A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice

Procter & Gamble (P&G)

Status and phase

Completed

Phase 4

Conditions

Gingivitis

Treatments

Drug: Marketed Toothpaste

Drug: Marketed Cavity Protection Toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT03936569

2018122

Details and patient eligibility

About

The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.

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 16 gradable teeth;
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 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;
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.