Assessment Polyether Ether Ketone (PEEK) Custom Made Plates Versuscustom Made Titanium Plates in Treatment of Mandibular Body Fractures

July 24, 2026 updated by: Nahla Mahmoud Awad, Cairo University

Radiographic Assessment of Accuracy of Computer-assisted Polyether Ether Ketone (PEEK) Custom Made Plates Versus Computer-assisted Custom Made Titanium Plates in Treatment of Mandibular Body Fractures (A Randomized Clinical Trial)

The design of the custom made Plates is customized to meet the individual needs of each patient and surgeon. By selecting plate design features, surgeons can customize the plate to create a patient specific solution. The Patient Specific Plates are manufactured to the planned patient anatomy, eliminating the time needed for intraoperative adaption and creating a stronger plate with a lower overall profile.

But Custom made plates were made in many materials such as titanium, Vitalium, PEEK, etc In this study we will compare the PEEK one with the titanium one to know which one is better in all aspects and if the PEEK one can overcome the shortcoming of the titanium one or not.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In patients with mandibular body fractures, will PEEK custom made plates be more efficient in reduction of body fractures accurately than titanium custom made plates (in terms of radiographic and clinical parameters)?

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Giza, Cairo Governorate, Egypt, 12515
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with at least a unilateral body fracture indicated for Open reduction internal fixation.

    --Dentate adult patients.

  • All ages and both sexes were included in this study.

Exclusion Criteria:

  • Patients with systemic disease (may affect normal healing).
  • Patients with old and/or mal united fractures (affect accuracy of re-reduced the fractured segments).
  • Patients whom cannot tolerate follow up intervals (affect accuracy of study results).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEEK
computer-assisted Polyether ether ketone (PEEK) custom made plates
Procedure: computer-assisted Polyether ether ketone (PEEK) custom made plates
computer-assisted Polyether ether ketone (PEEK) custom made plates in mandibular body fractures management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic assessment of accuracy in mandibular body fractures management
Time Frame: 3 months
using Mimics software
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

July 20, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cairo uniiversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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