New biomaterials including surface modifications should undergo in vitro and in vivo evaluation before clinical trials. The objective of our in vivo study was to evaluate the biocompatibility of one of the newly fabricated zirconia implant surfaces, called "mds". For this purpose, the osseointegration of these implants was analyzed after implantation in surgically created defects in the cranium of adult male rats. After a healing period of 28 and 56 days, respectively, bone tissue specimens containing the implants were processed and histologically analyzed. For this purpose, sections were stained with haematoxylin/eosin and Masson Goldner trichrome. No signs of cellular inflammatory infiltrate were found in any of the animals. After 28 days, slices showed pronounced development of blood vessels and bone regeneration. After 56 days of healing, direct bridging of the bone defects was detectable with distinctly visible kit lines. There were cell rich areas of connective tissue/bone marrow between zirconia discs and bearing bone. Histomorphometric analysis presented a regenerated bone mean value of 36.3% after 28 days of healing. After 56 days of healing, a 1.6 fold increased bone mean value was observed (58.2%). Using the same analysis, 1% and 39.9% of bone-implant-contact was visible after both healing periods, respectively. On average, connective tissue/marrow spaces occupied 99% of implant-contact-area after 28 days of healing. This area was reduced to 60.1% after 56 days. Within the limits of the animal investigation presented, it was concluded that the tested surface modification of zirconia implants were biocompatible and osseoconductive.

译文

包括表面修饰在内的新型生物材料应在临床试验之前进行体外和体内评估。我们体内研究的目的是评估一种新制造的氧化锆植入物表面 (称为 “mds”) 的生物相容性。为此,在成年雄性大鼠颅骨的手术缺陷中植入后,分析了这些植入物的骨整合。分别经过28天和56天的愈合后,对包含植入物的骨组织标本进行处理并进行组织学分析。为此,将切片用苏木精/伊红和Masson Goldner三色染色。在任何动物中均未发现细胞炎性浸润的迹象。28天后,切片显示出明显的血管发育和骨骼再生。愈合56天后,用明显可见的kit线可检测到骨缺损的直接桥接。氧化锆盘和轴承骨之间有结缔组织/骨髓的细胞丰富区域。组织形态计量学分析显示愈合28天后的再生骨平均值为36.3%。愈合56天后,观察到1.6倍增加的骨平均值 (58.2%)。使用相同的分析,在两个愈合时期后分别可见骨-植入物-接触的1% 和39.9%。平均而言,愈合28天后,结缔组织/骨髓空间占据了植入物接触区域的99%。56天后,该区域减少到60.1%。在提出的动物研究范围内,得出的结论是,经测试的氧化锆植入物的表面改性具有生物相容性和骨传导性。

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