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

Status and phase

Enrolling

Phase 4

Conditions

Plaque

Gingivitis

Treatments

Drug: sodium monofluorophosphate toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT07614490

CRO-2026-Sampling-CB-PG-GJ

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).