Clinical trial NCT00867035: Bad Breath Response to Tongue Scraper and Rinses
Official title: Bad Breath Response to Tongue Scraper and Rinses, a Double-blind, Randomized, Parallel Group Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Halitosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-03-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 criteria: Inclusion Criteria:

* Adult with threshold score of 2 on organoleptic halitosis evaluation

Exclusion Criteria:

* Taking another experimental drug, or antibiotic.

Primary outcomes:
measure: Percentage of Participants With Rosenberg Score at Indicated Time Points
timeFrame: baseline, 1 hour, 2 hours, 4 hours, 1 week
Secondary outcomes:
measure: Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour
timeFrame: 1hr
measure: Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours
timeFrame: 2hr
measure: Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours
timeFrame: 4 hours
measure: Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week
timeFrame: 1 week
measure: Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour
timeFrame: 1 hour
measure: Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours
timeFrame: 2 hours
measure: Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours
timeFrame: 4 hours
measure: Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week
timeFrame: 1 week
measure: Number of Bacteria on Tongue at 1 Week
timeFrame: 1 week
measure: Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate
timeFrame: 1 week
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCaliforniaSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Milton R Wirthlin, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wirthlin MR, Im T, Ellis RR, Hoover CI. Effect of tongue scraper and rinses on bad breath, a double-blind, randomized, parallel group clinical trial. J West Soc Periodontol Periodontal Abstr. 2011;59(3):67-73. No abstract available.