Bad Breath Response to Tongue Scraper and Rinses

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

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.

Study Overview

• Status: Completed
• Conditions: Halitosis
• Intervention / Treatment: Drug: Chlorhexidine gluconate and scraper; Drug: Chlorine dioxide and scraper

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCaliforniaSF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult with threshold score of 2 on organoleptic halitosis evaluation

Exclusion Criteria:

• Taking another experimental drug, or antibiotic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: "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 Names: "CloSYS"

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Milton R Wirthlin, DDS, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (Estimate): March 23, 2009

Study Record Updates

• Last Update Posted (Estimate): May 16, 2013
• Last Update Submitted That Met QC Criteria: May 15, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Halitosis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Dental Disinfectants; Chlorhexidine; Chlorhexidine gluconate; Chlorine dioxide
• Other Study ID Numbers: PGP1