Halitosis
Conditions
Brief 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.
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.
Interventions
DRUGChlorine dioxide and scraper
20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day
DRUGChlorhexidine 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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult with threshold score of 2 on organoleptic halitosis evaluation
Exclusion criteria
* Taking another experimental drug, or antibiotic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Rosenberg Score at Indicated Time Points | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours | 2hr | Using portable gas chromatograph |
| Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours | 4 hours | Using portable gas chromatograph |
| Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week | 1 week | Using portable gas chromatograph |
| Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour | 1 hour | Using portable gas chromatograph |
| Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour | 1hr | Using portable gas chromatograph |
| Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours | 4 hours | Using portable gas chromatograph |
| Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week | 1 week | Using portable gas chromatograph |
| Number of Bacteria on Tongue at 1 Week | 1 week | Total viable count(TVC) in colony forming units(CFU) on anaerobe agar |
| Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate | 1 week | — |
| Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours | 2 hours | Using portable gas chromatograph |
Countries
United States
Participant flow
Recruitment details
Screening in dental clinic March 2008-March 2009. With organoleptic(OLT)score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S), subjects invited to enter clinical trial. Subjects numbered in sequence from a computer-generated table of random numbers.
Pre-assignment details
Exclusions: 1)Inability to return for evaluation, 2)inability to follow directions, 3) afflicted with systemic disease involving volatile sulfur compounds (VSC), 4)currently taking antibiotics, 5) using medicine in syrup form, 6) advanced periodontal disease, 7) smoker.
Participants by arm
| Arm | Count |
|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day | 13 |
| Chlorhexidene Rinse and Tongue Scraper 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day | 9 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline to 1 Hour | Withdrawal by Subject | 1 | 1 |
| Baseline to 1 Week | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Chlorine Dioxide Rinse and Tongue Scraper | Chlorhexidene Rinse and Tongue Scraper | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 9 Participants | 22 Participants |
| Region of Enrollment United States | 13 participants | 9 participants | 22 participants |
| Rosenberg score of 2 or more | 13 participants | 9 participants | 22 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 1 / 9 |
| serious Total, serious adverse events | 0 / 13 | 0 / 9 |
Outcome results
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.
Time frame: baseline, 1 hour, 2 hours, 4 hours, 1 week
Population: two judges score breath odor by Rosenberg scale 0 to 5. Score of 2 is threshold for malodor. participants randomly assigned, ITT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 0 or 1 at 1 hour | 79 percentage of participants |
| Chlorine Dioxide Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 0 or 1 at 4 hours | 54 percentage of participants |
| Chlorine Dioxide Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 0 or 1 at 2 hours | 79 percentage of participants |
| Chlorine Dioxide Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 0 or 1 at 1 week | 64 percentage of participants |
| Chlorine Dioxide Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 2 or 3 at Baseline | 96 percentage of participants |
| Chlorhexidene Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 0 or 1 at 1 week | 81 percentage of participants |
| Chlorhexidene Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 2 or 3 at Baseline | 74 percentage of participants |
| Chlorhexidene Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 0 or 1 at 1 hour | 100 percentage of participants |
| Chlorhexidene Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 0 or 1 at 2 hours | 94 percentage of participants |
| Chlorhexidene Rinse and Tongue Scraper | Percentage of Participants With Rosenberg Score at Indicated Time Points | Percentage with score of 0 or 1 at 4 hours | 81 percentage of participants |
Comparison: Rosenberg scores compared baseline to 1 hour by Mann-Whitney U test.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: mann whitney u to compare rosenberg score baseline to 1 hourp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: baseline to 2 hoursp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: baseline to 4 hoursp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: baseline to 1 weekp-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: baseline to 2 hoursp-value: <0.01Wilcoxon (Mann-Whitney)
Comparison: baseline to 4 hoursp-value: <0.01Wilcoxon (Mann-Whitney)
Comparison: baseline to 1 weekp-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour
Using portable gas chromatograph
Time frame: 1hr
