Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04860427
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2021-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2021-04-08', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of functional mandibular movement between the two groups', 'timeFrame': 'preopertive, 1 week, 1month , 3 months , 6months', 'description': 'the change mandibular movement in mm'}, {'measure': 'comparison of occlusion between the two groups', 'timeFrame': 'preopertive, 1 week, 1month , 3 months , 6months', 'description': 'the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient'}, {'measure': 'comparison of helikmo index between the two groups', 'timeFrame': 'preopertive, 1 week, 1month , 3 months , 6months', 'description': 'the change in helikmo index score'}, {'measure': 'comparison in pain between the two groups', 'timeFrame': 'preopertive, 1 week, 1month', 'description': 'the change in pain value with Visual analogue Scale With a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain or discomfort)'}, {'measure': 'comparison in ramus height shortening between the two groups', 'timeFrame': '1 day, 3 months, 6 months.', 'description': 'radiographically: assess the adequacy of reduction by th change in ramus height in mm'}, {'measure': 'comparison in condylar angulation between the two groups', 'timeFrame': '1 day, 3 months, 6 months.', 'description': 'radiographically: assess the adequacy of reduction by measuring the change in condylar angulation'}, {'measure': 'bone density change comparison between the two groups', 'timeFrame': '1 day postoperative, 1month and 3months', 'description': 'assessment with CT in Hounsfield value measurements.'}], 'secondaryOutcomes': [{'measure': 'Transmasseteric Anteroparotid surgical approach', 'timeFrame': 'intraopertive', 'description': 'To evaluate the Transmasseteric Anteroparotid surgical approach for the subcondylar fracture regarding the time taken to reach the fracture line and convenience of the approach.'}, {'measure': 'the stress on plates by using finite element analysis', 'timeFrame': 'immediate postopertive', 'description': 'stress values (Mpa) were obtained in this study for each of the two models during load application'}, {'measure': 'the displacement (micromotion)', 'timeFrame': 'immediate postoperative', 'description': 'the amount of vertical displacement induced around the fracture surface (µm)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fracture of Condylar Process']}, 'descriptionModule': {'briefSummary': 'Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.\n\nA Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.\n\nDifferent plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.', 'detailedDescription': 'Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. It is the most controversial fractures regarding diagnosis and management.\n\nFor several years, closed reduction has been preferred over open reduction to avoid surgical complications. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.\n\nA Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.\n\nDifferent plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.\n\nAim: Our aim in this study is to assess the use of TCP in the subcondylar fracture in comparison to the use of conventional two miniplates method.\n\nMaterials and methods: This prospective randomized clinical trial will enroll 20 patients with subcondylar fracture indicated for open reduction and internal fixation. Group A will undergo fixation with TCP and group B will have two miniplates fixation. Both groups will have Transmasseteric Anteroparotid approach.\n\nResults: The results of the two groups will be compared clinically and radiographically.\n\nKeywords: Subcondylar fracture, Trapezoidal condylar plate, two miniplates, open treatment for condyle, geometric subcondylar plates, transmasseteric anteroparotid approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1- Medically fit patients free from relevant conditions that contraindicate surgery.\n\n 2- Patients with age ranged from 20-40 years old. 3- Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including Difficulty of obtaining adequate occlusion by closed method, Radiological signs of the following\n 1. Deviation of the fragment from the axis of the ascending ramus in medial or lateral direction more than 10°.(22)\n 2. Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.(22)\n 3. Dislocation of the condyle from the glenoid fossa.(48)\n\n Exclusion Criteria:\n* 1\\. Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems.\n\n 2\\. Any absolute contraindication for surgery. 3. Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively."}, 'identificationModule': {'nctId': 'NCT04860427', 'briefTitle': 'Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Trapezoidal Condylar Plate (TCP) Versus Two Miniplates in Treatment of Subcondylar Fracture', 'orgStudyIdInfo': {'id': 'IRB NO 00010556-IORG 0008839'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trapezoidal condylar plate', 'description': 'Trapezoidal condylar plate open reduction and internal fixation of subcondylar fractures', 'interventionNames': ['Device: trapezoidal condylar plate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'two miniplates', 'description': 'two miniplates open reduction and internal fixation of subcondylar fractures', 'interventionNames': ['Device: two miniplates']}], 'interventions': [{'name': 'trapezoidal condylar plate', 'type': 'DEVICE', 'description': 'trapezoidal condylar plate open reduction and fixation', 'armGroupLabels': ['Trapezoidal condylar plate']}, {'name': 'two miniplates', 'type': 'DEVICE', 'description': 'two miniplates open reduction and fixation', 'armGroupLabels': ['two miniplates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25588', 'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mona oraby, ass. lect.', 'role': 'CONTACT', 'email': 'drmonasamy@gmail.com', 'phone': '01000775330'}], 'facility': 'Mona Oraby', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'mona oraby, ass. lect.', 'role': 'CONTACT', 'email': 'drmonasamy@gmail.com', 'phone': '00201000775330'}, {'name': 'mohamed mekky, ass. lect.', 'role': 'CONTACT', 'email': 'mastermekky@gmail.com', 'phone': '00201211332210'}], 'overallOfficials': [{'name': 'nagy el prince, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'oral and maxillofacial surgery, alexanderia university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer, oral and maxillofacial surgery department', 'investigatorFullName': 'mona oraby', 'investigatorAffiliation': 'Alexandria University'}}}}