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

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Drug: Stannous Fluoride Dentifrice; Drug: Sodium Fluoride Dentifrice; Device: electric toothbrush; Device: manual toothbrush; Drug: Cetylpyridinium Chloride (CPC)

• Registration Number: NCT07211061
• Lead Sponsor: Procter and Gamble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-21
• Primary Completion: 2011-11-10
• Study Completion: 2011-11-10
• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Hygiene Regimen	Stannous Fluoride Dentifrice	toothpaste, electric toothbrush, and mouth rinse
Oral Hygiene Regimen	electric toothbrush	toothpaste, electric toothbrush, and mouth rinse
Oral Hygiene Regimen	Cetylpyridinium Chloride (CPC)	toothpaste, electric toothbrush, and mouth rinse
Negative Control	Sodium Fluoride Dentifrice	toothpaste and manual toothbrush
Negative Control	manual toothbrush	toothpaste and manual toothbrush

Primary Outcome Measures

Name	Time	Method
Bleeding (GBI)	Week 1, Week 3, and Week 6	Gingival Bleeding Index- evaluation of bleeding from gingival tissue, score from 0-2

Secondary Outcome Measures

Name	Time	Method
Inflammation (MGI)	Week 1, Week 3, and Week 6	Modified Gingival Index- evaluation of the level of gingival tissue inflammation, scores from 0-4

Trial Locations

Locations (1)

Bio-Sci Research (Out of Business); 🇺🇸 Las Vegas, Nevada, United States