.~Mild inflammation - slight change in color, slight edema. No bleeding on probing.~Moderate inflammation - redness, edema, and glazing. Bleeding on probing.~Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding." (NCT01549587)
Timeframe: 3 months
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Regular Oral Hygiene | 0.141 |
| Advanced Oral Hygiene Plus Counseling | 0.154 |
log[42.9-gestational age] (NCT01549587)
Timeframe: At delivery
| Intervention | log weeks (Least Squares Mean) |
|---|---|
| Regular Oral Hygiene | 1.3988 |
| Advanced Oral Hygiene Plus Counseling | 1.3271 |
"Score Criteria 0 Normal gingiva.~Mild inflammation - slight change in color, slight edema. No bleeding on probing.~Moderate inflammation - redness, edema, and glazing. Bleeding on probing.~Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding." (NCT01549587)
Timeframe: 2 months
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Regular Oral Hygiene | 0.124 |
| Advanced Oral Hygiene Plus Counseling | 0.137 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14
| Intervention | micrograms (μg)×F/centimeters(cm)2 (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 2426.51 |
| Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 1912.51 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14
| Intervention | μg×F/cm2 (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 1603.63 |
| Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 1337.72 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14
| Intervention | % SMH (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 30.75 |
| Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 41.61 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14
| Intervention | % SMH (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 41.61 |
| Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 34.66 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14
| Intervention | % SMH (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 30.75 |
| Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 25.05 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14
| Intervention | % SMH (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 41.61 |
| Contol Group | 26.23 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14
| Intervention | μg×F/cm2 (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 1337.72 |
| Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 1912.51 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14
| Intervention | μg×F/cm2 (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 2426.51 |
| Contol Group | 1132.18 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100. (NCT01563172)
Timeframe: At Baseline and at Day 14
| Intervention | % SMH (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 25.05 |
| Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 34.66 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores. (NCT01563172)
Timeframe: At Day 14
| Intervention | μg×F/cm2 (Least Squares Mean) |
|---|---|
| Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 1603.63 |
| Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 2426.51 |
Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment. (NCT01610167)
Timeframe: Immediately after treatment.
| Intervention | units on a scale (Mean) |
|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | -0.87 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | -0.86 |
| NUPRO(r) Classic Prophy Paste | 0.00 |
"Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with yes response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination." (NCT01610167)
Timeframe: 28 days (+/- 2 days) post treatment.
| Intervention | grams (Mean) |
|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | 10.19 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | 11.07 |
| NUPRO(r) Classic Prophy Paste | 1.15 |
Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. (NCT01610167)
Timeframe: 28 days (+/- 2 days) post treatment.
| Intervention | units on a scale (Mean) |
|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | -0.94 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | -0.95 |
| NUPRO(r) Classic Prophy Paste | 0.03 |
Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste). (NCT01610167)
Timeframe: Immediately after treatment to 28 days (+/- 2 days) post treatment.
| Intervention | Number of adverse events. (Number) |
|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | 0 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | 0 |
| NUPRO(r) Classic Prophy Paste | 0 |
"Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a yes response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment." (NCT01610167)
Timeframe: Immediately after treatment.
| Intervention | grams (Mean) |
|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | 12.36 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | 10.46 |
| NUPRO(r) Classic Prophy Paste | 0.60 |
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01641237)
Timeframe: Baseline to 4 hours
| Intervention | %SMHR (Mean) |
|---|---|
| NaF Dentifrice (1426 ppmF) | 30.9 |
| NaF Dentifrice (1150 ppmF) | 28.7 |
| NaF Dentifrice (250 ppmF) | 25.3 |
| Placebo Dentifrice (0 ppmF) | 21.0 |
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data. (NCT01641237)
Timeframe: Baseline to 4 hours
| Intervention | micrograms*F/centimeters^2 (Mean) |
|---|---|
| NaF Dentifrice (1426 ppmF) | 3.13 |
| NaF Dentifrice (1150 ppmF) | 3.07 |
| NaF Dentifrice (250 ppmF) | 2.09 |
| Placebo Dentifrice (0 ppmF) | 1.47 |
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. (NCT01641237)
Timeframe: Baseline to 4 hours
| Intervention | %SMHR (Mean) |
|---|---|
| NaF Dentifrice (1426 ppmF) | 30.89 |
| NaF Dentifrice (1150 ppmF) | 28.71 |
| NaF Dentifrice (250 ppmF) | 25.28 |
| Placebo Dentifrice (0 ppmF) | 21.03 |
Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100. (NCT01641237)
Timeframe: Baseline to 4 hours
| Intervention | % Relative Erosion Resistance (Mean) |
|---|---|
| NaF Dentifrice (1426 ppmF) | -38.83 |
| NaF Dentifrice (1150 ppmF) | -39.75 |
| NaF Dentifrice (250 ppmF) | -50.40 |
| Placebo Dentifrice (0 ppmF) | -71.21 |
SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome. (NCT01657903)
Timeframe: Baseline, 4 hours post treatment in each treatment period
| Intervention | Percentage SMH (Least Squares Mean) |
|---|---|
| NaF/KNO3 Toothpaste 1 | 32.24 |
| NaF/KNO3 Toothpaste 2 | 32.32 |
| NaF/KNO3 Toothpaste 3 | 34.53 |
| No Fluoride/KNO3 Toothpaste | 22.87 |
SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome. (NCT01657903)
Timeframe: Baseline, 2 hours post treatment in each treatment period
| Intervention | Percentage SMH (Least Squares Mean) |
|---|---|
| NaF/KNO3 Toothpaste 1 | 28.96 |
| NaF/KNO3 Toothpaste 2 | 28.92 |
| NaF/KNO3 Toothpaste 3 | 28.30 |
| No Fluoride/KNO3 Toothpaste | 17.90 |
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel. (NCT01657903)
Timeframe: Baseline, 4 hours post treatment in each treatment period
| Intervention | Percentage RER (Least Squares Mean) |
|---|---|
| NaF/KNO3 Toothpaste 1 | -36.66 |
| NaF/KNO3 Toothpaste 2 | -36.53 |
| NaF/KNO3 Toothpaste 3 | -36.98 |
| No Fluoride/KNO3 Toothpaste | -77.82 |
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel. (NCT01657903)
Timeframe: Baseline, 2 hours post treatment in each treatment period
| Intervention | % RER (Least Squares Mean) |
|---|---|
| NaF/KNO3 Toothpaste 1 | -43.76 |
| NaF/KNO3 Toothpaste 2 | -43.33 |
| NaF/KNO3 Toothpaste 3 | -41.88 |
| No Fluoride/KNO3 Toothpaste | -85.88 |
Enamel fluoride uptake is a measure of fluoridation of a caries lesion (NCT01665911)
Timeframe: Three Weeks per each of five arms
| Intervention | microgram fluoride per square cm (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| 0 mg fluoride in 200 ml milk | 1.5 mg fluoride in 100 ml milk | 1.5 mg fluoride in 200 ml milk | 3.0 mg fluoride in 100 ml milk | 3.0 mg fluoride in 200 ml milk | |
| All Participants | 1.2 | 2.4 | 2.12 | 3.09 | 2.67 |
% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization. (NCT01665911)
Timeframe: Three Weeks per each of five arms
| Intervention | percent (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| 0 mg fluoride in 200 ml milk | 1.5 mg fluoride in 100 ml milk | 1.5 mg fluoride in 200 ml milk | 3.0 mg fluoride in 100 ml milk | 3.0 mg fluoride in 200 ml milk | |
| All Participants | -3.4 | 2.6 | -0.2 | 5.4 | 6.0 |
"surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:~SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening)." (NCT01665911)
Timeframe: Three Weeks per each of five arms
| Intervention | percent (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| 0 mg fluoride in 200 ml milk | 1.5 mg fluoride in 100 ml milk | 1.5 mg fluoride in 200 ml milk | 3.0 mg fluoride in 100 ml milk | 3.0 mg fluoride in 200 ml milk | |
| All Participants | 20 | 24 | 22.5 | 26.7 | 25.4 |
"Assessment of sensitivity score Schiff air blast measurements long term after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: 28 days (+/- 2 days) post treatment.
| Intervention | units on a scale (Mean) |
|---|---|
| Group A | 0.87 |
| Group B | 1.11 |
| Group C | 1.67 |
"Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Pre-treatment measurement
| Intervention | units on a scale (Mean) |
|---|---|
| Group A | 1.72 |
| Group B | 1.70 |
| Group C | 1.65 |
"Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Pre-treatment measurement
| Intervention | grams (Mean) |
|---|---|
| Group A | 10.56 |
| Group B | 10.00 |
| Group C | 10.98 |
"Assessment of sensitivity score via air blast measurements immediately after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Immediately after treatment .
| Intervention | units on a scale (Mean) |
|---|---|
| Group A | 0.88 |
| Group B | 0.97 |
| Group C | 1.72 |
"Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Immediately after treatment .
| Intervention | grams (Mean) |
|---|---|
| Group A | 19.61 |
| Group B | 16.67 |
| Group C | 12.01 |
"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: 28 days post-prophylaxis treatment.
| Intervention | units on a scale (Mean) |
|---|---|
| Group A | 0.60 |
| Group B | 0.50 |
| Group C | 0.72 |
"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity prior to the baseline assessments.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Pre-Treatment
| Intervention | units on a scale (Mean) |
|---|---|
| Group A | 0.82 |
| Group B | 0.67 |
| Group C | 0.76 |
"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Immediately following post-prophylaxis treatment.
| Intervention | units on a scale (Mean) |
|---|---|
| Group A | 1.00 |
| Group B | 0.90 |
| Group C | 1.09 |
"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: Post-scaling procedure,immediate
| Intervention | units on a scale (Mean) |
|---|---|
| Group A | 1.31 |
| Group B | 0.98 |
| Group C | 1.28 |
"Assessment of sensitivity score via tactile measurements long term after treatment.~Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth." (NCT01669785)
Timeframe: 28 days (+/- 2 days) post treatment.
| Intervention | grams (Mean) |
|---|---|
| Group A | 19.89 |
| Group B | 16.51 |
| Group C | 12.07 |
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
| Intervention | Score 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 |
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
| Intervention | Score 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 |
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
| Intervention | grams (Mean) |
|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 7.31 |
| Sodium Monofluorophosphate | 6.32 |
| Sodium Fluoride | 4.09 |
| 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 3.64 |
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
| Intervention | Score 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 |
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
| Intervention | grams (Mean) |
|---|---|
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 10.15 |
| Sodium Monofluorophosphate | 5.88 |
| Sodium Fluoride | 4.39 |
| 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 11.97 |
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
| Intervention | Score 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 |
Change from baseline to one month and three month. (NCT01816048)
Timeframe: At baseline, one month, three months
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Cycle 1 (one month)71951270 | Cycle 4 (three months)71951270 | |||||
| No change | Increase in circulating tumors | Decrease in circulating tumors | ||||
| TAK-700 | 5 | |||||
| TAK-700 | 1 | |||||
| TAK-700 | 2 | |||||
The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment. (NCT01816048)
Timeframe: Up to 12 months
| Intervention | participants (Number) |
|---|---|
| TAK-700 | 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 4 weeks post administration of study treatment
| Intervention | Score on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 4 | Mean change from baseline at Week 4 | |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | 6.69 | 5.72 | -0.97 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 6.66 | 5.45 | -1.20 |
| Sodium Fluoride | 6.92 | 6.38 | -0.54 |
| Sodium Monofluorophosphate | 6.41 | 5.39 | -1.03 |
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
| Intervention | Score on a Scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 8 | Mean change from baseline at Week 8 | |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | 2.41 | 1.56 | -0.85 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 2.40 | 1.60 | -0.81 |
| Sodium Fluoride | 2.38 | 2.44 | 0.07 |
| Sodium Monofluorophosphate | 2.40 | 2.41 | 0.01 |
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
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Baseline | Mean change from baseline at Week 4 | |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | 132.55 | -4.39 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 136.53 | -3.91 |
| Sodium Fluoride | 133.89 | -7.50 |
| Sodium Monofluorophosphate | 121.09 | -3.80 |
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
| Intervention | grams (Median) | ||
|---|---|---|---|
| Baseline | Week 4 | Median change from baseline at Week 4 | |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | 10.00 | 10.00 | 0.00 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 10.00 | 10.00 | 0.00 |
