Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-01-04 @ 12:30 AM
Study NCT ID:
NCT06631235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-21
First Post:
2024-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-10-06', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'CBCT evaluation of TMJ', 'timeFrame': 'one year', 'description': 'adverse effects of aesthetic functional appliance on the condylar head'}], 'primaryOutcomes': [{'measure': 'skeletal effects', 'timeFrame': 'one year', 'description': 'cephalometric linear and angular measurements'}, {'measure': 'dental effects', 'timeFrame': 'one year', 'description': 'cephalometric linear and angular measurements'}, {'measure': 'soft tissue effects', 'timeFrame': 'one year', 'description': 'cephalometric linear and angular measurements'}], 'secondaryOutcomes': [{'measure': 'root resorption', 'timeFrame': 'one year', 'description': 'root resorption measured from CBCT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['classII', 'mandibular advancement', 'twin block'], 'conditions': ['Skeletal Malocclusion']}, 'descriptionModule': {'briefSummary': 'The goal of this is to evaluate the skeletal, dental and soft tissue effects between aesthetic functional appliance and Twin block appliance in treatment of skeletal class II in ( growing male/female patients)', 'detailedDescription': 'The sample will be randomly divided into 2 equal groups according to the appliance will be used:\n\nGroup 1: Aesthetic Functional appliance Group 2: Twin block\n\nMethods:\n\n\\*Radiographs (CBCT) will be taken before starting the treatment (T1) and after obtaining Class I occlusion and normal overjet (T2) by sequential appliances.\n\nappliances.\n\n* Lateral cephalograms -extracted from CBCT- will be used to evaluate the effect of the two appliances.\n* CBCT will be used to evaluate root resorption and bony changes in the condyle .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skeletal Class II pattern with ANB angle exceeding 6° and Wits appraisal of 2 mm or more.\n* Mandibular deficiency (SNB angle less than 77°).\n* Growing patients.\n* No prior orthodontic intervention.\n* The vertical skeletal classification shows a horizontal or neutral growth pattern.\n* Overjet ≥ 8mm.\n\nExclusion Criteria:\n\n* Developmental abnormalities with atypical or irregular patterns of growth and maturation.\n* Any indications or manifestations, as well as any prior medical records, of Tempro-Mandibular Joint (TMJ) disorders, such as the presence of clicking, pain, limitations, or deviations.'}, 'identificationModule': {'nctId': 'NCT06631235', 'briefTitle': 'Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II: Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'A04070240R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'twin block group', 'description': 'patient treated with twin block appliance', 'interventionNames': ['Other: orthopedic appliance']}, {'type': 'EXPERIMENTAL', 'label': 'aesthetic functional group', 'description': 'patient treated with aesthetic functional appliance', 'interventionNames': ['Other: aesthetic orthopedic appliance']}], 'interventions': [{'name': 'orthopedic appliance', 'type': 'OTHER', 'description': 'appliances are used to correct skeletal class II due to mandibular deficiency', 'armGroupLabels': ['twin block group']}, {'name': 'aesthetic orthopedic appliance', 'type': 'OTHER', 'description': 'aesthetic appliances are used to correct skeletal class II due to mandibular deficiency', 'armGroupLabels': ['aesthetic functional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Rana Ka Abozeid, Doctor', 'role': 'CONTACT', 'email': 'ranaabuzaid52@gmail.com', 'phone': '01009389116'}], 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'rana ka Abuzaid, orthodontist', 'role': 'CONTACT', 'email': 'ranaabuzaid52@gmail.com', 'phone': '1009389116'}, {'name': 'khaled Ah Awad, surgon', 'role': 'CONTACT', 'email': 'khaled_awd2013@yahoo.com', 'phone': '1009297331'}], 'overallOfficials': [{'name': 'rana ka Abuzaid, orthodontist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Egyption orthodontic socity'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '2 years', 'ipdSharing': 'YES', 'description': 'skeletal and dental results', 'accessCriteria': 'mandibular advancement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}