Clinical Trial: Bad Breath Response to Tongue Scraper and Rinses

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Bad Breath Response to Tongue Scraper and Rinses, a Double-blind, Randomized, Parallel Group Clinical Trial.

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.

Detailed Summary: 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.
Sponsor: University of California, San Francisco

Current Primary Outcome: 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.


Original Primary Outcome: organoleptic score [ Time Frame: one week ]

Current Secondary Outcome:

  • Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour [ Time Frame: 1hr ]
    Using portable gas chromatograph
  • Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours [ Time Frame: 2hr ]
    Using portable gas chromatograph
  • Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours [ Time Frame: 4 hours ]
    Using portable gas chromatograph
  • Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week [ Time Frame: 1 week ]
    Using portable gas chromatograph
  • Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour [ Time Frame: 1 hour ]
    Using portable gas chromatograph
  • Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours [ Time Frame: 2 hours ]
    Using portable gas chromatograph
  • Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours [ Time Frame: 4 hours ]
    Using portable gas chromatograph
  • Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week [ Time Frame: 1 week ]
    Using portable gas chromatograph
  • Number of Bacteria on Tongue at 1 Week [ Time Frame: 1 week ]
    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 ]


Original Secondary Outcome: concentration of volatile sulfur compounds in mouth air [ Time Frame: one week ]

Information By: University of California, San Francisco

Dates:
Date Received: March 20, 2009
Date Started: March 2008
Date Completion:
Last Updated: May 15, 2013
Last Verified: May 2013