Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.

Study Overview
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Brief Summary
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comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative IMMF.

Detailed Description
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Two group of patient with mandibular angle fracture indicated for open reduction and internal fixation ,first group will be fixed with 3d stut plate with post operative IMMF. Second group will be fixed with 3d strut plate with out post operative IMMF. Eligble patients will be randomised in equal proportions between study group (3d strut plate with out post operative IMMF) and control group (3d strut plate with post operative IMMF). A- 3D strut plate without post operative IMMF: Pre operative computed tomography will be done for patient. Intra operative :all cases will under go general anathesia. Exposure of the fracture segments using vestubular incision. Inter-maxillary fixation will be done. The fracture segment will be reduced in normal anatomic postion guided with occlusion. The fracture segment will be fixed in postion using 3d srut plate. Closure of surgical incision. Post operative computed tomograghy will be done for the patient. Patient will be dismissed from operation room without IMMF. B- 3D strut with post operative IMMF: Pre operative computed tomography will be done for patient. Intra operative :all cases will under go general anathesia. Exposure of the fracture segments using vestubular incision. Inter-maxillary fixation will be done. The fracture segment will be reduced in normal anatomic postion guided with occlusion. The fracture segment will be fixed in postion using 3d srut plate. Closure of surgical incision. Post operative computed tomograghy will be done for the patient. Patient will be dismissed from operation room with IMMF for 15 days. Follow up for both groups : Clinical examination will be done at first week post operative and patients will be examined every week for one month. Last follow up visit will be after three months post operative.

Official Title
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Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate in Two Groups One With IMMF and Anthor Without IMMF ;Randomized Clinical Trial.

Conditions
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Mandible Fracture

Intervention / Treatment
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* Procedure: 3d strut plate.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mandibular angle fracture with or witout other fracture indicated for Open reduction internal fixation in the mandible. Patient over 15 years old age and both sexes were included in this study. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. Patients with good general condition allowing major surgical procedure under general anesthesia. Patients with physical and psychological tolerance. Exclusion Criteria: Patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate . Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: A Radomized clinical trial. Parallel group study. A trial will be carried out in hospital of oral and maxillofacial surgery department - faculty of dentistry cairo university. Equal randomization: participants with equal probabilities for intervention. Positive controlled: both groups receiving treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group: 3d strut plate fixation without post op IMMF.<br>Open reduction and internal fixation with 3d strut plate without post operative IMMF. | Procedure: 3d strut plate.<br>* Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.<br>|
| Active Comparator: control group: 3d srut plate fixation with post op IMMF.<br>Open reduction and internal fixation with 3d strut plate with post operative IMMF for 15 days. | Procedure: 3d strut plate.<br>* Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stability of fracture segments. | post operative bimanual manipulation of the fracture segment. | 15 days post operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inferior alveolar nerve injury. | measurment by:Neurosensory testing: patient will be asked if there was numbness without stimulus and on stroking the lower lip skin with afinger.The patient will be asked to grade the sensation present on an analog scale from 0 (no sensation) to 10 (completely normal sensation) | pre operative and 1 week post operative. | 
| Accuracy of fracture reduction. | Post operative. Through computed tomography by measuring inter ramus distance using lingula as reference to measure. | one week post operative. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3d strut plate, mandibular angle fracture