| Sodium Fluoride | 10.00 | 10.00 | 0.00 |
| Sodium Monofluorophosphate | 10.00 | 10.00 | 0.00 |
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
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline at Week 8 | |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | 132.55 | -7.97 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 134.33 | -6.43 |
| Sodium Fluoride | 133.89 | -10.86 |
| Sodium Monofluorophosphate | 120.09 | -3.88 |
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
| Intervention | grams (Median) | ||
|---|---|---|---|
| Baseline | Week 8 | Median change from baseline at Week 8 | |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | 10.00 | 15.00 | 5.00 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 10.00 | 15.00 | 5.00 |
| Sodium Fluoride | 10.00 | 10.00 | 0.00 |
| Sodium Monofluorophosphate | 10.00 | 10.00 | 0.00 |
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
| Intervention | Score on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 4 | Mean change from baseline at Week 4 | |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | 2.41 | 1.94 | -0.47 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 2.39 | 1.83 | -0.56 |
| Sodium Fluoride | 2.38 | 2.31 | -0.07 |
| Sodium Monofluorophosphate | 2.40 | 2.31 | -0.09 |
"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
| Intervention | Score on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Week 8 | Mean change from baseline at Week 8 | |
| 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | 6.69 | 4.46 | -2.24 |
| 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 6.71 | 4.65 | -2.06 |
| Sodium Fluoride | 6.92 | 6.07 | -0.86 |
| Sodium Monofluorophosphate | 6.41 | 5.70 | -0.71 |
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 6 post treatment administration
| Intervention | Score on a Scale (Mean) |
|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.67 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.96 |
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 3 post treatment administration
| Intervention | Score on a Scale (Mean) |
|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.56 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.73 |
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 6 post treatment administration
| Intervention | Score on a Scale (Mean) |
|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 1.18 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 1.52 |
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 3 post treatment administration
| Intervention | Score on a Scale (Mean) |
|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.66 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.87 |
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 3 post treatment administration
| Intervention | Score on a Scale (Mean) |
|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.46 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.59 |
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 6 post treatment administration
| Intervention | Score on a Scale (Mean) |
|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 1.44 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 1.87 |
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 3 post treatment administration
| Intervention | Score on a Scale (Mean) |
|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.27 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.41 |
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). (NCT01962493)
Timeframe: Week 6 post treatment administration
| Intervention | Score on a Scale (Mean) |
|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 0.97 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | 1.22 |
Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease. (NCT01967862)
Timeframe: Up to 12 months
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Positive CT Scan | Positive Bone Scan | Positive MRI | Positive PET | |
| Diagnostic (CT, Bone Scan, WB/Axial MRI, F18 NaF PET/CT) | 0 | 0 | 12 | 17 |
Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02080273)
Timeframe: baseline
| Intervention | units on a scale (Mean) |
|---|---|
| Colgate Cavity Protection Toothpaste | 3.53 |
| Colgate Total Toothpaste | 3.55 |
| Parodontax | 3.59 |
Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02080273)
Timeframe: 3 months post treatment use
| Intervention | units on a scale (Mean) |
|---|---|
| Colgate Cavity Protection Toothpaste | 1.63 |
| Colgate Total Toothpaste | 1.27 |
| Parodontax | 1.67 |
Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02080273)
Timeframe: 3 weeks post treatment use
| Intervention | units on a scale (Mean) |
|---|---|
| Colgate Cavity Protection Toothpaste | 1.76 |
| Colgate Total Toothpaste | 1.65 |
| Parodontax | 1.67 |
Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02080273)
Timeframe: 6 months post treatment use
| Intervention | units on a scale (Mean) |
|---|---|
| Colgate Cavity Protection Toothpaste | 1.57 |
| Colgate Total Toothpaste | 0.95 |
| Parodontax | 1.47 |
Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) (NCT02080273)
Timeframe: baseline
| Intervention | units on a scale (Mean) |
|---|---|
| Colgate Cavity Protection Toothpaste | 1.77 |
| Colgate Total Toothpaste | 1.78 |
| Parodontax | 1.77 |
Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02080273)
Timeframe: 3 months post treatment use
| Intervention | units on a scale (Mean) |
|---|---|
| Colgate Cavity Protection Toothpaste | 3.31 |
| Colgate Total Toothpaste | 2.45 |
| Parodontax | 3.45 |
Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02080273)
Timeframe: 3 weeks post treatment use
| Intervention | units on a scale (Mean) |
|---|---|
| Colgate Cavity Protection Toothpaste | 3.46 |
| Colgate Total Toothpaste | 2.98 |
| Parodontax | 3.50 |
Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) (NCT02080273)
Timeframe: 6 months post treatment use
| Intervention | units on a scale (Mean) |
|---|---|
| Colgate Cavity Protection Toothpaste | 3.40 |
| Colgate Total Toothpaste | 1.65 |
| Parodontax | 3.23 |
"The primary analysis will be to compare the dentinal hypersensitivity between the 3 groups.~Air test: A 1 second blast of air from the air-water syringe was applied to the tooth.~Water test: Three drops of ice water were be placed on the tooth.~Schiff Score~Investigator observed participant reaction to test and scored on following scale:~0-Tooth/Subject does not respond to stimulus.~Tooth/Subject responds to stimulus, but does not request discontinuation of stimulus.~Tooth/Subject responds to stimulus and requests discontinuation or moves from stimulus.~Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus~VAS (visual analog scale):~The participant reported sensitivity on a scale of 0-10. 0 being no pain and 10 being worst pain imaginable." (NCT02136576)
Timeframe: 8 weeks after baseline
| Intervention | units on a scale (Median) | |||
|---|---|---|---|---|
| Air Schiff | Air VAS | Water Schiff | Water VAS | |
| Clinpro 5000 | 0 | 2 | 1 | 2 |
| Crest Cavity Protection & MI Paste Plus | 1 | 2 | 1 | 2 |
| Sensodyne | 1 | 3 | 1 | 4 |
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region. (NCT02151058)
Timeframe: 15 Days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control | 1.629 |
| Crest 3D | 1.382 |
| Investigative Mouth Rinse | 1.131 |
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region. (NCT02151058)
Timeframe: 4 Days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control | 1.621 |
| Crest 3D | 1.538 |
| Investigative Mouth Rinse | 1.502 |
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region. (NCT02151058)
Timeframe: 8 Days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control | 1.615 |
| Crest 3D | 1.439 |
| Investigative Mouth Rinse | 1.265 |
"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)." (NCT02151058)
Timeframe: 15 Days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control | 2.568 |
| Crest 3D | 1.909 |
| Investigative Mouth Rinse | 1.575 |
"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)." (NCT02151058)
Timeframe: 4 Days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control | 2.527 |
| Crest 3D | 2.242 |
| Investigative Mouth Rinse | 2.200 |
"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)." (NCT02151058)
Timeframe: 8 Days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control | 2.536 |
| Crest 3D | 2.023 |
| Investigative Mouth Rinse | 1.852 |
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain. (NCT02151058)
Timeframe: 4 Days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control | 1.651 |
| Crest 3D | 1.527 |
| Investigative Mouth Rinse | 1.483 |
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain. (NCT02151058)
Timeframe: 8 Days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control | 1.668 |
| Crest 3D | 1.438 |
| Investigative Mouth Rinse | 1.355 |
Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain. (NCT02151058)
Timeframe: 15 Days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control | 1.671 |
| Crest 3D | 1.396 |
| Investigative Mouth Rinse | 1.206 |
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). (NCT02187016)
Timeframe: 14 days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| AirFloss + Rinse1 | 0.09 |
| AirFloss + Rinse2 | 0.10 |
| String Floss | 0.11 |
| Manual Toothbrush | 0.04 |
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). (NCT02187016)
Timeframe: 28 days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| AirFloss + Rinse1 | 0.15 |
| AirFloss + Rinse2 | 0.16 |
| String Floss | 0.17 |
| Manual Toothbrush | 0.04 |
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation). (NCT02187016)
Timeframe: 14 days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| AirFloss + Rinse1 | 0.10 |
| AirFloss + Rinse2 | 0.10 |
| String Floss | 0.10 |
| Manual Toothbrush | 0.01 |
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). (NCT02187016)
Timeframe: 28 days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| AirFloss + Rinse1 | 0.08 |
| AirFloss + Rinse2 | 0.08 |
| String Floss | 0.09 |
| Manual Toothbrush | 0.01 |
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). (NCT02187016)
Timeframe: 14 days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| AirFloss + Rinse1 | 0.05 |
| AirFloss + Rinse2 | 0.05 |
| String Floss | 0.05 |
| Manual Toothbrush | 0.00 |
MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation). (NCT02187016)
Timeframe: 28 days
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| AirFloss + Rinse1 | 0.20 |
| AirFloss + Rinse2 | 0.22 |
| String Floss | 0.26 |
| Manual Toothbrush | 0.03 |
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge. (NCT02195583)
Timeframe: Baseline to 4 hours
| Intervention | Percentage of NAR (Least Squares Mean) |
|---|---|
| Sodium Fluoride (1426 Ppm) | -12.54 |
| Sodium Fluoride (1150 Ppm) | -13.45 |
| Sodium Fluoride (250 Ppm) | -17.81 |
| Sodium Fluoride (1426 Ppm) + Zinc Base A | -17.60 |
| Sodium Fluoride (1426 Ppm) + Zinc Base B | -18.98 |
| Sodium Fluoride (0 Ppm) | -50.60 |
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization. (NCT02195583)
Timeframe: Baseline to 4 hours
| Intervention | Percentage of SMHR (Least Squares Mean) |
|---|---|
| Sodium Fluoride (1426 Ppm) | 32.49 |
| Sodium Fluoride (1150 Ppm) | 31.81 |
| Sodium Fluoride (250 Ppm) | 27.56 |
| Sodium Fluoride (1426 Ppm) + Zinc Base A | 22.62 |
| Sodium Fluoride (1426 Ppm) + Zinc Base B | 23.22 |
| Sodium Fluoride (0 Ppm) | 24.78 |
The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2). (NCT02195583)
Timeframe: Baseline to 4 hours
| Intervention | microgram per square centimeter(μg/cm^2) (Least Squares Mean) |
|---|---|
| Sodium Fluoride (1426 Ppm) | 2.94 |
| Sodium Fluoride (1150 Ppm) | 2.70 |
| Sodium Fluoride (250 Ppm) | 1.85 |
| Sodium Fluoride (1426 Ppm) + Zinc Base A | 2.62 |
| Sodium Fluoride (1426 Ppm) + Zinc Base B | 2.37 |
| Sodium Fluoride (0 Ppm) | 0.98 |
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge. (NCT02195583)
Timeframe: Baseline to 4 hours
| Intervention | Percentage of CAR (Least Squares Mean) |
|---|---|
| Sodium Fluoride (1426 Ppm) | 45.00 |
| Sodium Fluoride (1150 Ppm) | 45.23 |
| Sodium Fluoride (250 Ppm) | 45.44 |
| Sodium Fluoride (1426 Ppm) + Zinc Base A | 40.29 |
| Sodium Fluoride (1426 Ppm) + Zinc Base B | 42.21 |
| Sodium Fluoride (0 Ppm) | 75.41 |
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration (NCT02207400)
Timeframe: 6 and 12 weeks
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| MGI at 6 weeks | MGI at 12 weeks | |
| Sodium Bicarbonate and Sodium Fluoride Dentifrice | 1.50 | 1.50 |
| Sodium Fluoride Dentifrice | 1.96 | 1.94 |
BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed (NCT02207400)
Timeframe: 6, 12 and 24 weeks
| Intervention | Units on a Scale (Mean) | ||
|---|---|---|---|
| BI Score Score at 6 weeks | BI Score Score at 12 weeks | BI Score Score at 24 weeks | |
| Sodium Bicarbonate and Sodium Fluoride Dentifrice | 0.15 | 0.19 | 0.17 |
| Sodium Fluoride Dentifrice | 0.30 | 0.28 | 0.31 |
Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours). (NCT02207400)
Timeframe: Baseline, 6, 12, 24 and 32 weeks
| Intervention | colony forming units per sample (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Staph Count at Baseline (n=24, 26) | Steph Count at 6 weeks (n=24, 26) | Steph Count at 12 weeks (n=24, 26) | Steph Count at 24 weeks (n=23, 25) | Steph Count at 32 weeks (n=21, 21) | Yeast Count at Baseline (n=24, 26) | Yeast Count at 6 weeks (n=23, 26) | Yeast Count at 12 weeks (n=24, 25) | Yeast Count at 24 weeks (n=17, 22) | Yeast Count at 32 weeks (n= 14, 14) | Coliform count at Baseline (n= 24, 26) | Coliform count at 6 weeks (n= 24, 26) | Coliform count at 12 weeks (n= 24, 26) | Coliform count at 24 weeks (n=23, 25) | Coliform count at 32 weeks (n=21, 21) | E. Coli count at Baseline (n=24, 26) | E. Coli count at 6 weeks (n=24, 26) | E. Coli count at 12 weeks (n=24, 26) | E. Coli count at 24 weeks (n=23, 25) | E. Coli count at 32 weeks (n=21, 21) | |
| Sodium Bicarbonate and Sodium Fluoride Dentifrice | 0.2 | 0.1 | 1.8 | 0.6 | 0.2 | 203.4 | 287.3 | 668.9 | 1479.6 | 2743.5 | 3.9 | 2.6 | 10.9 | 8.1 | 10.9 | 0 | 0.1 | 0.1 | 0.3 | 0.6 |
