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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine gluconate and scraper | Active Comparator | 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. |
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| Chlorine dioxide and scraper | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorine dioxide and scraper | Drug | 20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milton R Wirthlin, DDS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCaliforniaSF | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22141237 | Result | 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. |
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Exclusions: 1)Inability to return for evaluation, 2)inability to follow directions, 3) afflicted with systemic disease involving volatile sulfur compounds (VSC), 4)currently taking antibiotics, 5) using medicine in syrup form, 6) advanced periodontal disease, 7) smoker.
Screening in dental clinic March 2008-March 2009. With organoleptic(OLT)score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S), subjects invited to enter clinical trial. Subjects numbered in sequence from a computer-generated table of random numbers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorine Dioxide Rinse and Tongue Scraper | 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day |
| FG001 | Chlorhexidene Rinse and Tongue Scraper | 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 1 Hour |
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| Baseline to 2 Hours |
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| Baseline to 4 Hours |
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| Baseline to 1 Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorine Dioxide Rinse and Tongue Scraper | 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day |
| BG001 | Chlorhexidene Rinse and Tongue Scraper |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | two judges score breath odor by Rosenberg scale 0 to 5. Score of 2 is threshold for malodor. participants randomly assigned, ITT. | Posted | Number | percentage of participants | baseline, 1 hour, 2 hours, 4 hours, 1 week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlorine Dioxide Rinse and Tongue Scraper | 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Effect on taste threshhold | Nervous system disorders | Non-systematic Assessment |
Total number of subjects is less than the desired 50 persons; dimethyl sulfide measures distorted by materials in syringes; accuracy of portable gas chromatograph a concern.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Milton Robert Wirthlin, DDS, MS | Department of Orofacial Sciences, University of California, San Francisco | 415-476-1731 | m.robert.wirthlin@ucsf.edu; ddsmmr@att.net |
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| ID | Term |
|---|---|
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C025109 | chlorine dioxide |
| C010882 | chlorhexidine gluconate |
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| 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. |
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| 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 |
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20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Rosenberg score of 2 or more | 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 | Number | participants |
|
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day |
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| Secondary | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour | Using portable gas chromatograph | ITT | Posted | Mean | Standard Deviation | parts per billion (ppb) | 1hr |
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| Secondary | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours | Using portable gas chromatograph | ITT | Posted | Mean | Standard Deviation | parts per billion (ppb) | 2hr |
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| Secondary | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours | Using portable gas chromatograph | ITT | Posted | Mean | Standard Deviation | parts per billion (ppb) | 4 hours |
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| Secondary | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week | Using portable gas chromatograph | ITT | Posted | Mean | Standard Deviation | parts per billion (ppb) | 1 week |
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| Secondary | Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour | Using portable gas chromatograph | ITT | Posted | Mean | Standard Deviation | parts per billion (ppb) | 1 hour |
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| Secondary | Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours | Using portable gas chromatograph | Posted | Mean | Standard Deviation | parts per billion | 2 hours |
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| Secondary | Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours | Using portable gas chromatograph | ITT | Posted | Mean | Standard Deviation | parts per billion | 4 hours |
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| Secondary | Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week | Using portable gas chromatograph | ITT | Posted | Mean | Standard Deviation | parts per billion | 1 week |
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| Secondary | Number of Bacteria on Tongue at 1 Week | Total viable count(TVC) in colony forming units(CFU) on anaerobe agar | ITT | Posted | Mean | Standard Deviation | colony forming units (CFU) | 1 week |
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| Secondary | Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate | ITT | Posted | Mean | Standard Deviation | percentage black colonies | 1 week |
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| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Chlorhexidene Rinse and Tongue Scraper | 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day | 0 | 9 | 1 | 9 |
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