A Pilot Study to Evaluate a Method for Plaque When Comparing Stannous Fluoride Toothpaste to a Regular Dentifrice

Study Overview
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Brief Summary
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This study will evaluate the sensitivity of an assay and its ability to split a marketed stannous fluoride toothpaste versus a negative control.

Official Title
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A Pilot Study to Evaluate the Sensitivity of a Novel Molecular Method for Plaque Toxicity When Comparing Two-step Toothpaste to a Regular Dentifrice

Conditions
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Plaque, Gingivitis

Intervention / Treatment
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* Drug: stannous fluoride toothpaste
* Drug: cavity protection toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In order to be included in the study, each subject must: Provide written informed consent to participate in the study; Be 18 years of age or older; Agree not to participate in any other oral/dental product studies during the course of this study; Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed; Agree to maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time; Agree to refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss or whitening products; Agree to return for all scheduled visits and follow study procedures; Must have at least 16 natural teeth; Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study; Agree to refrain from all oral hygiene for at least 12 hours prior to each visit; Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit; Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index); Have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm; Have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm. Exclusion Criteria: Subjects are excluded from study participation where there is evidence of: Have had a dental prophylaxis within 2 weeks of plaque sampling visits; Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits; Have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment; Need an antibiotic prophylaxis prior to dental visits; A history of hypersensitivity to oral care products containing hydrogen peroxide; A history of hypersensitivity to dyes (from products containing food dyes); Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or Are pregnant (Self-reported) or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stannous fluoride toothpaste<br>brush twice a day for 8 weeks | Drug: stannous fluoride toothpaste<br>* 0.454% stannous fluoride toothpaste<br>|
| Sham Comparator: cavity protection toothpaste<br>brush twice a day for 8 weeks | Drug: cavity protection toothpaste<br>* 0.243% sodium fluoride toothpaste<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque scores |  | baseline | 
| plaque scores |  | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingivitis score |  | baseline | 
| gingivitis score |  | 8 weeks |