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

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

Study Overview

• Status: Recruiting
• Conditions: Gingivitis; Plaque
• Intervention / Treatment: Drug: sodium monofluorophosphate toothpaste

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeffery Milleman, DDS, MPA; Phone Number: 260-755-1099; Email: Milleman@salusresearch.us

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Recruiting
      • Salus Research, Inc.
      • Contact: Jeffery Milleman, DDS, MPA; Phone Number: 260-755-1099; Email: Milleman@salusresearch.us
      • Principal Investigator: Jeffery Milleman, DDS, MPA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Brushing with sodium fluoride toothpaste	Drug: sodium monofluorophosphate toothpaste; All subjects will receive the same treatment for standardization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Study Director: Gabriella John, MS, Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Infections; Gingival Diseases; Pathological Conditions, Signs and Symptoms; Plaque, Amyloid; Gingivitis
• Other Study ID Numbers: CRO-2026-Sampling-CB-PG-GJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depends on the inquiry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No