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

NCT07156812 | Completed Phase 4

• 1 other identifier: 00010556-12/2021
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mandibular Angle Fracture; Three Dimensional; Polyetheretherketone

Keywords

mandibular angle fracture; PEEK; three-dimensional plate fixation

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  12 weeks

Secondary Outcomes (3)

• Clinical evaluation for interfragmentary stability.

  12 weeks

• clinical evaluation of wound healing

  14 days

• Clinical evaluation of postoperative occlusion

  12 week

Study Arms (2)

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

EXPERIMENTAL

custome made 3D PEEK plate

Device: Custome made 3D PEEK plate

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

EXPERIMENTAL

3D Titanium plates

Device: 3D Titanium plate

Interventions

Custome made 3D PEEK plate DEVICE

Custome made 3D PEEK plate

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

3D Titanium plate DEVICE

Pre-bent 3D Titanium plate

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

Location

Related Publications (1)

• Kamal AO, Shaaban AM, Shokry MM, Abdelhamed IM. Custom-made 3D PEEK plates versus 3D titanium plates for mandibular angle fracture fixation: a randomized clinical trial. BMC Oral Health. 2026 Jan 30. doi: 10.1186/s12903-025-07646-z. Online ahead of print.

  PMID: 41618317 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: February 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

EG (1)