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

NCT07184762 | Active Not Recruiting

• 1 other identifier: 657\2023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Mandibular Fracture Treatment

Keywords

mandibular fracture; open reduction; z-shaped plate; conventional bone plates

Outcome Measures

Primary Outcomes (2)

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

  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

  within 1week postoperative, 1month, 4month

• Postoperative pain assessed using the Visual Analog Scale (VAS)

  postoperative pain assessed using the Visual Analog Scale (VAS). Range: 0 (no pain) - 10 (worst imaginable pain). Higher scores indicate worse pain

  day 1 , day 3, and 1week postoperative

Secondary Outcomes (1)

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

  1 week postoperative,1month, 3 months, 6 months

Study Arms (2)

z-plate

EXPERIMENTAL

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

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

conventional Miniplate

ACTIVE COMPARATOR

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

Procedure: open reduction and internal fixation with bone plate; Procedure: conventional miniplates.

Interventions

open reduction and internal fixation with bone plate PROCEDURE

mandibular fracture were reduced and fixed with bone plates.

conventional Miniplate; z-plate

z-plates. PROCEDURE

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

z-plate

conventional miniplates. PROCEDURE

mandibular fracture were reduced and fixed with conventional two miniplates.

conventional Miniplate

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University hospital, Ismailia

Ismailia, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal; Bone Plates

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Mohamed S. Hamed, professor

  Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University

  STUDY CHAIR

• Mohamed A. Elsholkamy, professor

  Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University

  STUDY DIRECTOR

• Amr A. Gomaa, associate professor

  plastic Surgery, Faculty of medicine, Suez Canal University

  STUDY DIRECTOR

• Eman M. Eldemardash, assistant lecturer

  Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer oral and maxillofacial surgery department, Faculty of Dentistry

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 22, 2025
• Study Start: January 28, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)