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

This study has been completed.

Sponsored by: Tokyo Medical and Dental University
Information provided by: Tokyo Medical and Dental University
ClinicalTrials.gov Identifier: NCT00655772
  Purpose

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


Condition Intervention Phase
Halitosis
Other: Chlorine Dioxide
Phase I

ChemIDplus related topics:   Glycerol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety Study
Official Title:   A Randomized, Double Blind, Crossover, Placebo-Controlled Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor

Further study details as provided by Tokyo Medical and Dental University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment:   15
Study Start Date:   February 2007
Study Completion Date:   April 2007
Primary Completion Date:   March 2007 (Final data collection date for primary outcome measure)

Intervention Details:
    Other: Chlorine Dioxide
    Experimental mouthwash (ClO2 Fresh®): 0.16% sodium chlorite (NaClO2) with an efficacy of 0.1% chlorine dioxide (ClO2),Placebo mouthwash: glycerin, mint oil and distilled water, contents are almost the same as those in the experimental mouthwash except ClO2.
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.

  Eligibility
Ages Eligible for Study:   19 Years to 38 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Clinical diagnosis of oral malodor
  • Rinsing the mouthwash

Exclusion Criteria:

  • oral malodor caused by foods
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655772

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

Sponsors and Collaborators
Tokyo Medical and Dental University

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

Responsible Party:   Dept. of Oral health promotion, Tokyo medical and dental university ( Kayoko Shinada/DDS, PhD )
Study ID Numbers:   1_Shinada
First Received:   March 28, 2008
Last Updated:   April 4, 2008
ClinicalTrials.gov Identifier:   NCT00655772
Health Authority:   Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Tokyo Medical and Dental University:
chlorine  
dioxide  
mouthwash  
organoleptic  
measurements
volatile
sulfur
compounds

Study placed in the following topic categories:
Chlorine dioxide
Signs and Symptoms
Glycerol
Signs and Symptoms, Digestive
Halitosis

Additional relevant MeSH terms:
Anti-Infective Agents
Disinfectants
Dental Disinfectants
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2008




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