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

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

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.

Study Overview

• Status: Completed
• Conditions: Plaque, Dental
• Intervention / Treatment: Drug: Colgate Dental Cream; Drug: Stannous fluoride toothpaste

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Krung Thep Maha Nakhon
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10250
      • M U International Oral Science Research, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; toothpaste brushing 2/day for 2 minutes	Drug: Colgate Dental Cream; product containing 0.76% sodium monofluorophosphate; Other Names: control
Experimental: Group II; toothpaste brushing 2/day for 2 minutes	Drug: Stannous fluoride toothpaste; product containing 0.45% stannous fluoride; Other Names: experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole mouth scores of dental plaque	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.	baseline, 2 week & 4 week
Measurement of total bacterial counts on tongue	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	baseline, 2 week & 4 week
Measurement of total bacterial counts on cheek	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	baseline, 2 week & 4 week
Measurement of gingivitis	Using the Loe-Silness index.Subjects presening will 1.0 or more for gingivitis [Loe-Silness] will be enrolled.	baseline, 2 week & 4 week
Measurement of total bacterial counts in saliva	Collected samples in saliva will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis	baseline, 2 week & 4 week

Collaborators and Investigators

• Sponsor: Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: bacteria; plaque; saliva
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Tin Fluorides
• Other Study ID Numbers: CRO-2022-12-BAC-SNF-THA-YPZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No