A Three Month Bleeding-Model Clinical Study

Study Overview
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Brief Summary
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The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.

Official Title
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A Three-Month Bleeding-Model Clinical Study

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: 0.454% stannous fluoride
* Drug: 0.76% sodium monofluorophosphate
* Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age; Provide written informed consent prior to participation and be given a signed copy of the informed consent form; Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; Have at least 20 gradable teeth; Have established gingivitis with 10-70% bleeding sites; Agree to return for scheduled visits and follow the study procedures; Agree to refrain from use of any non-study oral hygiene products for the duration of the study; Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study. Exclusion Criteria: Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit; Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; Having known hypersensitivity to the test products; Having removable oral appliances; Having fixed facial or lingual orthodontic appliances; Self-reported pregnancy or lactation; Having any diseases or condition that might interfere with the safe participation in the study; Having an inability to undergo study procedures.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positive Control<br>2 brushings per day (AM and PM) | Drug: 0.454% stannous fluoride<br>* Brush two times daily<br>|
| Sham Comparator: Negative Control<br>2 brushings per day (AM and PM) | Drug: 0.76% sodium monofluorophosphate<br>* Brush two times daily<br>|
| Experimental: Experimental Control<br>Brush with Positive control in the morning and negative control in the evening | Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM<br>* Brush two times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | Baseline | 
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | Week 4 | 
| Löe-Silness Gingivitis Evaluation | Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). | Week 12 |