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

NCT07614490 | Recruiting Phase 4 FDA Drug

• 1 other identifier: CRO-2026-Sampling-CB-PG-GJ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Relative abundance of Streptococcus and Porphyromonas

  Comparative relative abundance of Streptococcus and Porphyromonas in sites with high plaque/low gingivitis and high plaque/high gingivitis at Visit 3

  23-26 days

Study Arms (1)

Brushing with sodium fluoride toothpaste

OTHER

Drug: sodium monofluorophosphate toothpaste

Interventions

sodium monofluorophosphate toothpaste DRUG

All subjects will receive the same treatment for standardization

Brushing with sodium fluoride toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

RECRUITING

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriella John, MS

  Colgate Palmolive

  STUDY DIRECTOR

Central Study Contacts

Jeffery Milleman, DDS, MPA

CONTACT

260-755-1099; milleman@salusresearch.us

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 29, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (1)