| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| 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 | ||||
| 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. |
||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety Study | ||||
| Primary Outcome Measure † | 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 ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | 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 ] [ Designated as safety issue: Yes ] | ||||
| Condition † | Halitosis | ||||
| Intervention † | Other: Chlorine Dioxide | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 15 | ||||
| Start Date † | February 2007 | ||||
| Completion Date | April 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Male | ||||
| Ages | 19 Years to 38 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | Japan | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00655772 | ||||
| Organization ID | 1_Shinada | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Tokyo Medical and Dental University | ||||
| Collaborators †† | |||||
| Investigators † |
|
||||
| Information Provided By | Tokyo Medical and Dental University | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | March 28, 2008 | ||||
| Last Updated Date | April 4, 2008 | ||||
|
