Customized z Shaped Miniplate Versus Standard 2 Miniplates for Fixation of Parasymphyseal/Body Mandibular Fractures

Hams Hamed Abdelrahman22 enrolled

Overview

Mandibular fractures are a common type of facial fractures. The surgical treatment has developed over the years due to improved understanding of biomechanics, biomaterials and scientifically based treatment outcomes. since customized fixation mechanism is more suited to the bone surface which helps to meet the requirements of a semirigid fixation. Customized Z plate is a new geometry of miniplates that may provide superior preservation of mental nerve, stability, support and easier in adaptation compared to the standard 2 miniplates system for fixation of parasymhyseal/body mandibular fractures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mandibular Fractures

Interventions

Planning was done using Mimics Innovation Suite 15.0 software for surgical planning, surgical simulation, and modeling of a custom-made Z-pattern plate installed on a standard personal computer system. The milling of a plate design on a titanium block was be done.

conventional two miniplatesOTHER

Mobilization of the fracture, removal of any soft tissue entrapped within the fracture line, and management of teeth in the fracture line, either by extraction or preservation. Followed by bone reduction into proper anatomical occlusion. Then conventional two miniplates was used according to Champy's osteosynthesis lines

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients suffering from recent fractures at the parasymphysis/body of the mandible presented within 2 weeks of the date of trauma. * Radiographic evidence of parasymphyseal/body mandibular fracture that demands open reduction and internal fixation. * The patient is medically fit for general anesthesia Exclusion Criteria: * comminuted fracture. * Pathological fracture. * Presence of infection

Outcomes

Primary Outcomes

Change in pain scores

Patient asked to identify his pain sensation through a 10-point visual analogue scale (VAS) and the level of pain will be interpreted as (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).

Time frame: after 24-hours, one week, four weeks and six weeks

Presence of intra-fragmentary mobility

The mobility assessed by bi-manual palpation across the fracture site.

Time frame: up to 6 weeks

Change in bone density

Immediate CBCT scan will be used to assess the adequacy of fracture line reduction and fixation, and then another will be taken at 6th month to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan

Time frame: baseline and 6 months

Secondary Outcomes

Change in sensory nerve function

Presecne of alteration in sensation in lower lip and mental area (Yes/No)