A Three-Month Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices

Procter and Gamble1 site in 1 country116 target enrollmentSeptember 2, 2023

ConditionsGingivitis

Interventions0.76% Sodium Monofluorophosphate Dentifrice 0.454% Stannous Fluoride Dentifrice

Drugs0.76% Sodium Monofluorophosphate Dentifrice 0.454% Stannous Fluoride Dentifrice

Overview

Phase: Not Applicable
Intervention: 0.76% Sodium Monofluorophosphate Dentifrice
Conditions: Gingivitis
Sponsor: Procter and Gamble
Enrollment: 116
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 primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.

Registry

clinicaltrials.gov

Start Date

September 2, 2023

End Date

December 10, 2023

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 16 gradable teeth;
•Have mild to moderate gingivitis with at least 20 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;
•Agree to refrain from any oral hygiene the morning of your visit
•Agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing.

Exclusion Criteria

•Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
•Have 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 had a dental prophylaxis within 2 weeks of plaque sampling visits;
•Removable oral appliances;
•Fixed facial or lingual orthodontic appliances;
•Self-reported pregnancy or lactation;
•Any diseases or condition that might interfere with the safe participation in the study; and
•Inability to undergo study procedures.

Arms & Interventions

0.76% Sodium Monofluorophosphate Dentifrice

Intervention: 0.76% Sodium Monofluorophosphate Dentifrice

Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice

Intervention: 0.454% Stannous Fluoride Dentifrice

Marketed 0.454% Stannous Fluoride Dentifrice

Intervention: 0.454% Stannous Fluoride Dentifrice

0.454% Stannous Fluoride Dentifrice

Intervention: 0.454% Stannous Fluoride Dentifrice

Outcomes

Primary Outcomes

Löe-Silness Gingivitis Evaluation

Time Frame: 3 Months

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).