Patient Specific Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Patient Specific Three-Dimensional Titanium Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures. (Randomized Clinical Trial)

Conditions
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Mandibular Fractures

Intervention / Treatment
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* Device: Computer guided patient specific 3D titanium plate
* Device: Conventional titanium miniplates


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures Exclusion Criteria: Patients with bilateral mandibular fractures Patients with other mandibular or maxillofacial fractures Comminuted fractures Medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>Conventional titanium miniplates | Device: Conventional titanium miniplates<br>* 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.<br>* Other names: Control arm;|
| Experimental: Intervention arm<br>Patient specific 3D plates | Device: Computer guided patient specific 3D titanium plate<br>* 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.<br>* Other names: Intervention Arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measured immediately after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture gap distance | This is done using CBCT through measuring the fracture gap distance in millimeters to evaluate proper reduction and fixation | 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) | 0 and 3 months | 
| Operating time | The time of the surgery will be recorded using a stopwatch. | 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. | 0 and 3 months |