| Sodium Fluoride Dentifrice | 0.2 | 0 | 3.2 | 0.2 | 0.1 | 647.8 | 784.3 | 411.3 | 1522.3 | 1206.4 | 3.8 | 5.7 | 26.9 | 12.6 | 17.8 | 0 | 0 | 0 | 0.2 | 0 |
The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed (NCT02207400)
Timeframe: 24 weeks
| Intervention | Number of bleeding sites (Mean) |
|---|---|
| Sodium Bicarbonate and Sodium Fluoride Dentifrice | 13.24 |
| Sodium Fluoride Dentifrice | 24.90 |
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration (NCT02207400)
Timeframe: 24 weeks
| Intervention | Units on a scale (Mean) |
|---|---|
| Sodium Bicarbonate and Sodium Fluoride Dentifrice | 1.26 |
| Sodium Fluoride Dentifrice | 1.93 |
The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth. (NCT02207400)
Timeframe: 6, 12 and 24 weeks
| Intervention | Units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Overall Plaque Score at 6 weeks | Overall Plaque Score at 12 weeks | Overall Plaque Score at 24 weeks | Interproximal Plaque Score at 6 weeks | Interproximal Plaque Score at 12 weeks | Interproximal Plaque Score at 24 weeks | |
| Sodium Bicarbonate and Sodium Fluoride Dentifrice | 2.56 | 2.54 | 2.47 | 2.78 | 2.76 | 2.71 |
| Sodium Fluoride Dentifrice | 3.01 | 2.90 | 2.92 | 3.19 | 3.10 | 3.11 |
BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed (NCT02207400)
Timeframe: Baseline, 6 and 12 weeks
| Intervention | Number of bleeding sites (Mean) | ||
|---|---|---|---|
| Number of Bleeding Sites at Baseline | Number of Bleeding Sites at 6 weeks | Number of Bleeding Sites at 12 weeks | |
| Sodium Bicarbonate and Sodium Fluoride Dentifrice | 29.76 | 12.26 | 15.73 |
| Sodium Fluoride Dentifrice | 29.05 | 23.23 | 23.86 |
The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed (NCT02207907)
Timeframe: Baseline, 6, 12 and 24 weeks
| Intervention | Units on a Scale (Mean) | |||
|---|---|---|---|---|
| Bleeding Index Score at Baseline | Bleeding Index Score after 6 weeks | Bleeding Index Score after 12 weeks | Bleeding Index Score after 24 weeks | |
| 0% Sodium Bicarbonate Dentrifice | 0.47 | 0.41 | 0.35 | 0.37 |
| Sodium Bicarbonate Dentrifice | 0.45 | 0.25 | 0.21 | 0.19 |
The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration (NCT02207907)
Timeframe: Baseline, 24 weeks
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Modified Gingival Index at Baseline | Modified Gingival Index after 24 weeks | |
| 0% Sodium Bicarbonate Dentrifice | 2.54 | 2.43 |
| Sodium Bicarbonate Dentrifice | 2.53 | 2.23 |
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration (NCT02207907)
Timeframe: Baseline, 6 and 12 weeks
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| Modified Gingival Index at Baseline | Modified Gingival Index after 6 weeks | Modified Gingival Index after 12 weeks | |
| 0% Sodium Bicarbonate Dentrifice | 2.54 | 2.45 | 2.40 |
| Sodium Bicarbonate Dentrifice | 2.53 | 2.28 | 2.24 |
Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. (NCT02207907)
Timeframe: Baseline, 24 weeks
| Intervention | number of gingival bleeding sites (Mean) | |
|---|---|---|
| Number of Bleeding Sites at Baseline | Number of Bleeding sites after 24 weeks | |
| 0% Sodium Bicarbonate Dentrifice | 45.84 | 36.39 |
| Sodium Bicarbonate Dentrifice | 45.13 | 18.67 |
Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2. (NCT02207907)
Timeframe: Baseline, 6 and 12 weeks
| Intervention | number of gingival bleeding sites (Mean) | ||
|---|---|---|---|
| Number of Bleeding Sites at Baseline | Number of Bleeding Sites after 6 weeks | Number of Bleeding sites after 12 weeks | |
| 0% Sodium Bicarbonate | 45.84 | 40.27 | 34.23 |
| Sodium Bicarbonate Dentrifice | 45.13 | 25.40 | 20.83 |
The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth (NCT02207907)
Timeframe: Baseline, 6,12 and 24 weeks
| Intervention | Units on a scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Overall Plaque Score at Baseline | Overall Plaque Score after 6 weeks | Overall Plaque Score after 12 weeks | Overall Plaque Score after 24 weeks | Interproximal Plaque Score at Baseline | Interproximal Plaque Score after 6 weeks | Interproximal Plaque Score after 12 weeks | Interproximal Plaque Score after 24 weeks | |
| 0% Sodium Bicarbonate Dentrifice | 3.00 | 2.98 | 2.92 | 2.95 | 3.08 | 3.05 | 3.01 | 3.03 |
| Sodium Bicarbonate Dentrifice | 3.04 | 2.65 | 2.55 | 2.52 | 3.12 | 2.73 | 2.64 | 2.61 |
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure. (NCT02221349)
Timeframe: 60 days
| Intervention | Units on a scale (Mean) |
|---|---|
| Oxalate Liquid & Gel Plus SnF2 Paste | -1.643 |
| Oxalate Liquid & Gel Plus NaF Paste | -1.500 |
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. (NCT02221349)
Timeframe: 60 days
| Intervention | Units on a scale (Mean) |
|---|---|
| Oxalate Liquid & Gel Plus SnF2 Paste | -29.82 |
| Oxalate Liquid & Gel Plus NaF Paste | -24.67 |
The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity. (NCT02226562)
Timeframe: Baseline to 8 week
| Intervention | Score on scale (Least Squares Mean) |
|---|---|
| Dentifrice Plus Oral Rinse | -1.47 |
| Dentifrice Alone | -0.37 |
Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. (NCT02226562)
Timeframe: Baseline to 4 week
| Intervention | Score on scale (Mean) |
|---|---|
| Dentifrice Plus Oral Rinse | -1.64 |
| Dentifrice Alone | -0.86 |
Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. (NCT02226562)
Timeframe: Baseline to 8 week
| Intervention | Score on scale (Mean) |
|---|---|
| Dentifrice Plus Oral Rinse | -3.05 |
| Dentifrice Alone | -1.05 |
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT02226562)
Timeframe: Baseline to 8 week
| Intervention | Gram(g) (Mean) |
|---|---|
| Dentifrice Plus Oral Rinse | 31.32 |
| Dentifrice Alone | 3.74 |
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT02226562)
Timeframe: Baseline to 4 week
| Intervention | Gram (g) (Mean) |
|---|---|
| Dentifrice Plus Oral Rinse | 14.11 |
| Dentifrice Alone | 0.74 |
The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity. (NCT02226562)
Timeframe: Baseline to 4 week
| Intervention | Scores on scale (Mean) |
|---|---|
| Dentifrice Plus Oral Rinse | -0.94 |
| Dentifrice Alone | -0.31 |
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3. (NCT02233998)
Timeframe: 3 Weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control (W002194-221P) | 2.434 |
| 19292-116A | 1.965 |
| 11965-059 | 2.055 |
Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3. (NCT02233998)
Timeframe: 3 Weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control (W002194-221P) | 0.098 |
| 19292-116A | 0.067 |
| 11965-059 | 0.072 |
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3. (NCT02233998)
Timeframe: Baseline to 3 Weeks
| Intervention | percentage of PI scores of 0 or 1 (Mean) |
|---|---|
| Negative Control (W002194-221P) | 3.2 |
| 19292-116A | 20.9 |
| 11965-059 | 18.3 |
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3. (NCT02233998)
Timeframe: Baseline to 3 Weeks
| Intervention | percentage of PI scores of >= 3 (Mean) |
|---|---|
| Negative Control (W002194-221P) | 0.1 |
| 19292-116A | 23.5 |
| 11965-059 | 18.9 |
Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3. (NCT02233998)
Timeframe: Baseline to 3 Weeks
| Intervention | percentage of PI scores of >= 2 (Mean) |
|---|---|
| Negative Control (W002194-221P) | 3.2 |
| 19292-116A | 20.9 |
| 11965-059 | 18.3 |
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3. (NCT02233998)
Timeframe: 3 Weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Negative Control (W002194-221P) | 2.004 |
| 19292-116A | 1.770 |
| 11965-059 | 1.807 |
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3. (NCT02233998)
Timeframe: Baseline to 3 Weeks
| Intervention | percentage of MGI scores of >= 3 (Mean) |
|---|---|
| Negative Control (W002194-221P) | -0.6 |
| 19292-116A | 0.9 |
| 11965-059 | 0.3 |
Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3. (NCT02233998)
Timeframe: Baseline to 3 Weeks
| Intervention | percentage of BI scores of 0 (Mean) |
|---|---|
| Negative Control (W002194-221P) | 0.3 |
| 19292-116A | 2.5 |
| 11965-059 | 2.1 |
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3. (NCT02233998)
Timeframe: Baseline to 3 Weeks
| Intervention | percentage of MGI scores of 0 or 1 (Mean) |
|---|---|
| Negative Control (W002194-221P) | 5.5 |
| 19292-116A | 27.5 |
| 11965-059 | 24.3 |
The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant. (NCT02319668)
Timeframe: At Day 3
| Intervention | log(10) colony forming equivalents (CFE) (Mean) |
|---|---|
| Test and Reference Product | 7.63 |
| Reference Product | 7.43 |
The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery (NCT02319668)
Timeframe: Up to 7 days post implant surgery
| Intervention | log (10) CFE × Day (Mean) |
|---|---|
| Test and Reference Product | 8.57 |
| Reference Product | 8.37 |
The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. (NCT02319668)
Timeframe: At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7
| Intervention | log (10) CFE (Mean) | |||||
|---|---|---|---|---|---|---|
| At Day 0 (pre rinse), (n=19,19) | At Day 0 (pre implant), (n=19, 18) | At Day 0 (mid implant), (n=19, 18) | At Day 0 (post implant), (n=19,18) | At Day 1 (n=19, 17) | At Day 7 (n=19, 17) | |
| Reference Product | 7.74 | 8.01 | 7.84 | 7.81 | 7.06 | 7.38 |
| Test and Reference Products | 7.55 | 7.65 | 7.58 | 7.58 | 7.44 | 7.72 |
Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol. Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery. After 30 minutes, the settle plates lids were replaced. This was repeated during the dental prophylaxis procedure using 5 fresh settle plates. All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days. The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation (NCT02319668)
Timeframe: At Baseline
| Intervention | log (10) CFU/mL (Mean) | |
|---|---|---|
| Pre prophylaxis | Post prophylaxis | |
| Reference Product | 0.91 | 1.33 |
| Test and Reference Product | 0.94 | 1.31 |
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
| Intervention | gram (g) (Mean) | ||||
|---|---|---|---|---|---|
| At Baseline | At Week 4 | Change from baseline at Week 4 | At Week 8 | Change from baseline at Week 8 | |
| Comparator Dentifrice | 12.18 | 23.61 | 11.42 | 33.58 | 21.42 |
| Test Dentifrice | 12.79 | 25.45 | 12.72 | 32.88 | 20.10 |
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
| Intervention | score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| At Baseline | At Week 4 | Change from baseline at Week 4 | At Week 8 | Change from baseline at Week 8 | |
| Comparator Dentifrice | 2.68 | 2.11 | -0.57 | 1.58 | -1.09 |
| Test Dentifrice | 2.72 | 2.13 | -0.59 | 1.65 | -1.08 |
"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
| Intervention | score on a scale (Mean) | |
|---|---|---|
| At Week 4 | Change from baseline at Week 4 | |
| Comparator Dentifrice | 40.60 | -15.24 |
| Test Dentifrice | 40.71 | -12.12 |
"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
| Intervention | score on a scale (Mean) | ||
|---|---|---|---|
| At Baseline | At Week 8 | Change from baseline at Week 8 | |
| Comparator Dentifrice | 55.89 | 30.51 | -25.16 |
| Test Dentifrice | 53.05 | 31.62 | -21.50 |
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline. (NCT02384044)
Timeframe: 1 Day
| Intervention | Units on a scale (Mean) |
|---|---|
| Crest® Sensi-Stop™ Strips | -22.933 |
| Colgate® Sensitivity Relief Pen | -3.200 |
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure. (NCT02384044)
Timeframe: 1 Day
| Intervention | Units on a scale (Mean) |
|---|---|
| Crest® Sensi-Stop™ Strips | -0.800 |
| Colgate® Sensitivity Relief Pen | 0.000 |
"The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering <50% of the area, 2 = decalcification covering > 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Thus, for each tooth the value can range between 0 and 12.~16 teeth per subject were evaluated, for each subject the value of each tooth was added - thus the range per one subject can be between 0 and 192.~A mean over all participants in one group was calculated. A higher score means a worse outcome." (NCT02424097)
Timeframe: Baseline and 12-months
| Intervention | units on a scale (Mean) |
|---|---|
| MI Paste & MI Varnish | 40.2 |
| Standard of Care | 41.3 |
"The International Caries Detection and Assessment System (ICDAS II) is a standardized method of caries lesion assessment.The score is based on apparent lesion severity, with scores from 0 to 6.The buccal surface of each tooth was divided into 4 quadrants, and for each quadrant a score was assigned with ICDAS scores: 0 = sound, 1 = first visual change in enamel, after air drying, 2 = distinct demineralization visual change in enamel, 3 = localized enamel breakdown due to caries with no visible dentin, 4 = surface with underlying dark shadow from dentin with or without enamel breakdown, 5 = distinct cavity with visible dentin, 6 = extensive cavity with visible dentin.~The ICDAS scores were calculated as the sum of the highest ICDAS scores assigned to each examined tooth per subject. 16 teeth per subject were evaluated, thus, for each subject the value can range between 0 and 96.~A mean over all participants in one group was calculated. A higher score means a worse outcome." (NCT02424097)
Timeframe: Baseline and 12-months
| Intervention | score on a scale (Mean) |
|---|---|
| MI Paste & MI Varnish | 22.3 |
| Standard of Care | 22.6 |
Saliva stored at 0 - 20°C was used for determining pH (NCT02533466)
Timeframe: Baseline, 30 mins post dietary acid challenge
| Intervention | pH units (Mean) |
|---|---|
| Test Product | -0.71 |
| Reference Product | -0.51 |
Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high. (NCT02533466)
Timeframe: Baseline, 7 hours post dietary acid challenge
| Intervention | scores on a scale (Mean) |
|---|---|
| Test Product | -0.25 |
| Reference Product | -0.36 |
Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high. (NCT02533466)
Timeframe: Baseline, 30 mins post dietary acid challenge
| Intervention | scores on a scale (Mean) |
|---|---|
| Test Product | -1.81 |
| Reference Product | -1.50 |
Saliva stored at 0 - 20°C was used for determining pH (NCT02533466)
Timeframe: Baseline, 7 hours post dietary acid challenge
| Intervention | pH units (Mean) |
|---|---|
| Test Product | 0.00 |
| Reference Product | 0.16 |
Saliva stored at 0 - 20°C was used for determining calcium concentration (NCT02533466)
