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

Procter & Gamble (P&G)

Status and phase: Completed; Phase 4

Conditions: Gingivitis

Treatments: Device: electric toothbrush; Drug: Sodium Fluoride Dentifrice; Drug: Cetylpyridinium Chloride (CPC); Device: manual toothbrush; Drug: Stannous Fluoride Dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT07211061

2011068

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 2 patient groups

Oral Hygiene Regimen

Experimental group

Description:

toothpaste, electric toothbrush, and mouth rinse

Treatment:

Drug: Stannous Fluoride Dentifrice

Drug: Cetylpyridinium Chloride (CPC)

Device: electric toothbrush

Negative Control

Active Comparator group

Description:

toothpaste and manual toothbrush

Treatment:

Device: manual toothbrush

Drug: Sodium Fluoride Dentifrice