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NCT Number: NCT07184762

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

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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Key information

Conditions

Mandibular Fracture Treatment Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Mandibular Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University hospital, Ismailia

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable fractures at the symphysial or parasymphysis region of the mandible.
  • 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.
  • A fracture that demands open reduction and internal fixation
  • Medically fit patients for general anesthesia

Exclusion criteria

  • Comminuted, infected mandibular fracture.
  • Pediatric patients below 14 years of age
  • geriatric patients with completely edentulous mouth.

Treatment and study plan

open reduction and internal fixation with bone plate

Procedure

mandibular fracture were reduced and fixed with bone plates.

z-plates.

Procedure

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

conventional miniplates.

Procedure

mandibular fracture were reduced and fixed with conventional two miniplates.

Primary outcomes

  1. Radiographic evaluation (Bone density ratio at fracture line ) measured using orthopantomograms (OPGs) by ImageJ software.

    Time frame: 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

  2. Postoperative pain assessed using the Visual Analog Scale (VAS)

    Time frame: 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 outcomes

  1. Clinical fracture stability evaluated by manual mobility test and tenderness on palpation.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Acronym: z-FIX

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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