Back to resultsA Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor
Primary Purpose
Halitosis
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Chlorine Dioxide
Sponsored by
About this trial
This is an interventional prevention trial for Halitosis focused on measuring chlorine, dioxide, mouthwash, organoleptic, measurements, volatile, sulfur, compounds
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of oral malodor
- Rinsing the mouthwash
Exclusion Criteria:
- oral malodor caused by foods
Sites / Locations
- Dept. Oral health promotion, Tokyo medical and dental university
Outcomes
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.
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.
Full Information
NCT ID
NCT00655772
First Posted
March 28, 2008
Last Updated
April 4, 2008
Sponsor
Tokyo Medical and Dental University
1. Study Identification
Unique Protocol Identification Number
NCT00655772
Brief Title
A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor
Official Title
A Randomized, Double Blind, Crossover, Placebo-Controlled Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tokyo Medical and Dental University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
chlorine, dioxide, mouthwash, organoleptic, measurements, volatile, sulfur, compounds
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Chlorine Dioxide
Other Intervention Name(s)
ClO2 Fresh®
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of oral malodor
Rinsing the mouthwash
Exclusion Criteria:
oral malodor caused by foods
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kayoko Shinada, DDS, PhD
Organizational Affiliation
Dept. of Oral health promotion, Tokyo medical and dental university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Oral health promotion, Tokyo medical and dental university
City
Yushima Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8549
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19068114
Citation
Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Kawaguchi Y. A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor. Trials. 2008 Dec 9;9:71. doi: 10.1186/1745-6215-9-71.
Results Reference
derived
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A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor
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