A Bleeding-Model Clinical Study

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Drug: 0.454% stannous fluoride; Drug: 0.76% sodium monofluorophosphate; Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM

• Registration Number: NCT05916508
• Lead Sponsor: Procter and Gamble

Brief Summary

The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-19
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Status Verified: 2023-06
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-14
• Study First Posted: 2023-06-23
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Be at least 18 years of age;
• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
• Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
• Have at least 20 gradable teeth;
• Have established gingivitis with ≥10 % bleeding sites;
• Agree to return for scheduled visits and follow the study procedures;
• Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
• Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria

• Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
• Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
• Having known hypersensitivity to the test products;
• Having removable oral appliances;
• Having fixed facial or lingual orthodontic appliances;
• Self-reported pregnancy or lactation;
• Having any diseases or condition that might interfere with the safe participation in the study;
• Having an inability to undergo study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive Control	0.454% stannous fluoride	2 brushings per day (AM and PM)
Negative Control	0.76% sodium monofluorophosphate	2 brushings per day (AM and PM)
Experimental Control	0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM	Brush with Positive control in the morning and negative control in the evening

Primary Outcome Measures

Name	Time	Method
Löe-Silness Gingivitis Evaluation	Week 4	Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

Trial Locations

Locations (1)

Silverstone Research Group; 🇺🇸 Las Vegas, Nevada, United States