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

Alexandria University18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Mandibular Angle Fracture Three Dimensional Polyetheretherketone

Interventions

Custome made 3D PEEK plateDEVICE

Custome made 3D PEEK plate

3D Titanium plateDEVICE

Pre-bent 3D Titanium plate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of dentistry, Alexandria university

Alexandria, Egypt

Outcomes

Primary Outcomes

Radiographic evaluation for the assessment of mean bone density at the fracture line [Time Frame: 12 weeks]

Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)

Time frame: 12 weeks

Bite force recovery.

bite force recovery measured by a Piezoresistive force transduce sensor: FlexiForce A201 sensor (FlexiForce sensor, by Tekscan Boston, MA, USA. www.tekscan.com)

Time frame: 12 weeks

Secondary Outcomes

Clinical evaluation for interfragmentary stability.

Intra-fragmentary mobility was evaluated by bimanual palpation at the fracture site

Time frame: 12 weeks

clinical evaluation of wound healing

Wound healing is graded according to Southampton wound-grading system

Time frame: 14 days

Clinical evaluation of postoperative occlusion

By checking the maximal intercuspal position (centric occlusion) to ensure proper occlusal relationship including molar relation, canine relation and midline centralization

Time frame: 12 week

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.