A Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth

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

The clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva

Study Overview

• Status: Not yet recruiting
• Conditions: Gingivitis; Plaque
• Intervention / Treatment: Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste; Drug: stannous fluoride toothpaste

Detailed Description

This parallel design clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva.

The effects of the test toothpaste will be compared to a commercially available fluoride dentifrice that will serve as a control.

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

Contacts and Locations

• Study Contact: Name: Terdphong Triratana, DDS; Phone Number: 66-81-622-2124; Email: ratana@muinter.in.th
• Study Contact Backup: Name: Phraekhun Kanjanakuha; Email: ratana@muinter.in.th

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 mouth rinses. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1 Toothpaste; Instructed to brush will full ribbon, 2x day/2 min with toothpaste	Drug: stannous fluoride toothpaste; toothpaste
Active Comparator: Test 2 toothpaste; Instructed to brush will full ribbon, 2x day/2 min with toothpaste	Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste; toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loe-Silness	gingivitis index of 1.0 or more	baseline, 2 week and 4 week
Turesky Modification of Quigley-Hein	whole mouth scores of dental plaque of 1.5 or more	baseline, 2 week and 4 week

Collaborators and Investigators

• Sponsor: Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Infections; Gingival Diseases; Pathological Conditions, Signs and Symptoms; Plaque, Amyloid; Gingivitis; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Dentifrices; Toothpastes; fluorophosphate; Supersmile
• Other Study ID Numbers: CRO-2026-05-BAC-SNI-THA-YPZ

Drug and device information, study documents

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