Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT01250769
Status:
COMPLETED
Last Update Posted:
2012-09-19
First Post:
2010-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluating the Effect of Tooth Cleaning Devices on Oral Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wendy.jenkins@philips.com', 'phone': '425 908-1208', 'title': 'Director of Clinical Operations', 'organization': 'Philips Healthcare, Office of Medical and Health Affairs'}, 'certainAgreement': {'otherDetails': 'Philips shall have the final authority to determine whether or not to publish study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day.', 'otherNumAtRisk': 73, 'otherNumAffected': 0, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.', 'otherNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Apthous ulcer above tooth #7 on attached gingiva', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Left forearm deep vein thrombosis', 'notes': 'Assessed by the PI as definitely not related to the investigational product. SAE outcome was recovered/resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Residual Protein Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day.'}, {'id': 'OG001', 'title': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day.'}, {'id': 'OG002', 'title': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.'}, {'id': 'OG003', 'title': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '38.2'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '26.2', 'upperLimit': '29.8'}, {'value': '20.4', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '22.2'}, {'value': '20.2', 'groupId': 'OG003', 'lowerLimit': '15.6', 'upperLimit': '24.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days', 'description': 'Residual protein concentration of interproximal plaque samples', 'unitOfMeasure': 'ug/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.'}, {'type': 'SECONDARY', 'title': 'Residual Protein Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day.'}, {'id': 'OG001', 'title': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day.'}, {'id': 'OG002', 'title': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.'}, {'id': 'OG003', 'title': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000', 'lowerLimit': '33.2', 'upperLimit': '46.2'}, {'value': '36.2', 'groupId': 'OG001', 'lowerLimit': '33.7', 'upperLimit': '38.7'}, {'value': '33.6', 'groupId': 'OG002', 'lowerLimit': '31.1', 'upperLimit': '36.2'}, {'value': '33.9', 'groupId': 'OG003', 'lowerLimit': '27.4', 'upperLimit': '40.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'Residual protein concentration of interproximal plaque samples', 'unitOfMeasure': 'ug/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.'}, {'type': 'SECONDARY', 'title': 'Modified Gingival Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day.'}, {'id': 'OG001', 'title': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day.'}, {'id': 'OG002', 'title': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.'}, {'id': 'OG003', 'title': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '1.27', 'upperLimit': '1.63'}, {'value': '1.48', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '1.55'}, {'value': '1.26', 'groupId': 'OG002', 'lowerLimit': '1.19', 'upperLimit': '1.33'}, {'value': '1.39', 'groupId': 'OG003', 'lowerLimit': '1.21', 'upperLimit': '1.57'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days', 'description': 'Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.'}, {'type': 'SECONDARY', 'title': 'Modified Gingival Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day.'}, {'id': 'OG001', 'title': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day.'}, {'id': 'OG002', 'title': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.'}, {'id': 'OG003', 'title': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'groupId': 'OG000', 'lowerLimit': '1.18', 'upperLimit': '1.52'}, {'value': '1.44', 'groupId': 'OG001', 'lowerLimit': '1.38', 'upperLimit': '1.51'}, {'value': '1.23', 'groupId': 'OG002', 'lowerLimit': '1.17', 'upperLimit': '1.3'}, {'value': '1.41', 'groupId': 'OG003', 'lowerLimit': '1.24', 'upperLimit': '1.58'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.'}, {'type': 'SECONDARY', 'title': 'Gingival Bleeding Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day.'}, {'id': 'OG001', 'title': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day.'}, {'id': 'OG002', 'title': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.'}, {'id': 'OG003', 'title': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.28', 'upperLimit': '0.43'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.29'}, {'value': '0.18', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.21'}, {'value': '0.19', 'groupId': 'OG003', 'lowerLimit': '0.12', 'upperLimit': '0.27'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days', 'description': 'Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.'}, {'type': 'SECONDARY', 'title': 'Gingival Bleeding Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day.'}, {'id': 'OG001', 'title': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day.'}, {'id': 'OG002', 'title': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.'}, {'id': 'OG003', 'title': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.38'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.29'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '0.13', 'upperLimit': '0.19'}, {'value': '0.2', 'groupId': 'OG003', 'lowerLimit': '0.12', 'upperLimit': '0.27'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day.'}, {'id': 'FG001', 'title': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day.'}, {'id': 'FG002', 'title': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.'