Timeframe: Baseline, 7 hours post dietary acid challenge
| Intervention | ppm (Mean) |
|---|---|
| Test Product | 4.38 |
| Reference Product | 0.00 |
Saliva stored at 0 - 20°C was used for determining calcium concentration (NCT02533466)
Timeframe: Baseline, 30 mins post dietary acid challenge
| Intervention | ppm (Mean) |
|---|---|
| Test Product | -12.81 |
| Reference Product | -16.29 |
"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable" (NCT02533466)
Timeframe: Baseline, 2 hours post acid challenge
| Intervention | Scores on grading scale (Median) |
|---|---|
| Test Product | 3.83 |
| Reference Product | 2.33 |
"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable" (NCT02533466)
Timeframe: Baseline, 4 hours post acid challenge
| Intervention | Scores on grading scale (Median) |
|---|---|
| Test Product | 3.17 |
| Reference Product | 1.08 |
"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable" (NCT02533466)
Timeframe: Baseline, 7 hours post acid challenge
| Intervention | Scores on grading scale (Median) |
|---|---|
| Test Product | 2.58 |
| Reference Product | 0.75 |
"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable" (NCT02533466)
Timeframe: Baseline, 30 minutes post dietary acid challenge
| Intervention | Scores on grading scale (Median) |
|---|---|
| Test Product | 3.75 |
| Reference Product | 3.17 |
"Oral salivary sample obtained and plated on MSB (mitis salivarius-bacitracin) agar petri dish to determine Streptococcus mutans (S. mutans) levels.~Values in each row in the Outcome Measure Data Table represent percentage change (increase denoted by positive number, decrease denoted by negative number) in S. mutans colonies from baseline (pre rinse/chew) sample for a single participant within that particular Arm/Group. Row titles have been arbitrarily identified as 'First Participant', 'Second Participant', 'Third Participant' and 'Fourth Participant.' No values are shown for 'Third Participant' and 'Fourth Participant' for the Chlorhexidine gluconate (0.12%) and Deionized water Arm/Group since only 2 participants were enrolled within each group. One result is obtained from each pre and post sample combination (percentage change)." (NCT02598778)
Timeframe: Sample obtained at baseline (pre rinse/chew) and immediately after treatment (post rinse/chew). Timed for 30 seconds (oral rinses) or 2 minutes (chewing gum)
| Intervention | Percentage change in S. mutans colonies (Number) | |||
|---|---|---|---|---|
| First Participant | Second Participant | Third Participant | Fourth Participant | |
| Paraffin Wax Chewing Gum (Sugar-free) | 53.13 | 88.89 | 161.54 | 176.26 |
| Sodium Fluoride (0.05%) | -75 | -100 | -100 | -100 |
"Oral salivary sample obtained and plated on MSB (mitis salivarius-bacitracin) agar petri dish to determine Streptococcus mutans (S. mutans) levels.~Values in each row in the Outcome Measure Data Table represent percentage change (increase denoted by positive number, decrease denoted by negative number) in S. mutans colonies from baseline (pre rinse/chew) sample for a single participant within that particular Arm/Group. Row titles have been arbitrarily identified as 'First Participant', 'Second Participant', 'Third Participant' and 'Fourth Participant.' No values are shown for 'Third Participant' and 'Fourth Participant' for the Chlorhexidine gluconate (0.12%) and Deionized water Arm/Group since only 2 participants were enrolled within each group. One result is obtained from each pre and post sample combination (percentage change)." (NCT02598778)
Timeframe: Sample obtained at baseline (pre rinse/chew) and immediately after treatment (post rinse/chew). Timed for 30 seconds (oral rinses) or 2 minutes (chewing gum)
| Intervention | Percentage change in S. mutans colonies (Number) | |
|---|---|---|
| First Participant | Second Participant | |
| Chlorhexidine Gluconate (0.12%) | -100 | -100 |
| Deionized Water | -39.29 | -46.15 |
Saliva and dental plaque samples will be collected, and the abundance of specific oral microbes such as Streptococcus mutans, Streptococcus sanguinis will be quantified by microbial 16S rRNA sequencing. (NCT02988349)
Timeframe: baseline , 2 week
| Intervention | percentage of bacteria (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: sm in supragingival plaque | Baseline: sm in subgingival plaque | Baseline: sm in saliva | Baseline: ss in supragingival plaque | Baseline: ss in subgingival plaque | Baseline: ss in saliva | 2 week: sm in supragingival plaque | 2 week: sm in subgingival plaque | 2 week: sm in saliva | 2 week: ss in supragingival plaque | 2 week: ss in subgingival plaque | 2 week: ss in saliva | |
| Caries-active Subjects | 0.14636 | 0.11956 | 0.01314 | 0.521506667 | 1.539913333 | 0.18324 | 0.009526667 | 0.00284 | 0.003006667 | 3.21486 | 3.232233333 | 2.040286667 |
| Caries-free Subjects | 0.00756 | 0.00629 | 0.00608 | 1.007766667 | 2.064646667 | 0.812706667 | 0.003406667 | 0.0033 | 0.002493333 | 1.655106667 | 4.588546667 | 1.3109 |
Saliva and dental plaque samples will be collected and microbial enzyme activity will be quantified in the lab. Measures include relative enzyme activity of arginine deiminase, urease and lactase dehydrogenase as determined by standard laboratory enzymatic assay protocols. (NCT02988349)
Timeframe: baseline ,2 week
| Intervention | enzyme activity (μmol/min/g) (Mean) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| baseline: ADS activity in supragingival plaque | baseline: ADS activity in subgingival plaque | baseline: ADS activity in saliva plaque | baseline: urease activity in supragingival plaque | baseline: urease activity in subgingival plaque | baseline: urease activity in saliva | baseline: LDH activity in supragingival plaque | baseline: LDH activity in subgingival plaque | baseline: LDH activity in saliva | 2 week: ADS activity in supragingival plaque | 2 week: ADS activity in subgingival plaque | 2 week: ADS activity in saliva | 2 week: urease activity in supragingival plaque | 2 week: urease activity in subgingival plaque | 2 week: urease activity in saliva | 2 week: LDH activity in supragingival plaque | 2 week: LDH activity in subgingival plaque | 2 week: LDH activity in saliva | |
| Caries-active Subjects | 0.3653 | 0.29110 | 0.23470 | 0.3207 | 0.34630 | 0.17920 | 20.965090 | 17.576110 | 16.053870 | 0.8418 | 0.73600 | 0.34850 | 0.6508 | 0.69680 | 0.25260 | 14.096910 | 11.649030 | 15.268450 |
| Caries-free Subjects | 0.8945 | 0.63150 | 0.75870 | 0.6795 | 0.71840 | 0.72900 | 8.859050 | 7.267220 | 7.508787 | 1.0771 | 0.74650 | 0.77410 | 0.5871 | 0.73330 | 0.73240 | 11.347060 | 8.664124 | 9.496731 |
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity. (NCT03238352)
Timeframe: Week 8
| Intervention | Score on Scale (Mean) | |
|---|---|---|
| Schiff score at baseline | Change from baseline in Schiff score at Week 8 | |
| Negative Control (0.02% w/w Sodium Fluoride) | 2.68 | -0.75 |
| Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | 2.52 | -0.64 |
| Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | 2.59 | -1.94 |
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. (NCT03238352)
Timeframe: Week 8
| Intervention | Grams (Mean) | |
|---|---|---|
| Tactile threshold at baseline | Change from baseline at Week 8 | |
| Negative Control (0.02% w/w Sodium Fluoride) | 10.25 | 23.75 |
| Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | 10.23 | 11.59 |
| Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | 10.35 | 61.28 |
The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area. (NCT03285984)
Timeframe: Baseline to 4 Weeks
| Intervention | Score on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Post Baseline | Change from Baseline after 4 weeks | |
| Test Product 1 | 2.90 | 1.76 | -1.13 |
| Test Product 2 | 2.92 | 1.78 | -1.14 |
| Test Product 3 | 2.89 | 1.77 | -1.11 |
| Test Product 4 | 2.86 | 1.96 | -0.90 |
The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area. (NCT03285984)
Timeframe: Baseline to 4 Weeks
| Intervention | Score on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Post Baseline | Change from Baseline | |
| Test Product 1 | 2.90 | 1.76 | -1.13 |
| Test Product 4 | 2.86 | 1.96 | -0.90 |
The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment
| Intervention | Percentage RER (Least Squares Mean) |
|---|---|
| Test Product | -23.65 |
| Placebo Product | -56.94 |
The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment
| Intervention | Percentage RER (Least Squares Mean) |
|---|---|
| Test Product | -23.65 |
| Comparator Product | -34.63 |
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as: %SMHR = [(E1-R)/(E1-B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment
| Intervention | Percentage SMHR (Least Squares Mean) |
|---|---|
| Test Product | 29.67 |
| Comparator Product | 22.10 |
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = [(E1-R)/(E1-B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment
| Intervention | Percentage SMHR (Least Squares Mean) |
|---|---|
| Test Product | 29.67 |
| Placebo Product | 21.98 |
The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment
| Intervention | Microgram fluoride per square centimeter (Least Squares Mean) |
|---|---|
| Test Product | 2.98 |
| Comparator Product | 2.01 |
The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable. (NCT03296072)
Timeframe: After 4 hrs following single exposure of treatment
| Intervention | Microgram fluoride per square centimeter (Least Squares Mean) |
|---|---|
| Test Product | 2.98 |
| Placebo Product | 1.17 |
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
| Intervention | Grams (Mean) | ||
|---|---|---|---|
| Tactile threshold at baseline | Tactile threshold at Week 8 | Change from baseline at Week 8 | |
| Negative Control (1400 Ppm Fluoride as SMFP) | 11.42 | 36.49 | 25.00 |
| Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride]) | 11.80 | 33.93 | 22.31 |
| Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride]) | 11.13 | 28.52 | 17.38 |
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
| Intervention | Score on Scale (Mean) | ||
|---|---|---|---|
| Schiff score at baseline | Schiff score at Week 8 | Change from baseline in Schiff score at Week 8 | |
| Negative Control (1400 Ppm Fluoride as SMFP) | 2.23 | 1.50 | -0.72 |
| Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride]) | 2.18 | 1.70 | -0.48 |
| Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride]) | 2.22 | 1.69 | -0.53 |
"Lesions will be analyzed after in situ demineralization and the following three parameters calculated:~Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]~Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)~Maximum mineral density at the surface-zone - SZmax" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure
| Intervention | Integrated Mineral Loss - ∆Z (Mean) |
|---|---|
| Bovine Specimens 0 Ppm F | 1240 |
| Bovine Specimens 250 Ppm F | 902 |
| Bovine Specimens 500 Ppm F | 664 |
| Bovine Specimens 1100 Ppm F | 684 |
| Human Specimens 0 Ppm F | 1526 |
| Human Specimens 250 Ppm F | 912 |
| Human Specimens 500 Ppm F | 901 |
| Human Specimens 1100 Ppm F | 859 |
"The extent of remineralization will be calculated based on the method of [Gelhard et al., 1979].~SMH recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure." (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure
| Intervention | Percent Surface Microhardness Recovery (Mean) |
|---|---|
| Bovine Specimens 0 Ppm F | 13.96 |
| Bovine Specimens 250 Ppm F | 30.59 |
| Bovine Specimens 500 Ppm F | 40.74 |
| Bovine Specimens 1100 Ppm F | 48.28 |
| Human Specimens 0 Ppm F | 7.42 |
| Human Specimens 250 Ppm F | 16.27 |
| Human Specimens 500 Ppm F | 21.59 |
| Human Specimens 1100 Ppm F | 26.75 |
"The %NAR will be calculated by the method of Corpron [Corpron et al., 1986]:~Net Acid Resistance = [(D1-D2) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure
| Intervention | % Net Acid Resistance (Mean) |
|---|---|
| Bovine Specimens 0 Ppm F | -22.68 |
| Bovine Specimens 250 Ppm F | 11.43 |
| Bovine Specimens 500 Ppm F | 18.66 |
| Bovine Specimens 1100 Ppm F | 31.79 |
| Human Specimens 0 Ppm F | -18.60 |
| Human Specimens 250 Ppm F | 1.99 |
| Human Specimens 500 Ppm F | 8.31 |
| Human Specimens 1100 Ppm F | 16.87 |
The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2. (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure
| Intervention | µg F/cm^2 (Mean) |
|---|---|
| Bovine Specimens 0 Ppm F | 0.96 |
| Bovine Specimens 250 Ppm F | 2.25 |
| Bovine Specimens 500 Ppm F | 2.69 |
| Bovine Specimens 1100 Ppm F | 2.98 |
| Human Specimens 0 Ppm F | 0.96 |
| Human Specimens 250 Ppm F | 2.14 |
| Human Specimens 500 Ppm F | 2.50 |
| Human Specimens 1100 Ppm F | 2.73 |
"Lesions will be analyzed after in situ demineralization and the following three parameters calculated:~Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]~Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)~Maximum mineral density at the surface-zone - SZmax (arbitrary unit from TMR software)" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure
| Intervention | SZmax (Mean) |
|---|---|
| Bovine Specimens 0 Ppm F | 62.17 |
| Bovine Specimens 250 Ppm F | 62.54 |
| Bovine Specimens 500 Ppm F | 67.13 |
| Bovine Specimens 1100 Ppm F | 65.93 |
| Human Specimens 0 Ppm F | 61.22 |
| Human Specimens 250 Ppm F | 62.99 |
| Human Specimens 500 Ppm F | 61.38 |
| Human Specimens 1100 Ppm F | 63.66 |
"Using the data from the four centrally located enamel specimens, the equation used will compare explicitly the reduction in SMH brought by the first and second acid challenges:~Comparative Acid Resistance = [(D2-R) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure
| Intervention | % Comparative Acid Resistance (Mean) |
|---|---|
| Bovine Specimens 0 Ppm F | 36.42 |
| Bovine Specimens 250 Ppm F | 19.20 |
| Bovine Specimens 500 Ppm F | 22.16 |
| Bovine Specimens 1100 Ppm F | 16.27 |
| Human Specimens 0 Ppm F | 25.82 |
| Human Specimens 250 Ppm F | 14.31 |
| Human Specimens 500 Ppm F | 13.33 |
| Human Specimens 1100 Ppm F | 9.71 |
"Lesions will be analyzed after in situ demineralization and the following three parameters calculated:~Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]~Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)~Maximum mineral density at the surface-zone - SZmax" (NCT03383783)
