A Three-Month Bleeding-Model Clinical Study

Procter and Gamble1 site in 1 country90 target enrollmentNovember 15, 2021

Interventions0.454% stannous fluoride 0.76% sodium monofluorophosphate 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM

Drugs0.454% stannous fluoride 0.76% sodium monofluorophosphate 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM

Overview

Phase: Not Applicable
Intervention: 0.454% stannous fluoride
Conditions: Gingivitis
Sponsor: Procter and Gamble
Enrollment: 90
Locations: 1
Primary Endpoint: Löe-Silness Gingivitis Evaluation
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 15, 2021

End Date

February 11, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Procter and Gamble

Responsible Party

Sponsor

Eligibility Criteria

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 10-70% 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.

Arms & Interventions

Positive Control

2 brushings per day (AM and PM)

Intervention: 0.454% stannous fluoride

Negative Control

2 brushings per day (AM and PM)

Intervention: 0.76% sodium monofluorophosphate

Experimental Control

Brush with Positive control in the morning and negative control in the evening

Intervention: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM

Outcomes

Primary Outcomes

Löe-Silness Gingivitis Evaluation

Time Frame: Week 12

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).