Ireland
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Recruiting Phase 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

NCT07614490 · tracked via the Priya Life Science USA tracker
Phase
Phase 4
Started
2026-04-20
Last updated
2026-05-29

Condition(s) studied

GingivitisPlaque

Investigational drug(s) / intervention(s)

sodium monofluorophosphate toothpaste

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Relative abundance of Streptococcus and Porphyromonas — 23-26 days
    Comparative relative abundance of Streptococcus and Porphyromonas in sites with high plaque/low gingivitis and high plaque/high gingivitis at Visit 3

Trial sites (1)

FacilityCityRegionStatus
Salus Research, Inc. Fort Wayne Indiana Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07614490 on ClinicalTrials.gov ↗ ← All trials in the USA