Brief Title: a Clinical Study to Assess Gingivitis

Procter & Gamble (P&G)

Status: Completed

Conditions: Gingival Diseases

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06659471

2021117

Details and patient eligibility

About

The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

0.76% Sodium Monofluorophosphate

Sham Comparator group

Description:

0.76% Sodium Monofluorophosphate

Treatment:

Drug: 0.76% Sodium Monofluorophosphate Dentifrice

0.454% Stannous Fluoride

Active Comparator group

Description:

0.454% Stannous Fluoride

Treatment:

Drug: 0.454% Stannous Fluoride Dentifrice

0.454% Stannous Fluoride, 4.7 pH

Experimental group

Description:

0.454% Stannous Fluoride, 4.7 pH

Treatment:

Drug: 0.454% Stannous Fluoride Dentifrice

0.454% Stannous Fluoride, 5.8 pH

Experimental group

Description:

0.454% Stannous Fluoride, 5.8 pH

Treatment:

Drug: 0.454% Stannous Fluoride Dentifrice