A 3-Month Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice

2018122

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.

2018-10-29

2019-01-25

2019-01-25

Completed

Early phase I

90

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

2023-06-08