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

Not Applicable

Completed

• Conditions: Oral Malodor
• Interventions: Drug: 0.454% stannous fluoride; Drug: 0.76% sodium monofluorophosphate

• Registration Number: NCT07223073
• Lead Sponsor: Colgate Palmolive

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-21
• Primary Completion: 2018-01-12
• Study Completion: 2018-01-12
• Status Verified: 2025-10
• Study First Submitted: 2025-10-29
• Study First Submitted QC: 2025-10-29
• Last Update Submitted: 2025-10-29
• Study First Posted: 2025-10-31
• Last Update Posted: 2025-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test 1 toothpaste	0.454% stannous fluoride	-
Test 2 Toothpaste	0.76% sodium monofluorophosphate	-

Primary Outcome Measures

Name	Time	Method
Mean Organoleptic scores for each treatment group	Baseline, 12 hours post brushing and 3 weeks	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.

Trial Locations

Locations (1)

M U International Oral Science Research, Ltd.; 🇹🇭 Bangkok, Bangkok, Thailand