Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02030002
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2013-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tgruenhe@umn.edu', 'phone': '612-625-3903', 'title': 'Thorsten Gruenheid', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'APC Flash-Free Adhesive Coated Appliance System', 'description': 'APC Flash-Free Adhesive Coated Appliance System\n\nAPC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System\n\nOnly the 45 participants who received treatment are included in the adverse event reporting.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'APC II Adhesive Coated Appliance System', 'description': 'APC II Adhesive Coated Appliance System\n\nAPC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System\n\nOnly the 45 participants who received treatment are included in the adverse event reporting.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bonding Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APC Flash-Free Adhesive Coated Appliance System', 'description': 'APC Flash-Free Adhesive Coated Appliance System\n\nAPC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System'}, {'id': 'OG001', 'title': 'APC II Adhesive Coated Appliance System', 'description': 'APC II Adhesive Coated Appliance System\n\nAPC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System'}], 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At appliance placement, 30 minutes', 'description': 'The time taken to bond each tooth was timed to the nearest second using a digital stopwatch. Timing was started after enamel surface preparation and stopped before light curing. Outcome reported in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the treatment are included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Bond Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APC Flash-Free Adhesive Coated Appliance System', 'description': 'APC Flash-Free Adhesive Coated Appliance System\n\nAPC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System'}, {'id': 'OG001', 'title': 'APC II Adhesive Coated Appliance System', 'description': 'APC II Adhesive Coated Appliance System\n\nAPC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year post treatment', 'description': 'Bond failure (yes or no) was recorded at standardized appointments at intervals of 4 weeks. Outcome is reported as the cumulative number of failed bracket bonds across all participants at 1 year post-treatment.', 'unitOfMeasure': 'failed bracket bonds', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 45 participants who completed treatment, 43 completed the follow-up period and are included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APC Flash-Free Adhesive Coated Appliance System', 'description': 'APC Flash-Free Adhesive Coated Appliance System\n\nAPC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System'}, {'id': 'OG001', 'title': 'APC II Adhesive Coated Appliance System', 'description': 'APC II Adhesive Coated Appliance System\n\nAPC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System'}], 'classes': [{'categories': [{'measurements': [{'value': '2.53', 'spread': '.36', 'groupId': 'OG000'}, {'value': '2.29', 'spread': '.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of treatment, 10 minutes.', 'description': 'In case of a bond failure, the adhesive remnant index (ARI) was scored. The ARI is a point-based system ranking: 0, no adhesive left on the tooth; 1, less than half of the adhesive left on the tooth; 2, more than half of the adhesive left on the tooth; and 3, all adhesive left on the tooth.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 45 participants who completed treatment, 43 completed the follow-up period. One additional participant is excluded from this analysis due to a change in treatment plan that made them eligible according to the inclusion/exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Time Required for Adhesive Remnant Cleanup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APC Flash-Free Adhesive Coated Appliance System', 'description': 'APC Flash-Free Adhesive Coated Appliance System\n\nAPC Flash-Free Adhesive Coated Appliance System: APC Flash-Free Adhesive Coated Appliance System'}, {'id': 'OG001', 'title': 'APC II Adhesive Coated Appliance System', 'description': 'APC II Adhesive Coated Appliance System\n\nAPC II Adhesive Coated Appliance System: APC II Adhesive Coated Appliance System'}], 'classes': [{'categories': [{'measurements': [{'value': '167.3', 'spread': '63.5', 'groupId': 'OG000'}, {'value': '215.1', 'spread': '79.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At completion of treatment, 30 minutes.', 'description': 'If adhesive remained after bracket de-bonding, then the time required to remove the remnant adhesive was measured using a digital stop-watch. Outcome is reported in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 45 participants who completed treatment, 43 completed the follow-up period. One additional participant is excluded from this analysis due to a change in treatment plan that made them eligible according to the inclusion/exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'This is a single-arm, split-mouth study. Participants receive both treatments at the same time. Participants had APC Flash-Free Adhesive Appliance System on one side of their mouth and APCII Adhesive Appliance System on the other side. The side allocation was randomized as follows. A randomization scheme with equal distribution of the two side allocations was generated using the online randomization tool at http://www.graphpad.com/quickcalcs. Allocation concealment was achieved with sequentially numbered, opaque sealed envelopes (SNOSE) containing the side allocation of the adhesives, which were prepared before the trial. An independent third party was responsible for opening the next envelope in sequence and implementing the randomization process.'}], 'periods': [{'title': 'Enrollment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Participant had change in treatment plan and no longer met the inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participants signed consent, but enrollment was completed before their treatment began.