Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-07 @ 11:35 AM
Study NCT ID:
NCT06850194
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008844', 'term': 'Micrognathism'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'skeletal stability', 'timeFrame': '6 months', 'description': 'Skeletal stability will be assessed by lateral cephalometric x-ray. It will be done pre operatively, immediate postoperative, and 6 months later'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mandibular Deficiency']}, 'descriptionModule': {'briefSummary': '* Patients will be collected from faculty of dentistry\n* bilateral vertical ramus osteotomy (VRO )with iliac graft group (group I):- 10 patients will be treated via VRO and iliac crest or\n* bilateral sagital spilt osteotomy (BSSO) group (group II):- 10 patients will be treated via BSSO\n* All patients will be studied by comprehensive clinical oral and maxillofacial examination and lateral cephalometric radiographic analyses, within 1 week before the surgery (T0), immediately after the surgery (T1), and 6 months after surgery (T2).\n* All lateral cephalometric radiographs and clinical photographs must be standardized for all cases.\n* After pre-surgical orthodontic treatment , a lateral cephalograph Will be obtained for planning the surgical movement of both jaws\n* Surgical models and surgical stent will be fabricated.\n* All surgical procedures will be performed under nasal intubation and general anesthesia to surgically reposition the maxilla in standard LeFort I setback fosteotomy; the BSSO group will be underwent BSSO, and VRO group will be underwent VRO\n* The bony segments will be fixed in the new position with the use of custom made plates (specific for each patient )'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with age above 18 years old suffered from skeletal class II with severe mandibular deficiency\n\nExclusion Criteria:\n\n* patients with chin deviation,\n* severe temporomandibular joint (TMJ) symptoms.\n* Sever periodontal disease\n* pregnancy,\n* previous mandibular surgery,\n* inability to follow-up for the study protocol'}, 'identificationModule': {'nctId': 'NCT06850194', 'briefTitle': 'Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'Evaluating the Efficacy of Vertical Ramus Osteotomy With Iliac Graft Versus Bilateral Sagittal Split Osteotomy for the Correction of Mandibular Deficiency in Skeletal Class II Cases Management. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral Sagittal Split Osteotomy Group', 'interventionNames': ['Procedure: bilateral sagittal splitting osteotomy']}, {'type': 'EXPERIMENTAL', 'label': 'vertical ramus osteotomy with iliac graft group', 'interventionNames': ['Procedure: vertical ramus osteotomy with iliac graft']}], 'interventions': [{'name': 'vertical ramus osteotomy with iliac graft', 'type': 'PROCEDURE', 'description': 'in the VRO group all patient will undergo vertical ramus osteotomy surgery with iliac graft to correct the sever mandibular defficiency', 'armGroupLabels': ['vertical ramus osteotomy with iliac graft group']}, {'name': 'bilateral sagittal splitting osteotomy', 'type': 'PROCEDURE', 'description': 'all patients in this group will undergo to bilateral sagittal split osteotomy to correct the sever mandibular deficiency', 'armGroupLabels': ['Bilateral Sagittal Split Osteotomy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Beni-seuf', 'state': 'Egypt', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'shaimaa m refahee', 'role': 'CONTACT', 'email': 'smr11@fayoum.edu.eg', 'phone': '0201227407987'}], 'facility': 'Beni-Suief University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor oral and maxillofacial surgery', 'investigatorFullName': 'Shaimaa Mohsen', 'investigatorAffiliation': 'Fayoum University'}}}}