A Bleeding-Model Clinical Study

Procter & Gamble (P&G)

Status: Completed

Conditions: Gingivitis

Treatments: Drug: 0.454% stannous fluoride; Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM; Drug: 0.76% sodium monofluorophosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05916508

2020112

Details and patient eligibility

About

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.

Enrollment: 90 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Positive Control

Active Comparator group

Description:

2 brushings per day (AM and PM)

Treatment:

Drug: 0.454% stannous fluoride

Negative Control

Sham Comparator group

Description:

2 brushings per day (AM and PM)

Treatment:

Drug: 0.76% sodium monofluorophosphate

Experimental Control

Experimental group

Description:

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

Treatment:

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