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NCT Number: NCT06940115

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

titanium trapezoidal plates

Other

ORIF subcondylar fracture using trapezoidal titanium plates

PEEK trapezoidal plates

Other

ORIF subcondylar fracture using trapezoidal PEEK plates

Primary outcomes

  1. Maximum mouth opening

    Time frame: 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

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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