Bad Breath Response to Tongue Scraper and Rinses
This study has been completed.
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00867035
First received: March 20, 2009
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
Medical center personnel were screened organoleptically for bad breath by 2 investigators using Rosenberg scale 0-5, and measurement of breath sample in portable gas chromatograph. With a threshold score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(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 mouthwash. 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: Chlorine dioxide and scraper Drug: Chlorhexidine gluconate and scraper |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Bad Breath Response to Tongue Scraper and Rinses, a Double-blind, Randomized, Parallel Group Clinical Trial. |
Resource links provided by NLM:
MedlinePlus related topics:
Bad Breath
Drug Information available for:
Chlorhexidine
Sodium gluconate
Manganese gluconate
Chlorine
Chlorine dioxide
Chlorhexidine gluconate
Hibiclens
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Percentage of Participants With Rosenberg Score at Indicated Time Points [ Time Frame: baseline, 1 hour, 2 hours, 4 hours, 1 week ] [ Designated as safety issue: No ]2 investigators are trained to evaluate smell using the Rosenberg scale which measures foul smelling breath. The Rosenberg scale is validated and is scored 0-5 with 0= no bad breath, 5=worst bad breath. A score of 2 is the threshold at which bad breath is determined.
Secondary Outcome Measures:
- Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour [ Time Frame: 1hr ] [ Designated as safety issue: No ]Using portable gas chromatograph
- Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours [ Time Frame: 2hr ] [ Designated as safety issue: No ]Using portable gas chromatograph
- Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Using portable gas chromatograph
- Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]Using portable gas chromatograph
- Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Using portable gas chromatograph
- Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Using portable gas chromatograph
- Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Using portable gas chromatograph
- Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]Using portable gas chromatograph
- Number of Bacteria on Tongue at 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]Total viable count(TVC) in colony forming units(CFU) on anaerobe agar
- Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | March 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Chlorhexidine gluconate and scraper
The intervention was accomplished by subject after instructions from investigator: twice a day a tongue scraper was used with 4 or more strokes, followed by 20ml of 0.12% chlorhexidine gluconate mouthwash used for 30 sec, for one week.
|
Drug: Chlorhexidine gluconate and scraper
The intervention was accomplished by subject after instructions by investigator: twice a day the scraper was used for 4 strokes then 20ml 0.12% chlorhexidine gluconate rinse for 30sec, for one week.
Other Name: "Peridex"
|
|
Experimental: Chlorine dioxide and scraper
The intervention was accomplished by subject after instructions by investigator: twice a day the scraper was used for 4 strokes then 20ml 0.1% stabilized chlor8ine dioxide rinse for 30sec, for one week.
|
Drug: Chlorine dioxide and scraper
20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day
Other Name: "CloSYS"
|
Detailed Description:
Subjects in trial had oral and periodontal exam and scored the Ramfjord teeth(#3, 9, 12, 19, 25, 28) for Plaque Index(PlI), Gingival Index(GI), probing depth (PD), recession. A tongue coating index is scored and sample of coating on dorsum taken for culture of total viable count and percentage of black sulfide-producing colonies on anaerobe agar with lead acetate 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 concentration of hydrogen sulfide, methyl mercaptan in portable gas 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 |
Criteria
Inclusion Criteria:
- Adult with threshold score of 2 on organoleptic halitosis evaluation
Exclusion Criteria:
- Taking another experimental drug, or antibiotic.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867035
Locations
| United States, California | |
| UCaliforniaSF | |
| San Francisco, California, United States, 94143 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Milton R Wirthlin, DDS | University of California, San Francisco |
More Information
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00867035 History of Changes |
| Other Study ID Numbers: | PGP1 |
| Study First Received: | March 20, 2009 |
| Results First Received: | July 1, 2009 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Halitosis Signs and Symptoms, Digestive Signs and Symptoms Chlorhexidine Chlorhexidine gluconate Chlorine dioxide Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Disinfectants Dermatologic Agents Dental Disinfectants |
ClinicalTrials.gov processed this record on May 23, 2013