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

NCT ID: NCT06353165

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2023-04-12

Brief Summary

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.

Conditions

Plaque, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group I

toothpaste brushing 2/day for 2 minutes

Group Type: ACTIVE_COMPARATOR

Colgate Dental Cream

Intervention Type: DRUG

product containing 0.76% sodium monofluorophosphate

Group II

toothpaste brushing 2/day for 2 minutes

Group Type: EXPERIMENTAL

Stannous fluoride toothpaste

Intervention Type: DRUG

product containing 0.45% stannous fluoride

Interventions

Stannous fluoride toothpaste

product containing 0.45% stannous fluoride

Intervention Type: DRUG

Colgate Dental Cream

product containing 0.76% sodium monofluorophosphate

Intervention Type: DRUG

Other Intervention Names

experimental; control

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

M U International Oral Science Research, Ltd.

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id