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Completed

NCT Number: NCT00867035

Bad Breath Response to Tongue Scraper and Rinses

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.

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Key information

Conditions

Halitosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCaliforniaSF

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult with threshold score of 2 on organoleptic halitosis evaluation

Exclusion criteria

  • Taking another experimental drug, or antibiotic.

Treatment and study plan

Chlorine dioxide and scraper

Drug

20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day

Other names: "CloSYS"

Chlorhexidine gluconate and scraper

Drug

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 names: "Peridex"

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 23, 2009
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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