Dental plaque and gum health study using fluoride toothpaste in adults with varying gingivitis and plaque levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm Phase 4 study enrolling up to 100 adults to examine oral health measures across groups with different gingivitis levels and plaque. Participants will receive a standard fluoride toothpaste and undergo oral exams, saliva and plaque collection, gingival crevicular fluid sampling, and complete questionnaires. Data will help describe how plaque and gum inflammation relate to each other and how the toothpaste performs in real-world use. The study will aim to enroll 80 participants completing the protocol at Salus Research, Inc. under Colgate-Palmolive sponsorship.

Why it matters

Who can join: the full rules

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).

Where it's running

• Salus Research, Inc.
  Fort Wayne, Indiana, United States Recruiting

Study contacts

• Study coordinator: Jeffery Milleman, DDS, MPA
• Email: milleman@salusresearch.us
• Phone: 260-755-1099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.