Polyetheretherketone (PEEK) has become the biomaterial of choice for repairing craniofacial defects over time. Prospects for the point-of-care (POC) fabrication of PEEK customized implants have surfaced thanks to the developments in three-dimensional (3D) printing systems. Consequently, it has become essential to investigate the characteristics of these in-house fabricated implants so that they meet the necessary standards and eventually provide the intended clinical benefits. This study aimed to investigate the effects of the steam sterilization method on the dimensional accuracy of POC 3D-printed PEEK customized cranial implants. The objective was to assess the influence of standard sterilization procedures on material extrusion-based 3D-printed PEEK customized implants with non-destructive material testing. Fifteen PEEK customized cranial implants were fabricated using an in-house material extrusion-based 3D printer. After fabrication, the cranial implants were digitalized with a professional-grade optical scanner before and after sterilization. The dimensional changes for the 3D-printed PEEK cranial implants were analyzed using medically certified 3D image-based engineering software. The material extrusion 3D-printed PEEK customized cranial implants displayed no statistically significant dimensional difference with steam sterilization (p > 0.05). Evaluation of the cranial implants' accuracy revealed that the dimensions were within the clinically acceptable accuracy level with deviations under 1.00 mm. Steam sterilization does not significantly alter the dimensional accuracy of the in-house 3D-printed PEEK customized cranial implants.
Keywords: accuracy; alloplastic implant; computer-assisted; cranioplasty; material extrusion; patient-specific; polymer; printing; sterilization; three-dimensional.