Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-01 @ 11:26 AM
Study NCT ID:
NCT07094867
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain scores', 'timeFrame': 'after 24-hours, one week, four weeks and six weeks', 'description': 'Patient asked to identify his pain sensation through a 10-point visual analogue scale (VAS) and the level of pain will be interpreted as (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).'}, {'measure': 'Presence of intra-fragmentary mobility', 'timeFrame': 'up to 6 weeks', 'description': 'The mobility assessed by bi-manual palpation across the fracture site.'}, {'measure': 'Change in bone density', 'timeFrame': 'baseline and 6 months', 'description': 'Immediate CBCT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another will be taken at 6th month to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan'}], 'secondaryOutcomes': [{'measure': 'Change in sensory nerve function', 'timeFrame': 'after 24-hours, one week, four weeks and six weeks', 'description': 'Presecne of alteration in sensation in lower lip and mental area (Yes/No)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mandibular Fractures']}, 'descriptionModule': {'briefSummary': 'Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. since customized fixation mechanism is more suited to the bone surface which helps to meet the requirements of a semirigid fixation. Customized Z plate is a new geometry of miniplates that may provide superior preservation of mental nerve, stability, support and easier in adaptation compared to the standard 2 miniplates system for fixation of parasymhyseal/body mandibular fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from recent fractures at the parasymphysis/body of the mandible presented within 2 weeks of the date of trauma.\n* Radiographic evidence of parasymphyseal/body mandibular fracture that demands open reduction and internal fixation.\n* The patient is medically fit for general anesthesia\n\nExclusion Criteria:\n\n* comminuted fracture.\n* Pathological fracture.\n* Presence of infection'}, 'identificationModule': {'nctId': 'NCT07094867', 'briefTitle': 'Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures (a Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '0866-02/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group "Customzied z Plate"', 'interventionNames': ['Other: customized Z shaped miniplate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment "Miniplates"', 'interventionNames': ['Other: conventional two miniplates']}], 'interventions': [{'name': 'customized Z shaped miniplate', 'type': 'OTHER', 'description': 'Planning was done using Mimics Innovation Suite 15.0 software for surgical planning, surgical simulation, and modeling of a custom-made Z-pattern plate installed on a standard personal computer system. The milling of a plate design on a titanium block was be done.', 'armGroupLabels': ['Test Group "Customzied z Plate"']}, {'name': 'conventional two miniplates', 'type': 'OTHER', 'description': "Mobilization of the fracture, removal of any soft tissue entrapped within the fracture line, and management of teeth in the fracture line, either by extraction or preservation. Followed by bone reduction into proper anatomical occlusion. Then conventional two miniplates was used according to Champy's osteosynthesis lines", 'armGroupLabels': ['Conventional treatment "Miniplates"']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Dental Public Health and biostatistical consultanat', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}