NCT07211061

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

A SIX WEEK CLINICAL STUDY TO EVALUATE THE EFFECT OF A REGIMEN ON GINGIVITIS

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	Stannous Fluoride Dentifrice	brush 2x a day in using a power brush (2 minutes of brushing)
DRUG	Sodium Fluoride Dentifrice	brush in their customary manner
DEVICE	electric toothbrush	brush using a electric brush (2 minutes of brushing)
DRUG	Cetylpyridinium Chloride (CPC)	use 20 ml of mouth rinse for 30 seconds
DEVICE	manual toothbrush	brush in their customary manner

Timeline

• Start date: 2011-09-21
• Primary completion: 2011-11-10
• Completion: 2011-11-10
• First posted: 2025-10-07
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States