Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-28

Study Completion Date

2025-11-30

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Mandibular Fracture Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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z-plate

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

Group Type EXPERIMENTAL

open reduction and internal fixation with bone plate

Intervention Type PROCEDURE

mandibular fracture were reduced and fixed with bone plates.

z-plates.

Intervention Type PROCEDURE

mandibular fracture were reduced and fixed with z-plate miniplates.

conventional Miniplate

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

Group Type ACTIVE_COMPARATOR

open reduction and internal fixation with bone plate

Intervention Type PROCEDURE

mandibular fracture were reduced and fixed with bone plates.

conventional miniplates.

Intervention Type PROCEDURE

mandibular fracture were reduced and fixed with conventional two miniplates.

Interventions

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open reduction and internal fixation with bone plate

mandibular fracture were reduced and fixed with bone plates.

Intervention Type PROCEDURE

z-plates.

mandibular fracture were reduced and fixed with z-plate miniplates.

Intervention Type PROCEDURE

conventional miniplates.

mandibular fracture were reduced and fixed with conventional two miniplates.

Intervention Type PROCEDURE

Eligibility Criteria

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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