A Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste

A Randomized Single-center, Double-blind, Two-cell Parallel-group Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Oral Malodor 12 Hours Post-brushing Overnight After 3 Weeks of Twice a Day (Morning and Evening) Product Use.

To investigate the clinical efficacy of a new toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate on oral malodor reduction via organoleptic scores 12 hours post-brushing overnight after 3 weeks of twice a day (morning and evening) product use.

Study Overview

• Status: Completed
• Conditions: Oral Malodor
• Intervention / Treatment: Drug: 0.454% stannous fluoride; Drug: 0.76% sodium monofluorophosphate

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok, Bangkok, 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 adults between the ages of 18-70 (inclusive)
• Subjects must be in general good health
• Subjects must be in good oral health based on self-assessment
• Subjects must be available for the duration of the study for all time point assessments
• Subjects were required to possess a minimum of 20 natural uncrowned teeth (excluding third molars)
• Subjects were required to sign an Informed Consent form
• No known history or allergies to personal care/consumer products or their ingredients.

Exclusion Criteria:

• Participated in any other oral clinical studies during the duration of this study
• Had full or partial (upper or lower) dentures
• Women who are pregnant or lactating (breast feeding)
• Use of tobacco products, (5) History of allergies to common mouthwash ingredients
• Use of phenolic flavored products, such as mint flavored candies and chewing gum the morning of the study of during the sampling periods
• Immune compromised individuals (HIV, AIDS, immune suppressive drug therapy
• Individuals who, due to medical conditions cannot go without eating or drinking for the post use treatment evaluation time points (6-hours plus overnight).

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	Drug: 0.454% stannous fluoride; fluoride toothpaste
Active Comparator: Test 2 Toothpaste	Drug: 0.76% sodium monofluorophosphate; regular fluoride toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Organoleptic scores for each treatment group	For each subject at each evaluation time point, the hedonic breath-odor scores assigned by the four (4) judges were averaged to yield a single subject-wise score. Statistical analyses were performed on these average organoleptic hedonic scores.	Baseline, 12 hours post brushing and 3 weeks

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Terdphong Triratana, DDS, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): January 12, 2018
• Study Completion (Actual): January 12, 2018

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Estimated): October 31, 2025

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cariostatic Agents; Inorganic Chemicals; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Tin Compounds; Tin Fluorides; fluorophosphate
• Other Study ID Numbers: CRO-2017-10-OM-SNHW-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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes