A Clinical Study to Investigate Stannous Fluoride Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste

CRO-2022-12-BAC-SNF-THA-YPZ

This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use.

2023-03-08

2023-04-12

2023-04-12

Completed

Early phase I

100

Inclusion Criteria: * Male and female subjects, ages 18-70, inclusive. * Subject is available during study duration and has no allergies to oral hygiene formulations. * A minimum of 20 natural teeth with facial and lingual scorable surfaces. * A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules. * Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more \[Turesky Modification of Quigley-Hein\] and gingivitis index of 1.0 or more \[Loe-Silness\]. Exclusion Criteria: * Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study. * History of dental prophylaxis or treatments in the past month or during study duration. * History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment. * Subjects scheduled for medical procedures for the duration of the study. * Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc. * History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients. * History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS. * History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures. * Oral soft tissue pathology. * History of active or severe periodontal disease and loose teeth. * Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations). * Fixed or removable orthodontic appliance or removable partial dentures. * Self-reported pregnancy or lactation. * Subjects known to be an alcoholic, or a recovering alcoholic. * History or current use of recreational drugs or other habit promoting products. * Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period. * Ability to refrain from oral hygiene for twelve (12) hours prior to scheduled visit.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'blinded', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2024-04-15