Clinical and Radiographical Assessment of Patients With Sub-condylar Fracture Using Polyetheretherketone (PEEK) Trapezoidal Plates Versus Titanium Trapezoidal Plates

NCT06940115 | Not Yet Recruiting DMC

• 1 other identifier: PEEK plate in condyle fracture
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Some of titanium's drawbacks that is commonly used in maxillofacial surgery included scatter artefacts on regular imaging, implant exposure and inflammation, high thermal conductivity, and high elastic modulus. Very few clinical studies have been published on using a PEEK plate in the mandibular fractures and to the best of the author's knowledge, this is the first study that will be done comparing trapezoidal condylar 3D printed PEEK plates and titanium trapezoidal condylar plate in subcondylar fractures in terms of clinical and radiographical outcomes.

Conditions

Condylar Neck Fractures; Polyetheretherketone; Mandible Fracture

Keywords

PEEK PLATES; TRAPEZOIDAL PLATES; CAD/CAM

Outcome Measures

Primary Outcomes (1)

• Maximum mouth opening

  Maximum mouth opening is the distance between the incisal edges of the upper and lower central incisors at the midline when the mouth is opened as wide as possible without pain. It will be measured in millimeters (mm) using a caliper

  outcome will be measured postoperatively in 4 different time points. 1st time point is at 1 week after surgery. 2nd time is point at 1 month after surgery. 3rd time point is at 3 months after surgery. 4th time point is at 6 months after surgery

Study Arms (2)

control group

EXPERIMENTAL

CAD/CAM titanium trapezoidal plates

Other: titanium trapezoidal plates

comparator group

EXPERIMENTAL

CAD/CAM polyetheretherketone (PEEK) trapezoidal plates

Other: PEEK trapezoidal plates

Interventions

titanium trapezoidal plates OTHER

ORIF subcondylar fracture using trapezoidal titanium plates

control group

PEEK trapezoidal plates OTHER

ORIF subcondylar fracture using trapezoidal PEEK plates

comparator group

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or older, irrespective of gender
• Recent mandibular subcondylar fractures indicated for open reduction and internal fixation

You may not qualify if:

• Medically compromised patients contradicting operation (ASA III, IV \& V).
• Patients receiving radiotherapy or chemotherapy.
• Infection at the fracture line.
• Pathological fractures and old fractures
• comminuted fractures

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 23, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-03