Anti-bacterial Clinical Study on Teeth, Tongue, Cheek, Gum, and Saliva

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Plaque, Dental

Treatments

Drug: Colgate Dental Cream

Drug: Stannous fluoride toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT06353165

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

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.