Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle

April 7, 2026 updated by: Osama Abdelaziz Abdelreheem Abdelhaleem, Cairo University

Comparative Evaluation of 3D-printed Polyetheretherketone (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle

Is patient specific customized computer assisted 3D PEEK plates more superior to 3D titanium plate in fixation of mandibular angle fractures?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open Reduction Internal fixation (ORIF) of mandibular angle fractures using titanium plating systems had several drawbacks including sepsis with subsequent wound dehiscence and the need for 2nd surgery which is attributed to bone loss as a result of the elevated modulus of elasticity of titanium hardware. Accordingly, attempts were made to overcome problems encountered with the titanium plating system. In this study, custom made PEEK 3D plates will be used in ORIF of mandibular angle fractures. The main beneficial property of PEEK material is its lower modulus of elasticity that is close to that of living bone with subsequent elimination of the problem of stress shielding phenomenon encountered with titanium plating system. PEEK material has other advantages including biocompatibility, mechanical strength, durability, resistance to high degree of temperature without dimensional alteration.

Study Type

Interventional

Enrollment (Actual)

22

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, Egypt
        • Osama Abdelaziz Abdelreheem

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with mandibular angle fractures indicated for open reduction and internal fixation (ORIF).
  2. Patients aged 18 years and above.
  3. Both male and female patients.
  4. Patients medically fit for surgery under general anesthesia.
  5. Patients providing informed consent.

Exclusion Criteria:

  1. Patients with pathological fractures.
  2. Patients with comminuted fractures not suitable for fixation with plates.
  3. Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
  4. Patients with a history of previous mandibular surgery in the same region.
  5. Patients who are unable or unwilling to comply with follow-up.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computer-assisted PEEK custom made 3D plates
Patients were treated using computer-assisted patient-specific PEEK plates manufactured by CAD/CAM technology and fixed using titanium screws.
Device: Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.
Patient-specific PEEK plates manufactured using CAD/CAM technology and fixed using titanium screws.
Active Comparator: 3D titanium plates on the mandibular angle will be fixed using titanium screws
Patients were treated using conventional 3D titanium plates fixed with titanium screws after reduction of the fracture.
Device: Conventional 3D titanium plates
Conventional 3D titanium plates used for fixation of mandibular angle fractures with titanium screws.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative occlusion stability(binary: yes/no)
Time Frame: 1 week, 1 month, and 6 months postoperatively
Occlusal stability was recorded as stable or unstable. Occlusal stability was assessed clinically by evaluating the intercuspation between maxillary and mandibular teeth. Proper occlusion was defined as normal intercuspation without premature contacts or occlusal discrepancies. Any deviation, including open bite or malocclusion, was recorded during follow-up.
1 week, 1 month, and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Condylar seating (binary: yes/no)
Time Frame: 1 week, 1 month, and 6 months postoperatively
Condylar seating was assessed radiographically using standardized panoramic radiographs. The position of the mandibular condyle within the glenoid fossa was evaluated. Proper condylar seating was defined as a normal anatomical position without displacement. Any deviation from the normal position was recorded as improper.
1 week, 1 month, and 6 months postoperatively
Postoperative infection (binary: yes/no)
Time Frame: 1 week, 1 month, and 6 months postoperatively
Postoperative infection was recorded as present or absent.
1 week, 1 month, and 6 months postoperatively
Wound dehiscence (binary: yes/no)
Time Frame: 1 week, 1 month, and 6 months postoperatively
Wound dehiscence was recorded as present or absent.
1 week, 1 month, and 6 months postoperatively
Need for second surgical intervention ( binary: yes/no)
Time Frame: 1 week, 1 month, and 6 months postoperatively
Need for second surgery was recorded as yes or no.
1 week, 1 month, and 6 months postoperatively

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Hamida Refaae, PhD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

May 20, 2023

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3D-printed (PEEK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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