Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures (z-FIX)

Suez Canal University

Status: Active, not recruiting

Conditions: Mandibular Fracture Treatment

Treatments: Procedure: conventional miniplates.; Procedure: z-plates.; Procedure: open reduction and internal fixation with bone plate

Study type: Interventional

Funder types: Other

Identifiers

NCT07184762

657\2023

Details and patient eligibility

About

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)

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

z-plate

Experimental group

Description:

mandibular fracture will be reduced and fixed with Z shaped bone plate

Treatment:

Procedure: open reduction and internal fixation with bone plate

Procedure: z-plates.

conventional Miniplate

Active Comparator group

Description:

mandibular fracture will be reduced and fixed with conventional two miniplates.

Treatment:

Procedure: open reduction and internal fixation with bone plate

Procedure: conventional miniplates.