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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
RecruitingPhase 4
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 study protocol and procedures. * Minimum of 20 natural teeth with scorable facial and lingual surfaces Exclusion Criteria: * 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).
About the study
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
What is being tested
- sodium monofluorophosphate toothpaste (drug)
Sponsor: Colgate Palmolive · Participants: 100 · Started: Apr 20, 2026
Contact the study team
- Jeffery Milleman, DDS, MPA · Phone: 260-755-1099
Official record on ClinicalTrials.gov — NCT07614490
Locations in the U.S.
| Indiana | Salus Research, Inc., Fort Wayne |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.