Gingival Diseases
Conditions
Brief summary
The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.
Interventions
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Bleeding Sites | 3 months, 1 month | Number of bleeding sites derived from the Löe-Silness Gingivitis Evaluation based on a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Löe-Silness Gingivitis Evaluation | 3 months, 1 month | 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