Timeframe: Enamel specimens will be evaluated after 14 days of intra-oral exposure
| Intervention | Micrometers (Mean) |
|---|---|
| Bovine Specimens 0 Ppm F | 52.01 |
| Bovine Specimens 250 Ppm F | 41.74 |
| Bovine Specimens 500 Ppm F | 34.85 |
| Bovine Specimens 1100 Ppm F | 27.31 |
| Human Specimens 0 Ppm F | 60.73 |
| Human Specimens 250 Ppm F | 42.12 |
| Human Specimens 500 Ppm F | 37.38 |
| Human Specimens 1100 Ppm F | 36.02 |
Bleeding on probing (BOP) is an objective indicator of inflammation. BPI (Bleeding Point Index) is a validated index used to measure BOP. BOP is determined at the buccal, lingual and proximal surfaces of all teeth using BPI scores. BPI scores are measured at baseline and 2 weeks, followed by a wash out period of one week. BPI score is measured again at baseline and 2 weeks after cross over in intervention. Change in BPI scores will give the estimation of effect of the intervention. BPI score- minimum value is 0% and Maximum is 100% of bleeding surfaces in each individual patient with teeth. A positive error means that the predicted value is larger than the true value, and a negative error means that the predicted value is less than the true value. The mean error should be close to zero. Sometimes it will be negative or positive depending on the population.. Higher mean score is poor outcome. However, higher reduction in mean score compared to baseline is better outcome. (NCT03989427)
Timeframe: Baseline and 2 weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Brushing First and Flossing Later (BF) | 0.396 |
| Flossing First and Brushing Later (FB) | -1.028 |
"Rustogi Modified Navy Plaque Index(RMNPI) is a self validated tool to assess dental plaque accumulation on the teeth surfaces. RMNPI scores are used to assess change in plaque scores at baseline and at the end of 2 weeks .This will be followed by a 1 week wash out period. Then there is a cross over in the intervention. RMNPI scores are measured again from Baseline and 2 weeks. Maximum number of surfaces examined are 504 per person. A Minimum value of 0 and maximum value of 1 can be calculated in each patient.~Higher mean score is a worse outcome. However,higher percent reduction in mean score when compared to baseline is better outcome." (NCT03989427)
Timeframe: Baseline and 2 weeks
| Intervention | score on a scale (Mean) |
|---|---|
| Brushing First and Flossing Later (BF) | 0.042 |
| Flossing First and Brushing Later (FB) | 0.101 |
BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. (NCT04050722)
Timeframe: Week 2
| Intervention | score on a scale (Mean) |
|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) | 0.15 |
| Colgate Cavity Protection (Negative Control Dentifrice) | 0.22 |
TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth divided into 3 areas;3 scores recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria:0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque (up to 1mm) at cervical margin,3-band of plaque wider than 1mm but covering less than(<)1/3 of tooth surface,4-plaque covering more than or equal to (>=)1/3 but <2/3 of tooth surface,5-plaque covering >=2/3 of tooth surface. Lower scores indicate better results. Mean Overall TPI score for each participant was derived from total TPI score over all tooth sites divided by number of tooth sites scored. Overall mean calculated for all participants was reported. (NCT04050722)
Timeframe: Week 2 and Week 3
| Intervention | score on a scale (Mean) | |
|---|---|---|
| At Week 2 | At Week 3 | |
| Colgate Cavity Protection (Negative Control Dentifrice) | 2.81 | 2.76 |
| Sensodyne Repair and Protect (Test Dentifrice) | 2.35 | 2.33 |
Number of bleeding sites were derived from the bleeding index (BI). BI method used to assess gingival bleeding as a measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe app. 1 mm into gingival sulcus (at app. 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments were performed 1 quadrant at a time; BI scores were recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. A bleeding site was a site scored as 1 or 2. Mean of all bleeding sites was calculated and reported. (NCT04050722)
Timeframe: Week 2 and Week 3
| Intervention | number of bleeding sites (Mean) | |
|---|---|---|
| At Week 2 | At Week 3 | |
| Colgate Cavity Protection (Negative Control Dentifrice) | 31.7 | 28.0 |
| Sensodyne Repair and Protect (Test Dentifrice) | 21.0 | 19.7 |
MGI used to assess for visual symptoms of gingivitis (redness, texture, edema) for all evaluable teeth, four sites per tooth (facial surface - papilla and margin; lingual/palatal surface - papilla and margin). MGI scores were recorded as per given scoring criteria: 0- Absence of inflammation, 1- Mild inflammation: slight change in color, little change in texture of any portion of marginal or papillary gingival unit, 2- Mild inflammation: criteria as [1] but involving entire marginal or papillary gingival unit, 3- Moderate inflammation: glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit, 4- Severe inflammation: marked redness, edema and/or hypertrophy of marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower scores indicate better results. Mean whole mouth MGI score for each participant was derived from total MGI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. (NCT04050722)
Timeframe: Week 2 and Week 3
| Intervention | score on a scale (Mean) | |
|---|---|---|
| At Week 2 | At Week 3 | |
| Colgate Cavity Protection (Negative Control Dentifrice) | 2.18 | 2.15 |
| Sensodyne Repair and Protect (Test Dentifrice) | 2.08 | 2.05 |
TPI assessed supra-gingival plaques on facial and lingual surfaces of all evaluable teeth. Each tooth was divided into 3 areas; 3 scores were recorded facially (mesiofacial,facial,distofacial) and 3 scores lingually (mesiolingual,lingual,distolingual) generating a total of 6 scores per tooth. Plaque was identified using disclosing solution followed by rinsing with tap water(10 milliliters for 10 seconds) and scored as per given scoring criteria: 0-no plaque,1-separate flecks of plaque at cervical margin,2-thin continuous band of plaque(up to 1 mm)at cervical margin,3-band of plaque wider than 1mm but covering <1/3 of tooth surface,4-plaque covering >=1/3 but <2/3 of tooth surface,5-plaque covering >=2/3 of tooth surface. Lower scores indicate better results. Mean Interproximal TPI score for each participant was derived from total TPI score over all interproximal tooth sites divided by number of interproximal tooth sites scored. Mean calculated for all participants was reported. (NCT04050722)
Timeframe: Week 2 and Week 3
| Intervention | score on a scale (Mean) | |
|---|---|---|
| At Week 2 | At Week 3 | |
| Colgate Cavity Protection (Negative Control Dentifrice) | 2.90 | 2.88 |
| Sensodyne Repair and Protect (Test Dentifrice) | 2.48 | 2.47 |
BI method used to assess gingival bleeding as measure of gingival health for facial and lingual/palatal gingival surfaces of all evaluable teeth, six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Examiner inserted a round-end probe approximately(app.) 1millimeter(mm) into gingival sulcus (at app 60 degrees) and moved around tooth, from distal interproximal area to mesial interproximal area, gently stretching gingival epithelium. Gingival bleeding was assessed 30 seconds after probing. Assessments performed 1 quadrant at a time; BI scores recorded as per given scoring criteria: 0=absence of bleeding on probing,1=bleeding observed within 30 seconds of probing,2=bleeding observed immediately on probing. Lower scores indicate better results. Mean whole mouth BI score for each participant was derived from total BI score divided by number of tooth sites scored. Overall mean calculated for all participants was reported. (NCT04050722)
Timeframe: Week 3
| Intervention | score on a scale (Mean) |
|---|---|
| Sensodyne Repair and Protect (Test Dentifrice) | 0.14 |
| Colgate Cavity Protection (Negative Control Dentifrice) | 0.20 |
"SCHIFF cold air sensitivity scale was used to measure the intensity of pain due to dentin hypersensitivity using air blast stimulus. Patients' response of pain was assessed by the doctor according to following score range from; 0(no response of pain), 1 (pain response but no request of discontinuity of stimulus), 2(pain response with request of discontinuity of stimulus), 3(Immediate pain response for discontinuity of stimulus). Percent change in mean scores = ( one minute score-Baseline score) / Baseline score" (NCT04249336)
Timeframe: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
| Intervention | percentage of change in mean scores (Mean) | |||
|---|---|---|---|---|
| 1- minute | 5-minutes | Day-3 | Week-4 | |
| BioMin F | 18 | 27 | 22 | 58 |
| Colgate Sensitive Pro Relief | 45 | 56 | 24 | 55 |
| Colgate Total | 15 | 19 | 10 | 22 |
| Sensodyne Rapid Action | 37 | 51 | 25 | 45 |
Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using mechanical stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score (NCT04249336)
Timeframe: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
| Intervention | percentage of change in mean scores (Mean) | |||
|---|---|---|---|---|
| 1-minute | 5-minutes | Day-3 | Week-4 | |
| BioMin F | 25 | 27 | 28 | 59 |
| Colgate Sensitive Pro Relief | 56 | 61 | 38 | 66 |
| Colgate Total | 16 | 20 | 18 | 27 |
| Sensodyne Rapid Action | 46 | 51 | 32 | 57 |
Visual Analogue Scale was used to measure the intensity of pain due to dentin hypersensitivity using Water Jet Stimulus. Patient's response of pain was assessed on vertical line of 0 to 10cm by asking him to move finger on the line and stop it where he felt pain. Score range from; 0 (no pain at 0cm), 1(mild pain at 1cm), 2(mild pain at 2cm), 3(mild pain at 3cm), 4(moderate pain at 4cm), 5(moderate pain at 5cm), 6(moderate pain at 6cm), 7(severe pain at 7cm), 8(severe pain at 8cm), 9(severe pain at 9cm),10(worst imaginable pain at 10cm). Percent change in mean scores = (one minute score-Baseline score) / Baseline score (NCT04249336)
Timeframe: (Base line to 1 minute) (Base line to 5 minutes)(Base line to day 3)(Base line to week 4)
| Intervention | percentage of change in mean scores (Mean) | |||
|---|---|---|---|---|
| 1-minute | 5-minutes | Day-3 | Week-4 | |
| BioMin F | 22 | 27 | 30 | 67 |
| Colgate Sensitive Pro Relief | 52 | 56 | 34 | 57 |
| Colgate Total | 18 | 21 | 18 | 29 |
| Sensodyne Rapid Action | 46 | 52 | 32 | 55 |
Supra-gingival plaque was assessed on the facial and lingual/palatal surfaces of all scorable teeth, six sites per tooth using TPI which indicated plaque accumulation in the gingival area of the tooth. Each tooth surface was divided into 3 areas; three scores were recorded facially (mesiofacial, facial, distofacial) and three scores lingually (mesiolin-gual, lingual and distolingual) generating a total of six scores per tooth. The plaque was disclosed and scored on a 6-point scale ranged from 0 to 5 where: 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3=Band of plaque wider than 1 mm but covering less than (<) 1/3 of the tooth surface, 4=Plaque covering greater than or equal to (>=) 1/3 but < 2/3 of the tooth surface, 5=Plaque covering >= 2/3 of the tooth surface. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Week 6 | Week 12 | |
| Intervention Group | 2.12 | 2.07 |
| Non-intervention Group | 2.97 | 3.02 |
OHI was calculated as sum score of mean CI and mean ODI. CI scoring:0=no calculus present,1=supragingival calculus covering not >1/3 of exposed tooth surface,2=supragingival calculus covering >1/3 but not >2/3 of exposed tooth surface/presence of individual flecks of subgingival calculus around cervical portion of tooth/both,3=supragingival calculus covering >2/3 of exposed tooth surface/continuous band of subgingival calculus around cervical portion of tooth/both. ODI scoring:0=no debris/stain present,1= supragingival calculus covering not >1/3 of exposed tooth surface,2=supragingival calculus covering>1/3 but not >2/3 of exposed tooth surface/presence of individual flecks of subgingival calculus around cervical portion of tooth/both,3=supragingival calculus covering >2/3 of exposed tooth surface/continuous band of subgingival calculus around cervical portion of tooth/ both. Thus, total OHI score range was 0 to 6. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Week 6 | Week 12 | |
| Intervention Group | 0.30 | 0.30 |
| Non-intervention Group | 0.69 | 0.64 |
"The cleanliness of the partial denture was evaluated based on the modification of the Clinical Categorization of Denture Cleanliness Index. A suitable dental probe was used to gently scrape the surfaces of the RPD and the PDCI was scored. All surfaces of the RPD were assessed and the highest score applicable was recorded. PDCI scoring system included 5-point scale ranged from 0 to 4, where 0=No visible plaque; no matter adherent to the dental probe on light scraping, 1=No visible plaque; matter adherent to the dental probe on light scraping, 2=Deposits of plaque just visible on careful examination without need to confirm by scraping, 3=Deposits of plaque clearly visible, 4=Gross plaque deposits (velvet appearance). Higher score indicates worst outcome." (NCT04290624)
Timeframe: Week 6 and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Week 6 | Week 12 | |
| Intervention Group | 1.2 | 1.1 |
| Non-intervention Group | 1.7 | 1.9 |
The extent of oral debris (defined as soft foreign matter on the surface of teeth) on each tooth surface was determined by running the side of a number 5 explorer (Shephard's crook) probe along the buccal, labial and lingual surfaces and noting the occlusal or incisal extent of the debris as it was removed from the tooth surface. The ODI was assessed on the facial and lingual surfaces of each scorable tooth. The ODI for each participant was calculated as the mean score of all tooth surfaces (facial/lingual).ODI scoring system included 4-point scale ranged from 0 to 3 where: 0=No debris or stain present, 1=Soft debris covering not > 1/3 of the tooth surface the presence of extrinsic stains without other debris regardless of surface area covered, 2= Soft debris covering more than one third, but not more than two thirds, of the exposed tooth surface, 3=Soft debris covering more than two thirds of the exposed tooth surface. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Week 6 | Week 12 | |
