Bad Breath Response to Tongue Scraper and Rinses

University of California San Francisco (UCSF)

Status: Completed

Conditions: Halitosis

Treatments: Drug: Chlorine dioxide and scraper; Drug: Chlorhexidine gluconate and scraper

Study type: Interventional

Funder types: Other

Identifiers

NCT00867035

PGP1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult with threshold score of 2 on organoleptic halitosis evaluation

Exclusion criteria

• Taking another experimental drug, or antibiotic.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

Chlorhexidine gluconate and scraper

Active Comparator group

Description:

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.

Treatment:

Drug: Chlorhexidine gluconate and scraper

Chlorine dioxide and scraper

Experimental group

Description:

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.

Treatment:

Drug: Chlorine dioxide and scraper