摘要
目的: 寻找一种陶瓷材料替代金属材料成为种植体核心材料。以口腔黏膜刺激试验作为二级试验，观察碳化硅种植材料的生物安全性。
方法：实验于2007-03/06在沈阳药科大学药理实验室完成。选择雄性家兔25只，双侧颊黏膜无病变。将碳化硅种植材料制成直径为5 mm，厚度为1 mm圆片，阴性对照为牙胶材料，阳性对照为工业用聚氯乙烯。用医用无创伤缝合线将试件固定于家兔口腔双侧颊黏膜上，一侧为阳性对照物，另一侧为碳化硅试件和阴性对照物。术后2周观察动物有无全身不良反应，另外每日观察圆片接触局部的黏膜反应，有无色泽异常、充血、糜烂、渗出等异常现象。2周后麻醉后处死动物，取与试件直接接触部位颊黏膜全层组织，行苏木精-伊红染色观察其组织学改变。
结果：纳入动物25只，均进入结果分析。①大体观察：碳化硅试样圆片固定良好，局部黏膜表面完整清晰，无异常反应如充血、出血、糜烂、溃疡等，与阴性对照无明显差异；阳性对照工业用聚氯乙烯圆片与家兔的颊黏膜表面出现了一定程度的充血、水肿。②组织学观察：碳化硅试件组和阴性对照组的黏膜被覆复层鳞状上皮，表面角化，未见上皮钉突伸长、黏膜表面过度角化、棘层增生等异常变化，基底膜完整，下方毛囊丰富，固有层纤维细胞组织致密，未见炎细胞，黏膜下层肌肉丰富。阳性对照组被覆复层鳞状上皮，紧接基底膜区可见炎细胞散在浸润，肌纤维旁、腺体内均可见炎细胞散在浸润，中性粒细胞为主、少量嗜酸细胞浆细胞，腺胞萎缩消失，导管增生扩张，局部中性粒细胞灶性浸润，血管内可见中性粒细胞，毛囊周围有中性粒细胞包绕浸润。
结论：碳化硅种植材料对实验动物颊黏膜无不良刺激反应。
关键词：碳化硅；种植；生物安全性；黏膜刺激；生物材料

刘文伟，王弢，战德松.以口腔黏膜刺激试验检测碳化硅种植材料的生物安全性[J].中国组织工程研究与临床康复，2008，12(6):1059-1062 [www.zglckf.com/zglckf/ejournal/upfiles/08-6/6k-1059(ps).pdf]

Biosafty of SiC implant material evaluated by oral mucous membrane irritation test

Abstract

AIM：To find out a kind of ceramic material to substitute metal material for implants. This study was to evaluate the biocompatibility of the SiC implant material with the oral mucous membrane irritation test.
METHODS: The experiment was carried out in the Pharmacological Laboratory of Shenyang Pharmaceutical University between March and June in 2007. Twenty-five male rabbits were used in this study, without bilateral cheek mucous membranes. The SiC implant material was made into wafers with 5 mm diameter and 1 mm thickness, as the test material; while gutta percha was taken as negative control, and polyviny chloride (PVC) as positive control. All the materials were fixed to the oral cheek mucous membrane of healthy rabbits with medical non-invasive suture, positive control on one side whereas SiC material and negative control on the other side. In two weeks, the general reaction and the oral mucous reaction in contacted site were observed, such as color, hyperaemia, erosion, and effusion. All the rabbits were sacrificed under anesthesia two weeks later, and the whole tissue of cheek mucous membrane in the directly contacted site were harvested and detected by hematoxylin-eosin staining for histological changes.
RESULTS: All 25 rabbits were involved in the result analysis.①SiC test piece was fixed well, part of mucous membranes were complete and clear. There was no abnormal reaction such as hyperaemia, haemorrhage, erosion, and ulcer. No significant difference was found compared with negative controls. But there were obvious hyperaemia and edema in the site where PVC was implanted.②In the SiC group and negative control group, the mucous membranes were coated with stratified squamous epithelia and showed cuticularization. No elongated epithelial peg, hyperkeratosis or hyperacanthosis was visible. The basal lamina was complete and abundant in folliculus pili, and fibrocyte tissues were dense in proper lamina without the inflammatory cells. There were plenty of muscles in inferior mucous. In the positive control group, the stratified squamous epithelia coating was observed, inflammatory cells infiltrated in the basement membrane zone, surrounding the muscle fibers, and in glandular organ. Heterophil granulocyte was dominant, accompanied by few acidocytes. Glandular cells shrank and even disappeared, ductal hyperplasia distended. Parts of heterophil granulocytes infiltrated in vessels and surrounding folliculus pili.
CONCLUSION: The SiC implant material has no adverse irritation reaction to the cheek mucous membrane of animals.

Liu WW, Wang T, Zhan DS. Biosafty of SiC implant material evaluated by oral mucous membrane irritation test.Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu 2008;12(6):1059-1062(China)
[www.zglckf.com/zglckf/ejournal/upfiles/08-6/6k-1059(ps).pdf]