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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06940115
Enrollment
24
Registered
2025-04-23
Start date
2025-05-01
Completion date
2026-08-15
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condylar Neck Fractures, Mandible Fracture, Polyetheretherketone

Keywords

PEEK PLATES, TRAPEZOIDAL PLATES, CAD/CAM

Brief summary

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.

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.

Interventions

OTHERtitanium trapezoidal plates

ORIF subcondylar fracture using trapezoidal titanium plates

OTHERPEEK trapezoidal plates

ORIF subcondylar fracture using trapezoidal PEEK plates

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum mouth openingoutcome 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 surgeryMaximum 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026