Clinical and Microbiological Effects of a Mouthwash Containing Chlorine Dioxide
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|ClinicalTrials.gov Identifier: NCT00748943|
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : September 12, 2008
|Condition or disease||Intervention/treatment||Phase|
|Halitosis||Other: Chlorine Dioxide||Phase 1|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Clinical Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor and Salivary Periodontal and Malodorous Bacteria Using for 7days|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||June 2007|
- Other: Chlorine Dioxide
Experimental mouthwash (ClO2 Fresh®) contained 0.16% sodium chlorite (NaClO2)Other Name: ClO2 Fresh®
- Oral malodor [ Time Frame: 7 days ]
- Periodontal bacteria [ Time Frame: 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748943
|Principal Investigator:||Kayoko Shinada, DDS,phD||Dept. of Oral health promotion, Tokyo medical and dental university|