自凝水凝胶义齿软衬材料的生物学性能评价研究

Biological evaluating on self-curing hydrogel for dental soft lining matecial

目的 评价新研制的自凝水凝胶义齿软衬材料临床前的生物安全性 ;探讨材料的结构与生物学性能之间的关系。方法 参照ISO 740 5 - 1997(E)最新标准 ,对该水凝胶材料进行了细胞毒性试验、急性经口全身毒性试验、口腔粘膜刺激试验、致敏试验、Ames试验和溶血试验。结果 体内外生物学试验结果表明 :该材料无明显的细胞毒性、溶血性、致敏性、致突变性、急性全身毒性以及对口腔粘膜的刺激性 ;水凝胶材料本身的结构和吸水膨胀性能为良好的生物学性能提供了基础条件。结论 自凝水凝胶义齿软衬材料具有良好的生物相容性。

Objective To evaluate the biological safety of new self-curing hydrogel for dental soft lining material before clinical use; and to discuss the relation of the structure and biological properties.Methods Cytotoxicity test, acute systemic toxicity test (by oral), oral mucous membrane irritating test, sensitization test, Ames test and haemolysis test were investigated according to standard of ISO 7405-1997(E). Results There were almost no obvious cytotoxicity and heamolysis, no sensitivity, no mutagenicity, no acute systemic toxicity and no irritant reaction for oral mucous membrane. The structure and water expansion of hydrogel itself may provide a basic condition for a good biological property.Conclusion There was a good biocompatibility for this kind of self-curing hydrogel as a dental soft lining material.