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Bad Breath Response to Tongue Scraper and Rinses

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00867035
First received: March 20, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 20, 2009
March 20, 2009
July 2008
June 2009   (final data collection date for primary outcome measure)
organoleptic score [ Time Frame: one week ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
concentration of volatile sulfur compounds in mouth air [ Time Frame: one week ] [ Designated as safety issue: No ]
Same as current
 
 
 
Bad Breath Response to Tongue Scraper and Rinses
Bad Breath Response to Tongue Scraper and Rinses

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.

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.
Interventional
 
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Halitosis
  • Drug: stabilized chlorine dioxide mouthwash
    20ml of 0.1% stabilized chlorine dioxide mouthwash used for 30sec as adjunct to tongue scraper twice a day
    Other Name: CloSYS
  • Drug: chlorhexidine gluconate
    20ml of 0.12% chlorhexidine gluconate used for 30 sec as mouthwash adjunct to tongue scraper of one week.
    Other Name: Peridex
  • Experimental: 1
    Drug. tongue scraper and 20ml of 0.1% chlorine dioxide mouthwash used for 30sec twice a day
    Intervention: Drug: stabilized chlorine dioxide mouthwash
  • Active Comparator: 2
    Drug. tongue scraper and 20ml of 0.12% chlorhexidine gluconate mouthwash used for 30 sec twice a day
    Intervention: Drug: chlorhexidine gluconate
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
July 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult with threshold score of 2 on organoleptic halitosis evaluation

Exclusion Criteria:

  • Taking another experimental drug, or antibiotic.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00867035
PGP1
Yes
Milton Robert Wirthlin, DDS, MS, Department of Orofacial Sciences, UCSF
University of California, San Francisco
 
Principal Investigator: Milton R Wirthlin, DDS University of California, San Francisco
University of California, San Francisco
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP