A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

Study Overview
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Brief Summary
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The objective of this learning clinical study is to assess the gingivitis effects of four different dentifrices over a 3-month period.

Official Title
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A Three-Month Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: 0.76% Sodium Monofluorophosphate Dentifrice
* Drug: 1.15% Sodium Monofluorophosphate Dentifrice
* Drug: 0.454% Stannous Fluoride Dentifrice
* Drug: 0.454% Stannous Fluoride Dentifrice


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 16 gradable teeth; Have mild to moderate gingivitis with a range of 10% to 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 antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit; Have 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; Removable oral appliances; Fixed facial or lingual orthodontic appliances; Self-reported pregnancy or lactation; Any diseases or condition that might interfere with the safe participation in the study; and 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 |
| --- | --- |
| Sham Comparator: 0.76% Sodium Monofluorophosphate Dentifrice<br> | Drug: 0.76% Sodium Monofluorophosphate Dentifrice<br>* Whole mouth brushing with a toothpaste, twice daily for the duration of the study.<br>|
| Sham Comparator: 1.15% Sodium Monofluorophosphate Dentifrice<br> | Drug: 1.15% Sodium Monofluorophosphate Dentifrice<br>* Whole mouth brushing with a toothpaste, twice daily for the duration of the study.<br>|
| Active Comparator: Marketed 0.454% Stannous Fluoride Dentifrice<br> | Drug: 0.454% Stannous Fluoride Dentifrice<br>* Whole mouth brushing with a toothpaste, twice daily for the duration of the study.<br>|
| Active Comparator: 0.454% Stannous Fluoride Dentifrice<br> | Drug: 0.454% Stannous Fluoride Dentifrice<br>* Whole mouth brushing with a toothpaste, twice daily for the duration of the study.<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). | 3 Months | 

Secondary 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). | 1 Month |