Case reportClinical application of 3D-printed PEEK implants for repairing mandibular defects
Introduction
Severe mandibular segmental defects caused by traumatic injury, infection sequelae, or oncological resection are very common in the clinic, and have significant negative effects on patients' facial appearance and corresponding oral functions, which can also lead to substantial psychological trauma (Futran and Mendez, 2006). Reconstruction of the mandible is often necessary due to the patient's need for improved appearance and oral function, and is a substantial challenge for surgeons. Currently, there is no doubt that autologous bone graft is the gold standard approach, and the most widely used technique for repairing mandibular defects in the clinic. Its advantages include ideal structural and histocompatibility properties for osteointegration, ideal physiological and anatomical properties, and a lack of immune rejection (Moussa and Dym, 2020). However, autologous bone is a limited resource, harvesting autologous bone results in damage to the donor site, and autologous bone grafting cannot be used to achieve accurate personalized reconstruction, unless the operator has extensive clinical experience (Koper et al., 2019). Therefore, an increasing range of alloplastic materials has been introduced to replace autologous bone for repairing mandibular defects. Among the alloplastic substitute materials, titanium and its alloy implants are the most widely used in mandible reconstruction due to their excellent mechanical properties and biocompatibility (Kuttenberger and Hardt, 2001). However, although they can be used to achieve specific mandibular reconstruction, there are still drawbacks, such as their high thermal conductivity, high elastic modulus, implant exposure and inflammation, and scatter artifacts on routine imaging. Therefore, researchers continue to search for better alternative materials to overcome the above limitations.
Polyether ether ketone (PEEK) is a well-known polyaromatic, semicrystalline, thermoplastic polymer with specific chemical and mechanical properties. Compared with other allografts, PEEK is a bioinert compound with an elastic modulus of approximately 3–4 GPa, which is close to that of human cortical bone (7–30 GPa) (Kizuki et al., 2015; Peron et al., 2018). After implantation, PEEK remains stable in the body without toxicity, and shows high compatibility with soft tissues (Lethaus et al., 2012). In addition, PEEK and its composites possess natural radiolucency and are compatible with ultrasound and computed tomography (CT) (Mursch and Behnke-Mursch, 2018). Recent studies have reported the use of 3D-printed patient-specific PEEK implants in complex cranioplasty, orthopedic surgery, cardiac surgery, dentistry, and other surgical fields for the repair and reconstruction of different bone defects (Jalbert et al., 2014; Panayotov et al., 2016; van de Vijfeijken et al., 2019). Moreover, the use of custom-made onlay and inlay PEEK implants in maxillofacial reconstruction has also demonstrated good results (Scolozzi et al., 2007; Suresh et al., 2018; Saponaro et al., 2020). However, these PEEK implants have been mainly used for malar-orbit combo reconstruction, orbital dystopia, malar depression, and forehead or skull defects (Murnan and Christensen, 2021). Specifically, in the existing studies, the use of PEEK implants in the mandible has been limited to improving mandibular retrognathism or asymmetry (Jarvinen et al., 2019; Olate et al., 2021). In other words, the use of PEEK implants in the reconstruction of mandibular segmental defects is not well documented in the literature. In this study, the aim was to evaluate and summarize the postoperative outcomes and complications in patients who underwent surgical procedures with mandibular reconstruction using 3D-printed PEEK implants.
Section snippets
Patient selection
The authors designed and conducted a prospective clinical trial that was approved by the Medical Ethics Committee of the School of Stomatology, the Fourth Military Medical University (reference no. IRB-REV-2018037) and registered in the Chinese Clinical Trial Registry (registration no. ChiCTR2000032688). All operative procedures and methods were performed in accordance with the relevant guidelines and regulations of the committee and the registry. Six patients (three females and three males)
Discussion
PEEK was first proposed as a material for biomedical applications in 1998, by Invibio, Ltd (Thornton-Cleveleys, UK), and was launched for long-term implantable applications by Victrex (Imperial Chemical Industry, London, UK) (Kurtz and Devine, 2007; Green, 2015). Since then, PEEK has been successfully used to reconstruct skeletal defects throughout the body, due to its outstanding biocompatibility, stability and resistance to chemical- and radiation-induced damage (Katzer et al., 2002; Wang
Conclusion
On the premise of strict selection of indications, titanium screws alone can meet the retention requirements of PEEK implants. It should be noted that, due to PEEK's bioinertness and lack of osteointegration, local soft-tissue conditions should be evaluated and adjusted before implantation, and the design of the PEEK implant should be adjusted as appropriate.
Clinical trial registration
Chinese Clinical Trial Registry (registration number ChiCTR2000032688); the treatment of maxillofacial deformity and defect with PEEK material based on 3D printing technology; https://www.chictr.org.cn/showproj.aspx?proj=51462.
Funding
This research was financially supported by the State Key Laboratory of Military Stomatology of China (grant no. 2019ZA08), the Key R&D Program of Shaanxi Province (grant no. 2020ZDLSF04-09), and the Key-Area Research and Development Program of Guangdong Province (grant no. 2018B090906001).
Author contributions
Yunpeng Li: contributed to performing the operations, and to data acquisition, analysis, and interpretation. Zhiye Li: contributed to data acquisition, analysis, and interpretation. Liang Kong: contributed to the conception, design, and data analysis and interpretation, and critically revised the manuscript. Lei Tian: contributed to the design, and to data analysis and interpretation. Dichen Li: contributed to the design and production of 3D-printed PEEK implants. Bin Lu: helped perform the
Declarations of interest
The authors confirm that there are no conflicts of interest associated with this work.
Acknowledgements
The authors thank Haiqiang Li, Bingfeng Cong, Fuding Shen, Zhihe Zhao, and other colleagues in the Department of Oral and Maxillofacial Surgery, School of Stomatology, Fourth Military Medical University, for their full cooperation and support.
The authors thank Haiqiang Li, Bingfeng Cong, Fuding Shen, Zhihe Zhao, and other colleagues in the Department of Oral and Maxillofacial Surgery, School of Stomatology, Fourth Military Medical University, for their full cooperation and support.
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These authors contributed equally to this work.