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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings