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

NCT07223073 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2017-10-OM-SNHW-THA-YPZ
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Malodor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test 1 toothpaste

EXPERIMENTAL

Drug: 0.454% stannous fluoride

Test 2 Toothpaste

ACTIVE COMPARATOR

Drug: 0.76% sodium monofluorophosphate

Interventions

0.454% stannous fluoride DRUG

fluoride toothpaste

Test 1 toothpaste

0.76% sodium monofluorophosphate DRUG

regular fluoride 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 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

M U International Oral Science Research, Ltd.

Bangkok, Bangkok, 10250, Thailand

Location

MeSH Terms

Interventions

Tin Fluorides; fluorophosphate

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Terdphong Triratana, DDS

  Mahidol University

  PRINCIPAL INVESTIGATOR

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: October 29, 2025
• First Posted: October 31, 2025
• Study Start: December 21, 2017
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)