Clinical Trials in the USA / NCT06966492
Starting soon
Phase 4
Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.
NCT06966492 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Gingival Inflammation
Investigational drug(s) / intervention(s)
Stannous Fluoride Toothpaste (SnF)
Stannous Fluoride Toothpaste (SnF): stannous fluoride toothpaste
Study summary
This is a clinical research study designed to measure changes in inflammation and the oral microbiome during a phase of good oral hygiene and the absence of oral hygiene. The goal of the study is to investigate the interplay between local oral inflammation, microbiota and systemic immune responses.
Eligibility
Inclusion Criteria:
1. Males and females, between 18-65 years of age;
2. Availability for the duration of the study;
3. ASA 1 Good general health (absence of any self-reported systemic disease or condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
4. Willingness to provide information related to their medical history;
5. Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);
6. Informed Consent Form signed.
Exclusion Criteria:
1. Subjects with more that 2 sites with pocket depth of \> 4 mm and those presenting purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone;
2. Oral pathology or a history of allergy to testing products;
3. Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner;
4. Subject participating in any other clinical study;
5. Subject pregnant or breastfeeding;
6. Subject allergic to oral care products and personal care consumer products
7. Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
8. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
9. Current smokers (or users of tobacco and vaping products) and subjects with a history of alcohol or drug abuse;
10. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
11. Individuals with orthodontic bands or removable partial dentures.
12. Dental prophylaxis in the previous 3 months prior to the baseline examination
Primary outcome measure(s)
- Gingival Bleeding Index described by Ainamo & Bay, 1976 — From enrollment and at each successive visit until to the end of the study
Gingival Bleeding Index (Ainamo \& Bay, 1976) The six surfaces of teeth will be scored and recorded for absence or presence of bleeding after gentle probing.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| UT Health School of Dentistry | Houston | Texas |
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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 NCT06966492 on ClinicalTrials.gov ↗ ← All trials in the USA