Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
Study NCT ID:
NCT06740292
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2024-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). Group A was treated with InterFlex plates, and Group B with conventional miniplates'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-14', 'studyFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2024-12-14', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical evaluation for Intra-fragmentary mobility', 'timeFrame': 'six weeks', 'description': 'Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site'}], 'primaryOutcomes': [{'measure': 'Radiographic evaluation for the assessment of mean bone density at the fracture line', 'timeFrame': '3 months', 'description': 'Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)'}], 'secondaryOutcomes': [{'measure': 'Clinical evaluation for pain', 'timeFrame': 'six weeks', 'description': 'Pain was assessed using Visual Analogue Scale (VAS)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anterior mandibular fracture', 'symphyseal fracture', 'para-symphyseal fracture', 'InterFlex plate', 'functionally stabilized fixation', 'miniplate'], 'conditions': ['Anterior Mandibular Fracture']}, 'descriptionModule': {'briefSummary': 'the study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.', 'detailedDescription': 'A total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with recent anterior mandibular fracture located between the mental foramina.\n* adults without gender predilection who agreed to follow-up,\n* fractures requiring open reduction and internal fixation, and\n* those medically fit for general anesthesia were included\n\nExclusion Criteria:\n\n* medically compromised patients,\n* fractures with infection,\n* pathological or old fractures,\n* completely edentulous patients,\n* comminuted fractures'}, 'identificationModule': {'nctId': 'NCT06740292', 'acronym': 'InterFlex', 'briefTitle': 'InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures.', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures. a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '0117-12/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with anterior mandibular fracture managed with conventional miniplates', 'description': 'Patients with anterior mandibular fracture managed with conventional miniplates', 'interventionNames': ['Device: conventional miniplates']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with anterior mandibular fracture managed with InterFlex plates', 'description': 'Patients with anterior mandibular fracture managed with InterFlex plates', 'interventionNames': ['Device: InterFlex plates']}], 'interventions': [{'name': 'conventional miniplates', 'type': 'DEVICE', 'description': 'conventional miniplates in double configuration', 'armGroupLabels': ['Patients with anterior mandibular fracture managed with conventional miniplates']}, {'name': 'InterFlex plates', 'type': 'DEVICE', 'description': 'InterFlex plates in configuration', 'armGroupLabels': ['Patients with anterior mandibular fracture managed with InterFlex plates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21523', 'city': 'Alexandria', 'state': 'Alexandria Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'ipdSharing': 'YES', 'description': 'all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study', 'accessCriteria': 'to any one who required them after deidentification'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}