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Bad Breath Response to Tongue Scraper and Rinses

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ClinicalTrials.gov Identifier: NCT00867035
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Halitosis Drug: Chlorine dioxide and scraper Drug: Chlorhexidine gluconate and scraper

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bad Breath Response to Tongue Scraper and Rinses, a Double-blind, Randomized, Parallel Group Clinical Trial.
Study Start Date : March 2008
Primary Completion Date : March 2009
Study Completion Date : June 2009


Arms and Interventions

Arm Intervention/treatment
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"


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants With Rosenberg Score at Indicated Time Points [ Time Frame: baseline, 1 hour, 2 hours, 4 hours, 1 week ]
    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 :
  1. Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour [ Time Frame: 1hr ]
    Using portable gas chromatograph

  2. Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours [ Time Frame: 2hr ]
    Using portable gas chromatograph

  3. Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours [ Time Frame: 4 hours ]
    Using portable gas chromatograph

  4. Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week [ Time Frame: 1 week ]
    Using portable gas chromatograph

  5. Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour [ Time Frame: 1 hour ]
    Using portable gas chromatograph

  6. Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours [ Time Frame: 2 hours ]
    Using portable gas chromatograph

  7. Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours [ Time Frame: 4 hours ]
    Using portable gas chromatograph

  8. Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week [ Time Frame: 1 week ]
    Using portable gas chromatograph

  9. Number of Bacteria on Tongue at 1 Week [ Time Frame: 1 week ]
    Total viable count(TVC) in colony forming units(CFU) on anaerobe agar

  10. Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate [ Time Frame: 1 week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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
First Posted: March 23, 2009    Key Record Dates
Results First Posted: May 16, 2013
Last Update Posted: May 16, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms
Chlorhexidine
Chlorhexidine gluconate
Chlorine dioxide
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Dental Disinfectants