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

NCT ID: NCT07211061

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-21
• Study Completion Date: 2011-11-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oral Hygiene Regimen

toothpaste, electric toothbrush, and mouth rinse

Group Type: EXPERIMENTAL

Stannous Fluoride Dentifrice

Intervention Type: DRUG

brush 2x a day in using a power brush (2 minutes of brushing)

electric toothbrush

Intervention Type: DEVICE

brush using a electric brush (2 minutes of brushing)

Cetylpyridinium Chloride (CPC)

Intervention Type: DRUG

use 20 ml of mouth rinse for 30 seconds

Negative Control

toothpaste and manual toothbrush

Group Type: ACTIVE_COMPARATOR

Sodium Fluoride Dentifrice

Intervention Type: DRUG

brush in their customary manner

manual toothbrush

Intervention Type: DEVICE

brush in their customary manner

Interventions

Stannous Fluoride Dentifrice

brush 2x a day in using a power brush (2 minutes of brushing)

Intervention Type: DRUG

Sodium Fluoride Dentifrice

brush in their customary manner

Intervention Type: DRUG

electric toothbrush

brush using a electric brush (2 minutes of brushing)

Intervention Type: DEVICE

Cetylpyridinium Chloride (CPC)

use 20 ml of mouth rinse for 30 seconds

Intervention Type: DRUG

manual toothbrush

brush in their customary manner

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent to participate in the study;
• Be 18 years of age or older;
• Agree not to participate in any other oral/dental product studies during the course of this study;
• Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
• Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
• Have a Baseline MGI score of at least 1.75 but not greater than 2.3;
• Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
• Agree to return for all scheduled visits and follow study procedures;
• Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.

Exclusion Criteria

• Have had a dental prophylaxis within 2 weeks of Baseline visit;
• Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
• Have rampant caries, open or untreated caries, severe gingivitis, or advanced periodontitis requiring prompt treatment; or,
• Need an antibiotic prophylaxis prior to dental visits,
• Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study,
• Are pregnant (Self-reported) or lactating.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bio-Sci Research (Out of Business)

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

2011068

Identifier Type: -

Identifier Source: org_study_id