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| Sponsor: | Tokyo Medical and Dental University |
|---|---|
| Information provided by: | Tokyo Medical and Dental University |
| ClinicalTrials.gov Identifier: | NCT00655772 |
Purpose
A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.
| Condition | Intervention | Phase |
|---|---|---|
|
Halitosis |
Other: Chlorine Dioxide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double Blind, Crossover, Placebo-Controlled Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor |
| Enrollment: | 15 |
| Study Start Date: | February 2007 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 19 Years to 38 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Japan | |
| Dept. Oral health promotion, Tokyo medical and dental university | |
| Yushima Bunkyo-ku, Tokyo, Japan, 113-8549 | |
| Principal Investigator: | Kayoko Shinada, DDS, PhD | Dept. of Oral health promotion, Tokyo medical and dental university |
More Information
| Responsible Party: | Kayoko Shinada/DDS, PhD, Dept. of Oral health promotion, Tokyo medical and dental university |
| ClinicalTrials.gov Identifier: | NCT00655772 History of Changes |
| Other Study ID Numbers: | 1_Shinada |
| Study First Received: | March 28, 2008 |
| Last Updated: | April 4, 2008 |
| Health Authority: | Japan: Ministry of Education, Culture, Sports, Science and Technology |
|
chlorine dioxide mouthwash organoleptic |
measurements volatile sulfur compounds |
|
Halitosis Signs and Symptoms, Digestive Signs and Symptoms Chlorine dioxide Dental Disinfectants |
Disinfectants Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |