Bad Breath Response to Tongue Scraper and Rinses

NCT ID: NCT00867035

Last Updated: 2013-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-06-30

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.

Conditions

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Halitosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Chlorhexidine gluconate and scraper

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Chlorine dioxide and scraper

Intervention Type DRUG

20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day

Interventions

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Chlorine dioxide and scraper

20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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"CloSYS" "Peridex"

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Milton R Wirthlin, DDS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCaliforniaSF

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22141237 (View on PubMed)

Other Identifiers

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PGP1

Identifier Type: -

Identifier Source: org_study_id

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