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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Condylar Neck Fractures; Mandible Fracture; Polyetheretherketone

Treatments: Other: titanium trapezoidal plates; Other: PEEK trapezoidal plates

Study type: Interventional

Funder types: Other

Identifiers

NCT06940115

PEEK plate in condyle fracture

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

24 participants in 2 patient groups

control group

Experimental group

Description:

CAD/CAM titanium trapezoidal plates

Treatment:

Other: titanium trapezoidal plates

comparator group

Experimental group

Description:

CAD/CAM polyetheretherketone (PEEK) trapezoidal plates

Treatment:

Other: PEEK trapezoidal plates