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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.
Sponsor:
Information provided by:
Tokyo Medical and Dental University
ClinicalTrials.gov Identifier:
NCT00655772
First received: March 28, 2008
Last updated: April 4, 2008
Last verified: March 2008
  Purpose

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


Condition Intervention Phase
Halitosis
Other: Chlorine Dioxide
Phase 1

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

Resource links provided by NLM:


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.
    Other Name: ClO2 Fresh®
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
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

No publications provided

Responsible Party: Kayoko Shinada/DDS, PhD, Dept. of Oral health promotion, Tokyo medical and dental university
ClinicalTrials.gov Identifier: NCT00655772     History of Changes
Other Study ID Numbers: 1_Shinada
Study First Received: March 28, 2008
Last Updated: April 4, 2008
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

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

ClinicalTrials.gov processed this record on November 27, 2014