drugset / Trial / NCT07211061

A Study is to Evaluate a Regimen on Gingivitis Using Traditional and Novel Assessment Methods

NCT07211061

Phase 4 Completed 69 enrolled Procter and Gamble
RandomizedParallel-groupTriple-blindTreatment

Summary

Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to brush 2x a day in using a power brush (2 minutes of brushing), followed by using 20 ml of mouth rinse for 30 seconds for 6 weeks. The negative control group will be asked to brush 2x a day using a manual toothbrush in their customary manner for 6 weeks. Oral Soft Tissue (OST) assessments, gingivitis and plaque measurements will be taken at 4 time-points: Baseline (BL); Week 1; Week 3; and Week 6.

Timeline

Start
2011-09-21
Primary completion
2011-11-10
Completion
2011-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetylpyridinium Small molecule 20 ml Topical
Comparator sodium fluoride Unknown Topical
Subject stannous fluoride Small molecule Topical

Indications