Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2026-02-22 @ 7:25 AM
Study NCT ID:
NCT02187016
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2014-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003742', 'term': 'Dental Devices, Home Care'}], 'ancestors': [{'id': 'D003748', 'term': 'Dental Equipment'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009910', 'term': 'Oral Hygiene'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '702-901-444', 'title': 'Pejjmon Amini, DMD', 'organization': 'Silverstone Research Group'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Oral changes from baseline evaluated at Day 14 and 28', 'eventGroups': [{'id': 'EG000', 'title': 'AirFloss + Rinse1', 'description': 'AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.', 'otherNumAtRisk': 79, 'otherNumAffected': 2, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AirFloss + Rinse2', 'description': 'AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.', 'otherNumAtRisk': 78, 'otherNumAffected': 1, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'String Floss', 'description': 'String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute', 'otherNumAtRisk': 78, 'otherNumAffected': 1, 'seriousNumAtRisk': 78, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Manual Toothbrush', 'description': 'Manual Toothbrush is used twice a day for 1 minute', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gingival Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AirFloss + Rinse1', 'description': 'AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG001', 'title': 'AirFloss + Rinse2', 'description': 'AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG002', 'title': 'String Floss', 'description': 'String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute'}, {'id': 'OG003', 'title': 'Manual Toothbrush', 'description': 'Manual Toothbrush is used twice a day for 1 minute'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days', 'description': 'MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AirFloss + Rinse1', 'description': 'AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG001', 'title': 'AirFloss + Rinse2', 'description': 'AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG002', 'title': 'String Floss', 'description': 'String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute'}, {'id': 'OG003', 'title': 'Manual Toothbrush', 'description': 'Manual Toothbrush is used twice a day for 1 minute'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AirFloss + Rinse1', 'description': 'AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG001', 'title': 'AirFloss + Rinse2', 'description': 'AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG002', 'title': 'String Floss', 'description': 'String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute'}, {'id': 'OG003', 'title': 'Manual Toothbrush', 'description': 'Manual Toothbrush is used twice a day for 1 minute'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days', 'description': 'GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AirFloss + Rinse1', 'description': 'AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG001', 'title': 'AirFloss + Rinse2', 'description': 'AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG002', 'title': 'String Floss', 'description': 'String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute'}, {'id': 'OG003', 'title': 'Manual Toothbrush', 'description': 'Manual Toothbrush is used twice a day for 1 minute'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AirFloss + Rinse1', 'description': 'AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG001', 'title': 'AirFloss + Rinse2', 'description': 'AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG002', 'title': 'String Floss', 'description': 'String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute'}, {'id': 'OG003', 'title': 'Manual Toothbrush', 'description': 'Manual Toothbrush is used twice a day for 1 minute'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days', 'description': 'RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AirFloss + Rinse1', 'description': 'AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG001', 'title': 'AirFloss + Rinse2', 'description': 'AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'OG002', 'title': 'String Floss', 'description': 'String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute'}, {'id': 'OG003', 'title': 'Manual Toothbrush', 'description': 'Manual Toothbrush is used twice a day for 1 minute'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AirFloss + Rinse1', 'description': 'AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'FG001', 'title': 'AirFloss + Rinse2', 'description': 'AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'FG002', 'title': 'String Floss', 'description': 'String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute'}, {'id': 'FG003', 'title': 'Manual Toothbrush', 'description': 'Manual Toothbrush is used twice a day for 1 minute'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '287', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AirFloss + Rinse1', 'description': 'AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'BG001', 'title': 'AirFloss + Rinse2', 'description': 'AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.'}, {'id': 'BG002', 'title': 'String Floss', 'description': 'String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute'}, {'id': 'BG003', 'title': 'Manual Toothbrush', 'description': 'Manual Toothbrush is used twice a day for 1 minute'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '12.20', 'groupId': 'BG000'}, {'value': '35.6', 'spread': '10.70', 'groupId': 'BG001'}, {'value': '34.9', 'spread': '11.00', 'groupId': 'BG002'}, {'value': '35.1', 'spread': '12.10', 'groupId': 'BG003'}, {'value': '35.7', 'spread': '11.50', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '184', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '287', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', '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': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2014-07-01', 'resultsFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-23', 'studyFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14', 'timeFrame': '14 days', 'description': 'MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28', 'timeFrame': '28 days', 'description': 'MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).'