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| Sponsored by: |
University of California, San Francisco |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00867035 |
Purpose
Medical center personnel are screened organoleptically for bad breath by 2 investigators using Rosenberg scale 0-5, and measurement of breath sample in gas chromatograph. With a threshold score of 2 or more, or 75ppb H2S, subjects invited to enter clinical trial of the mechanical effect of daily tongue scraping with the adjunctive use of 0.12% chlorhexidine gluconate mouthwash or 0.1% stabilized chlorine dioxide. Subjects randomly assigned in double-blind trial for one week. The null hypothesis is there will be no difference between the two rinses as adjuncts to tongue scraping.
| Condition | Intervention |
|---|---|
|
Halitosis |
Drug: stabilized chlorine dioxide mouthwash Drug: chlorhexidine gluconate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Bio-equivalence Study |
| Official Title: | Bad Breath Response to Tongue Scraper and Rinses |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Drug. tongue scraper and 20ml of 0.1% chlorine dioxide mouthwash used for 30sec twice a day
|
Drug: stabilized chlorine dioxide mouthwash
20ml of 0.1% stabilized chlorine dioxide mouthwash used for 30sec as adjunct to tongue scraper twice a day
|
|
2: Active Comparator
Drug. tongue scraper and 20ml of 0.12% chlorhexidine gluconate mouthwash used for 30 sec twice a day
|
Drug: chlorhexidine gluconate
20ml of 0.12% chlorhexidine gluconate used for 30 sec as mouthwash adjunct to tongue scraper of one week.
|
Subjects in trial will have oral and periodontal exam and score the Ramfjord teeth for PlI, GI, PD, recession. A tongue index is scored and sample of coating on dorsum taken for culture of total viable count and % black colonies on anaerobe agar with sulfur added. Subjects given hygiene instruction and instruction on use of scraper, then rinse with 20ml assigned mouthwash 30sec. Breath assessed by organoleptic means and mouth air sample in chromatograph at 0, 1, 2, and 4 hours. Subjects use scraper and mouthwash twice daily for one week and return for final exam.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCaliforniaSF | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Milton R Wirthlin, DDS | University of California, San Francisco |
More Information
| Responsible Party: | Department of Orofacial Sciences, UCSF ( Milton Robert Wirthlin, DDS, MS ) |
| Study ID Numbers: | PGP1 |
| Study First Received: | March 20, 2009 |
| Last Updated: | March 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00867035 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Infective Agents, Local Chlorine dioxide Signs and Symptoms Disinfectants |
Chlorhexidine Signs and Symptoms, Digestive Chlorhexidine gluconate Halitosis |
|
Anti-Infective Agents Chlorhexidine Signs and Symptoms, Digestive Dental Disinfectants Pharmacologic Actions Signs and Symptoms Chlorine dioxide |
Anti-Infective Agents, Local Disinfectants Chlorhexidine gluconate Therapeutic Uses Halitosis Dermatologic Agents |
