Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:24 AM
Study NCT ID:
NCT07318857
Status:
COMPLETED
Last Update Posted:
2026-01-06
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation of the Transfer Accuracy of Semi-Digital and Fully Digital Indirect Bonding Trays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Linear Transfer Accuracy', 'timeFrame': 'Immediately after the bonding procedure (Day 1)', 'description': 'Linear deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software.\n\nUnit of Measure: Millimeters'}, {'measure': 'Angular Transfer Accuracy', 'timeFrame': 'Immediately after the bonding procedure (Day 1)', 'description': 'Angular deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software.\n\nUnit of Measure: Degrees'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Indirect Bonding']}, 'descriptionModule': {'briefSummary': 'This randomized clinical study compares the transfer accuracy of semi-digital and fully digital indirect bonding trays in orthodontic treatment. Thirty-two patients were randomly divided into two groups to receive brackets bonded with either semi-digital trays (thermoformed on 3D printed models) or fully digital trays (directly 3D printed). The primary outcome measures are linear and angular deviations between the virtually planned and actual clinical bracket positions, analyzed using 3D superimposition techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 12-25 years in permanent dentition\n* Had a mild irregularity (≤ 3mm)\n* Requiring comprehensive fixed orthodontic treatment and had no previous orthodontic therapy\n* Not having malformed, excessively rotated, large restorations or missing teeth in the upper arch\n\nExclusion Criteria:\n\n* Inadequate oral hygiene\n* Had severe crowding\n* Systemic or craniofacial anomalies'}, 'identificationModule': {'nctId': 'NCT07318857', 'briefTitle': 'Clinical Investigation of the Transfer Accuracy of Semi-Digital and Fully Digital Indirect Bonding Trays', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Clinical Investigation of the Transfer Accuracy of Semi-Digital and Fully Digital Indirect Bonding Trays', 'orgStudyIdInfo': {'id': 'SU-ORTO-2542'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Semi-Digital Transfer Tray Group', 'description': 'Indirect bonding using transfer trays prepared by thermoforming over 3D printed models', 'interventionNames': ['Procedure: Semi-Digital Indirect Bonding']}, {'type': 'EXPERIMENTAL', 'label': 'Fully Digital Transfer Tray Group', 'description': 'Indirect bonding using directly 3D printed transfer trays designed in CAD software', 'interventionNames': ['Procedure: Fully Digital Indirect Bonding']}], 'interventions': [{'name': 'Semi-Digital Indirect Bonding', 'type': 'PROCEDURE', 'description': 'Bonding brackets using thermoformed transfer trays.', 'armGroupLabels': ['Semi-Digital Transfer Tray Group']}, {'name': 'Fully Digital Indirect Bonding', 'type': 'PROCEDURE', 'description': 'Bonding brackets using 3D printed transfer trays.', 'armGroupLabels': ['Fully Digital Transfer Tray Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Orthodontics, Faculty of Dentistry, Selcuk University', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ramazan Emre Karakoç', 'investigatorAffiliation': 'Selcuk University'}}}}