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Trial record 16 of 32 for:    Hydrogen Sulfide

Bad Breath Response to Tongue Scraper and Rinses

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ClinicalTrials.gov Identifier: NCT00867035
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Halitosis
Interventions Drug: Chlorine dioxide and scraper
Drug: Chlorhexidine gluconate and scraper
Enrollment 22
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.
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Period Title: Baseline to 1 Hour
Started 13 9
Completed 12 8
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Period Title: Baseline to 2 Hours
Started 12 8
Completed 12 8
Not Completed 0 0
Period Title: Baseline to 4 Hours
Started 12 8
Completed 12 8
Not Completed 0 0
Period Title: Baseline to 1 Week
Started 12 8
Completed 11 8
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper Total
Hide Arm/Group Description 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day Total of all reporting groups
Overall Number of Baseline Participants 13 9 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 9 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
9
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 9 participants 22 participants
Female
4
  30.8%
3
  33.3%
7
  31.8%
Male
9
  69.2%
6
  66.7%
15
  68.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 9 participants 22 participants
13 9 22
Rosenberg score of 2 or more   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 9 participants 22 participants
13 9 22
[1]
Measure Description: 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
1.Primary Outcome
Title Percentage of Participants With Rosenberg Score at Indicated Time Points
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
two judges score breath odor by Rosenberg scale 0 to 5. Score of 2 is threshold for malodor. participants randomly assigned, ITT.
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 13 9
Measure Type: Number
Unit of Measure: percentage of participants
Percentage with score of 2 or 3 at Baseline 96 74
Percentage with score of 0 or 1 at 1 hour 79 100
Percentage with score of 0 or 1 at 2 hours 79 94
Percentage with score of 0 or 1 at 4 hours 54 81
Percentage with score of 0 or 1 at 1 week 64 81
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper
Comments Rosenberg scores compared baseline to 1 hour by Mann-Whitney U test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Chlorhexidene Rinse and Tongue Scraper
Comments mann whitney u to compare rosenberg score baseline to 1 hour
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper
Comments baseline to 2 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper
Comments baseline to 4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper
Comments baseline to 1 week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Chlorhexidene Rinse and Tongue Scraper
Comments baseline to 2 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Chlorhexidene Rinse and Tongue Scraper
Comments baseline to 4 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Chlorhexidene Rinse and Tongue Scraper
Comments baseline to 1 week
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour
Hide Description Using portable gas chromatograph
Time Frame 1hr
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: parts per billion (ppb)
10.1  (18.6) 9.12  (13.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments Concentrations of H2S in mouth air at 1 hour analyzed between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours
Hide Description Using portable gas chromatograph
Time Frame 2hr
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 12 8
Mean (Standard Deviation)
Unit of Measure: parts per billion (ppb)
12.7  (12.9) 3.88  (7.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments Concentrations of H2S in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours
Hide Description Using portable gas chromatograph
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 12 8
Mean (Standard Deviation)
Unit of Measure: parts per billion (ppb)
12.7  (16.1) 7.0  (9.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments Concentrations of H2S in mouth air at 4 hours analyzed between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week
Hide Description Using portable gas chromatograph
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: parts per billion (ppb)
9.17  (13.1) 20.2  (29.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments Concentrations of H2S in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour
Hide Description Using portable gas chromatograph
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: parts per billion (ppb)
17.5  (27.0) 36.0  (51.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments Concentrations of MM in mouth air at 1 hour analyzed between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours
Hide Description Using portable gas chromatograph
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 12 8
Mean (Standard Deviation)
Unit of Measure: parts per billion
14.5  (27.4) 23.9  (33.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments Concentrations of MM in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours
Hide Description Using portable gas chromatograph
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 12 8
Mean (Standard Deviation)
Unit of Measure: parts per billion
14.4  (21.2) 6.88  (9.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments Concentrations of MM in mouth air at 4 hours analyzed between groups. Each time point was compared between groups by Students t test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week
Hide Description Using portable gas chromatograph
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: parts per billion
9.75  (16.6) 2.12  (3.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments Concentrtations of MM in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Number of Bacteria on Tongue at 1 Week
Hide Description Total viable count(TVC) in colony forming units(CFU) on anaerobe agar
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: colony forming units (CFU)
15500000  (25400000) 28400000  (65400000)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments 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 groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate
Hide Description [Not Specified]
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description:
20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: percentage black colonies
43.1  (22.8) 27.8  (15.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chlorine Dioxide Rinse and Tongue Scraper, Chlorhexidene Rinse and Tongue Scraper
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Hide Arm/Group Description 20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day 20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
All-Cause Mortality
Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chlorine Dioxide Rinse and Tongue Scraper Chlorhexidene Rinse and Tongue Scraper
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      1/9 (11.11%)    
Nervous system disorders     
Effect on taste threshhold *  0/13 (0.00%)  0 1/9 (11.11%)  1
*
Indicates events were collected by non-systematic assessment
Total number of subjects is less than the desired 50 persons; dimethyl sulfide measures distorted by materials in syringes; accuracy of portable gas chromatograph a concern.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Milton Robert Wirthlin, DDS, MS
Organization: Department of Orofacial Sciences, University of California, San Francisco
Phone: 415-476-1731
EMail: m.robert.wirthlin@ucsf.edu; ddsmmr@att.net
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00867035     History of Changes
Other Study ID Numbers: PGP1
First Submitted: March 20, 2009
First Posted: March 23, 2009
Results First Submitted: July 1, 2009
Results First Posted: May 16, 2013
Last Update Posted: May 16, 2013