NCT07520227

Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle

Comparative Evaluation of 3D-printed Polyetheretherketone (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Is patient specific customized computer assisted 3D PEEK plates more superior to 3D titanium plate in fixation of mandibular angle fractures?

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.

Conditions

• Fracture Mandible

Interventions

Type	Name	Description
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.
DEVICE	Conventional 3D titanium plates	Conventional 3D titanium plates used for fixation of mandibular angle fractures with titanium screws.

Timeline

• Start date: 2023-05-20
• Primary completion: 2024-10-30
• Completion: 2024-12-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Egypt