Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT02221856
Status:
UNKNOWN
Last Update Posted:
2017-02-09
First Post:
2014-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Appliance Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2014-08-15', 'studyFirstSubmitQcDate': '2014-08-19', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discrepancy between predicated and actual tooth positions', 'timeFrame': 'up to 12 months'}], 'secondaryOutcomes': [{'measure': 'assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system', 'timeFrame': 'up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Conventional orthodontic treatment', 'Motion View'], 'conditions': ['Malocclusion']}, 'descriptionModule': {'briefSummary': "Technological advances have made computer aided orthodontic treatment planning possible. 3D dental scanners and software make it possible to design and approve the outcome before treatment begins. Manufacturers have provided different customized appliance systems that would help practitioners achieve those computer-designed outcomes. The purpose of this study is to determine the accuracy of computer-guided indirect bonding of orthodontic brackets at achieving the predicted alignment and comparing that to the accuracy of conventional orthodontic bracket placement at achieving a predetermined goal. The results of this study will help orthodontists and patients know if there is an advantage to using custom appliances. The study will be a prospective clinical study and will include a total of 60 arches from 30 patients enrolled at the Harvard School of Dental Medicine. 15 patients will be assigned to each of the two study groups (Motion View or control). Both groups will have a 3D intra-oral scan to measure the initial discrepancy and determine the computer-simulated design that the orthodontist believes is the optimized outcome. At the end of each patient's participation, a 3D intraoral scan will be taken and used to assess intra-arch leveling and alignment using ABO's objective grading system's criteria for alignment, marginal ridges and buccolingual inclination. Each arch will then be superimposed on the predicted outcome to determine how accurate each system was at achieving the planned movements in all 3 dimensions. We hypothesize that the accuracy of computer-guided indirect bonding (Motion View) at achieving the predicted outcomes will differ in comparison to the accuracy of conventional orthodontic bracket placement at achieving a predetermined goal."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects seeking orthodontic care\n* All permanent teeth must be erupted, excluding second and third molars\n* Class I, II, and III cases\n* No more than 7 mm crowding\n* No more than 45 degrees of rotations\n\nExclusion Criteria:\n\n* Presence of systemic disease\n* Craniofacial anomalies, including cleft lip and palate\n* Syndromes affecting bone or teeth\n* Congenitally missing teeth, excluding third molars\n* Presence of bridges or implants\n* Periodontal disease\n* Use of drugs affecting tooth movement or bone metabolism (NSAIDS, bisphosphonates, PTH, corticosteroids)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02221856', 'briefTitle': 'A Comparison of the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Appliance Placement', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Dental Medicine'}, 'officialTitle': 'A Prospective Clinical Trial Comparing the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Orthodontic Appliance Placement', 'orgStudyIdInfo': {'id': 'Masoud-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motion View', 'interventionNames': ['Procedure: Motion View']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Orthodontic Treatment', 'interventionNames': ['Procedure: Conventional Orthodontic Treatment']}], 'interventions': [{'name': 'Motion View', 'type': 'PROCEDURE', 'description': "Motion View, a software we are using to place brackets virtually on a 3D rendition of a patients teeth, will be used to indirectly bond brackets onto patient's teeth with a 3D printed plastic transfer JIG in which the brackets will be precisely placed on the patients teeth according to the computer-guided software.", 'armGroupLabels': ['Motion View']}, {'name': 'Conventional Orthodontic Treatment', 'type': 'PROCEDURE', 'description': 'orthodontic treatment using non-customized brackets and stock wires', 'armGroupLabels': ['Conventional Orthodontic Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mohamed Masoud', 'role': 'CONTACT'}, {'name': 'Mohamed Masoud, BDS, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Harvard School of Dental Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Mohamed Masoud, BDS, DMSc', 'role': 'CONTACT', 'email': 'Mohamed_Masoud@hsdm.harvard.edu', 'phone': '617-432-4281'}], 'overallOfficials': [{'name': 'Mohamed Masoud, BDS, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Dental Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Dental Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Masoud', 'investigatorAffiliation': 'Harvard School of Dental Medicine'}}}}