Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT05038293
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2021-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Plaque Removal of a Novel Brushing Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ddaubert@uw.edu', 'phone': '206-685-3766', 'title': 'Dr. Diane Daubert', 'organization': 'University of Washington Department of Periodontics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'baseline visit up to 1.5 hours. (study was one visit only)', 'description': 'definition does not differ', 'eventGroups': [{'id': 'EG000', 'title': 'Automated Mouthpiece-based Toothbrush', 'description': 'Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink.\n\nAutomated mouthpiece-based toothbrush: One-time use during study visit.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 2, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Manual Toothbrush', 'description': 'Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water.\n\nManual toothbrush: One-time use during study visit.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'minor abrasion', 'notes': 'minor soft tissue abrasion from brushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Automated Mouthpiece-based Toothbrush', 'description': 'Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink.\n\nAutomated mouthpiece-based toothbrush: One-time use during study visit.'}, {'id': 'OG001', 'title': 'Manual Toothbrush', 'description': 'Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water.\n\nManual toothbrush: One-time use during study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '.287', 'upperLimit': '.293'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '.578', 'upperLimit': '.628'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline,1 minute after brushing', 'description': 'Average Change from baseline plaque index after brushing with the automated mouthpiece-based brushing device versus a manual toothbrush. The Turesky Modification of the Quigley-Hein Plaque Index evaluates 6 areas per tooth and gives a score from 0-5 with 0 being no plaque and 5 being the highest amount of plaque and the average score for all sites was used for analysis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'participants aged 5-17 years'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Automated Mouthpiece-based Toothbrush', 'description': 'Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink.\n\nAutomated mouthpiece-based toothbrush: One-time use during study visit.'}, {'id': 'OG001', 'title': 'Manual Toothbrush', 'description': 'Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water.\n\nManual toothbrush: One-time use during study visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 1 minute after brushing', 'description': 'Number of participants with soft tissue abrasion after brushing with the automated mouthpiece-based.brushing device versus a manual toothbrush. An intraoral soft tissue examination will be done before and after brushing and a binary scale will be used to note any areas of abrasion (yes or no). Outcome is the presence of any soft tissue abrasion that was not present prior to brushing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '5-17 year old subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Automated Mouthpiece-based Toothbrush', 'description': 'Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink.\n\nAutomated mouthpiece-based toothbrush: One-time use during study visit.'}, {'id': 'FG001', 'title': 'Manual Toothbrush', 'description': 'Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water.\n\nManual toothbrush: One-time use during study visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'device was not operating properly for one subject.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'one subject was dropped due to a behavioral issue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'subjects were recruited via flyers posted at the Center for Pediatric Dentistry at the University of Washington. If parents were interested they contacted the study coordinator for a phone screening.', 'preAssignmentDetails': '62 parents called for a phone screening. Of those,48 subjects presented for the first appointment but 6 were not enrolled due to not meeting inclusion and exclusion criteria. 42 subjects were consented and enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Automated Mouthpiece-based Toothbrush', 'description': 'Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink.\n\nAutomated mouthpiece-based toothbrush: One-time use during study visit.'}, {'id': 'BG001', 'title': 'Manual Toothbrush', 'description': 'Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water.\n\nManual toothbrush: One-time use during study visit.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '17'}, {'value': '10.8', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '17'}, {'value': '10.45', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'description': 'age, continuous', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '24 were enrolled but 2 dropped'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-07', 'size': 370511, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-25T17:43', 'hasProtocol': True}, {'date': '2021-05-14', 'size': 133377, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-25T17:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessors and the principal investigator will be blind to toothbrush device assignment. In order to maintain blinding and eliminate assessor bias, study team members instructing and observing participants in the use of the assigned toothbrushing device will not be outcomes assessors.