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目的:初步评价自制牙表面仿釉质涂层材料(羟基磷灰石涂剂)的生物相容性,为材料的最终临床应用提供实验依据。方法:根据YY/T 0127.10-2009、GB/T 16886.10-2005、YY/T 0127.8-2001所规定的方法,分别进行AMES试验、迟发型超敏反应试验、皮下植入试验,评价材料的生物相容性。结果:自制牙表面仿釉质涂层材料浸提液组的回变菌落数未超过溶剂对照组回变菌落数的2倍,无致突变性;致敏试验表明移去贴敷物24 h、48 h、72 h后,试验动物贴敷部位均无红斑和水肿出现,致敏率为0,无明显的致敏性;皮下植入试验结果显示4 W和12 W实验组和对照组的差异均无统计学意义(P>0.05),而两组在4 W和12 W的差异均有统计学意义(P<0.05),表现出炎症反应减轻,提示了愈合的趋势。结论:初步认为牙表面仿釉质涂层材料具有良好的生物相容性。
OBJECTIVE: To evaluate the biocompatibility of self-made enamel coating material (hydroxyapatite coating) on the surface of dental implants and provide experimental evidence for the final clinical application of the material. Methods: According to the methods of YY / T 0127.10-2009, GB / T 16886.10-2005 and YY / T 0127.8-2001, AMES test, delayed-type hypersensitivity test and subcutaneous implantation test were respectively conducted to evaluate the biological phase Capacitive. Results: The numbers of back-changed colonies of the self-made enamel coating material leaching solution group did not exceed 2 times of the number of colonies returned by the solvent control group, and there was no mutagenicity. The sensitization test showed that the removal rate of the attachments was 24 h and 48 h , 72 h later, there was no erythema and edema appearing in the application site of the experimental animals, the sensitization rate was 0, and there was no obvious sensitization. The results of subcutaneous implantation showed that there was no difference between 4 W and 12 W experimental group and control group (P> 0.05). However, the difference between the two groups was statistically significant at 4 W and 12 W (P <0.05), showing a reduction of inflammatory response, suggesting a trend of healing. Conclusion: It is preliminarily believed that the tooth enamel coating has good biocompatibility.