Clinical Research Study to Evaluate the Stain Removal Efficacy of a Toothpaste Containing Stannous Fluoride as Compared to Negative Control Toothpaste.

CRO-2020-04-STN-SNF-PR-BGS

The objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.

2020-07-27

2020-09-14

2020-09-14

Completed

Early phase I

80

Inclusion Criteria: * Signed Informed Consent Form * Good general health * Male and female subjects, aged 21-70, inclusive * Present 12 scoreable natural anterior teeth * A minimum mean Composite Lobene Index score of 1 or greater * Available for the duration of the study * Clinical evidence of a tendency to form extrinsic stain on anterior teeth Exclusion Criteria: * Presence of orthodontic bands * 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 * Use of antibiotics or stain inducing medications 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 * Self-reported pregnancy and/or women who are breast feeding * Dental prophylaxis received in the past four weeks prior to baseline examinations * History of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide * On any prescription medicines that might interfere with the study outcome * History of alcohol and/or drug abuse * Exposed to a tooth whitening procedure during the last 3 months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}

2024-02-05