Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-04-12 @ 3:56 AM
Study NCT ID:
NCT00867035
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2009-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bad Breath Response to Tongue Scraper and Rinses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006209', 'term': 'Halitosis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025109', 'term': 'chlorine dioxide'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.robert.wirthlin@ucsf.edu; ddsmmr@att.net', 'phone': '415-476-1731', 'title': 'Milton Robert Wirthlin, DDS, MS', 'organization': 'Department of Orofacial Sciences, University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Effect on taste threshhold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Rosenberg Score at Indicated Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'title': 'Percentage with score of 2 or 3 at Baseline', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Percentage with score of 0 or 1 at 1 hour', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Percentage with score of 0 or 1 at 2 hours', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Percentage with score of 0 or 1 at 4 hours', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Percentage with score of 0 or 1 at 1 week', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'Rosenberg scores compared baseline to 1 hour by Mann-Whitney U test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'mann whitney u to compare rosenberg score baseline to 1 hour', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'baseline to 2 hours', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'baseline to 4 hours', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'baseline to 1 week', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'baseline to 2 hours', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'baseline to 4 hours', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'baseline to 1 week', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, 1 hour, 2 hours, 4 hours, 1 week', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'two judges score breath odor by Rosenberg scale 0 to 5. Score of 2 is threshold for malodor. participants randomly assigned, ITT.'}, {'type': 'SECONDARY', 'title': 'Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '9.12', 'spread': '13.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Concentrations of H2S in mouth air at 1 hour analyzed between groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1hr', 'description': 'Using portable gas chromatograph', 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '7.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Concentrations of H2S in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2hr', 'description': 'Using portable gas chromatograph', 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '9.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Concentrations of H2S in mouth air at 4 hours analyzed between groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'Using portable gas chromatograph', 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '9.17', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '29.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Concentrations of H2S in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Using portable gas chromatograph', 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '36.0', 'spread': '51.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Concentrations of MM in mouth air at 1 hour analyzed between groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'Using portable gas chromatograph', 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '33.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Concentrations of MM in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hours', 'description': 'Using portable gas chromatograph', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '9.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Concentrations of MM in mouth air at 4 hours analyzed between groups. Each time point was compared between groups by Students t test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'Using portable gas chromatograph', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '9.75', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '3.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Concentrtations of MM in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Using portable gas chromatograph', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Bacteria on Tongue at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '15500000', 'spread': '25400000', 'groupId': 'OG000'}, {'value': '28400000', 'spread': '65400000', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': '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', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Total viable count(TVC) in colony forming units(CFU) on anaerobe agar', 'unitOfMeasure': 'colony forming units (CFU)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'OG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': '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.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'unitOfMeasure': 'percentage black colonies', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'FG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}], 'periods': [{'title': 'Baseline to 1 Hour', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Baseline to 2 Hours', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Baseline to 4 Hours', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Baseline to 1 Week', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chlorine Dioxide Rinse and Tongue Scraper', 'description': '20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day'}, {'id': 'BG001', 'title': 'Chlorhexidene Rinse and Tongue Scraper', 'description': '20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Rosenberg score of 2 or more', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-15', 'studyFirstSubmitDate': '2009-03-20', 'resultsFirstSubmitDate': '2009-07-01', 'studyFirstSubmitQcDate': '2009-03-20', 'lastUpdatePostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-15', 'studyFirstPostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Rosenberg Score at Indicated Time Points', 'timeFrame': 'baseline, 1 hour, 2 hours, 4 hours, 1 week', '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.'}], 'secondaryOutcomes': [{'measure': 'Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour', 'timeFrame': '1hr', 'description': 'Using portable gas chromatograph'}, {'measure': 'Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours', 'timeFrame': '2hr', 'description': 'Using portable gas chromatograph'}, {'measure': 'Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours', 'timeFrame': '4 hours', 'description': 'Using portable gas chromatograph'}, {'measure': 'Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week', 'timeFrame': '1 week', 'description': 'Using portable gas chromatograph'}, {'measure': 'Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour', 'timeFrame': '1 hour', 'description': 'Using portable gas chromatograph'}, {'measure': 'Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours', 'timeFrame': '2 hours', 'description': 'Using portable gas chromatograph'}, {'measure': 'Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours', 'timeFrame': '4 hours', 'description': 'Using portable gas chromatograph'}, {'measure': 'Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week', 'timeFrame': '1 week', 'description': 'Using portable gas chromatograph'}, {'measure': 'Number of Bacteria on Tongue at 1 Week', 'timeFrame': '1 week', 'description': 'Total viable count(TVC) in colony forming units(CFU) on anaerobe agar'}, {'measure': 'Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Halitosis']}, 'referencesModule': {'references': [{'pmid': '22141237', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult with threshold score of 2 on organoleptic halitosis evaluation\n\nExclusion Criteria:\n\n* Taking another experimental drug, or antibiotic.'}, 'identificationModule': {'nctId': 'NCT00867035', 'briefTitle': 'Bad Breath Response to Tongue Scraper and Rinses', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Bad Breath Response to Tongue Scraper and Rinses, a Double-blind, Randomized, Parallel Group Clinical Trial.', 'orgStudyIdInfo': {'id': 'PGP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine gluconate and scraper', 'description': '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.', 'interventionNames': ['Drug: Chlorhexidine gluconate and scraper']}, {'type': 'EXPERIMENTAL', 'label': 'Chlorine dioxide and scraper', 'description': '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.', 'interventionNames': ['Drug: Chlorine dioxide and scraper']}], 'interventions': [{'name': 'Chlorine dioxide and scraper', 'type': 'DRUG', 'otherNames': ['"CloSYS"'], 'description': '20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day', 'armGroupLabels': ['Chlorine dioxide and scraper']}, {'name': 'Chlorhexidine gluconate and scraper', 'type': 'DRUG', 'otherNames': ['"Peridex"'], 'description': '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.', 'armGroupLabels': ['Chlorhexidine gluconate and scraper']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCaliforniaSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Milton R Wirthlin, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}