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Completed

NCT Number: NCT07223073

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

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.

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Key information

Conditions

Oral Malodor

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

M U International Oral Science Research, Ltd.

Bangkok, 10250, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

0.454% stannous fluoride

Drug

fluoride toothpaste

0.76% sodium monofluorophosphate

Drug

regular fluoride toothpaste

Primary outcomes

  1. Mean Organoleptic scores for each treatment group

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2025
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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