Assessing cytotoxicity: a comparative analysis of biodegradable and conventional 3D-printing materials post-steam sterilization for surgical guides.

Matthias W Gielisch, Daniel G E Thiem, Ulrike Ritz, Christoph Bösing, Bilal Al-Nawas, Peer W Kämmerer
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Abstract

Introduction.Ecological concerns and the depletion of petroleum resources have driven the exploration of biodegradable 3D-printing materials derived from bio-renewable sources, such as polylactic acid (PLA) and polyhydroxyalkanoates (PHA). This study aimed to compare the potential cytotoxic effects of a biodegradable PLA/PHA blend filament, a conventional photopolymer (MED610), and a combination of MED610 with a support material (SUP705) before and after steam sterilization in vitro, with a focus on their application in the production of surgical guides.Materials and Methods.PLA/PHA, MED610, and SUP705 (both in their pure and steam-sterilized forms;n= 6 per group) were assessed for their cytotoxic effects on human fibroblasts using the neutral red uptake assay. Positive controls included zinc diethyldithiocarbamate and zinc dibutyldithiocarbamate, while high-density polyethylene served as a negative control. A stock solution of the extraction medium was used as the vehicle control (VC).Results.Significant differences in cell viability were observed between pure PLA/PHA (1.2 ± 0.24) and MED610 (0.94 ± 0.08) (p= 0.005). However, both materials exhibited non-cytotoxicity, with cell viability exceeding 70% compared to VCs. SUP705 (0.58 ± 0.42) demonstrated significantly reduced cell viability compared to PLA/PHA (p= 0.001) and MED610 (p= 0.007). After steam sterilization, no significant difference in cell viability was noted between MED610 (1.0 ± 0.08) and PLA/PHA (1.2 ± 0.25) (p= 0.111). While both materials remained non-cytotoxic after sterilization, SUP705 (0.60 ± 0.45) exhibited cytotoxic effects compared to MED610 (p= 0.006) and PLA/PHA (p< 0.001). Steam sterilization did not induce significant cytotoxic effects in the investigated materials (p= 0.123).Conclusion.Pure and steam-sterilized PLA/PHA and MED610 were not cytotoxic, supporting their potential use in the production of surgical guides. However, the observed cytotoxicity of SUP705 suggests caution in scenarios requiring sterile conditions, as the removal of support material from complex printed parts may be challenging. The consideration of PLA/PHA is recommended in such settings to ensure biocompatibility.

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评估细胞毒性:用于手术导板的可生物降解和传统三维打印材料蒸汽灭菌后的比较分析。
导言:生态问题和石油资源的枯竭促使人们探索从生物可再生资源中提取的可生物降解的三维打印材料,如聚乳酸(PLA)和聚羟基烷酸酯(PHA)。本研究旨在比较可生物降解的聚乳酸/PHA混合丝、传统光聚合物(MED610)以及MED610与支撑材料(SUP705)的组合在体外蒸汽灭菌前后的潜在细胞毒性效应,重点是它们在手术导板生产中的应用。材料与方法:采用中性红吸收试验评估聚乳酸/聚羟乙基纤维素、MED610 和 SUP705(包括纯品和蒸汽灭菌品;n= 每组 6 个)对人成纤维细胞的细胞毒性作用。阳性对照包括二乙基二硫代氨基甲酸锌和二丁基二硫代氨基甲酸锌,而高密度聚乙烯则作为阴性对照。结果表明,纯聚乳酸/PHA(1.2 ± 0.24)和 MED610(0.94 ± 0.08)之间的细胞活力存在显著差异(p= 0.005)。不过,这两种材料都表现出无细胞毒性,与 VC 相比,细胞存活率超过 70%。与 PLA/PHA(p= 0.001)和 MED610(p= 0.007)相比,SUP705(0.58 ± 0.42)的细胞存活率明显降低。蒸汽灭菌后,MED610(1.0 ± 0.08)和 PLA/PHA (1.2 ± 0.25)的细胞活力没有明显差异(p= 0.111)。虽然两种材料在灭菌后仍无细胞毒性,但与 MED610(p= 0.006)和 PLA/PHA (p< 0.001)相比,SUP705(0.60 ± 0.45)表现出细胞毒性效应。结论:纯聚乳酸/聚羟乙烯和蒸汽灭菌聚乳酸/聚羟乙烯和 MED610 没有细胞毒性,这支持了它们在外科手术导板生产中的潜在用途。然而,观察到的 SUP705 的细胞毒性表明,在需要无菌条件的情况下应谨慎使用,因为从复杂的打印部件中去除支撑材料可能具有挑战性。在这种情况下,建议考虑使用聚乳酸/聚羟乙酸,以确保生物相容性。
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