NCT07156812

Custom-Made 3D PEEK for Fixation of Mandibular Angle Fractures.

Custom-Made 3D PEEK Plates Versus 3D Titanium Plates in Mandibular Angle Fracture Fixation: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This investigation aimed to determine the clinical and radiographic efficacy of patient-specific, custom-made 3D PEEK plates in comparison with 3D titanium plates for the management of mandibular angle fractures.

Detailed description

Eighteen patients with recent mandibular angle fractures indicated for open reduction and internal fixation were randomly allocated into two groups. The study group (n = 9) underwent fixation with custom-made 3D PEEK plates, while the control group (n = 9) received prebent 3D titanium plates adapted on virtually reduced models. Follow-up extended to 12 weeks. Clinical parameters included operative time, postoperative occlusion, interfragmentary stability, wound healing, and bite force recovery. Radiographic evaluation was conducted using computed tomography scans acquired immediately postoperatively and at 12 weeks, assessing fracture healing and mean bone density.

Conditions

• Mandibular Angle Fracture
• Three Dimensional
• Polyetheretherketone

Interventions

Type	Name	Description
DEVICE	Custome made 3D PEEK plate	Custome made 3D PEEK plate
DEVICE	3D Titanium plate	Pre-bent 3D Titanium plate

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

1 site across 1 country: Egypt