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

Procter & Gamble (P&G)

Status: Completed

Conditions: Gingivitis

Treatments: Drug: 0.454% Stannous Fluoride Dentifrice; Drug: 0.76% Sodium Monofluorophosphate Dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT06140784

2023043

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 4 patient groups

0.76% Sodium Monofluorophosphate Dentifrice

Sham Comparator group

Treatment:

Drug: 0.76% Sodium Monofluorophosphate Dentifrice

Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice

Active Comparator group

Treatment:

Drug: 0.454% Stannous Fluoride Dentifrice

Drug: 0.454% Stannous Fluoride Dentifrice

Drug: 0.454% Stannous Fluoride Dentifrice

Marketed 0.454% Stannous Fluoride Dentifrice

Active Comparator group

Treatment:

Drug: 0.454% Stannous Fluoride Dentifrice

Drug: 0.454% Stannous Fluoride Dentifrice

Drug: 0.454% Stannous Fluoride Dentifrice

0.454% Stannous Fluoride Dentifrice

Active Comparator group

Treatment:

Drug: 0.454% Stannous Fluoride Dentifrice

Drug: 0.454% Stannous Fluoride Dentifrice

Drug: 0.454% Stannous Fluoride Dentifrice