Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:52 AM
Study NCT ID:
NCT07454694
Status:
COMPLETED
Last Update Posted:
2026-03-06
First Post:
2025-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Of The Effects Of Clear Aligners And Twinblock Appliances In Functional Treatment Of Class II Malocclusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057887', 'term': 'Overbite'}], 'ancestors': [{'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}, {'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Cephalometric Measurements (mm and degrees) After Functional Appliance Therapy', 'timeFrame': 'Baseline and after completion of functional appliance therapy (approximately 7-13 months)', 'description': 'Cephalometric measurements will be evaluated on lateral cephalometric radiographs using a customized analysis derived from Steiner, McNamara, Tweed, Ricketts, and Arnett analyses.\n\nA total of 47 skeletal, dental, airway, hyoid, and soft tissue parameters will be assessed. Linear measurements will be recorded in millimeters (mm) and angular measurements in degrees. Landmarks will be manually identified on digital lateral cephalometric radiographs.'}, {'measure': 'Change from Baseline in Mandibular Bone Fractal Dimension Values After Functional Appliance Therapy', 'timeFrame': 'Baseline and after completion of functional appliance therapy (approximately 7-13 months)', 'description': 'Fractal dimension values will be calculated using the box-counting method on panoramic radiographs (mandibular condyle, angulus, and corpus) and lateral cephalometric radiographs (symphysis).\n\nFractal dimension is a unitless numerical value used to evaluate trabecular bone complexity. Higher values indicate greater trabecular complexity, whereas lower values indicate reduced trabecular structure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Class II malocclusion', 'Twinblock', 'clear aligners', 'mandibular advancement'], 'conditions': ['Class II Malocclusion', 'Mandibular Retrognathism']}, 'descriptionModule': {'briefSummary': 'This prospective clinical study aimed to compare the skeletal and dentofacial effects of Twin Block (TWB) and clear aligners with mandibular advancement, and to evaluate mandibular trabecular bone changes through fractal analysis (FA).', 'detailedDescription': 'A total of 34 patients with dentoskeletal Class II malocclusion were included in the study: 16 patients in the Invisalign® Mandibular Advancement (MA) group and 18 patients in the TWB group .Panoramic and lateral cephalometric radiographs were obtained at baseline(T0) and after functional treatment(T1). Skeletal, dental, and soft tissue structures were evaluated on the pretreatment and posttreatment radiographs using cephalometric analysis, while trabecular bone architecture was assessed by fractal analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Angle Class II molar and canine relationship\n* Overjet greater than 6 mm\n* Patients in the growth spurt period\n\nExclusion Criteria:\n\n* History of orthodontic treatment\n* Missing teeth\n* Patients in mixed dentition period\n* Systemic diseases affecting growth or bone metabolism'}, 'identificationModule': {'nctId': 'NCT07454694', 'briefTitle': 'Comparison Of The Effects Of Clear Aligners And Twinblock Appliances In Functional Treatment Of Class II Malocclusion', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Comparison Of The Effects Of Clear Aligners And Twinblock Appliances In Functional Treatment Of Class II Malocclusion', 'orgStudyIdInfo': {'id': '118118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clear Aligner Group', 'description': 'Mandibular advancement with clear aligners', 'interventionNames': ['Device: Invisalign Clear Aligners']}, {'type': 'EXPERIMENTAL', 'label': 'Twinblock Group', 'description': 'Mandibular Advancement with Twinblock Functional Appliance', 'interventionNames': ['Device: Twinblock Functional Appliance']}], 'interventions': [{'name': 'Invisalign Clear Aligners', 'type': 'DEVICE', 'description': 'Functional appliances are used for mandibular advancement in the treatment of mandibular retrognathia in orthodontics. The Twinblock is a conventional functional appliance, and nowadays mandibular advancement can also be achieved with clear aligners. In this study, these two appliances were used.', 'armGroupLabels': ['Clear Aligner Group']}, {'name': 'Twinblock Functional Appliance', 'type': 'DEVICE', 'description': 'Functional appliances are used for mandibular advancement in the treatment of mandibular retrognathia in orthodontics. The Twinblock is a conventional functional appliance, and nowadays mandibular advancement can also be achieved with clear aligners. In this study, these two appliances were used.', 'armGroupLabels': ['Twinblock Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ezgi Sunal Akturk, Assistant Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Saglik Bilimleri Universitesi'}, {'name': 'Gokmen Kurt, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Bezmialem Vakif University'}, {'name': 'Ahsen Irem Toktas, Research Assistant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}