HalitosisNCT00867035
Bad Breath Response to Tongue Scraper and Rinses
A study testing Chlorine dioxide and scraper and Chlorhexidine gluconate and scraper in people with Halitosis, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- Chlorine dioxide and scraper and Chlorhexidine gluconate and scraper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult with threshold score of 2 on organoleptic halitosis evaluation
Who cannot join
- Taking another experimental drug, or antibiotic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Halitosis
- Being tested
- Chlorine dioxide and scraper, Chlorhexidine gluconate and scraper
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorine dioxide and scraperDrug
Also called "CloSYS"
20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day
Chlorhexidine gluconate and scraperDrug
Also called "Peridex"
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Chlorhexidine gluconate and scraper |
| 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. Receives: Drug: Chlorine dioxide and scraper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1 hour, 2 hours, 4 hours, 1 week
Secondary outcomes (10)
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour
Using portable gas chromatograph
Measured: 1hr
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours
Using portable gas chromatograph
Measured: 2hr
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours
Using portable gas chromatograph
Measured: 4 hours
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week
Using portable gas chromatograph
Measured: 1 week
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour
Using portable gas chromatograph
Measured: 1 hour
Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours
Using portable gas chromatograph
Measured: 2 hours
Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours
Using portable gas chromatograph
Measured: 4 hours
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week
Using portable gas chromatograph
Measured: 1 week
Number of Bacteria on Tongue at 1 Week
Total viable count(TVC) in colony forming units(CFU) on anaerobe agar
Measured: 1 week
Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HalitosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milton R Wirthlin, DDS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867035
- Sponsor's protocol ID
- PGP1
- Status last verified
- May 2013
- First submitted
- 20 Mar 2009
- Last updated
- 16 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 22141237
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bad Breath Response to Tongue Scraper and Rinses, a Double-blind, Randomized, Parallel Group Clinical Trial.
- ClinicalTrials.gov ID
- NCT00867035
- Acronym / sponsor ID
- PGP1
- Conditions
- Halitosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Posted 16 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine gluconate and scraper | Active comparator | Drug: Chlorhexidine gluconate and scraperThe 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. |
| Chlorine dioxide and scraper | Experimental | Drug: Chlorine dioxide and scraperThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult with threshold score of 2 on organoleptic halitosis evaluation
Key exclusion criteria (1 listed)
- Taking another experimental drug, or antibiotic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorine dioxide and scraperAlso: "CloSYS"20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day | Drug | Chlorine dioxide and scraper |
| Chlorhexidine gluconate and scraperAlso: "Peridex"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. | Drug | Chlorhexidine gluconate and scraper |
Primary outcome
Percentage of Participants With Rosenberg Score at Indicated Time Points
Time frame: baseline, 1 hour, 2 hours, 4 hours, 1 week
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.
10 secondary outcomes
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour
Time frame: 1hr
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours
Time frame: 2hr
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours
Time frame: 4 hours
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week
Time frame: 1 week
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour
Time frame: 1 hour
Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours
Time frame: 2 hours
Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours
Time frame: 4 hours
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week
Time frame: 1 week
Number of Bacteria on Tongue at 1 Week
Time frame: 1 week
Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22141237Wirthlin 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milton R Wirthlin, DDS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorine dioxide and scraper and Chlorhexidine gluconate and scraper in people with Halitosis, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Rosenberg Score at Indicated Time Points (time frame: baseline, 1 hour, 2 hours, 4 hours, 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00867035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2013.