Bad Breath Response to Tongue Scraper and Rinses

Halitosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867035
• Other study ID #: PGP1
• Status: Completed
• Phase: N/A
• First received: March 20, 2009
• Last updated: May 15, 2013
• Start date: March 2008
• Est. completion date: June 2009

Study information

• Verified date: May 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult with threshold score of 2 on organoleptic halitosis evaluation

Exclusion Criteria:

• Taking another experimental drug, or antibiotic.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Halitosis

Intervention

Drug:
• Chlorine dioxide and scraper
20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day
• 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.

Locations

Country	Name	City	State
United States	UCaliforniaSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline, 1 hour, 2 hours, 4 hours, 1 week	No
Secondary	Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour	Using portable gas chromatograph	1hr	No
Secondary	Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours	Using portable gas chromatograph	2hr	No
Secondary	Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours	Using portable gas chromatograph	4 hours	No
Secondary	Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week	Using portable gas chromatograph	1 week	No
Secondary	Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour	Using portable gas chromatograph	1 hour	No
Secondary	Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours	Using portable gas chromatograph	2 hours	No
Secondary	Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours	Using portable gas chromatograph	4 hours	No
Secondary	Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week	Using portable gas chromatograph	1 week	No
Secondary	Number of Bacteria on Tongue at 1 Week	Total viable count(TVC) in colony forming units(CFU) on anaerobe agar	1 week	No
Secondary	Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate		1 week	No