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

NCT07223073 — Phase 3, Completed, 80 participants, Colgate Palmolive

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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.

RegistryNCT07223073
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment80 (Actual)
SponsorColgate Palmolive (Industry)
ConditionsOral Malodor
Interventions0.454% stannous fluoride, 0.76% sodium monofluorophosphate (Drug)
Datesstart 2017-12-21, primary completion 2018-01-12, completion 2018-01-12, first posted 2025-10-31, last updated 2025-10-31
Locations1 site in Thailand

Related Papers Related Patents Related Grants Related Experts
All trials for Oral Malodor All trials of 0.454% stannous fluoride All trials of 0.76% sodium monofluorophosphate

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Test 1 toothpasteExperimentalDrug: 0.454% stannous fluoride
Test 2 ToothpasteActive comparatorDrug: 0.76% sodium monofluorophosphate
  • 0.454% stannous fluoride (Drug): fluoride toothpaste
  • 0.76% sodium monofluorophosphate (Drug): regular fluoride toothpaste

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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).

+Locations (1)

FacilityCityCountryStatus
M U International Oral Science Research, Ltd.Bangkok, BangkokThailand

+Investigators