Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT06392204
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008337', 'term': 'Mandibular Fractures'}], 'ancestors': [{'id': 'D007572', 'term': 'Jaw Fractures'}, {'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-28', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-04-28', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Guide accuracy in repositioning of the fractured segments and in comparison to the preoperative 3D virtual surgical plan.', 'timeFrame': 'Outcome will be assessed with preoperative CT (T1-Week 1)immediate postoperative CT at (T3-Week 3)', 'description': 'Accuracy of postoperative reduction by superimposition of 3D CT data on a 3D specialized software'}], 'secondaryOutcomes': [{'measure': 'Postoperative occlusion', 'timeFrame': 'Outcome will be assessed clinically at T2 (Week 2) and T3 (Week 3)', 'description': 'Assessment of postoperative occlusion clinically using a millimeter caliper, occlusion will be categorized into; satisfactory (no gap), mild derangement (gap of 1-2 mm) and deranged (gap more than 2 mm)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mandibular Fractures']}, 'descriptionModule': {'briefSummary': 'This proposed study aims at creating a computer designed patient specific device and titanium plates, that are 3D manufactured in accordance to a preoperative computer aided virtual surgical procedure, aiming to obtain proper alignment of fractured segments of the lower jaw and restore proper teeth positioning therefore overcoming the possible complications of the conventional methods.\n\nRecruited participants will be randomly allocated to a treatment groupp, whether the novel method group or a standard treatment group.\n\nPreoperative panoramic radiograph and a Computed tomography scan will be obtained for each patient.\n\nSurgical procedure will be conducted unde general anesthetic. Medications will be prescribed after surgery and instructions will be given to each patient.\n\nFollow up will be on a weekly basis for the first 6 weeks followed by a followup visit once a month for 6 months.\n\nPostoperative panoramic radiograph and a Computed tomography scan will be obtained at 1 week after the surgical procrdure and again 6 months later.\n\nDigital data obtained from computed tomography scans along with clinical data will be analysed and studied to determine the accuracy of the computer aided device and for comparison with the standard method of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with unilateral mandibular angle fracture with or without associated mandibular fractures in need of open reduction and internal fixation.\n2. Patients above 18 years old\n3. Sufficient dentition to reproduce the occlusal relationships\n4. Patient's consent to participate\n\nExclusion Criteria:\n\n1. Patients with comminuted mandibular angle fracture(s)\n2. Patients with any systemic disease that may affect normal healing\n3. Patients undergoing chemotherapy or radiotherapy related to the head and neck region\n4. Intra-bony lesions in the fracture area that may interfere with proper anatomical reduction."}, 'identificationModule': {'nctId': 'NCT06392204', 'briefTitle': "CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique", 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': "Assessment of Mandibular CAD/CAM Angle Fracture Reduction/Plate Guide and Customized 3D Grid Plate Versus Champy's Technique (A Randomized Controlled Trial)", 'orgStudyIdInfo': {'id': 'PSIs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Custom made reduction guides and 3D grid plates', 'description': 'Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate', 'interventionNames': ['Procedure: CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stock titanium plates', 'description': 'Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate', 'interventionNames': ["Procedure: Champy's techqniue"]}], 'interventions': [{'name': 'CAD/CAM patient specfifc fracture reduction/plate guide and customized 3D grid plate', 'type': 'PROCEDURE', 'description': 'Mandibular angle fracture reduction and fixation using digitally designed and fabricated patient specific fracture reduction/plate positioning guide and customized 3D grid plate', 'armGroupLabels': ['Custom made reduction guides and 3D grid plates']}, {'name': "Champy's techqniue", 'type': 'PROCEDURE', 'description': 'Mandibular angle fracture reduction and fixation using a single superior border 2.0 miniplate', 'armGroupLabels': ['Stock titanium plates']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Arwa Hosni, MSc', 'role': 'CONTACT', 'email': 'arwa.loay@dentistry.cu.edu.eg', 'phone': '+20 100 176 2308'}, {'name': 'Mohamed AbdElRasoul', 'role': 'CONTACT', 'phone': '+20 100 961 2708'}], 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Arwa Louay Ali Hosni', 'investigatorAffiliation': 'Cairo University'}}}}