Clinical and Radiographical Assessment of Patients With Sub-condylar Fracture Using Polyetheretherketone (PEEK) Trapezoidal Plates Versus Titanium Trapezoidal Plates

Clinical and Radiographical Assessment of Patients With Sub-condylar Fracture Using CAD/CAM Polyetheretherketone (PEEK) Trapezoidal Plates Versus CAD/CAM Titanium Trapezoidal Plates: Randomized Controlled Clinical Study

Some of titanium's drawbacks that is commonly used in maxillofacial surgery included scatter artefacts on regular imaging, implant exposure and inflammation, high thermal conductivity, and high elastic modulus. Very few clinical studies have been published on using a PEEK plate in the mandibular fractures and to the best of the author's knowledge, this is the first study that will be done comparing trapezoidal condylar 3D printed PEEK plates and titanium trapezoidal condylar plate in subcondylar fractures in terms of clinical and radiographical outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Mandible Fracture; Polyetheretherketone; Condylar Neck Fractures
• Intervention / Treatment: Other: titanium trapezoidal plates; Other: PEEK trapezoidal plates

Detailed Description

Mandibular subcondylar fractures are common injuries that require treatment to restore function and aesthetic. Titanium plates have long been the gold standard for fixation in these fractures due to their strength, durability, and ability to provide rigid stabilization. However, they are associated with limitations such as a higher elastic modulus than bone, imaging artifacts (e.g., CT or MRI interference), and hardware-related complications. These drawbacks have prompted interest in alternative materials like polyetheretherketone (PEEK).

PEEK is a novel biomaterial with promising properties, including biocompatibility, a modulus of elasticity closer to bone, and reduced imaging artifacts. These characteristics suggest it may mitigate some of the challenges associated with titanium plates. The improved elasticity of PEEK could reduce stress shielding and enhance functional recovery, while its imaging compatibility could simplify postoperative assessments.

Researchers have shown significant interest in the application of PEEK composites in trauma plating systems, total replacement implants, and tissue scaffolds, highlighting its potential as a versatile biomaterial. Despite these advantages, evidence specifically evaluating PEEK trapezoidal plates for subcondylar fractures remains scarce, there are a no clinical studies directly comparing the outcomes of PEEK and titanium trapezoidal plates in terms of clinical outcomes. Conducting a study to evaluate these two materials would provide valuable evidence to guide material selection in mandibular subcondylar fracture management.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 years or older, irrespective of gender
• Recent mandibular subcondylar fractures indicated for open reduction and internal fixation

Exclusion Criteria:

• Medically compromised patients contradicting operation (ASA III, IV & V).
• Patients receiving radiotherapy or chemotherapy.
• Infection at the fracture line.
• Pathological fractures and old fractures
• comminuted fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control group; CAD/CAM titanium trapezoidal plates	Other: titanium trapezoidal plates; ORIF subcondylar fracture using trapezoidal titanium plates
Experimental: comparator group; CAD/CAM polyetheretherketone (PEEK) trapezoidal plates	Other: PEEK trapezoidal plates; ORIF subcondylar fracture using trapezoidal PEEK plates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum mouth opening	Maximum mouth opening is the distance between the incisal edges of the upper and lower central incisors at the midline when the mouth is opened as wide as possible without pain. It will be measured in millimeters (mm) using a caliper	outcome will be measured postoperatively in 4 different time points. 1st time point is at 1 week after surgery. 2nd time is point at 1 month after surgery. 3rd time point is at 3 months after surgery. 4th time point is at 6 months after surgery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: CAD/CAM; PEEK PLATES; TRAPEZOIDAL PLATES
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures
• Other Study ID Numbers: PEEK plate in condyle fracture

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No