Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide
NCT ID: NCT00748943
Last Updated: 2008-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2007-03-31
2007-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Interventions
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Chlorine Dioxide
Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
38 Years
MALE
Yes
Sponsors
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Tokyo Medical and Dental University
OTHER
Responsible Party
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Dept. of Oral health promotion, Tokyo medical and dental university
Principal Investigators
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Kayoko Shinada, DDS,phD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Oral health promotion, Tokyo medical and dental university
References
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Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Zaitsu T, Ohnuki M, Wright FA, Kawaguchi Y. Effects of a mouthwash with chlorine dioxide on oral malodor and salivary bacteria: a randomized placebo-controlled 7-day trial. Trials. 2010 Feb 12;11:14. doi: 10.1186/1745-6215-11-14.
Other Identifiers
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2_Shinada
Identifier Type: -
Identifier Source: secondary_id
2_Shinada
Identifier Type: -
Identifier Source: org_study_id