Trapezoidal Condylar Plate (TCP) in Treatment of Subcondylar Fracture
NCT ID: NCT04860427
Last Updated: 2021-07-22
Study Results
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Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-06-10
2021-09-15
Brief Summary
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A 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.
Different 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.
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Detailed Description
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For 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.
A 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.
Different 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.
Aim: 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.
Materials 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.
Results: The results of the two groups will be compared clinically and radiographically.
Keywords: Subcondylar fracture, Trapezoidal condylar plate, two miniplates, open treatment for condyle, geometric subcondylar plates, transmasseteric anteroparotid approach.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Trapezoidal condylar plate
Trapezoidal condylar plate open reduction and internal fixation of subcondylar fractures
trapezoidal condylar plate
trapezoidal condylar plate open reduction and fixation
two miniplates
two miniplates open reduction and internal fixation of subcondylar fractures
two miniplates
two miniplates open reduction and fixation
Interventions
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trapezoidal condylar plate
trapezoidal condylar plate open reduction and fixation
two miniplates
two miniplates open reduction and fixation
Eligibility Criteria
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Inclusion Criteria
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
1. Deviation of the fragment from the axis of the ascending ramus in medial or lateral direction more than 10°.(22)
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)
3. Dislocation of the condyle from the glenoid fossa.(48)
Exclusion Criteria
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.
20 Years
40 Years
ALL
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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mona oraby
Assistant lecturer, oral and maxillofacial surgery department
Principal Investigators
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nagy el prince, professor
Role: STUDY_CHAIR
oral and maxillofacial surgery, alexanderia university
Locations
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Mona Oraby
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB NO 00010556-IORG 0008839
Identifier Type: -
Identifier Source: org_study_id
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