Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates

NCT07850570 | Not Yet Recruiting DMC

• 1 other identifier: MDP.26.08.38
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Mandibular fractures represent a significant portion of maxillofacial trauma, primarily resulting from motor vehicle accidents, interpersonal violence, and sports-related injuries 1. Achieving successful treatment requires accurate anatomical reduction, stable internal fixation, and restoration of pre-traumatic occlusion and masticatory function 2. Open reduction and internal fixation (ORIF) using titanium miniplates has long served as the gold standard for mandibular fracture management due to their superior mechanical strength, excellent biocompatibility, and proven structural reliability 3. Despite their widespread clinical adoption, conventional titanium plates present notable drawbacks. Their high elastic modulus compared to human cortical bone often leads to stress shielding, which can impede normal bone healing and cause local osteopenia 4.Additionally, titanium hardware can cause temperature sensitivity, scatter artifacts on computed tomography (CT) and magnetic resonance imaging (MRI) scans, and may necessitate secondary surgical removal due to palpability or infection 5. To address these limitations, Polyether Ether Ketone (PEEK)-a high-performance thermoplastic polymer has emerged as a promising alternative biomaterial in maxillofacial surgery. PEEK exhibits an elastic modulus close to natural bone, thereby reducing stress shielding and promoting physiological strain distribution during fracture healing 6. Furthermore, PEEK is radiolucent, non-magnetic, and chemically inert, allowing artifact-free postoperative radiologic assessment 7. With advancements in digital dentistry, computer-aided design and computer-aided manufacturing (CAD/CAM) alongside 3D printing have enabled the fabrication of patient-specific, custom-made implants. Custom-made titanium and PEEK plates eliminate the need for intraoperative manual bending, significantly reducing surgical time, improving contour accuracy, and enhancing mechanical stability across the fracture site 8. While custom-made titanium provides rigid fixation suitable for high-load zones, custom-made PEEK implants offer an biomechanically compatible and artifact-free alternative. However, direct comparative clinical and biomechanical evaluations between custom-made titanium and custom-made PEEK plates for mandibular fracture fixation remain limited. Therefore, this study aimed to evaluate and compare the clinical outcome, stability, and surgical efficiency of custom-made titanium versus custom-made PEEK plates in the fixation of mandibular fractures.

Conditions

Mandibular Fractures

Keywords

PEEK plates-Titanium plates-mandibular fracture

Outcome Measures

Primary Outcomes (1)

• The adequacy of the reduction of the fractured segment

  will be determined by an assessment of the inferior border of the mandible as follows: 1. Excellent reduction: whenever alignment of the inferior border of mandible will be maintained across the fracture line. 2. Good reduction: if a discrepancy of 1-3 mm is noted. 3. Fair reduction: if a discrepancy of 3-5mm is noted. 4. Poor reduction: if the discrepancy is \> 5 mm.

  immediately and 6 months after the surgery consequently

Study Arms (2)

Custom-Made Titanium Plate

EXPERIMENTAL

Custom-Made Titanium Plate for Fixation of Mandibular Fractures

Device: Custom-Made Titanium Plate

Custom-Made PEEK Plate

EXPERIMENTAL

Custom-made polyether ether ketone (PEEK) plate used for fixation of mandibular fractures.

Device: Custom-Made PEEK Plate

Interventions

Custom-Made PEEK Plate DEVICE

Custom-made polyether ether ketone (PEEK) plate used for fixation of mandibular fractures.

Custom-Made PEEK Plate

Custom-Made Titanium Plate DEVICE

Custom-made titanium plate used for fixation of mandibular fractures.

Custom-Made Titanium Plate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Patients age ranging from 18 to 50 years. 2) Unilateral and/or bilateral simple or compound fractures of the mandibular symphysis, parasymphysis or body regions that are displaced and require open reduction with internal fixation.
• \) The fractures must be recent, having occurred no longer than 10 days prior to the surgical treatment.
• \) Healthy patients who are classified according to the American Society of Anesthesiologists (ASA) physical status classification as class I.

You may not qualify if:

• \) Patients suffer from pathological fractures. 2) Comminuted and infected fractures. 3) Fracture of the atrophic edentulous ridge 4) Old mandibular fractures (more than 10 days). 5) Patients with ASA classes II, III, IV, and V.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

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 Officials

• Aya ali Elsies, assistant lecturer

  Faculty of Dentistry, Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

aya ali Elsies, assistant lecturer

CONTACT

0201091797600; ayaalialsies@mans.edu.eg

mahmoud hamdy sediek, doctor

CONTACT

0201123988907; mahmoudseddeik1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start: September 24, 2026
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): September 24, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)