Mandibular fractures represent a significant portion of maxillofacial trauma, primarily resulting from motor vehicle accidents, interpersonal violence, and sports-related injuries. Achieving successful treatment requires accurate anatomical reduction, stable internal fixation, and restoration of pre-traumatic occlusion and masticatory function . 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 .
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 .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 .
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. Furthermore, PEEK is radiolucent, non-magnetic, and chemically inert, allowing artifact-free postoperative radiologic assessment .
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 . 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.