he goal of this clinical trial is to evaluate Z shaped bone plate in mandibular fracture treatment regarding post operative healing, function restoration and esthetic. aims to answer are: In mandibular trauma population, what is the difference between internal fixation using conventional miniplates compared to z shaped bone plates regarding post operative healing, function restoration and esthetic? Participants will be divided equally and randomly in 2 groups as follows: Group A: eight patients treated with Z shaped bone plate. (Study group) Group B: eight patients restored with conventional two miniplates.(control group)
Introduction: Various miniplate systems have been developed in recent years including three-dimensional miniplate, microplates and bioresorbable plate, and their advantages and disadvantages have been compared and studied. To overcome the shortcomings of 3D plating system such as difficulty in adaptation and fixation in fractures involving the mental nerve, a Z plate has been designed. Aim: to evaluate Z shaped bone plates in mandibular fracture management clinically, radiographically, and histologically. Methodology: sixteen patients with mandibular fracture grouped to two groups group A managed by Z plates, group B managed by two miniplates. Patients will follow up clinically postoperative. Radiographic evaluation will be performed immediately postoperative, 1 month and 4 months Experimental study will be on dogs and histological evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
mandibular fracture were reduced and fixed with bone plates.
mandibular fracture were reduced and fixed with z-plate miniplates.
mandibular fracture were reduced and fixed with conventional two miniplates.
Suez Canal University hospital, Ismailia
Ismailia, Egypt
Radiographic evaluation (Bone density ratio at fracture line ) measured using orthopantomograms (OPGs) by ImageJ software.
Radiographic evaluation using orthopantomograms (OPGs) is performed immediately postoperatively, at 1 month and 4 months. To assess bone density along the fracture line, a densitometric analysis was conducted using the ImageJ system. Digital images are analyzed using ImageJ software. The mean gray value of a region of interest (ROI) drawn along the entire length of the fracture line was calculated. This gray value represents the relative bone density within the fracture site. Range: 0.0 - 1.0 (unitless ratio). Higher values indicate greater bone density and better healing
Time frame: within 1week postoperative, 1month, 4month
Postoperative pain assessed using the Visual Analog Scale (VAS)
postoperative pain assessed using the Visual Analog Scale (VAS). Range: 0 (no pain) - 10 (worst imaginable pain). Higher scores indicate worse pain
Time frame: day 1 , day 3, and 1week postoperative
Clinical fracture stability evaluated by manual mobility test and tenderness on palpation.
Outcome: Stable vs. unstable fracture (binary measure) assessed through bimanual digital manipulation i. Stable \>\> no movement of fragments. ii. Nonstable\>\> presence of movement
Time frame: 1 week postoperative,1month, 3 months, 6 months
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