RecruitingPhase 4NCT07614490
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
Sponsor
Colgate Palmolive
Enrollment
100 participants
Start Date
Apr 20, 2026
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 study protocol and procedures.
- Minimum of 20 natural teeth with scorable facial and lingual surfaces
Exclusion Criteria16
- Medical condition which requires premedication prior to dental visits/procedure.
- Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
- Active disease of the hard oral tissues.
- Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- Subjects with fixed or removable orthodontic appliances or removable partial dentures.
- Dental prophylaxis within 30 days prior to study start.
- Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start.
- Use of chemotherapeutic oral care products within two weeks prior to study start.
- Participation in any other clinical study within 30 days prior to enrollment into this study.
- Subjects who must receive dental treatment during the study dates.
- Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.
- Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
- Pregnant or lactating subjects, or subjects planning to become pregnant during the course of the study.
- Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
- Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGsodium monofluorophosphate toothpaste
All subjects will receive the same treatment for standardization
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07614490
Related Trials
Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools
NCT060064291 location
The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases
NCT076367331 location
Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis
NCT076076391 location
Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
NCT074248461 location
Evaluation of the Effect of the Toothpaste on Delicate Gums
NCT074947471 location