Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-28 @ 12:24 PM
Study NCT ID:
NCT06188403
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2023-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057909', 'term': 'Orthognathic Surgery'}], 'ancestors': [{'id': 'D013515', 'term': 'Surgery, Oral'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-12-09', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic accuracy between postoperative plan and postoperative result.', 'timeFrame': 'one month', 'description': 'Cone Beam Computed tomography (CBCT) is used at 1 month to assess surgical outcome by comparing the clinical results with the virtually planned outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orthognathic', 'virtual planning', 'custom plates'], 'conditions': ['Orthognathic Surgery']}, 'descriptionModule': {'briefSummary': 'patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* . Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy.\n\nExclusion Criteria:\n\n1. Patients with acute infection at surgery site.\n2. Patient with Systemic disorders contraindicating surgery.\n3. Smokers.\n4. Alcohol or drug abuse is prohibited.\n5. patients who suffered from craniofacial syndrome.\n6. patients who had previous orthognathic surgery.\n7. patients who had previous maxillary or mandibular trauma'}, 'identificationModule': {'nctId': 'NCT06188403', 'acronym': 'customortho', 'briefTitle': 'Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Comparison of Radiographic Accuracy Between Pre-bent Titanium Plates and 3D Customized Titanium Plates After le Fort 1 Osteotomy in Orthognathic Surgery', 'orgStudyIdInfo': {'id': 'Orthognathic2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '(group one) will be treated with custom titanium plates and guide to reposition the maxilla', 'description': '7 patients are included in this arm. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate are placed to reposition the maxilla according to the virtual surgical planning.', 'interventionNames': ['Procedure: Orthognathic surgery (lefort1)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(group 2) will be treated with prebent titanium plates', 'description': '7 patients are included in this arm. le fort 1 osteotomy using surgical guide and pre-bent stock titanium plates are used after their adaptation on the model of postoperative plan.', 'interventionNames': ['Procedure: Orthognathic surgery (lefort1)']}], 'interventions': [{'name': 'Orthognathic surgery (lefort1)', 'type': 'PROCEDURE', 'otherNames': ['Dentofacial surgery'], 'description': 'Lefort 1 osteotomy to reposition the maxilla using two different techniques to achieve more accurate results , one with guide for cutting and placing pre bent stock plates and the other method using custom titanium plates with guide for cutting and placing the plate', 'armGroupLabels': ['(group 2) will be treated with prebent titanium plates', '(group one) will be treated with custom titanium plates and guide to reposition the maxilla']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21619', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University, Faculty of dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}