Skip to main content
OpenTrials
Completed

NCT Number: NCT07156812

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mandibular Angle Fracture Polyetheretherketone Three Dimensional

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custome made 3D PEEK plate

Device

Custome made 3D PEEK plate

3D Titanium plate

Device

Pre-bent 3D Titanium plate

Primary outcomes

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

    Time frame: 12 weeks

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

  2. Bite force recovery.

    Time frame: 12 weeks

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

Secondary outcomes

  1. Clinical evaluation for interfragmentary stability.

    Time frame: 12 weeks

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

  2. clinical evaluation of wound healing

    Time frame: 14 days

    Wound healing is graded according to Southampton wound-grading system

  3. Clinical evaluation of postoperative occlusion

    Time frame: 12 week

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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.