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

NCT07211061 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2025-10-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211061 on ClinicalTrials.gov