Clinical, Radiographic and Histological Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures
| Registry | NCT07184762, acronym z-FIX |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 18 (Actual) |
| Sponsor | Suez Canal University (Other) |
| Conditions | Mandibular Fracture Treatment |
| Interventions | open reduction and internal fixation with bone plate, z-plates., conventional miniplates. (Procedure) |
| Dates | start 2024-01-28, primary completion 2025-09-01 (estimated), completion 2025-11-01 (estimated), first posted 2025-09-22, last updated 2025-09-22 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Mandibular Fracture Treatment All trials of open reduction and internal fixation with bone plate All trials of z-plates.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| z-plate | Experimental | Procedure: open reduction and internal fixation with bone plate; Procedure: z-plates. | mandibular fracture will be reduced and fixed with Z shaped bone plate |
| conventional Miniplate | Active comparator | Procedure: open reduction and internal fixation with bone plate; Procedure: conventional miniplates. | mandibular fracture will be reduced and fixed with conventional two miniplates. |
Sex: All, ages: 19 Years to 50 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Suez Canal University hospital, Ismailia | Ismailia | Egypt |