N/A
N=22
Bad Breath Response to Tongue Scraper and Rinses
Halitosis
Bottom Line
View on ClinicalTrials.gov: NCT00867035 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Percentage of Participants With Rosenberg Score at Indicated Time Points — 96; 74; 79; 100 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chlorine dioxide and scraper (Drug); Chlorhexidine gluconate and scraper (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Rosenberg Score at Indicated Time Points |
96; 74; 79; 100; 79; 94 | <0.001 sig |
| SECONDARY Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour |
10.1; 9.12 | >0.05 |
| SECONDARY Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours |
12.7; 3.88 | >0.05 |
| SECONDARY Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours |
12.7; 7.0 | >0.05 |
| SECONDARY Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week |
9.17; 20.2 | >0.05 |
| SECONDARY Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour |
17.5; 36.0 | >0.05 |
| SECONDARY Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours |
14.5; 23.9 | >0.05 |
| SECONDARY Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours |
14.4; 6.88 | >0.05 |
| SECONDARY Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week |
9.75; 2.12 | >0.05 |
| SECONDARY Number of Bacteria on Tongue at 1 Week |
15500000; 28400000 | >0.05 |
| SECONDARY Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate |
43.1; 27.8 | >0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- Adult with threshold score of 2 on organoleptic halitosis evaluation
Exclusion Criteria
- Taking another experimental drug, or antibiotic.
Data sourced from ClinicalTrials.gov (NCT00867035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.