| Intervention Group | 0.22 | 0.20 |
| Non-intervention Group | 0.50 | 0.46 |
The MGI focuses on the visual symptoms of gingivitis (redness, texture, edema). The MGI was assessed for the facial and lingual/palatal gingiva of all evaluable teeth, four sites per tooth (facial surface - papilla and margin; lingual/palatal surface - papilla and margin). The MGI scoring included 5-point scale ranged from 0 to 4, where 0=Absence of inflammation, 1=Mild inflammation: slight change in color, little change in texture of any portion of the marginal or papillary gingival unit, 2=Mild inflammation: criteria as (1) but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, 4=Severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Week 6 | Week 12 | |
| Intervention Group | 1.52 | 1.50 |
| Non-intervention Group | 1.92 | 1.86 |
The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted into the gingival crevice to a depth of approximately 1 millimeter [mm] and then run around the tooth (at approximately 60 degrees to the long axis of the tooth) gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Three scores were recorded bucally/labially (distal, body, mesial sites) and 3 scores lingually/palatally (distal, body, mesial sites). All scorable teeth in 1 quadrant were probed first (approximately 30 seconds) before recording the number of gingival units which bled. The BI scoring included 3-point scale ranged from 0 to 2, where 0=no bleeding, 1=bleeding within 30 seconds of probing, 2=bleeding immediately on probing. Sites with a score of 1 or 2 were classified as 'bleeding' sites. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 12
| Intervention | Score on a scale (Mean) |
|---|---|
| Intervention Group | 0.45 |
| Non-intervention Group | 0.76 |
The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted into the gingival crevice to a depth of approximately 1 mm and then run around the tooth (at approximately 60 degrees to the long axis of the tooth) gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Three scores were recorded bucally/labially (distal, body, mesial sites) and 3 scores lingually/palatally (distal, body, mesial sites). All scorable teeth in 1 quadrant were probed first (approximately 30 seconds) before recording the number of gingival units which bled. The BI scoring included 3-point scale ranged from 0 to 2, where 0=no bleeding, 1=bleeding within 30 seconds of probing, 2=bleeding immediately on probing. Sites with a score of 1 or 2 were classified as 'bleeding' sites. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6
| Intervention | Score on a scale (Mean) |
|---|---|
| Intervention Group | 0.45 |
| Non-intervention Group | 0.76 |
Supra-gingival plaque was assessed on the facial and lingual/palatal surfaces of all scorable teeth, six sites per tooth using TPI which indicated plaque accumulation in the gingival area of the tooth. Each tooth surface was divided into 3 areas; three scores were recorded facially (mesiofacial, facial, distofacial) and three scores lingually (mesiolin-gual, lingual and distolingual) generating a total of six scores per tooth. The plaque was disclosed and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3=Band of plaque wider than 1 mm but covering < 1/3 of the tooth surface, 4=Plaque covering >= 1/3 but < 2/3 of the tooth surface, 5=Plaque covering >= 2/3 of the tooth surface. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Week 6 | Week 12 | |
| Intervention Group | 2.31 | 2.24 |
| Non-intervention Group | 3.22 | 3.29 |
Number of gingival bleeding sites were measured during BI assessment. BI assesses the severity and number of bleeding points elicited on probing as a measure of gingival condition. To perform the assessment, a probe was inserted approximately 1 mm into the gingival sulcus (at approximately 60 degrees) and moved around the tooth, from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. Sites which showed signs of bleeding immediately on probing or within 30 seconds of probing were classified as a bleeding sites. (NCT04290624)
Timeframe: Week 6 and Week 12
| Intervention | Number of sites (Mean) | |
|---|---|---|
| Week 6 | Week 12 | |
| Intervention Group | 53.1 | 52.9 |
| Non-intervention Group | 81.7 | 80.8 |
The extent of calculus on each tooth surface (buccal and lingual) was determined by visual examination. Only definite deposits of hard calculus were recorded. The CI was assessed on the facial and lingual surfaces of each scorable tooth. The CI for each participant was calculated as the mean score of all tooth surfaces (facial/lingual). CI scoring included 4-point scale ranged from 0 to 3 where: 0=No calculus present, 1=Supragingival calculus covering not greater than (>) 1/3 of exposed tooth surface, 2=Supragingival calculus covering > 1/3 but not > 2/3 of exposed tooth surface or presence of individual flecks of Subgingival calculus around cervical portion of tooth or both, 3= supragingival calculus covering > 2/3 of exposed tooth surface or a continuous band of Subgingival calculus around cervical portion of tooth or both. Higher score indicates worst outcome. (NCT04290624)
Timeframe: Week 6 and Week 12
| Intervention | Score on a scale (Mean) | |
|---|---|---|
| Week 6 | Week 12 | |
| Intervention Group | 0.08 | 0.10 |
| Non-intervention Group | 0.19 | 0.18 |
Any self-reported (questionnaire) clinical symptom(s). A symptom checklist included cough, runny nose, scratchy/sore throat, fever, chills, fatigue, muscle ache, shortness of breath, diarrhea/nausea/vomiting, loss of taste/smell, and red /painful eye. (Clinical symptoms were collected at baseline and at 3 months; only problems with the study mouth rinse were collected daily through 4 weeks.) (NCT04409873)
Timeframe: Baseline to 3 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Control (Distilled Water) | 1 |
| Oral-B Mouth Sore (H2O2) Mouthwash | 0 |
| Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash | 0 |
| CloSYS (ClO2) Mouthwash | 0 |
| Listerine Mouthwash | 0 |
Any hospitalization(s) from baseline to 4 weeks. Hospitalization(s) were collected on adverse event, unanticipated problem, and final disposition forms. (NCT04409873)
Timeframe: Baseline to 4 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Control (Distilled Water) | 0 |
| Oral-B Mouth Sore (H2O2) Mouthwash | 0 |
| Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash | 0 |
| CloSYS (ClO2) Mouthwash | 0 |
| Listerine Mouthwash | 0 |
The change in the outcome measure, SARS-CoV-2 viral load, in saliva wash RT-PCR was measured by Cycle Threshold (Ct) value. Ct value refers to the number of cycles it takes for the fluorescent signal generated during the PCR reaction to cross a certain threshold, indicating the presence of the target nucleic acid sequence, here, SARS-CoV-2. The lower the Ct value, the faster the threshold is crossed and the higher the viral load in a biological sample, suggesting a higher concentration of the SARS-CoV-2 virus in that sample. (NCT04409873)
Timeframe: Baseline to 4 weeks
| Intervention | Absolute Change in Cycle Threshold (Mean) |
|---|---|
| Control (Distilled Water) | -0.6 |
| Oral-B Mouth Sore (H2O2) Mouthwash | -0.4 |
| Crest Pro-Health Multi-Protection (C21H38ClN) Mouthwash | 0.8 |
| CloSYS (ClO2) Mouthwash | -0.4 |
| Listerine Mouthwash | -1.4 |
Viral clearance is defined as two negative RT-PCR (of swabs from oropharynx and nasopharynx) results at least 24 hours apart (NCT04410159)
Timeframe: Day 6
| Intervention | Participants (Count of Participants) |
|---|---|
| Povidone-iodine | 5 |
| Essential Oils | 4 |
| Tap Water | 1 |
| Control | 0 |
abnormal chest x-ray or CT scan (NCT04410159)
Timeframe: Day 0-14
| Intervention | Participants (Count of Participants) |
|---|---|
| Povidone-iodine | 0 |
| Essential Oils | 0 |
| Tap Water | 0 |
| Control | 0 |
Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation (NCT04410159)
Timeframe: Day 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Povidone-iodine | 0 |
| Essential Oils | 0 |
| Tap Water | 0 |
| Control | 0 |
RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12 (NCT04410159)
Timeframe: Day 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Povidone-iodine | 5 |
| Essential Oils | 4 |
| Tap Water | 2 |
| Control | 1 |
Abnormal absolute lymphocytic count Abnormal C-reactive protein (NCT04410159)
Timeframe: Day 0-14
| Intervention | Participants (Count of Participants) |
|---|---|
| Povidone-iodine | 0 |
| Essential Oils | 0 |
| Tap Water | 0 |
| Control | 0 |
| Substance | Relationship Strength | Studies | Trials | Classes | Roles |
|---|---|---|---|---|---|
| allantoin [no description available] | 2.01 | 1 | 0 | imidazolidine-2,4-dione; ureas | Escherichia coli metabolite; human metabolite; Saccharomyces cerevisiae metabolite; vulnerary |
| benzoic acid Benzoic Acid: A fungistatic compound that is widely used as a food preservative. It is conjugated to GLYCINE in the liver and excreted as hippuric acid.. benzoic acid : A compound comprising a benzene ring core carrying a carboxylic acid substituent.. aromatic carboxylic acid : Any carboxylic acid in which the carboxy group is directly bonded to an aromatic ring. | 3.45 | 1 | 1 | benzoic acids | algal metabolite; antimicrobial food preservative; drug allergen; EC 1.13.11.33 (arachidonate 15-lipoxygenase) inhibitor; EC 3.1.1.3 (triacylglycerol lipase) inhibitor; human xenobiotic metabolite; plant metabolite |
| betaine glycine betaine : The amino acid betaine derived from glycine. | 4.35 | 2 | 2 | amino-acid betaine; glycine derivative | fundamental metabolite |
| citric acid, anhydrous Citric Acid: A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.. citric acid : A tricarboxylic acid that is propane-1,2,3-tricarboxylic acid bearing a hydroxy substituent at position 2. It is an important metabolite in the pathway of all aerobic organisms. | 3.82 | 2 | 1 | tricarboxylic acid | antimicrobial agent; chelator; food acidity regulator; fundamental metabolite |
| chlorine chloride : A halide anion formed when chlorine picks up an electron to form an an anion. | 4.87 | 4 | 2 | halide anion; monoatomic chlorine | cofactor; Escherichia coli metabolite; human metabolite |
| hydrogen sulfide Hydrogen Sulfide: A flammable, poisonous gas with a characteristic odor of rotten eggs. It is used in the manufacture of chemicals, in metallurgy, and as an analytical reagent. (From Merck Index, 11th ed). hydrogen sulfide : A sulfur hydride consisting of a single sulfur atom bonded to two hydrogen atoms. A highly poisonous, flammable gas with a characteristic odour of rotten eggs, it is often produced by bacterial decomposition of organic matter in the absence of oxygen.. thiol : An organosulfur compound in which a thiol group, -SH, is attached to a carbon atom of any aliphatic or aromatic moiety. | 2 | 1 | 0 | gas molecular entity; hydracid; mononuclear parent hydride; sulfur hydride | Escherichia coli metabolite; genotoxin; metabolite; signalling molecule; toxin; vasodilator agent |
| glycerol Moon: The natural satellite of the planet Earth. It includes the lunar cycles or phases, the lunar month, lunar landscapes, geography, and soil. | 2.42 | 2 | 0 | alditol; triol | algal metabolite; detergent; Escherichia coli metabolite; geroprotector; human metabolite; mouse metabolite; osmolyte; Saccharomyces cerevisiae metabolite; solvent |
| iodine Iodine: A nonmetallic element of the halogen group that is represented by the atomic symbol I, atomic number 53, and atomic weight of 126.90. It is a nutritionally essential element, especially important in thyroid hormone synthesis. In solution, it has anti-infective properties and is used topically.. diiodine : Molecule comprising two covalently bonded iodine atoms with overall zero charge.. | 4.87 | 2 | 1 | diatomic iodine | nutrient |
| methylmercaptan methylmercaptan: intermediate in the manufacturing of jet fuels, pesticides, fungicides, plastics, synthesis of methionine; odor may cause nausea; narcotic in high concentrations; depresses urea biosynthesis; RN given refers to parent cpd; structure | 2 | 1 | 0 | alkanethiol | human metabolite; Saccharomyces cerevisiae metabolite |
| nitrates Nitrates: Inorganic or organic salts and esters of nitric acid. These compounds contain the NO3- radical. | 2.63 | 2 | 0 | monovalent inorganic anion; nitrogen oxoanion; reactive nitrogen species | |
| nitrites Nitrites: Salts of nitrous acid or compounds containing the group NO2-. The inorganic nitrites of the type MNO2 (where M=metal) are all insoluble, except the alkali nitrites. The organic nitrites may be isomeric, but not identical with the corresponding nitro compounds. (Grant & Hackh's Chemical Dictionary, 5th ed) | 2.13 | 1 | 0 | monovalent inorganic anion; nitrogen oxoanion; reactive nitrogen species | human metabolite |
| oxalic acid Oxalic Acid: A strong dicarboxylic acid occurring in many plants and vegetables. It is produced in the body by metabolism of glyoxylic acid or ascorbic acid. It is not metabolized but excreted in the urine. It is used as an analytical reagent and general reducing agent.. oxalic acid : An alpha,omega-dicarboxylic acid that is ethane substituted by carboxyl groups at positions 1 and 2. | 3.47 | 1 | 1 | alpha,omega-dicarboxylic acid | algal metabolite; human metabolite; plant metabolite |
| phenol [no description available] | 3 | 1 | 0 | phenols | antiseptic drug; disinfectant; human xenobiotic metabolite; mouse metabolite |
| urea pseudourea: clinical use; structure. isourea : A carboximidic acid that is the imidic acid tautomer of urea, H2NC(=NH)OH, and its hydrocarbyl derivatives. | 4.41 | 2 | 2 | isourea; monocarboxylic acid amide; one-carbon compound | Daphnia magna metabolite; Escherichia coli metabolite; fertilizer; flour treatment agent; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| menthol Menthol: A monoterpene cyclohexanol produced from mint oils. | 4.42 | 2 | 2 | p-menthane monoterpenoid; secondary alcohol | volatile oil component |
| alendronate alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups. | 3.45 | 1 | 1 | 1,1-bis(phosphonic acid); primary amino compound | bone density conservation agent; EC 2.5.1.1 (dimethylallyltranstransferase) inhibitor |
