Mandibular Fracture Treatment
Conditions
Keywords
mandibular fracture, open reduction, z-shaped plate, conventional bone plates
Brief summary
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)
Detailed description
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.
Interventions
PROCEDUREopen reduction and internal fixation with bone plate
mandibular fracture were reduced and fixed with bone plates.
PROCEDUREz-plates.
mandibular fracture were reduced and fixed with z-plate miniplates.
PROCEDUREconventional miniplates.
mandibular fracture were reduced and fixed with conventional two miniplates.
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable fractures at the symphysial or parasymphysis region of the mandible. 2. Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate, month, 3 months,6 months. 3. A fracture that demands open reduction and internal fixation 4. Medically fit patients for general anesthesia
Exclusion criteria
1. Comminuted, infected mandibular fracture. 2. Pediatric patients below 14 years of age 3. geriatric patients with completely edentulous mouth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic evaluation (Bone density ratio at fracture line ) measured using orthopantomograms (OPGs) by ImageJ software. | within 1week postoperative, 1month, 4month | 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 |
| Postoperative pain assessed using the Visual Analog Scale (VAS) | day 1 , day 3, and 1week postoperative | postoperative pain assessed using the Visual Analog Scale (VAS). Range: 0 (no pain) - 10 (worst imaginable pain). Higher scores indicate worse pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical fracture stability evaluated by manual mobility test and tenderness on palpation. | 1 week postoperative,1month, 3 months, 6 months | Outcome: Stable vs. unstable fracture (binary measure) assessed through bimanual digital manipulation i. Stable \>\> no movement of fragments. ii. Nonstable\>\> presence of movement |
Countries
Egypt
Outcome results
None listed