立体光固化成型氧化锆陶瓷的生物安全性评价

doi:10.13591/j.cnki.kqyx.2022.01.008

口腔医学 ›› 2022, Vol. 42 ›› Issue (1): 47-52.doi: 10.13591/j.cnki.kqyx.2022.01.008

立体光固化成型氧化锆陶瓷的生物安全性评价

赵祯¹, 代康¹, 于海¹, 赵喆², 高勃¹

1 军事口腔医学国家重点实验室,国家口腔疾病临床医学研究中心,陕西省口腔医学重点实验室,第四军医大学口腔医院修复科,陕西西安(710032);
2 嘉兴饶稷科技有限公司,浙江嘉兴(314100)

修回日期:2021-10-26 出版日期:2022-01-28 发布日期:2022-01-28
通讯作者: 高勃 Tel:(029)84776469,E-mail:gaobo@fmmu.edu.cn
基金资助:
国家口腔疾病临床医学研究中心资助课题(LCA202011)

Biocompatibility of zirconia ceramic fabricated by stereolithography

ZHAO Zhen, DAI Kang, YU Hai, ZHAO Zhe, GAO Bao

State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Provincial Key Laboratory of Stomatology & Dept. of Prosthodontics, Hospital of Stomatology, Fourth Military Medical University,Xi'an 710032, China

Revised:2021-10-26 Online:2022-01-28 Published:2022-01-28

摘要/Abstract

摘要： 目的评价立体光固化成型氧化锆陶瓷的生物安全性。方法依照国标GB/T 16886.5—2017、GB/T 16886.10—2017及医药行业标准YY/T 0127.14—2009、YY/T 0127.13—2018对该陶瓷材料进行实验,包括体外细胞毒性实验、皮肤致敏实验、急性经口毒实验及黏膜刺激实验。结果体外细胞毒性实验结果显示不同浓度浸提液组细胞培养24 h后存活率均＞90%;皮肤致敏实验中,实验组红斑反应程度及发生率等于阴性对照组,证实陶瓷材料对皮肤无致敏作用;急性经口毒实验观察实验组大鼠大体器官及HE染色均未见明显异常;黏膜刺激实验观察金黄地鼠颊囊粘膜未见充血、糜烂等异常表现,HE染色未见角化不良、基底细胞空泡样变,证实对黏膜无刺激性。结论立体光固化成型氧化锆陶瓷的生物安全性初步满足临床要求。

关键词: 氧化锆陶瓷, 立体光固化, 生物安全性

Abstract: Objective To evaluate the biocompatibility of zirconia ceramic fabricated by stereolithography. Methods According to GB/T 16886.5—2017, GB/T 16886.10—2017, YY/T 0127.14—2009 and YY/T 0127.13—2018, samples were prepared and tested with general cytotoxicity test, skin sensitization test, acute oral toxicity test and oral mucous irritation test. Results General cytotoxicity test showed that the survival rate of cells cultured for 24 h in different concentration extract groups was >90%. The degree and incidence of erythema reaction in the skin sensitization test group were equal to those in the negative control group, which proved that the ceramic material had no sensitization effect on skin. Acute oral toxicity test of rats in the experimental group showed no obvious abnormalities in gross organs and HE staining. Results of oral mucous irritation test showed that no hyperemia and erosion were observed in the cheek pouch mucosa of hamster; no dyskeratosis and vacuolar changes of basal cells were observed in HE staining, which proved that the ceramic material had no irritation on mucosa. Conclusion The biocompatibility of zirconia ceramic fabricated by stereolithography meets elementary clinical requirements.

Key words: zirconia ceramic, stereolithography, biocompatibility

中图分类号:

R783.1

赵祯, 代康, 于海, 赵喆, 高勃. 立体光固化成型氧化锆陶瓷的生物安全性评价[J]. 口腔医学, 2022, 42(1): 47-52.

ZHAO Zhen, DAI Kang, YU Hai, ZHAO Zhe, GAO Bao. Biocompatibility of zirconia ceramic fabricated by stereolithography[J]. Stomatology, 2022, 42(1): 47-52.