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-blind, parallel group, randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2021-07-22', 'resultsFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-30', 'studyFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index', 'timeFrame': 'baseline,1 minute after brushing', 'description': 'Average Change from baseline plaque index after brushing with the automated mouthpiece-based brushing device versus a manual toothbrush. The Turesky Modification of the Quigley-Hein Plaque Index evaluates 6 areas per tooth and gives a score from 0-5 with 0 being no plaque and 5 being the highest amount of plaque and the average score for all sites was used for analysis.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush', 'timeFrame': 'baseline, 1 minute after brushing', 'description': 'Number of participants with soft tissue abrasion after brushing with the automated mouthpiece-based.brushing device versus a manual toothbrush. An intraoral soft tissue examination will be done before and after brushing and a binary scale will be used to note any areas of abrasion (yes or no). Outcome is the presence of any soft tissue abrasion that was not present prior to brushing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Gingivitis', 'toothbrushing', 'oral hygiene', 'biofilm'], 'conditions': ['Dental Plaque']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to compare how a novel, automated mouthpiece-based toothbrushing device removes dental plaque compared to a manual toothbrush.', 'detailedDescription': 'Plaque is one of the main etiological factors in dental decay and the principal etiological factor for periodontal diseases. Although toothbrushes have greatly evolved, dexterity is still the key component to an efficient cleaning routine. The primary goal is to examine 60 participants to determine the efficacy of a new powered teeth cleaning device designed to bypass the variability of individual dexterity compared with manual toothbrushing.\n\nThis is a single-blind, randomized controlled trial. Sixty pediatric patients will be recruited for the study and randomized into treatment and control groups, subdivided into primary (20), mixed (20), and permanent dentition (20). Participants will be asked to abstain from brushing, flossing, gum or mouthwash use for 24 hours prior to the study visit. Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index before and after a one-time brushing with the assigned study device. A soft tissue assessment will be conducted and intraoral photos taken pre- and post-brushing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 5-17\n* In good general health\n* Fluent in English\n* Parent or guardian willing and able to provide written informed consent\n* Have 16 scorable teeth (non-crown/bridge/or full amalgams)\n* Have had a dental cleaning and exam in the past 24 months\n\nExclusion Criteria:\n\n* Advanced periodontal disease or severe gum disease\n* Mouth or teeth pain that prevents brushing in any areas\n* Intraoral piercings (tongue or lip) that cannot be removed\n* Non-controlled diabetes\n* Any autoimmune or infectious disease or any medical condition that would delay wound healing\n* Untreated visible cavities or untreated dental work\n* Oral or gum surgery in the previous 2 months\n* Take antibiotic premedication for dental procedures\n* Undergoing or require extensive dental or orthodontic treatment\n* Current smoker\n* Generalized recession over 1mm'}, 'identificationModule': {'nctId': 'NCT05038293', 'briefTitle': 'Efficacy of Plaque Removal of a Novel Brushing Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Efficacy of Plaque Removal of a Novel Brushing Device Compared to a Manual Toothbrush', 'orgStudyIdInfo': {'id': 'STUDY00013154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Automated mouthpiece-based toothbrush', 'description': 'Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink.', 'interventionNames': ['Device: Automated mouthpiece-based toothbrush']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual toothbrush', 'description': 'Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water.', 'interventionNames': ['Device: Manual toothbrush']}], 'interventions': [{'name': 'Automated mouthpiece-based toothbrush', 'type': 'DEVICE', 'otherNames': ['Novel toothbrushing device'], 'description': 'One-time use during study visit.', 'armGroupLabels': ['Automated mouthpiece-based toothbrush']}, {'name': 'Manual toothbrush', 'type': 'DEVICE', 'description': 'One-time use during study visit.', 'armGroupLabels': ['Manual toothbrush']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington, School of Dentistry, Regional Clinical Dental Research Center (RCDRC)', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Diane M Daubert, RDH, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor: School of Dentistry', 'investigatorFullName': 'Diane M Daubert RDH, MS, PhD', 'investigatorAffiliation': 'University of Washington'}}}}