Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture

Study Overview
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Brief Summary
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The aim of the study to evaluate the effect of customized V pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters.

Detailed Description
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The mandibular angle is one of the most common sites for fractures, accounting for 23-42% of all cases of mandibular fractures. Moreover, mandibular angle fractures have the highest postoperative complications among all mandibular fractures, and the loosening of screws and fracturing of plates are main reasons for the complications.The most widely used treatment modality for mandibular angle fracture is the use of one miniplate fixation ,The other one uses two mini-plates, with a upper mini-plate fixed at the same place of previous treatment which corresponds to the tension band of the mandible, and the lower mini-plate fixed at the inferior border of the mandible which corresponds to the compression band of the mandible, however, based on recent experimental and clinical studies, the stability provided by the miniplate fixation of mandibular angle fractures has become a point of contention among surgeons .In order to decrease the need for plate removal, reduce the operative time and improve the stability of the fixation system, a customized V pattern plate design is an appropriate plate structure for fractured mandible using the minimum output values for stress of plate and displacement of bony segments to seek maximum reduction volume on an original plate .Patient satisfaction include: clinical parameters such are occlusion, pain, facial swelling, maximal mouth opening, sensory function, and surgical wound ,these should be evaluated postoperatively ,radio graphical evaluation is also an important parameter to assess adequate reduction of the fractured segments .

Official Title
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Evaluation of the Effect of Customized V Plate Fixation Versus a Conventional Superior -Inferior Miniplates Fixation of Mandibular Angle Fracture on Mouth Opening and Radiographical Parameters Randomized Clinical Trial

Conditions
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Mandibular Fractures

Intervention / Treatment
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* Procedure: Customized V plate fixation
* Procedure: Conventional miniplates fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with at least a unilateral unfavorable angle fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midrace. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome Exclusion Criteria: Patients with systemic disease (may affect normal healing). Patients with old and/or malunited fractures (affect accuracy of reduction of the fractured segments). Patients whom cannot tolerate follow up intervals (affect accuracy of study results).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Customized V plate fixation<br>Computed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate | Procedure: Customized V plate fixation<br>* (CT) scan is taken for the patients and a customized V pattern plate will be designed .Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position guided by the CAD/CAM plate. MMF will be done.Fracture fragments will be fixed using CAD/CAM plate .<br>|
| Active Comparator: Conventional miniplates fixation<br>Conventional superior-inferior miniplates fixation of mandibular angle fixation | Procedure: Conventional miniplates fixation<br>* Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position. MMF will be done.Fracture fragments will be fixed using conventional miniplates fixation of angle fracture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth Opening | Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm | Every week for 1 month ,3 months and 6 months postoperative | 
| Radiographical parameters | Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean | At 3 and 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion | Occlusion will be evaluated by intraoral examination and write in dental chart whether normal or abnormal occlusion | immediate postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angle fracture, superior-inferior plate fixation, custom made plate fixation, postoperative complications