Gingivitis
Conditions
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.
Interventions
Brush two times daily
Brush two times daily
Brush two times daily
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 % 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed