A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor

April 4, 2008 updated by: Tokyo Medical and Dental University

A Randomized, Double Blind, Crossover, Placebo-Controlled Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor

A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups: experimental or control group. In the first test phase, the subjects in the experimental group were instructed to rinse with the mouthwash containing ClO2 and those in the control group with the placebo mouthwash without ClO2. In the second test phase after one week washout period, same procedure was conducted with the opposite mouthwashes. Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with OM, and the concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S) which are the main volatile sulfur compounds (VSCs) of human oral malodor were evaluated with GC.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

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

  • Japan
    • Tokyo
      • Yushima Bunkyo-ku, Tokyo, Japan, 113-8549
        • Dept. Oral health promotion, Tokyo medical and dental university

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

17 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Clinical diagnosis of oral malodor
  • Rinsing the mouthwash

Exclusion Criteria:

  • oral malodor caused by foods

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: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with organoleptic measurements.
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with the concentrations of 3 kinds gases of human oral malodor analyzing with gas chromatography.
Time Frame: 4 hours
4 hours

Collaborators and Investigators

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

Sponsor

Tokyo Medical and Dental University

Investigators

  • Principal Investigator: Kayoko Shinada, DDS, PhD, Dept. of Oral health promotion, Tokyo medical and dental university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2007

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 4, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1_Shinada

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.

Clinical Trials on Halitosis

Clinical Trials on Chlorine Dioxide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe