RecruitingPhase 4
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 · NCT07614490
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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 4
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- April 20, 2026
- Record last updated
- May 29, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is 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
Being studied: sodium monofluorophosphate toothpaste
Conditions: Gingivitis; Plaque
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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).
Recruiting US locations
Salus Research, Inc.
Fort Wayne, IN 46825
Site contact: Jeffery Milleman, DDS, MPA · 260-755-1099 · Milleman@salusresearch.us
Study contacts (from the official record)
- Jeffery Milleman, DDS, MPA · 260-755-1099 · milleman@salusresearch.us