Bad Breath Response to Tongue Scraper and Rinses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00867035
First received: March 20, 2009
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Halitosis
Drug: Chlorine dioxide and scraper
Drug: Chlorhexidine gluconate and scraper

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bad Breath Response to Tongue Scraper and Rinses, a Double-blind, Randomized, Parallel Group Clinical Trial.

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Percentage of Participants With Rosenberg Score at Indicated Time Points [ Time Frame: baseline, 1 hour, 2 hours, 4 hours, 1 week ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour [ Time Frame: 1hr ] [ Designated as safety issue: No ]
    Using portable gas chromatograph

  • Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours [ Time Frame: 2hr ] [ Designated as safety issue: No ]
    Using portable gas chromatograph

  • Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Using portable gas chromatograph

  • Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Using portable gas chromatograph

  • Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Using portable gas chromatograph

  • Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Using portable gas chromatograph

  • Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Using portable gas chromatograph

  • Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Using portable gas chromatograph

  • Number of Bacteria on Tongue at 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chlorhexidine gluconate and scraper
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.
Drug: Chlorhexidine gluconate and scraper
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 Name: "Peridex"
Experimental: Chlorine dioxide and scraper
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.
Drug: Chlorine dioxide and scraper
20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day
Other Name: "CloSYS"

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult with threshold score of 2 on organoleptic halitosis evaluation

Exclusion Criteria:

  • Taking another experimental drug, or antibiotic.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867035

Locations
United States, California
UCaliforniaSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Milton R Wirthlin, DDS University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00867035     History of Changes
Other Study ID Numbers: PGP1
Study First Received: March 20, 2009
Results First Received: July 1, 2009
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms
Chlorhexidine
Chlorhexidine gluconate
Chlorine dioxide
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Dental Disinfectants

ClinicalTrials.gov processed this record on April 17, 2014