Clinical Study to Collect and Analyze Dental Plaque and Oral Health Measures in a Population With High Plaque/Low Gingivitis and High Plaque/High Gingivitis
Colgate Palmolive
Summary
The objective of this clinical research study is to collect and analyze plaque and oral health measures in a population with high plaque/low gingivitis and high plaque/high gingivitis
Description
This study is a single-arm clinical trial. Up to one hundred (100) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in order to complete the study with eighty (80) subjects. Subjects will undergo oral examinations, gingival crevicular fluid collection, saliva collection, plaque collection, and will complete questionnaires. All subjects will all be supplied with a study toothbrush and toothpaste.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female volunteers at least 18 years of age and in general good health. * Willing and able to understand and sign the informed consent form. * Must have a whole mouth mean TPI score ≥ 3.25 * N=40 must have moderate-severe gingivitis (Whole Mouth Mean MGI≥2.5 or percent bleeding sites based on EBI ≥20%) and N=40 must have mild gingivitis (Whole Mouth Mean MGI≤2.5 and percent bleeding sites based on EBI\<20%) * Must have at least two areas in the mouth with high plaque/low inflammation and two areas with high plaque/high inflammation * Be willing to conform to the s…
Interventions
- Drugsodium monofluorophosphate toothpaste
All subjects will receive the same treatment for standardization
Location
- Salus Research, Inc.Fort Wayne, Indiana