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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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

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Mandibular Angle Fracture Three Dimensional Polyetheretherketone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). Group A was treated with custom made 3D PEEK plates and Group B with 3D titanium plates.

Study Groups

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

custome made 3D PEEK plate

Group Type EXPERIMENTAL

Custome made 3D PEEK plate

Intervention Type DEVICE

Custome made 3D PEEK plate

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

3D Titanium plates

Group Type EXPERIMENTAL

3D Titanium plate

Intervention Type DEVICE

Pre-bent 3D Titanium plate

Interventions

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Custome made 3D PEEK plate

Intervention Type DEVICE

3D Titanium plate

Pre-bent 3D Titanium plate

Intervention Type DEVICE

Eligibility Criteria

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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