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

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Mandibular Angle Fracture; Three Dimensional; Polyetheretherketone

Treatments: Device: 3D Titanium plate; Device: Custome made 3D PEEK plate

Study type: Interventional

Funder types: Other

Identifiers

NCT07156812

00010556-12/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with recent mandibular angle fracture adults without gender predilection who agreed to follow-up, fractures requiring open reduction and internal fixation, medically fit for general anesthesia

Exclusion criteria

• medically compromised patients, fractures with infection, pathological or old fractures, completely edentulous patients, comminuted fractures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

patients with recent mandibular angle fractures managed with custome made 3D PEEK plate

Experimental group

Description:

custome made 3D PEEK plate

Treatment:

Device: Custome made 3D PEEK plate

patients with recent mandibular angle fractures managed with 3D Titanium plates

Experimental group

Description:

3D Titanium plates

Treatment:

Device: 3D Titanium plate