Actively Recruiting
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
Led by Colgate Palmolive · Updated on 2026-05-29
100
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying oral health by collecting and analyzing dental plaque and gingivitis measures in adults with different levels of plaque and gingival inflammation. This Phase 4 clinical trial aims to better understand the bacterial composition and oral health status in populations with high plaque but varying degrees of gingivitis. All participants will receive the same treatment consisting of brushing with a sodium monofluorophosphate toothpaste supplied by the study. The trial is a single-arm design enrolling up to 100 adults, with a target of 80 completing the study. Participants will use the provided toothbrush and toothpaste throughout the study period. Participants will undergo oral examinations and provide samples including gingival crevicular fluid, saliva, and plaque. They will also complete questionnaires about their oral health. Researchers will measure the relative abundance of specific bacteria, such as Streptococcus and Porphyromonas, over approximately 23 to 26 days. The study includes monitoring oral health changes and collecting data to assess plaque and gingivitis levels.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Whole mouth mean TPI score of 3.25 or greater.
- Must have moderate-severe gingivitis (Whole Mouth Mean MGI 2.5 or higher or percent bleeding sites based on EBI 20% or greater) for 40 participants and mild gingivitis (Whole Mouth Mean MGI 2.5 or lower and percent bleeding sites based on EBI less than 20%) for another 40 participants.
- Must have at least two areas in the mouth with high plaque/low inflammation and two areas with high plaque/high inflammation.
- Willing to follow the study protocol and procedures.
- Have a minimum of 20 natural teeth with scorable facial and lingual surfaces.
You will not qualify if you...
- Medical condition requiring premedication before dental visits or procedures.
- Known allergy to personal care or consumer products relevant to the study toothpaste.
- Active disease affecting hard oral tissues.
- Significant oral soft tissue diseases other than plaque-induced gingivitis.
- Use of fixed or removable orthodontic appliances or removable partial dentures.
- Dental cleaning within 30 days before the study.
- Use of antibiotics, antimicrobial, anti-inflammatory, or anticoagulant drugs within 30 days prior to study.
- Use of chemotherapeutic oral care products within two weeks before the study.
- Participation in another clinical study within 30 days before enrollment.
- Need for dental treatment during the study period.
- Immunocompromised conditions such as HIV, AIDS, or immunosuppressive therapy.
- Use of smokeless tobacco, vaping, e-cigarettes, or suspected substance abuse.
- Current smokers or those who quit less than one month before the study.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Medical conditions preventing fasting or gum chewing for four hours before visits.
- Infectious or blood-borne diseases like Hepatitis, HIV, or tuberculosis.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 23 to 26 days
Participants will use a sodium monofluorophosphate toothpaste provided by the study while undergoing oral examinations and sample collections including saliva, plaque, and gingival fluid. They will also complete questionnaires about their oral health.
Multiple visits during treatment to collect samples and perform examinations
Trial Site Locations
Total: 1 location
1
Salus Research, Inc.
Fort Wayne, Indiana, United States, 46825
Actively Recruiting
Research Team
J
Jeffery Milleman, DDS, MPA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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