Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Three Month Study

CRO-2019-03-PG-SNF-FL-BGS

The objective of this study is to evaluate the clinical efficacy of a toothpaste containing stannous fluoride as compared to Colgate Fluoride Toothpaste in reducing plaque and gingivitis - a three- month study.

2019-03-06

2019-06-06

2019-07-01

Completed

Early phase I

88

Inclusion Criteria: * Subjects, ages 18-70, inclusive. * Availability for the six-month duration ofthe clinical research study. * Good general health. * Minimum of 20 uncrowned permanent natural teeth (excluding third molars). * Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. * Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein °Plaque Index (Turesky Modification). * Signed Informed Consent Form. Exclusion Criteria: * Presence of partial denture. * Presence of partial removable dentures. * Tumor(s) of the soft or hard tissues of the oral cavity. * Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). * Five or more carious lesions requiring immediate restorative treatment. * Antibiotic use any time during the one month prior to entry into the study. * Participation in any other clinical study or test panel within the one month prior to entry into the study. * Dental prophylaxis during the past two weeks prior to baseline examinations. * History of allergies to oral care/personal care consumer products or their ingredients. * On any prescription medicines that might interfere with the study outcome. * An existing medical condition which prohibits eating or drinking for periods up to 4 hours. * History of alcohol or drug abuse. * Pregnant or lactating subjects.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This was a 6-month, randomized, single-center, parallel group, double-blinded, clinical research study to assess the clinical efficacy of two toothpastes containing stannous fluoride (SnHW and CPH) as compared to Regular Fluoride Toothpaste on the reduction of established dental plaque and gingivitis in adults.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'CRO-2019-03-PG-SNF-FL-BGS Product XXX Brush your teeth twice daily (morning and evening) for two (2) minutes each time.\n\nCover the length of the toothbrush bristles with the toothpaste. For investigational use only by the study participant. Not for sale. For Adult Use Only. Keep out of reach of children under 6 years.\n\nIn case of emergency or for further information contact:', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 88, 'type': 'ACTUAL'}}

2022-09-27