Bad Breath Response to Tongue Scraper and Rinses

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Halitosis

Intervention / Treatment
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* Drug: Chlorine dioxide and scraper
* Drug: Chlorhexidine gluconate and scraper


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult with threshold score of 2 on organoleptic halitosis evaluation Exclusion Criteria: Taking another experimental drug, or antibiotic.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine gluconate and scraper<br>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<br>* 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.<br>* Other names: Peridex;|
| Experimental: Chlorine dioxide and scraper<br>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<br>* 20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day<br>* Other names: CloSYS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 1 hour, 2 hours, 4 hours, 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour | Using portable gas chromatograph | 1hr | 
| Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours | Using portable gas chromatograph | 2hr | 
| Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours | Using portable gas chromatograph | 4 hours | 
| Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week | Using portable gas chromatograph | 1 week | 
| Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour | Using portable gas chromatograph | 1 hour | 
| Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours | Using portable gas chromatograph | 2 hours | 
| Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours | Using portable gas chromatograph | 4 hours | 
| Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week | Using portable gas chromatograph | 1 week | 
| Number of Bacteria on Tongue at 1 Week | Total viable count(TVC) in colony forming units(CFU) on anaerobe agar | 1 week | 
| Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate |  | 1 week |