Recruiting

Oral Health

Sponsor:

Colgate Palmolive

Code:

NCT07614490

Conditions

Gingivitis

Plaque

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

sodium monofluorophosphate toothpaste

Study Details

Brief 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

Conditions

Gingivitis

Plaque

Study ID

NCT07614490

Start date

Apr 20, 2026

Status verified date

May, 2026

Completion date

Oct 15, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Brushing with sodium fluoride toothpaste

Interventions

sodium monofluorophosphate toothpaste

All subjects will receive the same treatment for standardization

Primary outcome measure

  • Relative abundance of Streptococcus and Porphyromonas [ Time Frame: 23-26 days ]

Central Contacts and Locations

Central contacts

Jeffery Milleman, DDS, MPA

260-755-1099milleman@salusresearch.us

Locations

Salus Research, Inc.

Recruiting

Fort Wayne, Indiana, United States, 46825

Contacts

Jeffery Milleman, DDS, MPA

260-755-1099Milleman@salusresearch.us

Principal Investigator:

Jeffery Milleman, DDS, MPA

More Information

Sponsor

Colgate Palmolive

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colgate Palmolive on 2026-05-29.