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

Phase 3

Completed

• Conditions: Plaque, Dental
• Interventions: Drug: Stannous fluoride toothpaste; Drug: Colgate Dental Cream

• Registration Number: NCT06353165
• Lead Sponsor: Colgate Palmolive

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-08
• Primary Completion: 2023-04-12
• Study Completion: 2023-04-12
• Study First Submitted: 2024-03-03
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-08
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Stannous fluoride toothpaste	toothpaste brushing 2/day for 2 minutes
Group I	Colgate Dental Cream	toothpaste brushing 2/day for 2 minutes

Primary Outcome Measures

Name	Time	Method
Measurement of total bacterial counts in saliva	baseline, 2 week & 4 week	Collected samples in saliva will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Measurement of total bacterial counts on cheek	baseline, 2 week & 4 week	Scrapings from the surface of the cheek mucosa. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Whole mouth scores of dental plaque	baseline, 2 week & 4 week	Measuring the dental plaque using the Turesky Modification of Quigley-Hein.Subjects presenting with whole mouth scores for dental plaque of 1.5 or more \[Turesky Modification of plaque will be enrolled.; Quigley-Hein.
Measurement of total bacterial counts on tongue	baseline, 2 week & 4 week	Scrapings from the surface of the tongue. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis
Measurement of gingivitis	baseline, 2 week & 4 week	Using the Loe-Silness index.Subjects presening will 1.0 or more for gingivitis \[Loe-Silness\] will be enrolled.

Trial Locations

Locations (1)

M U International Oral Science Research, Ltd.; 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand