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Active Not RecruitingNCT07184762

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

Clinical, Radiographic and Histological Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Suez Canal University · Academic / Other
Sex
All
Age
19 Years – 50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREopen reduction and internal fixation with bone platemandibular 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.

Timeline

Start date
2024-01-28
Primary completion
2025-09-01
Completion
2025-11-01
First posted
2025-09-22
Last updated
2025-09-22

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07184762. Inclusion in this directory is not an endorsement.