应用于牙科种植体的新型钛合金生物安全性检测

发布时间：2018-01-04 03:44

本文关键词：应用于牙科种植体的新型钛合金生物安全性检测　出处：《吉林大学》2016年硕士论文　论文类型：学位论文

【摘要】：目的与背景:口腔种植体的出现里程碑式的改变了牙列缺损和牙列缺失的修复方式。骨结合(Osseointergration)是种植体能够成功植入的理论基础,其指骨和种植体之间达到无纤维组织的稳定结合。为了能更好的达到骨结合,人们通过研发新型种植体材料及进行种植体表面改性来达到这一目的,随着材料学的发展和进步,越来越多的材料应用于种植体领域,种植所应用的材料要求具有良好的生物相容性,良好的抗腐蚀性,骨结合性及机械性能,其中无毒金属材料为种植体材料的首选。钛金属由于其出色的生物学性能,灵活性及抗腐蚀能力在临床具有广泛的应用,锆,钽,铌已经被证实具有出色的生物安全性和机械性能,对成骨细胞的增殖分泌具有促进作用。根据国际标准ISO-10993-5-2009和ISO-10993-3-2009中所描述的试验方法:植入生物体内30天的材料,必须进行生物安全性检测。本研究从对一种新型的含有锆,钽,铌的钛合金进行了体内及体外生物安全性的检测。方法:本实验采用华南理工大学提供的新型钛合金钛片。将阴性对照组选择为DMEM高糖培养基组。按照ISO-10993-12-2012制备各组钛片的浸提液,通过CCK-8实验评价各实验组钛片的细胞毒性,应用单细胞凝胶电泳实验检测实验组钛片的遗传毒性,评价各实验组钛片对成骨细胞DNA造成损伤的水平,通过皮下植入实验和急性毒性实验对各组钛片的体内安全性进行检测,对实验结果分别进行大体观察和组织学评价,通过SPSS软件将各实验组的实验结果进行统计学分析。结果:1:CCK-8实验结果:各实验组试件对成骨细胞均不会产生细胞毒性,对细胞增殖无抑制作用;2.SCGE结果:各组实验图像数据的OTM:(Olive tail moment:尾部DNA占总DNA的百分比与头、尾部中心间距的乘积)和%tail DNA(尾部DNA百分量,尾部和总彗星荧光百分比)与DMEM阴性对照组之间差异无显著性;提示各实验组,相对于纯钛,不会对成骨细胞造成DNA损伤,不具有遗传毒性。3.皮下植入实验结果:通过大体观察可以看出商业纯钛和两种钛合金对动物均无刺激,周围组织未见炎症,组织学观察可以看出Si组囊壁略不规整,有少量毛细血管充血。4.急性全身毒性实验结果:急性全身毒性实验结果:未见任何实验动物表现出较对照组明显的生物学反应,未见体重下降。结论:1.新型钛合金无细胞毒性,不会抑制成骨细胞的生长;2.新型钛合金对成骨细胞造成的DNA原始损伤与商业纯钛纯钛相同;3.新型钛合金对不对皮肤产生毒性反应,没有刺激作用,不产生炎症及过敏反应。4.新型钛合金无急性全身毒性。实验提示新型钛合金不具有细胞毒性、遗传毒性以、植入后局部反应及急性全身毒性,该种植体具有良好的体内体外生物安全性,肯定了其将来应用于临床的可能性,并为其提供了理论支持。
[Abstract]:Objective and background: the landmark appearance of dental implants has changed the repair of dentition defects and dentition. It is the theoretical basis for the successful implantation of implants. In order to achieve better osseointegration, people develop new implant materials and implant surface modification to achieve this goal. With the development and progress of material science, more and more materials are used in implant field. The materials used in implant are required to have good biocompatibility, good corrosion resistance, bone bonding and mechanical properties. Titanium is widely used in clinic because of its excellent biological properties, flexibility and corrosion resistance, zirconium and tantalum. Niobium has been proven to have excellent biological safety and mechanical properties. Promote the proliferation and secretion of osteoblasts. According to the test methods described in international standards ISO-10993-5-2009 and ISO-10993-3-2009:. The material implanted in the organism for 30 days. Biosafety tests must be performed. This study is based on a new type containing zirconium and tantalum. The biological safety of titanium alloy of niobium was determined in vivo and in vitro. Methods:. In this experiment, a new titanium alloy titanium tablet provided by South China University of Technology was used. The negative control group was selected as DMEM high sugar medium group. The extraction of each titanium slice was prepared according to ISO-10993-12-2012. Liquid. The cytotoxicity of titanium tablets in each experimental group was evaluated by CCK-8 assay, and the genotoxicity of titanium tablets in experimental group was detected by single cell gel electrophoresis (SCGE). To evaluate the level of DNA damage of osteoblasts induced by titanium tablets in each experimental group, and to detect the safety of titanium tablets in each group by subcutaneous implantation test and acute toxicity test. Gross observation and histological evaluation of the experimental results were carried out. The experimental results of each experimental group were statistically analyzed by SPSS software. Results: the results of 1: 1: CCK-8 experiment showed that no cytotoxicity to osteoblasts was found in all experimental groups. There was no inhibitory effect on cell proliferation. 2. SCGE results: OTM:(Olive tail momentum of each group of experimental image data: the percentage and head of tail DNA in total DNA. There was no significant difference between tail DNA (tail DNA 100 component, tail and total comet fluorescence percentage) and DMEM negative control group. These results suggest that the experimental group will not cause DNA damage to osteoblasts compared with pure titanium. Experimental results of subcutaneous implantation: commercial pure titanium and two kinds of titanium alloys were not irritated to animals, and no inflammation was found in the surrounding tissues. Histological observation shows that the cystic wall of Si group is slightly irregular. There was a small amount of capillary hyperemia. 4. Acute systemic toxicity test results: acute systemic toxicity test results: no experimental animals showed a more obvious biological response than the control group. Conclusion: the new titanium alloy has no cytotoxicity and does not inhibit the growth of osteoblasts. 2. The original damage of DNA to osteoblasts caused by new titanium alloy is the same as that of commercial pure titanium. 3. The new titanium alloy has no toxic reaction to the skin, no irritation, no inflammation and no allergic reaction. The new titanium alloy has no acute systemic toxicity. The experiment shows that the new titanium alloy has no cytotoxicity. Genetic toxicity, local reaction after implantation and acute systemic toxicity, the implant has good biological safety in vivo and in vitro, confirmed the possibility of its clinical application in the future, and provided theoretical support for it.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R783.6

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