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

• Status: Completed
• Trial end date: 2019-01-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Procter and Gamble
• Treatments: Fluorides; Tin Fluorides

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;

• 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.