The aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.
The study will be conducted on two groups: Intervention group: patient specific three-dimensional titanium plates CBCT or CT scan will be performed for the patient, the dicom files will be imported into a surgical planning software , plates will then be designed virtually and sent for three-dimensional (3D) printing. Control group: Conventional miniplates: In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
CBCT or CT scan will be done preoperatively and dicom files will be imported to mimics software to design and print the patient specific 3D titanium plate.
In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
Patient Satisfaction measured with visual analogue scale (0-10)
patient satisfaction is defined as patient-reported outcome measure while the structures and processes of care can be measured by patient-reported experiences (30). Measured on a visual analogue scale (VAS) (29) of 0-10 ,with zero being unsatisfied and 10 being satisfied. Patient Satisfaction is assessed regarding prescence of pain, occlusal discrepencies and overall patient satisfaction.
Time frame: Measured immediately after the surgery
Fracture gap distance
This is done using CBCT through measuring the fracture gap distance in millimeters to evaluate proper reduction and fixation
Time frame: 0 and 3 months
Occlusal bite force
The biting force will be measured through the follow up visits (1 week,3 months) by the bite force recorder at the incisor region, right and left molar region. The measurement of the bite force will be undertaken using a portable type of occlusal force gauge (GM10, Nagano Keiki, Japan) called OCCLUSAL FORCE-METER GM10. (36)
Time frame: 0 and 3 months
Operating time
The time of the surgery will be recorded using a stopwatch.
Time frame: time of the surgery
Plate palpability
Measured during all follow up visits, by questioning the patient ,where the patient will be informed of the site of the plates ,and asked if he feels the plates are palpable ,and will be measured by binary measuring unit (yes/no) , also the plates will be palpated by the operator at follow up visits.
Time frame: 0 and 3 months
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