Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures
- Conditions
- Mandible Fracture
- Interventions
- Procedure: Conventional lag screw fixationProcedure: Computer guided lag screw fixation
- Registration Number
- NCT03530891
- Lead Sponsor
- Cairo University
- Brief Summary
Comparison between computer guided lag screw fixation versus traditional lag screw fixation in open reduction and internal fixation of anterior mandibular fractures.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional lag screw fixation Conventional lag screw fixation Open reduction and internal fixation for anterior mandibular fracture using lag screws. Computer guided lag screw fixation Computer guided lag screw fixation Patient specific surgical guided will be used for open reduction and internal fixation for anterior mandibular fracture by lag screws.
- Primary Outcome Measures
Name Time Method Stability of fixed fractured segment 1st week post operative. stability of fixed fractured segment will be assessed using measuring device bimanual manipulation, measuring unit (binary yes or no)
- Secondary Outcome Measures
Name Time Method Accuracy of lag screw placement 1st week post operative. Accuracy of lag screw placement will be assessed by measuring device: Computer aided surgical simulation (CASS) software, measuring unit: Millimetre
supplemental fixation devices intra operative and one month post operative The need for intra operative or post operative supplemental fixation devices, measuring device clinical assessment. measuring unit: binary yes or no
Need for second surgery one month post operative The need for second surgical procedure will be assessed by clinical assessment (measuring device). measuring unit: binary (yes or no).
neurosensory disturbance one month post operative presence of neurosensory disturbance will be assessed using measuring device: subjective assessment, measuring unit (binary yes or no)
Trial Locations
- Locations (1)
Faculty of Oral and Dental Medicine - Cairo University
🇪🇬Giza, Egypt