Clinical Trials in the USA / NCT07614490
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | Recruiting |
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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