}, {'measure': 'Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14', 'timeFrame': '14 days', 'description': 'GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).'}, {'measure': 'Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28', 'timeFrame': '28 days', 'description': 'GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).'}, {'measure': 'Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14', 'timeFrame': '14 days', 'description': 'RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).'}, {'measure': 'Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28', 'timeFrame': '28 days', 'description': 'RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gingivitis', 'plaque', 'interproximal cleaning', 'dental floss'], 'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be willing and physically able to carry out all study procedures and be available at all times required for participation\n* Be able to fully understand and comply with the written and verbal instructions provided\n* Provide written Informed Consent\n* Be age 18 - 65 years\n* Agree to return study materials at the required visits\n* Be a non-smoker\n* Have a minimum of 20 'scorable' teeth (excluding 3rd molars)\n* Have a minimum average plaque score of \\> 0.5 per RMNPI scoring with 2-6 hours of plaque accumulation\n* Have a Gingival Bleeding Index of -\\>1 on at least 10 sites\n* Be a regular manual toothbrush user\n* Be a non or irregular flosser defined as using dental floss or any other interproximal cleaning technique once per week or less often\n\nExclusion Criteria:\n\n* A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion\n* Pregnant or nursing per subject report\n* A medical condition requiring antibiotic pre-medication prior to dental appointments\n* Diagnosis of xerostomia\n* Any oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth\n* Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator /Examiner discretion\n* Oral surgery within the last 2 months\n* Current use of professionally dispensed bleaching products\n* A known allergy or sensitivity to products planned for use in this study\n* Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study\n* Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study\n* Participation in an oral care study within the previous 90 days\n* Be an employee or a relative of an employee of the Site clinical research department, dental school, or a dental products manufacturing, research or marketing firm\n* Are a dental student or dental professional\n* A cardiac pacemaker or implanted cardiac defibrillator\n* Insulin-Dependent Diabetes\n* Current use of antibiotic medications or use within 4 weeks of enrollment\n* Current use of prescription-dose anti-inflammatory medications or anticoagulants; (including aspirin \\> 81 mg daily)\n* Presence of advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion\n* Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion\n* Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner discretion\n* Presence of orthodontic bands interfering with efficacy outcome(s) per Investigator/Examiner discretion\n* Have a professional prophylaxis within 4 weeks of the study\n* Be a regular power toothbrush user"}, 'identificationModule': {'nctId': 'NCT02187016', 'briefTitle': 'Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Oral Healthcare'}, 'officialTitle': 'A Randomized, Parallel Design Study to Assess the Effects of Three Interproximal Cleaning Modalities Versus a Manual Toothbrush Control on Gingivitis and Plaque Following a Period of Home Use', 'orgStudyIdInfo': {'id': 'MAH-13-0151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AirFloss + BreathRx', 'description': 'Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with BreathRx rinse once a day.', 'interventionNames': ['Device: AirFloss + BreathRx']}, {'type': 'EXPERIMENTAL', 'label': 'AirFloss + Listerine', 'description': 'Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with Listerine Cool Mint rinse once a day.', 'interventionNames': ['Device: AirFloss + Listerine']}, {'type': 'EXPERIMENTAL', 'label': 'Dental Floss', 'description': 'Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day.', 'interventionNames': ['Device: Dental Floss']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Toothbrush', 'description': 'Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute', 'interventionNames': ['Device: Manual Toothbrush']}], 'interventions': [{'name': 'AirFloss + BreathRx', 'type': 'DEVICE', 'description': 'Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.', 'armGroupLabels': ['AirFloss + BreathRx']}, {'name': 'AirFloss + Listerine', 'type': 'DEVICE', 'description': 'Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.', 'armGroupLabels': ['AirFloss + Listerine']}, {'name': 'Dental Floss', 'type': 'DEVICE', 'description': 'Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.', 'armGroupLabels': ['Dental Floss']}, {'name': 'Manual Toothbrush', 'type': 'DEVICE', 'description': 'Manual Toothbrush used twice daily, 1 minute.', 'armGroupLabels': ['Manual Toothbrush']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89146', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Silverstone Research Group', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Pejmon Amini, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Silverston Research Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Oral Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}