- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00748943
Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide
The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of oral malodor
Exclusion Criteria:
- Oral malodor caused by foods
Study Plan
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
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Periodontal bacteria
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kayoko Shinada, DDS,phD, Dept. of Oral health promotion, Tokyo medical and dental university
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2_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.
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