Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide

This study has been completed.
Sponsor:
Information provided by:
Tokyo Medical and Dental University
ClinicalTrials.gov Identifier:
NCT00748943
First received: September 8, 2008
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). However, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.


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: The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Oral malodor [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Periodontal bacteria [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: March 2007
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Chlorine Dioxide
    Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)
    Other Name: ClO2 Fresh®
Detailed Description:

Background: Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO2). Its clinical efficacies on oral malodor have been evaluated and reported, however, no clinical studies have investigated its microbiological efficacies on periodontal and malodorous bacteria. The aim of this study was to assess the inhibitory effects of a mouthwash containing ClO2 on morning oral malodor and on salivary periodontal and malodorous bacteria using for 7 days.

Methods: A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups. In the first test phase, the group 1 subjects (N = 8) were instructed to rinse with the experimental mouthwash containing ClO2 twice per day for 7 days, and those in group 2 (N = 7) to rinse with the control (placebo) mouthwash without ClO2. In the second test, phase after a one week washout period, each group had used the opposite mouthwash for 7 days. At baseline and after 7 days, oral malodor was evaluated with OM, and concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S), the main VSCs of human oral malodor, were evaluated with GC. Clinical outcome variables included plaque and gingival indices, and the Winkel Tongue Coating Index(WTCI). The samples of saliva were microbiologically investigated.

Outcome variables were compared by t-test and Mann-Whitney test.

  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

Exclusion Criteria:

  • Oral malodor caused by foods
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00748943

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 by Tokyo Medical and Dental University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kayoko Shinada/DDS, phD, Dept. of Oral health promotion, Tokyo medical and dental university
ClinicalTrials.gov Identifier: NCT00748943     History of Changes
Other Study ID Numbers: 2_Shinada, 2_Shinada
Study First Received: September 8, 2008
Last Updated: September 11, 2008
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Tokyo Medical and Dental University:
chlorine
dioxide
mouthwash
halitosis
bacteria
saliva

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms
Chlorine dioxide
Dental Disinfectants
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014