A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chlorid… (NCT06660069) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation
United States199 participantsStarted 2024-11-18
Plain-language summary
The aim of this study is to assess the ability of a marketed Cetylpyridinium Chloride (CPC) mouthwash alongside a marketed Stannous Fluoride (SnF2) toothpaste in improving gingival health and reducing plaque accumulation, compared to the use of a regular fluoride toothpaste alone in participants with clinically measurable plaque-induced gingivitis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant with at least 20 natural, permanent teeth.
✓. Participant with at least 40 evaluable surfaces for MGI, BI, and TPI.
✓. A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the Screening Visit.
✓. A participant with 10% - 30% bleeding sites.
✓. A participant with mean interproximal whole mouth TPI score \>=1.5.
Exclusion criteria
✕. A participant using any antibiotic medication within 4 weeks prior to screening or at any time during the study.
✕. A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
✕. A participant currently taking a systemic medication (example, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
✕. A participant who has used an antibacterial dentifrice or mouthwash (example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, within 4 weeks prior to screening.
✕. A participant who has taken (in the previous 4 weeks), any antibiotics.
What they're measuring
1
Overall Number of Bleeding Sites (NBS) at Week 12 (Toothpaste/Mouthwash Versus [vs.] Negative Control Toothpaste)
. A participant who has taken (in the previous 4 weeks) a systemic medication (example, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy (example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
✕. A participant who has used an antibacterial dentifrice or mouthwash (example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, in the period between Screening and the Baseline visit.
✕. A participant who has more than three tooth sites with probing pocket depth \>= 4 mm.