Clinical Study on Malodor

March 3, 2024 updated by: Colgate Palmolive

Clinical Investigation on Oral Malodor for a New Formula of Stannous Toothpaste as Compared to Colgate Cavity Protection Toothpaste Using Organoleptic Method

This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Dental Institute of Chengdu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Must be male or female 18 to 70 years of age
  • Must be in good general health
  • Must be in good oral health based on self-assessment
  • Must be available during the weeks of this study for all appointment time points
  • Should have a minimum of 20 natural uncrowned teeth (excluding third molars)
  • Should have a baseline mean oral malodor score greater than or equal to 6.0 and less than or equal to 8.0
  • Must give written informed consent
  • No known history of allergy to personal care/consumer products or their ingredients

Exclusion Criteria:

  • Participation in any other oral clinical studies for the duration of this study
  • Full or partial (upper or lower) dentures
  • Pregnant or lactating (breast feeding)
  • Use of tobacco products
  • History of allergy to common toothpaste ingredients
  • Use of phenolic flavored products, such as mint flavored candies and chewing gum, the morning of the study and during the sampling periods
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
  • Individuals who, due to medical conditions, cannot go without eating or drinking for the post use treatment evaluation time points (6 hrs. + overnight)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
Brushing twice daily in the morning and evening with 2 minutes each time
Drug: test product
toothpaste containing 0.45% stannous fluoride
Drug: Control product
toothpaste containing 0.76% sodium monofluorophosphate
Active Comparator: Group II
Brushing twice daily in the morning and evening with 2 minutes each time
Drug: test product
toothpaste containing 0.45% stannous fluoride
Drug: Control product
toothpaste containing 0.76% sodium monofluorophosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organoleptic Oral Malodor Evaluations
Time Frame: Oral malodor evaluations at baseline & 3 weeks
The measured levels of oral malodor will be expressed in organoleptic scales (1-9)
Oral malodor evaluations at baseline & 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Deyu Hu, DDS,MS, West China Dental Institute of Chengdu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

July 2, 2023

Study Completion (Actual)

July 2, 2023

Study Registration Dates

First Submitted

March 3, 2024

First Submitted That Met QC Criteria

March 3, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRO-2023-05-OMO-SNA-YPZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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