| cetylpyridinium Cetylpyridinium: Cationic bactericidal surfactant used as a topical antiseptic for skin, wounds, mucous membranes, instruments, etc.; and also as a component in mouthwash and lozenges. | 10.1 | 31 | 13 | pyridinium ion | |
| eucalyptol [no description available] | 4.72 | 3 | 2 | ||
| glutaral Glutaral: One of the protein CROSS-LINKING REAGENTS that is used as a disinfectant for sterilization of heat-sensitive equipment and as a laboratory reagent, especially as a fixative.. glutaraldehyde : A dialdehyde comprised of pentane with aldehyde functions at C-1 and C-5. | 2 | 1 | 0 | dialdehyde | cross-linking reagent; disinfectant; fixative |
| hexetidine Hexetidine: A bactericidal and fungicidal antiseptic. It is used as a 0.1% mouthwash for local infections and oral hygiene. (From Martindale, The Extra Pharmacopoeia, 30th ed, p797) | 5.38 | 4 | 1 | organic heteromonocyclic compound; organonitrogen heterocyclic compound | |
| lidocaine Lidocaine: A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.. lidocaine : The monocarboxylic acid amide resulting from the formal condensation of N,N-diethylglycine with 2,6-dimethylaniline. | 3.46 | 1 | 1 | benzenes; monocarboxylic acid amide; tertiary amino compound | anti-arrhythmia drug; drug allergen; environmental contaminant; local anaesthetic; xenobiotic |
| ketoconazole 1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively. | 1.97 | 1 | 0 | dichlorobenzene; dioxolane; ether; imidazoles; N-acylpiperazine; N-arylpiperazine | |
| methyl salicylate methyl salicylate: used in over-the-counter liniments, ointments, lotions for relief of musculoskeletal aches and pains; has hemolytic effect on human & sheep erythrocytes; RN given refers to parent cpd; structure in Merck Index, 9th ed, #5990. methyl salicylate : A benzoate ester that is the methyl ester of salicylic acid. | 4.92 | 4 | 2 | benzoate ester; methyl ester; salicylates | flavouring agent; insect attractant; metabolite |
| metronidazole Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.. metronidazole : A member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death. | 3.45 | 1 | 1 | C-nitro compound; imidazoles; primary alcohol | antiamoebic agent; antibacterial drug; antimicrobial agent; antiparasitic agent; antitrichomonal drug; environmental contaminant; prodrug; radiosensitizing agent; xenobiotic |
| pamidronate [no description available] | 3.45 | 1 | 1 | phosphonoacetic acid | |
| potassium chloride Potassium Chloride: A white crystal or crystalline powder used in BUFFERS; FERTILIZERS; and EXPLOSIVES. It can be used to replenish ELECTROLYTES and restore WATER-ELECTROLYTE BALANCE in treating HYPOKALEMIA.. potassium chloride : A metal chloride salt with a K(+) counterion. | 2.01 | 1 | 0 | inorganic chloride; inorganic potassium salt; potassium salt | fertilizer |
| sanguinarine benzophenanthridine alkaloid : A specific group of isoquinoline alkaloids that occur only in higher plants and are constituents mainly of the Papaveraceae family. | 7.8 | 12 | 1 | alkaloid antibiotic; benzophenanthridine alkaloid; botanical anti-fungal agent | |
| sodium fluoride [no description available] | 6.97 | 14 | 6 | fluoride salt | mutagen |
| triclosan [no description available] | 9.15 | 18 | 6 | aromatic ether; dichlorobenzene; monochlorobenzenes; phenols | antibacterial agent; antimalarial; drug allergen; EC 1.3.1.9 [enoyl-[acyl-carrier-protein] reductase (NADH)] inhibitor; EC 1.5.1.3 (dihydrofolate reductase) inhibitor; fungicide; persistent organic pollutant; xenobiotic |
| 2,3-bis(2-methoxy-4-nitro-5-sulfophenyl)-5-((phenylamino)carbonyl)-2h-tetrazolium hydroxide 2,3-bis(2-methoxy-4-nitro-5-sulfophenyl)-5-((phenylamino)carbonyl)-2H-tetrazolium hydroxide: structure given in first source | 2.48 | 2 | 0 | ||
| zinc chloride zinc chloride: RN given refers to parent cpd. zinc dichloride : A compound of zinc and chloride ions in the ratio 1:2. It exists in four crystalline forms, in each of which the Zn(2+) ions are trigonal planar coordinated to four chloride ions. | 3.8 | 2 | 1 | inorganic chloride; zinc molecular entity | astringent; disinfectant; EC 5.3.3.5 (cholestenol Delta-isomerase) inhibitor; Lewis acid |
| biguanides Biguanides: Derivatives of biguanide (the structure formula HN(C(NH)NH2)2) that are primarily used as oral HYPOGLYCEMIC AGENTS for the treatment of DIABETES MELLITUS, TYPE 2 and PREDIABETES.. biguanides : A class of oral hypoglycemic drugs used for diabetes mellitus or prediabetes treatment. They have a structure based on the 2-carbamimidoylguanidine skeleton. | 3.39 | 1 | 1 | guanidines | |
| sucrose Saccharum: A plant genus of the family POACEAE widely cultivated in the tropics for the sweet cane that is processed into sugar. | 2.75 | 3 | 0 | glycosyl glycoside | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; osmolyte; Saccharomyces cerevisiae metabolite; sweetening agent |
| 2,3,4,6-tetrachlorophenol 2,3,4,6-tetrachlorophenol: RN given refers to parent cpd; see also record for tetrachlorophenol with locants for chloro groups not specified. 2,3,4,6-tetrachlorophenol : A tetrachlorophenol in which the chlorines are located at positions 2, 3, 4, and 6. | 2 | 1 | 0 | tetrachlorophenol | xenobiotic metabolite |
| isoprene isoprene: used in manufacture of ''synthetic'' rubber, butyl rubber; copolymer in production of elastomers; structure. isoprene : A hemiterpene with the formula CH2=C(CH3)CH=CH2; the monomer of natural rubber and a common structure motif to the isoprenoids, a large class of other naturally occurring compounds. | 2.47 | 2 | 0 | alkadiene; hemiterpene; volatile organic compound | plant metabolite |
| bisphenol a 4,4'-isopropylidene diphenol: stimulates proliferative responses and cytokine productions of murine spleen cells and thymus cells in vitro. bisphenol : By usage, the methylenediphenols, HOC6H4CH2C6H4OH, commonly p,p-methylenediphenol, and their substitution products (generally derived from condensation of two equivalent amounts of a phenol with an aldehyde or ketone). The term also includes analogues in the the methylene (or substituted methylene) group has been replaced by a heteroatom.. bisphenol A : A bisphenol that is 4,4'-methanediyldiphenol in which the methylene hydrogens are replaced by two methyl groups. | 2.13 | 1 | 0 | bisphenol | endocrine disruptor; environmental contaminant; xenobiotic; xenoestrogen |
| methylmethacrylate Methylmethacrylate: The methyl ester of methacrylic acid. It polymerizes easily to form POLYMETHYL METHACRYLATE. It is used as a bone cement.. methyl methacrylate : An enoate ester having methacrylic acid as the carboxylic acid component and methanol as the alcohol component. | 1.98 | 1 | 0 | enoate ester; methyl ester | allergen; polymerisation monomer |
| n-vinyl-2-pyrrolidinone N-vinyl-2-pyrrolidinone: monomer of POVIDONE; structure given in first source | 4.87 | 2 | 1 | pyrrolidin-2-ones | |
| thymol Thymol: A phenol obtained from thyme oil or other volatile oils used as a stabilizer in pharmaceutical preparations, and as an antiseptic (antibacterial or antifungal) agent.. thymol : A phenol that is a natural monoterpene derivative of cymene. | 4.72 | 3 | 2 | monoterpenoid; phenols | volatile oil component |
| cyclohexanol Cyclohexanols: Monohydroxy derivatives of cyclohexanes that contain the general formula R-C6H11O. They have a camphorlike odor and are used in making soaps, insecticides, germicides, dry cleaning, and plasticizers.. cyclohexanols : An alcohol in which one or more hydroxy groups are attached to a cyclohexane skeleton. | 4.72 | 3 | 2 | cyclohexanols; secondary alcohol | solvent |
| thiazoles [no description available] | 2.05 | 1 | 0 | 1,3-thiazoles; mancude organic heteromonocyclic parent; monocyclic heteroarene | |
| malondialdehyde Malondialdehyde: The dialdehyde of malonic acid.. malonaldehyde : A dialdehyde that is propane substituted by two oxo groups at the terminal carbon atoms respectively. A biomarker of oxidative damage to lipids caused by smoking, it exists in vivo mainly in the enol form. | 1.98 | 1 | 0 | dialdehyde | biomarker |
| c.i. 42510 Rosaniline Dyes: Compounds that contain the triphenylmethane aniline structure found in rosaniline. Many of them have a characteristic magenta color and are used as COLORING AGENTS.. basic fuchsin : A four-component mixture of chemically related dyes comprising pararosanilin, rosanilin, magenta II and new fuchsin in varying amounts. rosanilin : A hydrochloride that is the monohydrochloride of 4-[(4-aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-2-methylaniline. One of the major constituents of Basic fuchsin, together with pararosanilin, magenta II and new fuchsin. | 3.46 | 1 | 1 | ||
| benzydamine Benzydamine: A benzyl-indazole having analgesic, antipyretic, and anti-inflammatory effects. It is used to reduce post-surgical and post-traumatic pain and edema and to promote healing. It is also used topically in treatment of RHEUMATIC DISEASES and INFLAMMATION of the mouth and throat.. benzydamine : A member of the class of indazoles carrying benzyl and 3-(dimethylamino)propyl groups at positions 1 and 3 respectively. A locally-acting nonsteroidal anti-inflammatory drug that also exhibits local anaesthetic and analgesic properties. | 3.08 | 1 | 0 | aromatic ether; indazoles; tertiary amino compound | analgesic; central nervous system stimulant; hallucinogen; local anaesthetic; non-steroidal anti-inflammatory drug |
| durapatite Durapatite: The mineral component of bones and teeth; it has been used therapeutically as a prosthetic aid and in the prevention and treatment of osteoporosis.. hydroxylapatite : A phosphate mineral with the formula Ca5(PO4)3(OH). | 2.17 | 1 | 0 | ||
| cocamidopropyl betaine cocamidopropyl betaine: structure given in first source; Genagen CAB, Tego Betain, Rewoteric AMB 14 usually contain 30% cocamidopropyl betaine (CAPB). cocamidopropyl betaine : A mixture of carboxamidopropyl betaines derived from fatty acids of varying chain lengths. The principal component is lauramidopropyl betaine.. lauramidopropyl betaine : An ammonium betaine in which the the ammonium nitrogen is substituted by two methyl groups and a lauramidopropyl group. It is the major (>50%) component of cocamidopropyl betaine. | 3.45 | 1 | 1 | ammonium betaine | surfactant |
| vantocil polihexanide: RN given refers to parent cpd | 3.39 | 1 | 1 | ||
| olaflur Olaflur: cariostatic agent | 4.4 | 2 | 2 | ||
| titanium Titanium: A dark-gray, metallic element of widespread distribution but occurring in small amounts with atomic number, 22, atomic weight, 47.867 and symbol, Ti; specific gravity, 4.5; used for fixation of fractures. | 2.48 | 2 | 0 | titanium group element atom | |
| zirconium Zirconium: A rather rare metallic element with atomic number 40, atomic weight 91.224, and symbol Zr. | 2.15 | 1 | 0 | titanium group element atom | |
| chlorine Chlorine: An element with atomic symbol Cl, atomic number 17, and atomic weight 35, and member of the halogen family. | 3.5 | 2 | 0 | diatomic chlorine; gas molecular entity | bleaching agent |
| chlorine dioxide chlorine dioxide: equal or superior to chlorine when used as wastewater disinfectant | 5.44 | 5 | 1 | chlorine dioxide | |
| fluorides [no description available] | 9.87 | 18 | 8 | halide anion; monoatomic fluorine | |
| carbamide peroxide Carbamide Peroxide: A urea peroxide compound that is commonly used in tooth whitening agents; topical anti-infective agents, and earwax remover.. urea hydrogen peroxide : A mixture obtained by combining equimolar amounts of hydrogen peroxide and urea. | 4.41 | 2 | 2 | mixture | disinfectant; oxidising agent; reagent |
| octenidine [no description available] | 3.51 | 1 | 1 | dihydropyridine | |
| delmopinol delmopinol: structure in first source | 2.61 | 2 | 0 | morpholines | |
| thiazolyl blue thiazolyl blue: RN & II refers to bromide. 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide : The bromide salt of 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium. | 2.05 | 1 | 0 | organic bromide salt | colorimetric reagent; dye |
| zoledronic acid Zoledronic Acid: An imidobisphosphonate inhibitor of BONE RESORPTION that is used for the treatment of malignancy-related HYPERCALCEMIA; OSTEITIS DEFORMANS; and OSTEOPOROSIS.. zoledronic acid : An imidazole compound having a 2,2-bis(phosphono)-2-hydroxyethane-1-yl substituent at the 1-position. | 3.45 | 1 | 1 | 1,1-bis(phosphonic acid); imidazoles | bone density conservation agent |
| meridol Meridol: contains amine fluoride 242 & stannous fluoride | 7.95 | 15 | 5 | ||
| chlorite [no description available] | 3.8 | 2 | 1 | chlorine oxoanion; monovalent inorganic anion | |
| povidone-iodine Povidone-Iodine: An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes. | 5.21 | 6 | 0 | ||
| zithromax Azithromycin: A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.. azithromycin : A macrolide antibiotic useful for the treatment of bacterial infections. | 3.44 | 1 | 1 | macrolide antibiotic | antibacterial drug; environmental contaminant; xenobiotic |
| sodium bicarbonate Sodium Bicarbonate: A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions. | 12.23 | 4 | 3 | one-carbon compound; organic sodium salt | antacid; food anticaking agent |
| quinine [no description available] | 4.33 | 2 | 2 | cinchona alkaloid | antimalarial; muscle relaxant; non-narcotic analgesic |
| c 31g C 31G: mixture of above cpds | 3.36 | 1 | 1 | ||
| sodium dodecyl sulfate Sodium Dodecyl Sulfate: An anionic surfactant, usually a mixture of sodium alkyl sulfates, mainly the lauryl; lowers surface tension of aqueous solutions; used as fat emulsifier, wetting agent, detergent in cosmetics, pharmaceuticals and toothpastes; also as research tool in protein biochemistry.. sodium dodecyl sulfate : An organic sodium salt that is the sodium salt of dodecyl hydrogen sulfate. | 8.54 | 14 | 4 | organic sodium salt | detergent; protein denaturant |
| tin [no description available] | 3.77 | 2 | 1 | carbon group element atom; elemental tin; metal atom | micronutrient |
| sulfur Sulfur: An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine. | 4.68 | 3 | 2 | chalcogen; nonmetal atom | macronutrient |