参考文献

[1] Gautam C, Joyner J, Gautam A,et al. Zirconia based dental ceramics: Structure, mechanical properties, biocompatibility and applications[J]. Dalton Trans, 2016, 45(48):19194-19215.
[2] Lian Q, Wu XQ, Li DC, et al. Accurate printing of a zirconia molar crown bridge using three-part auxiliary supports and ceramic mask projection stereolithography[J]. Ceram Int, 2019, 45(15):18814-18822.
[3] 曹彦泽, 魏洪波, 董加一, 等. 基于增材制造的口腔全瓷修复成型工艺研究进展与展望[J]. 中华口腔医学研究杂志(电子版), 2020, 14(2):65-70.
[4] Methani MM, Revilla-León M, Zandinejad A. The potential of additive manufacturing technologies and their processing parameters for the fabrication of all-ceramic crowns: A review[J]. J Esthet Restor Dent, 2020, 32(2):182-192.
[5] Dehurtevent M, Robberecht L, Hornez JC,et al. Stereolithography: A new method for processing dental ceramics by additive computer-aided manufacturing[J]. Dent Mater, 2017, 33(5):477-485.
[6] Sun JX, Binner J, Bai JM. 3D printing of zirconia via digital light processing: Optimization of slurry and debinding process[J]. J Eur Ceram Soc, 2020, 40(15):5837-5844.
[7] Lee JY, An J, Chua CK. Fundamentals and applications of 3D printing for novel materials[J]. Appl Mater Today, 2017, 7: 120-133.
[8] Wang WN, Yu H, Liu YF, et al. Trueness analysis of zirconia crowns fabricated with 3-dimensional printing[J]. J Prosthet Dent, 2019, 121(2):285-291.
[9] Wang WJ, Sun J. Dimensional accuracy and clinical adaptation of ceramic crowns fabricated with the stereolithography technique[J]. J Prosthet Dent, 2021, 125(4):657-663.
[10] 中华人民共和国国家质量监督检验检疫总局, 中国国家标准化管理委员会. 医疗器械生物学评价第5部分:体外细胞毒性试验: GB/T 16886.5—2017[S]. 北京: 中国标准出版社, 2017.
[11] 中华人民共和国国家质量监督检验检疫总局, 中国国家标准化管理委员会. 医疗器械生物学评价第10部分:刺激与皮肤致敏试验: GB/T 16886.10—2017[S]. 北京: 中国标准出版社, 2018.
[12] YY/T 0127.14—2009中华人民共和国医药行业标准[S].口腔材料生物实验方法: 短期全身毒性实验: 经口途径,2009.
[13] YY/T 0127.13—2018中华人民共和国医药行业标准[S].口腔材料生物实验方法: 口腔黏膜刺激实验,2018.
[14] Gautam C, Joyner J, Gautam A, et al. Zirconia based dental ceramics: structure, mechanical properties, biocompatibility and applications[J].Dalton Trans,2016, 45(48):19194-19215.
[15] Zhang Y, Lawn BR. Novel zirconia materials in dentistry[J]. J Dent Res, 2018, 97(2):140-147.
[16] 蒋媛, 杨杨. 二氧化锆的临床研究进展[J]. 临床口腔医学杂志, 2017,33(2):125-127.
[17] Chen Z,Li Z, Li J, et al. 3D printing of ceramics: A review[J]. J Eur Ceram Soc, 2018, 39(4):661-687.
[18] Hwa LC,Rajoo S, Noor A M, et al. Recent advances in 3D printing of porous ceramics: A review[J]. Curr Opin Solid St M, 2017 (21) 323-347.
[19] Shen M, Qin W, Xing B, et al. Mechanical properties of 3D printed ceramic cellular materials with triply periodic minimal surface architectures[J]. J Eur Ceram Soc, 2021,41(2):1481-1489.
[20] Shen M, Wang C, Zhao Z. Mechanical properties of ZrO₂ TPMS structures prepared by DLP 3D printing[J]. IOP Conference Series: Materials Science and Engineering, 2019, 678(1):012017.
[21] 国家药品监督管理局. 牙科学用于口腔的医疗器械生物相容性临床前评价第1单:评价与试验项目选择: YY/T 0268—2001[S]. 北京: 中国标准出版社, 2004.
[22] 胡煜雯, 高静贤. GB/T 16886.5-2017中MTT细胞毒性试验方法解读[J]. 中国医疗器械信息, 2018, 24(21):11-12,49.
[23] 徐玉茵, 韩颖, 田林奇, 等. GB/T 16886.5—2017中体外细胞毒性试验的比较与分析[J]. 医疗卫生装备, 2019, 40(7):74-77,93.
[24] 王文俊, 钱超,阿地力江·依米提, 等. 立体光固化快速成型氧化锆全瓷冠的实验研究[J]. 口腔颌面修复学杂志, 2018, 19(5):257-261.
[25] 郑韵哲, 吴琳, 杨晓东, 等. 泡沫碳化硅陶瓷的豚鼠致敏最大值试验[J]. 临床口腔医学杂志, 2008, 24(7):390-393.
[26] 裴国献, 魏宽海, 金丹. 组织工程学实验技术[M]. 北京: 人民军医出版社, 2006.

立体光固化成型氧化锆陶瓷的生物安全性评价

Biocompatibility of zirconia ceramic fabricated by stereolithography

PDF

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 8

编辑推荐

Metrics

本文评价

[1]	廖梦圆谢海峰沈佳娣戴诗琪陈晨. 三种高透氧化锆陶瓷的半透明度及颜色评价[J]. , 2020, 40(7): 597-601.
[2]	吴欣祎谢海峰陈冰卓孟虹良何峰陈晨. 一种通用粘接剂对不同CAD/CAM可切削材料的短期粘接成绩[J]. , 2019, 39(3): 203-206.
[3]	吉玉刘玉玲张青红李林章非敏刘梅. 溶胶凝胶自组装法硅涂层对氧化锆陶瓷与树脂短期粘结强度的影响[J]. , 2018, 38(7): 597-601.
[4]	周凯黄菲张娟王琛. 纳米羟基磷灰石在骨重建中的效应和机理[J]. , 2017, 37(5): 453-456.
[5]	钱梦珂沈树平顾郁嘉何峰张怀勤谢海峰. 醋酸及柠檬酸对牙科氧化锆陶瓷性能的影响[J]. , 2016, 36(7): 583-586.
[6]	景双林,黄丽娟,唐哲,曹灵,李琥,汤春波,张光东,于金华. 氧化锆陶瓷固位钉用于修复前牙切角缺损的临床观察[J]. , 2012, 32(12): 731-733.
[7]	李剑,龚中坚,陈国平,江水清. CAD/CAM氧化锆烤瓷后牙固定桥与常规烤瓷固定桥的临床应用比较研究[J]. , 2010, 30(09): 544-546.
[8]	刘奕;张学鹏;王雪;修稚萌;孙旭东. 灌注羟基磷灰石的多孔NiTi合金牙种植材料的研究[J]. , 2007, 27(8): 427-428.