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

Overview

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

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.

Interventions

• Drug sodium monofluorophosphate toothpaste
  All subjects will receive the same treatment for standardization

Primary outcome measures

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

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Salus Research, Inc. — Fort Wayne

Identifiers

NCT: NCT07614490 · CRO-2026-Sampling-CB-PG-GJ

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