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

NCT ID: NCT07223073

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2018-01-12

Brief Summary

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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

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Conditions

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Oral Malodor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test 1 toothpaste

Group Type EXPERIMENTAL

0.454% stannous fluoride

Intervention Type DRUG

fluoride toothpaste

Test 2 Toothpaste

Group Type ACTIVE_COMPARATOR

0.76% sodium monofluorophosphate

Intervention Type DRUG

regular fluoride toothpaste

Interventions

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0.454% stannous fluoride

fluoride toothpaste

Intervention Type DRUG

0.76% sodium monofluorophosphate

regular fluoride toothpaste

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terdphong Triratana, DDS

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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M U International Oral Science Research, Ltd.

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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CRO-2017-10-OM-SNHW-THA-YPZ

Identifier Type: -

Identifier Source: org_study_id