Bad Breath Response to Tongue Scraper and Rinses
Primary Purpose
Halitosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorine dioxide and scraper
Chlorhexidine gluconate and scraper
Sponsored by
About this trial
This is an interventional treatment trial for Halitosis
Eligibility Criteria
Inclusion Criteria:
- Adult with threshold score of 2 on organoleptic halitosis evaluation
Exclusion Criteria:
- Taking another experimental drug, or antibiotic.
Sites / Locations
- UCaliforniaSF
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Chlorhexidine gluconate and scraper
Chlorine dioxide and scraper
Arm 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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With Rosenberg Score at Indicated Time Points
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
Using portable gas chromatograph
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours
Using portable gas chromatograph
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours
Using portable gas chromatograph
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week
Using portable gas chromatograph
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour
Using portable gas chromatograph
Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours
Using portable gas chromatograph
Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours
Using portable gas chromatograph
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week
Using portable gas chromatograph
Number of Bacteria on Tongue at 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
Full Information
NCT ID
NCT00867035
First Posted
March 20, 2009
Last Updated
May 15, 2013
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00867035
Brief Title
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
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine gluconate and scraper
Arm Type
Active Comparator
Arm 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.
Arm Title
Chlorine dioxide and scraper
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Chlorine dioxide and scraper
Other Intervention Name(s)
"CloSYS"
Intervention Description
20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate and scraper
Other Intervention Name(s)
"Peridex"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Rosenberg Score at Indicated Time Points
Description
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.
Time Frame
baseline, 1 hour, 2 hours, 4 hours, 1 week
Secondary Outcome Measure Information:
Title
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour
Description
Using portable gas chromatograph
Time Frame
1hr
Title
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours
Description
Using portable gas chromatograph
Time Frame
2hr
Title
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours
Description
Using portable gas chromatograph
Time Frame
4 hours
Title
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week
Description
Using portable gas chromatograph
Time Frame
1 week
Title
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour
Description
Using portable gas chromatograph
Time Frame
1 hour
Title
Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours
Description
Using portable gas chromatograph
Time Frame
2 hours
Title
Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours
Description
Using portable gas chromatograph
Time Frame
4 hours
Title
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week
Description
Using portable gas chromatograph
Time Frame
1 week
Title
Number of Bacteria on Tongue at 1 Week
Description
Total viable count(TVC) in colony forming units(CFU) on anaerobe agar
Time Frame
1 week
Title
Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult with threshold score of 2 on organoleptic halitosis evaluation
Exclusion Criteria:
Taking another experimental drug, or antibiotic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton R Wirthlin, DDS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCaliforniaSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22141237
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.
Results Reference
result
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Bad Breath Response to Tongue Scraper and Rinses
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