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

NCT07458464 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: CRO-2026-05-BAC-SNI-THA-YPZ
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Plaque; Gingivitis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Test 1 Toothpaste

EXPERIMENTAL

Instructed to brush will full ribbon, 2x day/2 min with toothpaste

Drug: stannous fluoride toothpaste

Test 2 toothpaste

ACTIVE COMPARATOR

Instructed to brush will full ribbon, 2x day/2 min with toothpaste

Drug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste

Interventions

stannous fluoride toothpaste DRUG

toothpaste

Test 1 Toothpaste

0.76% Sodium Monofluorophosphate (Na MFP) toothpaste DRUG

toothpaste

Test 2 toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[Loe-Silness\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

MeSH Terms

Conditions

Plaque, Amyloid; Gingivitis

Interventions

fluorophosphate; Supersmile; Toothpastes

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Terdphong Triratana, DDS

CONTACT

66-81-622-2124; ratana@muinter.in.th

Phraekhun Kanjanakuha

CONTACT

ratana@muinter.in.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-03