Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT03747666
Status:
UNKNOWN
Last Update Posted:
2019-02-19
First Post:
2018-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2018-11-18', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biting force', 'timeFrame': '6 months', 'description': 'Biting force will be measured using occlusal biting force meter (Higher biting force record is better)'}], 'secondaryOutcomes': [{'measure': 'Stability of fractured segments', 'timeFrame': '6 weeks', 'description': 'Bi-manual manipulation (Binary Yes/No)'}, {'measure': 'Pain intensity', 'timeFrame': '10 days', 'description': 'Visual analog scale (0-10) 0=No pain \\& 10=Severe pain'}, {'measure': 'Occlusion', 'timeFrame': '6 months', 'description': 'Clinical examination (Intact/Deranged)'}, {'measure': 'Infection', 'timeFrame': '6 months', 'description': 'Clinical examination (Present/Absent)'}, {'measure': 'Hardware failure', 'timeFrame': '6 months', 'description': 'Clinical examination (Present/Absent)'}, {'measure': 'Paraesthesia', 'timeFrame': '6 months', 'description': 'Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation \\& 10= Normal sensation'}, {'measure': 'Wound dehiscence', 'timeFrame': '6 months', 'description': 'Clinical examination (Present/Absent)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mandible Fracture']}, 'descriptionModule': {'briefSummary': 'Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.', 'detailedDescription': 'Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.\n* Fractures amenable to treatment using intra oral approach.\n\nExclusion Criteria:\n\n* Medically compromised patients who are unfit for the procedure under general anesthesia.\n* Patients with comminuted fractures.\n* Patients with history of occlusion disturbances or skeletal malocclusion.\n* Patients with insufficient dentition to reproduce occlusion.'}, 'identificationModule': {'nctId': 'NCT03747666', 'briefTitle': 'Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures', 'orgStudyIdInfo': {'id': '30101980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Locking miniplate', 'description': 'The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.', 'interventionNames': ['Procedure: 2.0 single locking miniplates']}, {'type': 'EXPERIMENTAL', 'label': 'Non-locking miniplates', 'description': 'The fractured segments in the parasymphyseal region will be fixed using 2.0 two non-locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.', 'interventionNames': ['Procedure: 2.0 single locking miniplates']}], 'interventions': [{'name': '2.0 single locking miniplates', 'type': 'PROCEDURE', 'description': 'The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.', 'armGroupLabels': ['Locking miniplate', 'Non-locking miniplates']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hany Abdelkader Hussein', 'investigatorAffiliation': 'Cairo University'}}}}