Comparison between computer guided lag screw fixation versus traditional lag screw fixation in open reduction and internal fixation of anterior mandibular fractures.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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.
Under general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws.
Faculty of Oral and Dental Medicine - Cairo University
Giza, Egypt
RECRUITINGStability of fixed fractured segment
stability of fixed fractured segment will be assessed using measuring device bimanual manipulation, measuring unit (binary yes or no)
Time frame: 1st week post operative.
neurosensory disturbance
presence of neurosensory disturbance will be assessed using measuring device: subjective assessment, measuring unit (binary yes or no)
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: one month post operative
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