| nitrofurazone Nitrofurazone: A topical anti-infective agent effective against gram-negative and gram-positive bacteria. It is used for superficial WOUNDS AND INJURIES and skin infections. Nitrofurazone has also been administered orally in the treatment of TRYPANOSOMIASIS.. nitrofurazone : A semicarbazone resulting from the formal condensation of semicarbazide with 5-nitrofuraldehyde. A broad spectrum antibacterial drug, although with little activity against Pseudomonas species, it is used as a local application for burns, ulcers, wounds and skin infections. | 3.39 | 1 | 1 | ||
| chlorhexidine Chlorhexidine: A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.. chlorhexidine : A bisbiguanide compound with a structure consisting of two (p-chlorophenyl)guanide units linked by a hexamethylene bridge. | 16.9 | 98 | 31 | biguanides; monochlorobenzenes | antibacterial agent; antiinfective agent |
| amoxicillin-potassium clavulanate combination Amoxicillin-Potassium Clavulanate Combination: A fixed-ratio combination of amoxicillin trihydrate and potassium clavulanate. | 3.45 | 1 | 1 | ||
| erythrosine Erythrosine: A tetraiodofluorescein used as a red coloring in some foods (cherries, fish), as a disclosure of DENTAL PLAQUE, and as a stain of some cell types. It has structural similarity to THYROXINE.. erythrosin B : An organic sodium salt that is the disodium salt of 2-(2,4,5,7-tetraiodo-6-oxido-3-oxo-8a,10a-dihydroxanthen-9-yl)benzoic acid. | 1.98 | 1 | 0 | ||
| cellulose DEAE-Cellulose: Cellulose derivative used in chromatography, as ion-exchange material, and for various industrial applications. | 2.03 | 1 | 0 | glycoside | |
| sodium hypochlorite Sodium Hypochlorite: It is used as an oxidizing and bleaching agent and as a disinfectant. (From Grant & Hackh's Chemical Dictionary, 5th ed). sodium hypochlorite : An inorganic sodium salt in which hypochlorite is the counterion. It is used as a bleaching and disinfecting agent and is commonly found in household bleach. | 4.06 | 5 | 0 | inorganic sodium salt | bleaching agent; disinfectant |
| monoperoxysulfate monoperoxysulfate: RN given refers to mono-Na salt | 1.98 | 1 | 0 | ||
| tetracycline Tetracycline: A naphthacene antibiotic that inhibits AMINO ACYL TRNA binding during protein synthesis.. tetracycline : A broad-spectrum polyketide antibiotic produced by the Streptomyces genus of actinobacteria. | 1.98 | 1 | 0 | ||
| salicylates Salicylates: The salts or esters of salicylic acids, or salicylate esters of an organic acid. Some of these have analgesic, antipyretic, and anti-inflammatory activities by inhibiting prostaglandin synthesis.. hydroxybenzoate : Any benzoate derivative carrying a single carboxylate group and at least one hydroxy substituent.. salicylates : Any salt or ester arising from reaction of the carboxy group of salicylic acid, or any ester resulting from the condensation of the phenolic hydroxy group of salicylic acid with an organic acid.. salicylate : A monohydroxybenzoate that is the conjugate base of salicylic acid. | 20.23 | 241 | 108 | monohydroxybenzoate | plant metabolite |
| muramidase Muramidase: A basic enzyme that is present in saliva, tears, egg white, and many animal fluids. It functions as an antibacterial agent. The enzyme catalyzes the hydrolysis of 1,4-beta-linkages between N-acetylmuramic acid and N-acetyl-D-glucosamine residues in peptidoglycan and between N-acetyl-D-glucosamine residues in chitodextrin. EC 3.2.1.17. | 4.71 | 2 | 2 | ||
| polident Polident: contains sodium perborate & potassium monopersulfate | 2.75 | 3 | 0 |
| Condition | Indicated | Relationship Strength | Studies | Trials |
|---|---|---|---|---|
| Neisseria gonorrhoeae Infection [description not available] | 0 | 4.87 | 3 | 2 |
| Gonorrhea Acute infectious disease characterized by primary invasion of the urogenital tract. The etiologic agent, NEISSERIA GONORRHOEAE, was isolated by Neisser in 1879. | 0 | 4.87 | 3 | 2 |
| Herpes Simplex Virus Infection [description not available] | 0 | 2.41 | 1 | 0 |
| Herpes Simplex A group of acute infections caused by herpes simplex virus type 1 or type 2 that is characterized by the development of one or more small fluid-filled vesicles with a raised erythematous base on the skin or mucous membrane. It occurs as a primary infection or recurs due to a reactivation of a latent infection. (Dorland, 27th ed.) | 0 | 2.41 | 1 | 0 |
| 2019 Novel Coronavirus Disease [description not available] | 0 | 3.23 | 1 | 0 |
| Infections, Respiratory [description not available] | 0 | 3.7 | 1 | 1 |
| Respiratory Tract Infections Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases. | 0 | 3.7 | 1 | 1 |
| Dental Plaque A film that attaches to teeth, often causing DENTAL CARIES and GINGIVITIS. It is composed of MUCINS, secreted from salivary glands, and microorganisms. | 0 | 19.72 | 145 | 99 |
| Diseases of Pharynx [description not available] | 0 | 2.13 | 1 | 0 |
| Gingivitis Inflammation of gum tissue (GINGIVA) without loss of connective tissue. | 0 | 19.38 | 117 | 91 |
| Caries, Dental [description not available] | 0 | 4.2 | 6 | 0 |
| Dental Caries Localized destruction of the tooth surface initiated by decalcification of the enamel followed by enzymatic lysis of organic structures and leading to cavity formation. If left unchecked, the cavity may penetrate the enamel and dentin and reach the pulp. | 0 | 4.2 | 6 | 0 |
| Demineralization, Tooth [description not available] | 0 | 4.55 | 5 | 1 |
| Bacteremia The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion. | 0 | 6.63 | 7 | 3 |
| Ventilator-Associated Pneumonia [description not available] | 0 | 4.39 | 1 | 1 |
| Pneumonia, Ventilator-Associated Serious INFLAMMATION of the LUNG in patients who required the use of PULMONARY VENTILATOR. It is usually caused by bacterial CROSS INFECTION in hospitals. | 0 | 4.39 | 1 | 1 |
| Ache [description not available] | 0 | 5.06 | 3 | 3 |
| Alcohol Drinking Behaviors associated with the ingesting of ALCOHOLIC BEVERAGES, including social drinking. | 0 | 3.47 | 1 | 1 |
| Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS. | 0 | 5.06 | 3 | 3 |
| Dentin Hypersensitivity [description not available] | 0 | 3.47 | 1 | 1 |
| Group A Strep Infection [description not available] | 0 | 2.1 | 1 | 0 |
| Bacterial Endocarditides [description not available] | 0 | 2.1 | 1 | 0 |
| Endocarditis, Bacterial Inflammation of the ENDOCARDIUM caused by BACTERIA that entered the bloodstream. The strains of bacteria vary with predisposing factors, such as CONGENITAL HEART DEFECTS; HEART VALVE DISEASES; HEART VALVE PROSTHESIS IMPLANTATION; or intravenous drug use. | 0 | 2.1 | 1 | 0 |
| Streptococcal Infections Infections with bacteria of the genus STREPTOCOCCUS. | 0 | 2.1 | 1 | 0 |
| Tooth Discoloration Any change in the hue, color, or translucency of a tooth due to any cause. Restorative filling materials, drugs (both topical and systemic), pulpal necrosis, or hemorrhage may be responsible. (Jablonski, Dictionary of Dentistry, 1992, p253) | 0 | 7.2 | 8 | 5 |
| Hemorrhage, Gingival [description not available] | 0 | 12.25 | 27 | 26 |
| Gingival Hemorrhage The flowing of blood from the marginal gingival area, particularly the sulcus, seen in such conditions as GINGIVITIS, marginal PERIODONTITIS, injury, and ASCORBIC ACID DEFICIENCY. | 0 | 12.25 | 27 | 26 |
| Halitosis An offensive, foul breath odor resulting from a variety of causes such as poor oral hygiene, dental or oral infections, or the ingestion of certain foods. | 0 | 6.13 | 6 | 2 |
| Asialia [description not available] | 0 | 5.44 | 5 | 3 |
| Xerostomia Decreased salivary flow. | 0 | 5.44 | 5 | 3 |
| Parodontosis [description not available] | 0 | 7.95 | 10 | 3 |
| Periodontal Diseases Pathological processes involving the PERIODONTIUM including the gum (GINGIVA), the alveolar bone (ALVEOLAR PROCESS), the DENTAL CEMENTUM, and the PERIODONTAL LIGAMENT. | 0 | 7.95 | 10 | 3 |
| Mouth Diseases Diseases involving the MOUTH. | 0 | 3.43 | 1 | 1 |
| Taste Disorder, Anterior Tongue [description not available] | 0 | 3.43 | 1 | 1 |
| Pericementitis [description not available] | 0 | 5.57 | 6 | 3 |
| Periodontitis Inflammation and loss of connective tissues supporting or surrounding the teeth. This may involve any part of the PERIODONTIUM. Periodontitis is currently classified by disease progression (CHRONIC PERIODONTITIS; AGGRESSIVE PERIODONTITIS) instead of age of onset. (From 1999 International Workshop for a Classification of Periodontal Diseases and Conditions, American Academy of Periodontology) | 0 | 5.57 | 6 | 3 |
| Adult Periodontitis [description not available] | 0 | 10.02 | 8 | 4 |
| Diathesis [description not available] | 0 | 3.44 | 1 | 1 |
| Attachment Loss, Periodontal [description not available] | 0 | 6.19 | 4 | 3 |
| Atrophy of Gingiva [description not available] | 0 | 3.45 | 1 | 1 |
| Pocket, Periodontal [description not available] | 0 | 6.19 | 4 | 3 |
| Periodontal Pocket An abnormal extension of a gingival sulcus accompanied by the apical migration of the epithelial attachment and bone resorption. | 0 | 6.19 | 4 | 3 |
| Bisphosphonate Osteonecrosis [description not available] | 0 | 3.45 | 1 | 1 |
| Chromosome-Defective Micronuclei [description not available] | 0 | 2.07 | 1 | 0 |
| Caries, Cervical [description not available] | 0 | 2.06 | 1 | 0 |
| Dental Leakage The seepage of fluids, debris, and micro-organisms between the walls of a prepared dental cavity and the restoration. | 0 | 3.46 | 1 | 1 |
| Bacterial Pneumonia [description not available] | 0 | 9.62 | 9 | 9 |
| Health Care Associated Infection [description not available] | 0 | 9.62 | 9 | 9 |
| Cross Infection Any infection which a patient contracts in a health-care institution. | 0 | 9.62 | 9 | 9 |
| Pneumonia, Bacterial Inflammation of the lung parenchyma that is caused by bacterial infections. | 0 | 9.62 | 9 | 9 |
| Epulides [description not available] | 0 | 2.01 | 1 | 0 |
| Gingival Diseases Diseases involving the GINGIVA. | 0 | 2.01 | 1 | 0 |
| Tooth Erosion Progressive loss of the hard substance of a tooth by chemical processes that do not involve bacterial action. (Jablonski, Dictionary of Dentistry, 1992, p296) | 0 | 4.65 | 3 | 2 |
| Cold Sore [description not available] | 0 | 4.32 | 1 | 1 |
| Herpes Labialis Herpes simplex, caused by type 1 virus, primarily spread by oral secretions and usually occurring as a concomitant of fever. It may also develop in the absence of fever or prior illness. It commonly involves the facial region, especially the lips and the nares. (Dorland, 27th ed.) | 0 | 4.32 | 1 | 1 |
| Tooth Fractures Break or rupture of a tooth or tooth root. | 0 | 2.02 | 1 | 0 |
| Infection, Postoperative Wound [description not available] | 0 | 4.65 | 3 | 2 |
| Craniofacial Pain [description not available] | 0 | 3.37 | 1 | 1 |
| Facial Pain Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES. | 0 | 3.37 | 1 | 1 |
| Bone Loss, Perimenopausal [description not available] | 0 | 3.37 | 1 | 1 |
| Osteoporosis, Postmenopausal Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency. | 0 | 3.37 | 1 | 1 |
| HIV Human immunodeficiency virus. A non-taxonomic and historical term referring to any of two species, specifically HIV-1 and/or HIV-2. Prior to 1986, this was called human T-lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV). From 1986-1990, it was an official species called HIV. Since 1991, HIV was no longer considered an official species name; the two species were designated HIV-1 and HIV-2. | 0 | 6.98 | 1 | 0 |
| Moniliasis, Oral [description not available] | 0 | 3.58 | 3 | 0 |
| Infections, Prosthesis-Related [description not available] | 0 | 2.9 | 1 | 0 |
| Candidiasis, Oral Infection of the mucous membranes of the mouth by a fungus of the genus CANDIDA. (Dorland, 27th ed) | 0 | 3.58 | 3 | 0 |
| Hemorrhage, Oral [description not available] | 0 | 3.37 | 1 | 1 |
| Cancer of Mouth [description not available] | 0 | 1.99 | 1 | 0 |
| Mouth Neoplasms Tumors or cancer of the MOUTH. | 0 | 1.99 | 1 | 0 |
| Odontalgia [description not available] | 0 | 2.91 | 1 | 0 |
| Toothache Pain in the adjacent areas of the teeth. | 0 | 2.91 | 1 | 0 |
| Jaw, Edentulous, Partially Absence of teeth from a portion of the mandible and/or maxilla. | 0 | 3.39 | 1 | 1 |
| Calculus, Dental [description not available] | 0 | 4.34 | 2 | 2 |
| Disease Exacerbation [description not available] | 0 | 3.39 | 1 | 1 |
| Breast Cancer [description not available] | 0 | 2 | 1 | 0 |
| Xeroderma [description not available] | 0 | 2 | 1 | 0 |
| Breast Neoplasms Tumors or cancer of the human BREAST. | 0 | 2 | 1 | 0 |
| Ichthyosis Any of several generalized skin disorders characterized by dryness, roughness, and scaliness, due to hypertrophy of the stratum corneum epidermis. Most are genetic, but some are acquired, developing in association with other systemic disease or genetic syndrome. | 0 | 2 | 1 | 0 |
| Gingival Pocket An abnormal extension of a gingival sulcus not accompanied by the apical migration of the epithelial attachment. | 0 | 1.98 | 1 | 0 |
| Deficiency, Mental [description not available] | 0 | 1.98 | 1 | 0 |
| Intellectual Disability Subnormal intellectual functioning which originates during the developmental period. This has multiple potential etiologies, including genetic defects and perinatal insults. Intelligence quotient (IQ) scores are commonly used to determine whether an individual has an intellectual disability. IQ scores between 70 and 79 are in the borderline range. Scores below 67 are in the disabled range. (from Joynt, Clinical Neurology, 1992, Ch55, p28) | 0 | 1.98 | 1 | 0 |
| Recrudescence [description not available] | 0 | 3.36 | 1 | 1 |
| Aphthae [description not available] | 0 | 3.36 | 1 | 1 |
| Stomatitis, Aphthous A recurrent disease of the oral mucosa of unknown etiology. It is characterized by small white ulcerative lesions, single or multiple, round or oval. Two to eight crops of lesions occur per year, lasting for 7 to 14 days and then heal without scarring. (From Jablonski's Dictionary of Dentistry, 1992, p742) | 0 | 3.36 | 1 | 1 |
| Alcoholic Intoxication An acute brain syndrome which results from the excessive ingestion of ETHANOL or ALCOHOLIC BEVERAGES. | 0 | 1.97 | 1 | 0 |
| HIV Coinfection [description not available] | 0 | 1.97 | 1 | 0 |
| HIV Infections Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS). | 0 | 1.97 | 1 | 0 |
| Acute Post-operative Pain [description not available] | 0 | 3.36 | 1 | 1 |
| Pain, Postoperative Pain during the period after surgery. | 0 | 3.36 | 1 | 1 |