Bandić Ružica, Vuković Kekez Ivna, Čikeš Čulić Vedrana, Galić Ivan, Paić Karega Gordana, Kalibović Govorko Danijela
Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.
Department of Orthodontics, University of Split School of Medicine, Split, Croatia.
Acta Stomatol Croat. 2025 Jun;59(2):124-132. doi: 10.15644/asc59/2/2.
This study evaluated the cytotoxicity of different thermoplastic materials and the impact of thermoforming on their cytotoxicity.
Four 3D thermoplastic materials were tested before and after thermoforming: Zendura A (Bay Materials), Zendura FLX (Bay Materials), Erkoloc-pro (Erkodent), and CA Pro + (Scheu Dental). The samples were stored in artificial saliva and incubated at 37 °C for 14 days to simulate conditions in the oral cavity during one stage of clear aligner treatment. Then, the saliva was diluted with a complete culture medium at three concentrations: c1=10%, c2=20% and c3=30%. Cytotoxic activities of the materials were evaluated after incubation for 4h, 24h, 48h, and 72h by using the CCK-8 assay on human oral fibroblast cells (Innoprot, REF: P10868).
The mean measured values of metabolically active cells below 70% of the control were for c3 of non-thermoformed Zendura A and Erkoloc-pro, and thermoformed Zendura A, after 72-hour incubation. The analysis showed differences between non-thermoformed: Zendura A and Erkoloc-pro and Zendura FLX and CA Pro +, thermoformed: Zendura A and CA Pro +, and Zendura FLX and CA Pro + at certain conditions. Differences between concentrations (c2 vs. c3 and c1 vs. c3) in the non-thermoformed group were found. There were no statistically significant differences in cytotoxicity between non-thermoformed and thermoformed groups.
Cytotoxicity was observed in non-thermoformed and thermoformed materials, with significant differences between concentrations of the same material. However, the thermoforming process did not impact the cytotoxicity of clear aligner materials.
本研究评估了不同热塑性材料的细胞毒性以及热成型对其细胞毒性的影响。
对四种3D热塑性材料在热成型前后进行测试：Zendura A（贝材料公司）、Zendura FLX（贝材料公司）、Erkoloc-pro（爱尔康登特公司）和CA Pro +（舒牙科公司）。将样品储存在人工唾液中，并在37°C下孵育14天，以模拟透明矫治器治疗一个阶段期间口腔内的情况。然后，将唾液用完全培养基稀释至三种浓度：c1 = 10%、c2 = 20%和c3 = 30%。通过使用CCK-8法对人口腔成纤维细胞（Innoprot，参考编号：P10868）进行孵育4小时、24小时、48小时和72小时后，评估材料的细胞毒性活性。
在72小时孵育后，非热成型的Zendura A和Erkoloc-pro的c3组以及热成型的Zendura A组中代谢活性细胞的平均测量值低于对照的70%。分析表明，在某些条件下，非热成型的Zendura A和Erkoloc-pro与Zendura FLX和CA Pro +之间、热成型的Zendura A和CA Pro +之间以及Zendura FLX和CA Pro +之间存在差异。在非热成型组中发现了浓度之间的差异（c2与c3以及c1与c3）。非热成型组和热成型组之间的细胞毒性没有统计学上的显著差异。
在非热成型和热成型材料中均观察到细胞毒性，同一材料的不同浓度之间存在显著差异。然而，热成型过程并未影响透明矫治器材料的细胞毒性。
