A Bleeding-Model Clinical Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Positive Control 2 brushings per day (AM and PM) |
Drug: 0.454% stannous fluoride
Brush two times daily
|
Sham Comparator: Negative Control 2 brushings per day (AM and PM) |
Drug: 0.76% sodium monofluorophosphate
Brush two times daily
|
Experimental: Experimental Control 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
Brush two times daily
|
Outcome Measures
Primary Outcome Measures
- Löe-Silness Gingivitis Evaluation [Baseline]
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).
- Löe-Silness Gingivitis Evaluation [Week 4]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be at least 18 years of age;
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Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
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Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
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Have at least 20 gradable teeth;
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Have established gingivitis with ≥10 % bleeding sites;
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Agree to return for scheduled visits and follow the study procedures;
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Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
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Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.
Exclusion Criteria:
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Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
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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;
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Having known hypersensitivity to the test products;
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Having removable oral appliances;
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Having fixed facial or lingual orthodontic appliances;
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Self-reported pregnancy or lactation;
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Having any diseases or condition that might interfere with the safe participation in the study;
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Having an inability to undergo study procedures.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Silverstone Research Group | Las Vegas | Nevada | United States | 89146 |
Sponsors and Collaborators
- Procter and Gamble
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020112