Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures

Study Overview
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Brief Summary
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Comparison between computer guided lag screw fixation versus traditional lag screw fixation in open reduction and internal fixation of anterior mandibular fractures.

Detailed Description
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Two groups of patients with anterior mandibular fractures indicated for open reduction and internal fixation. First group will be subjected to computer guided lag screw fixation. Second group will be subjected to traditional lag screw fixation. Eligible patients will be randomised in equal proportions between study group (computer guided lag screw fixation) and control group (conventional lag screw fixation). A- Computer guided lag screw fixation group: Pre operative Computed tomography will be done for the patient. Computed tomography data will be imported into Computer aided surgical simulation software. Utilizing Computer aided surgical simulation software the fracture segments are virtually reduced and patient specific surgical guide is designed and sent to three dimension printer before operation. Intra operative: All cases will undergo surgery under general anaesthesia. Exposure of the fractured segments will be done using vestibular incision. Inter-maxillary fixation will be done The fractured segments will be reduced in normal anatomic position guided by occlusion. Fracture fragments will be fixed using lag screws utilizing patient specific surgical guide. Closure of the surgical incision. Post operative at first week Computed tomography will be done for the patient. Computed tomography data will be imported into computer aided surgical simulation software. Utilizing computer aided surgical simulation software the post operative computed tomography will be superimposed onto the pre operative planned simulation. B- Conventional titanium plates: Pre operative Computed tomography will be done for the patient. Computed tomography data will be imported into Computer aided surgical simulation software. Utilizing Computer aided surgical simulation software the fracture segments are virtually reduced. Intra operative: All cases will undergo surgery under general anaesthesia. Exposure of the fractured segments will be done using vestibular incision. Inter-maxillary fixation will be done. The fractured segments will be reduced in normal anatomic position guided by occlusion. The fracture fragments will be fixed using lag screws. Closure of the surgical incision. Post operative at first week Computed tomography will be done for the patient. Computed tomography data will be imported into computer aided surgical simulation software. Utilizing computer aided surgical simulation software the post operative computed tomography will be superimposed onto the pre operative planned simulation. Follow up for both groups: Clinical evaluation will be performed at first week postoperative then patients will be recalled every week for one month. Final follow up visit will be at 3 months post operative.

Official Title
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Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)

Conditions
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Mandible Fracture

Intervention / Treatment
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* Procedure: Computer guided lag screw fixation
* Procedure: Conventional lag screw fixation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with anterior mandibular fracture indicated for open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or mid face. All ages 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 anaesthesia . Patients with physical and psychological tolerance. Exclusion criteria: Patients with comminuted fractures as it is not indicated for compression osteosynthesis like lag screws. 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.
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
Interventional Model Description: A Randomized clinical trial. Parallel group study. A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University Equal randomization: participants with equal probabilities for intervention. Positive controlled: Both groups receiving treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer guided lag screw fixation<br>Patient specific surgical guided will be used for open reduction and internal fixation for anterior mandibular fracture by lag screws. | Procedure: Computer guided lag screw fixation<br>* Under general anaesthesia: Patient specific pre operative prefabricated surgical guide will be used intra operative for open reduction and internal fixation for anterior mandibular fracture using lag screws.<br>* Other names: computer assisted surgery;|
| Active Comparator: Conventional lag screw fixation<br>Open reduction and internal fixation for anterior mandibular fracture using lag screws. | Procedure: Conventional lag screw fixation<br>* Under general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws.<br>* Other names: traditional lag screw fixation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of fixed fractured segment | stability of fixed fractured segment will be assessed using measuring device bimanual manipulation, measuring unit (binary yes or no) | 1st week post operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurosensory disturbance | presence of neurosensory disturbance will be assessed using measuring device: subjective assessment, measuring unit (binary yes or no) | one month post operative | 
| Accuracy of lag screw placement | Accuracy of lag screw placement will be assessed by measuring device: Computer aided surgical simulation (CASS) software, measuring unit: Millimetre | 1st week post operative. | 
| supplemental fixation devices | The need for intra operative or post operative supplemental fixation devices, measuring device clinical assessment. measuring unit: binary yes or no | intra operative and one month post operative | 
| Need for second surgery | The need for second surgical procedure will be assessed by clinical assessment (measuring device). measuring unit: binary (yes or no). | one month post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior mandible fracture, surgery computer assisted