Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:25 AM
Study NCT ID:
NCT07390734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants complying with the inclusion criteria will be randomly assigned using a computer-generated list of random numbers to one of the two arms. Allocation will be performed by a trial independent individual and the allocation ratio is intended to be equal. Allocation will be in equal blocks to ensure that the study groups have equal number of participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic evaluation for the assessment of mean bone density at the fracture line', 'timeFrame': '4 months', 'description': 'Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)'}], 'secondaryOutcomes': [{'measure': 'Post operative pain', 'timeFrame': '3 months', 'description': '\\- Post operative pain This will be subjectively evaluated with a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['three dimensional plates', 'mandibular angle fracture', 'patient specific plate'], 'conditions': ['Mandibular Angle Fracture']}, 'descriptionModule': {'briefSummary': 'To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture.', 'detailedDescription': 'Eighteen patients with mandibular angle fractures will be selected. In nine fractures, custom-made three dimensional titanium plates will be used for fracture fixation (study group); while in the other nine, conventional two mini plates will be used (control group),via intra oral approach (combined with transbuccal approach) for both groups. Patients will be evaluated clinically, and radiographically (immediate and four months post operative) to evaluate the bone density at the fracture line.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients suffering from mandibular angle fracture indicated for open reduction and fixation.\n2. Non infected mandibular angle fractures present less than two weeks. 3. Good oral hygiene.\n\nExclusion Criteria:\n\n1. Medically compromised patients contradicting operation (ASA III, IV \\& V).\n2. Patients receiving radiotherapy or chemotherapy. 3- Bone diseases (Osteoporosis, Osteopetrosis, Osteomalacia…etc.) 4- Pathological fracture. 5- Old untreated fracture.'}, 'identificationModule': {'nctId': 'NCT07390734', 'briefTitle': 'Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '1023-01/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with recent mandibular angle fractures managed with custom-made 3D titanium plates', 'description': 'patients that will undergo internal fixation with custom-made 3D titanium plates through intaoral and transbuccal approach .', 'interventionNames': ['Device: custom-made 3D titanium plates']}, {'type': 'EXPERIMENTAL', 'label': 'patients with recent mandibular angle fractures managed with standared two mini plates', 'description': 'patient that will undergo internal fixation with standared two mini plates through intaoral and transbuccal approach.', 'interventionNames': ['Device: standared two mini plates']}], 'interventions': [{'name': 'custom-made 3D titanium plates', 'type': 'DEVICE', 'description': 'custom-made 3D titanium plates through intaoral and transbuccal approach .', 'armGroupLabels': ['patients with recent mandibular angle fractures managed with custom-made 3D titanium plates']}, {'name': 'standared two mini plates', 'type': 'DEVICE', 'description': 'internal fixation with standared two mini plates through intaoral and transbuccal approach.', 'armGroupLabels': ['patients with recent mandibular angle fractures managed with standared two mini plates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21523', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of dentistry, Alexandria university', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}