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}, {'title': 'APC Flash-Free Adhesive Coated Appliance', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'APC II Adhesive Coated Appliance System', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'This is a single-arm study. Participants receive both treatments at the same time. All participants are counted as one group at baseline.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'spread': '9.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who received the treatment are included. The 4 participants who signed a consent, but did not begin treatment are excluded.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-05-14', 'size': 228951, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-18T17:56', 'hasProtocol': False}, {'date': '2013-05-14', 'size': 463272, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-18T12:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Split-mouth'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-18', 'studyFirstSubmitDate': '2013-12-03', 'resultsFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2014-01-07', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-18', 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bonding Time', 'timeFrame': 'At appliance placement, 30 minutes', 'description': 'The time taken to bond each tooth was timed to the nearest second using a digital stopwatch. Timing was started after enamel surface preparation and stopped before light curing. Outcome reported in seconds.'}, {'measure': 'Bond Survival', 'timeFrame': '1 year post treatment', 'description': 'Bond failure (yes or no) was recorded at standardized appointments at intervals of 4 weeks. Outcome is reported as the cumulative number of failed bracket bonds across all participants at 1 year post-treatment.'}, {'measure': 'Amount of Adhesive Remaining on the Tooth Surface After Bracket Debonding', 'timeFrame': 'At completion of treatment, 10 minutes.', 'description': 'In case of a bond failure, the adhesive remnant index (ARI) was scored. The ARI is a point-based system ranking: 0, no adhesive left on the tooth; 1, less than half of the adhesive left on the tooth; 2, more than half of the adhesive left on the tooth; and 3, all adhesive left on the tooth.'}, {'measure': 'Time Required for Adhesive Remnant Cleanup', 'timeFrame': 'At completion of treatment, 30 minutes.', 'description': 'If adhesive remained after bracket de-bonding, then the time required to remove the remnant adhesive was measured using a digital stop-watch. Outcome is reported in seconds.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Malocclusion']}, 'referencesModule': {'references': [{'pmid': '30384932', 'type': 'DERIVED', 'citation': 'Grunheid T, Larson BE. Comparative assessment of bonding time and 1-year bracket survival using flash-free and conventional adhesives for orthodontic bracket bonding: A split-mouth randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Nov;154(5):621-628. doi: 10.1016/j.ajodo.2018.05.012.'}, {'pmid': '30230375', 'type': 'DERIVED', 'citation': 'Grunheid T, Larson BE. A comparative assessment of bracket survival and adhesive removal time using flash-free or conventional adhesive for orthodontic bracket bonding: A split-mouth randomized controlled clinical trial. Angle Orthod. 2019 Mar;89(2):299-305. doi: 10.2319/030918-195.1. Epub 2018 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare bonding time, bond survival, amount of adhesive remaining on the tooth surface after bracket debonding, and time required for adhesive remnant cleanup between a new "flash-free" and a conventional adhesive resin for orthodontic bracket bonding.', 'detailedDescription': 'Patients presenting for comprehensive orthodontic treatment with fixed appliances at the University of Minnesota, who are willing to participate, will be included in the initial study. Selection criteria will include full permanent dentition through the first molars, teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide, and no previous orthodontic treatment with fixed appliances. The patients will have their maxillary incisors, canines, and premolars bonded with ceramic orthodontic brackets pre-coated with a "flash-free" adhesive resin (Clarity Advanced Brackets APC flash-free, 3M Unitek, Monrovia, CA, USA) on one side and a conventional adhesive resin (Clarity Advanced Brackets APC II, 3M Unitek) on the other side. The side allocation and order of bonding will be randomized for each patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full permanent dentition including incisors, canines, premolars, and first molars\n* Teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide\n* No previous orthodontic treatment with fixed appliances\n\nExclusion Criteria:\n\n* Mental/emotional/developmental disability\n* Cleft lip and/or palate, craniofacial anomaly, or syndrome\n* Obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions\n* Prosthodontic or restored substrate extending on the labial surface of maxillary teeth\n* Known allergies to any acrylates contained in the study materials'}, 'identificationModule': {'nctId': 'NCT02030002', 'briefTitle': 'Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Use of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding: a Clinical Study of Bonding Time, Bond Survival, and Adhesive Remnant Cleanup', 'orgStudyIdInfo': {'id': '1/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APC Flash-Free Adhesive Coated Appliance System', 'description': 'APC Flash-Free Adhesive Coated Appliance System', 'interventionNames': ['Device: APC Flash-Free Adhesive Coated Appliance System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'APC II Adhesive Coated Appliance System', 'description': 'APC II Adhesive Coated Appliance System', 'interventionNames': ['Device: APC II Adhesive Coated Appliance System']}], 'interventions': [{'name': 'APC Flash-Free Adhesive Coated Appliance System', 'type': 'DEVICE', 'description': 'APC Flash-Free Adhesive Coated Appliance System', 'armGroupLabels': ['APC Flash-Free Adhesive Coated Appliance System']}, {'name': 'APC II Adhesive Coated Appliance System', 'type': 'DEVICE', 'description': 'APC II Adhesive Coated Appliance System', 'armGroupLabels': ['APC II Adhesive Coated Appliance System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Thorsten Gruenheid, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}