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

Not Applicable

Interventions: Device: Conventional titanium miniplates
Device: Computer guided patient specific 3D titanium plate

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Control Arm	Conventional titanium miniplates	Conventional titanium miniplates
Intervention arm	Computer guided patient specific 3D titanium plate	Patient specific 3D plates

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction measured with visual analogue scale (0-10)	Measured immediately after the surgery	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.

Secondary Outcome Measures

Name	Time	Method
Plate palpability	0 and 3 months	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.
Fracture gap distance	0 and 3 months	This is done using CBCT through measuring the fracture gap distance in millimeters to evaluate proper reduction and fixation
Occlusal bite force	0 and 3 months	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)
Operating time	time of the surgery	The time of the surgery will be recorded using a stopwatch.

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