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour | 10.1 parts per billion (ppb) | Standard Deviation 18.6 |
| Chlorhexidene Rinse and Tongue Scraper | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour | 9.12 parts per billion (ppb) | Standard Deviation 13.9 |
Comparison: Concentrations of H2S in mouth air at 1 hour analyzed between groups.p-value: >0.05t-test, 2 sided
Secondary
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week
Using portable gas chromatograph
Time frame: 1 week
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week | 9.17 parts per billion (ppb) | Standard Deviation 13.1 |
| Chlorhexidene Rinse and Tongue Scraper | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week | 20.2 parts per billion (ppb) | Standard Deviation 29.6 |
Comparison: Concentrations of H2S in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test.p-value: >0.05t-test, 2 sided
Secondary
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours
Using portable gas chromatograph
Time frame: 2hr
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours | 12.7 parts per billion (ppb) | Standard Deviation 12.9 |
| Chlorhexidene Rinse and Tongue Scraper | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours | 3.88 parts per billion (ppb) | Standard Deviation 7.57 |
Comparison: Concentrations of H2S in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test.p-value: >0.05t-test, 2 sided
Secondary
Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours
Using portable gas chromatograph
Time frame: 4 hours
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours | 12.7 parts per billion (ppb) | Standard Deviation 16.1 |
| Chlorhexidene Rinse and Tongue Scraper | Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours | 7.0 parts per billion (ppb) | Standard Deviation 9.99 |
Comparison: Concentrations of H2S in mouth air at 4 hours analyzed between groupsp-value: >0.05t-test, 2 sided
Secondary
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour
Using portable gas chromatograph
Time frame: 1 hour
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour | 17.5 parts per billion (ppb) | Standard Deviation 27 |
| Chlorhexidene Rinse and Tongue Scraper | Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour | 36.0 parts per billion (ppb) | Standard Deviation 51 |
Comparison: Concentrations of MM in mouth air at 1 hour analyzed between groupsp-value: >0.05t-test, 2 sided
Secondary
Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week
Using portable gas chromatograph
Time frame: 1 week
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week | 9.75 parts per billion | Standard Deviation 16.6 |
| Chlorhexidene Rinse and Tongue Scraper | Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week | 2.12 parts per billion | Standard Deviation 3.64 |
Comparison: Concentrtations of MM in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t testp-value: >0.05t-test, 2 sided
Secondary
Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours
Using portable gas chromatograph
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours | 14.5 parts per billion | Standard Deviation 27.4 |
| Chlorhexidene Rinse and Tongue Scraper | Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours | 23.9 parts per billion | Standard Deviation 33.5 |
Comparison: Concentrations of MM in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t testp-value: >0.05t-test, 2 sided
Secondary
Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours
Using portable gas chromatograph
Time frame: 4 hours
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours | 14.4 parts per billion | Standard Deviation 21.2 |
| Chlorhexidene Rinse and Tongue Scraper | Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours | 6.88 parts per billion | Standard Deviation 9.42 |
Comparison: Concentrations of MM in mouth air at 4 hours analyzed between groups. Each time point was compared between groups by Students t test.p-value: >0.05t-test, 2 sided
Secondary
Number of Bacteria on Tongue at 1 Week
Total viable count(TVC) in colony forming units(CFU) on anaerobe agar
Time frame: 1 week
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Number of Bacteria on Tongue at 1 Week | 15500000 colony forming units (CFU) | Standard Deviation 25400000 |
| Chlorhexidene Rinse and Tongue Scraper | Number of Bacteria on Tongue at 1 Week | 28400000 colony forming units (CFU) | Standard Deviation 65400000 |
Comparison: Counts of colony forming units from swab of 1square centimeter area on tongue at 1 week cultured on anaerobe plates for 1 week analyzed between groupsp-value: >0.05t-test, 2 sided
Secondary
Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate
Time frame: 1 week
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorine Dioxide Rinse and Tongue Scraper | Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate | 43.1 percentage black colonies | Standard Deviation 22.8 |
| Chlorhexidene Rinse and Tongue Scraper | Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate | 27.8 percentage black colonies | Standard Deviation 15.6 |
Comparison: Percentage of black colonies out of Total Viable Count cultured on anaerobe agar with lead acetate. Black colonies are those producing sulfides (H2S, MM)and creating black lead sulfide. Analyzed between groups. Groups compared at baseline and 1 week.p-value: >0.05t-test, 2 sided