}, {'id': 'FG003', 'title': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Day 14', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '73'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '168', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day.'}, {'id': 'BG001', 'title': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day.'}, {'id': 'BG002', 'title': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.'}, {'id': 'BG003', 'title': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '12.60', 'groupId': 'BG000'}, {'value': '39.6', 'spread': '11.60', 'groupId': 'BG001'}, {'value': '39.6', 'spread': '10.90', 'groupId': 'BG002'}, {'value': '41.2', 'spread': '12.80', 'groupId': 'BG003'}, {'value': '39.6', 'spread': '11.30', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': '1 subject who discontinued prior to Day 14 is excluded from the Manual Toothbrush 2 group\n\n1 subject who discontinued prior to Day 14 is excluded from Manual Toothbrush + Interproximal Cleaning Device 1 group', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '1 subject who discontinued prior to Day 14 is excluded from the Manual Toothbrush 2 group\n\n1 subject who discontinued prior to Day 14 is excluded from Manual Toothbrush + Interproximal Cleaning Device 1 group', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-21', 'studyFirstSubmitDate': '2010-05-05', 'resultsFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2010-11-29', 'lastUpdatePostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-21', 'studyFirstPostDateStruct': {'date': '2010-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual Protein Concentration', 'timeFrame': '14 days', 'description': 'Residual protein concentration of interproximal plaque samples'}], 'secondaryOutcomes': [{'measure': 'Residual Protein Concentration', 'timeFrame': '28 days', 'description': 'Residual protein concentration of interproximal plaque samples'}, {'measure': 'Modified Gingival Index', 'timeFrame': '14 days', 'description': 'Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)'}, {'measure': 'Modified Gingival Index', 'timeFrame': '28 days', 'description': 'Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)'}, {'measure': 'Gingival Bleeding Index', 'timeFrame': '14 days', 'description': 'Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)'}, {'measure': 'Gingival Bleeding Index', 'timeFrame': '28 days', 'description': 'Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental', 'dentist', 'plaque', 'IP Cleaning'], 'conditions': ['Dental Plaque']}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* are in good/excellent health;\n* are 18 - 70 years old;\n* have a minimum of 20 natural teeth (excluding 3rd molars);\n* have sufficient test sites;\n* have ≥ 20 bleeding sites;\n* are willing to participate and available for participation.\n\nExclusion Criteria:\n\n* have systemic diseases such as Down's syndrome, or known AIDS/HIV;\n* have insulin dependant Diabetes;\n* are pregnant or nursing by subject report;\n* have a cardiac pacemaker\n* are undergoing or require extensive dental or orthodontic treatment;\n* require antibiotic treatment for dental appointments;\n* have heavy deposits of calculus;\n* have severe gingivitis or periodontitis;\n* have extensive crown or bridge work and/or rampant decay;\n* currently use bleaching trays;\n* have any oral or extraoral piercing on lips or in mouth;\n* have a professional prophylaxis within 4 weeks of study;\n* participation in a prior study ≤ 20 days;\n* employed by a oral healthcare products company or research institution."}, 'identificationModule': {'nctId': 'NCT01250769', 'briefTitle': 'Evaluating the Effect of Tooth Cleaning Devices on Oral Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Oral Healthcare'}, 'officialTitle': 'Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health', 'orgStudyIdInfo': {'id': 'DRC-0703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Toothbrush 1', 'description': 'Manual Toothbrush used for 1 minute twice a day', 'interventionNames': ['Device: Manual Toothbrush']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Toothbrush 2', 'description': 'Manual Toothbrush used for 2 minutes twice a day', 'interventionNames': ['Device: Manual Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Manual Toothbrush + Interproximal Cleaning 1', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day', 'interventionNames': ['Device: Manual Toothbrush', 'Device: Interproximal Cleaning Device']}, {'type': 'EXPERIMENTAL', 'label': 'Manual Toothbrush + Interproximal Cleaning 2', 'description': 'Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day', 'interventionNames': ['Device: Manual Toothbrush', 'Device: Interproximal Cleaning Device']}], 'interventions': [{'name': 'Manual Toothbrush', 'type': 'DEVICE', 'otherNames': ['ADA Reference Toothbrush'], 'description': 'A standard size manual toothbrush to clean visible tooth surfaces', 'armGroupLabels': ['Manual Toothbrush + Interproximal Cleaning 1', 'Manual Toothbrush + Interproximal Cleaning 2', 'Manual Toothbrush 1', 'Manual Toothbrush 2']}, {'name': 'Interproximal Cleaning Device', 'type': 'DEVICE', 'otherNames': ['Philips AirFloss'], 'description': 'An electronic device that combines water and air to clean between the teeth', 'armGroupLabels': ['Manual Toothbrush + Interproximal Cleaning 1', 'Manual Toothbrush + Interproximal Cleaning 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'University Park Research Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}], 'overallOfficials': [{'name': 'Wendy Jenkins', 'role': 'STUDY_DIRECTOR', 'affiliation': 'POHC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Oral Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}