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糊状无机骨基质:猪颅骨原型制剂的临床前测试

Paste-like inorganic bone matrix: preclinical testing of a prototype preparation in the porcine calvaria.

作者信息

Busenlechner Dieter, Tangl Stefan, Fitzl Christine, Bernhart Thomas, Gruber Reinhard, Watzek Georg

机构信息

Department of Oral Surgery, Medical University of Vienna, Vienna, Austria.

出版信息

Clin Oral Implants Res. 2009 Oct;20(10):1099-104. doi: 10.1111/j.1600-0501.2009.01743.x. Epub 2009 Jul 20.

DOI:10.1111/j.1600-0501.2009.01743.x
PMID:19681965
Abstract

OBJECTIVE

To evaluate the osteoconductive properties and the volume stability of an injectable paste-like inorganic bone matrix (PBM) in porcine calvaria defects.

MATERIAL AND METHODS

We created six circumferential defects in the calvaria of 12 adult iberico pigs. The defects were filled with either PBM, Bio-Oss((R)) of different particle size, carrier alone, or left empty. PBM was composed of Bio-Oss((R)) with a particle size ranging from 250 to 500 mum and a hydrogel-carrier of carboxymethylcellulose and collagen. After 6 and 12 weeks of healing, the animals were sacrificed and undecalcified ground sections were prepared and subjected to histologic and histomorphometric analysis. To quantify the osteoconductive properties of PBM, bone volume per tissue volume (BV/TV) in the defect area was determined. To determine the volume stability, bone substitute volume per tissue volume (BSV/TV) was measured.

RESULTS

After 6 weeks, PBM particles in the center of the defect were surrounded by fibrous connective tissue, which was later replaced by bone. BV/TV in the PBM group increased from 29.7+/-12.7% (minimum 12.2%, maximum 43.7%) after 6 weeks to 43.9+/-14.9% (minimum 27.8%, maximum 63.9%) after 12 weeks (Mann-Whitney test; P=0.6). According to the Friedman test, BV/TV in groups containing Bio-Oss((R)) of different particle sizes, the carrier and the empty defects was similar to the results obtained with PBM (6 weeks P=0.8; 12 weeks P=0.22). BSV/TV in the PBM group was stable over time, with 10.1+/-9% (minimum 3.3%, maximum 27.6%) and 16.5+/-12.9% (minimum 1%, maximum 32.7%), after 6 and 12 weeks, respectively (P=0.72). BSV/TV in the PBM group was comparable to the results obtained with the Bio-Oss((R)) particles of different sizes (Friedman test; 6 weeks P=0.0503; 12 weeks P=0.56).

CONCLUSIONS

The results of this preclinical study showed that the PBM is osteoconductive and maintains the augmented volume, similar to commercial Bio-Oss((R)). These data suggest that the osteoconductive properties of Bio-Oss((R)) are maintained at the smaller particle size and in the presence of the carrier.

摘要

目的

评估可注射膏状无机骨基质(PBM)在猪颅骨缺损中的骨传导特性及体积稳定性。

材料与方法

我们在12只成年伊比利亚猪的颅骨上制造了6个环形缺损。缺损处分别填充PBM、不同粒径的Bio-Oss((R))、单独的载体或保持空缺。PBM由粒径范围为250至500微米的Bio-Oss((R))以及羧甲基纤维素和胶原蛋白的水凝胶载体组成。愈合6周和12周后,处死动物,制备不脱钙磨片并进行组织学和组织形态计量学分析。为量化PBM的骨传导特性,测定缺损区域的骨体积与组织体积之比(BV/TV)。为确定体积稳定性,测量骨替代物体积与组织体积之比(BSV/TV)。

结果

6周后,缺损中心的PBM颗粒被纤维结缔组织包围,随后被骨组织替代。PBM组的BV/TV从6周时的29.7±12.7%(最小值12.2%,最大值43.7%)增加到12周时的43.9±14.9%(最小值27.8%,最大值63.9%)(曼-惠特尼检验;P = 0.6)。根据弗里德曼检验,含有不同粒径Bio-Oss((R))、载体和空缺缺损组的BV/TV与PBM组的结果相似(6周时P = 0.8;12周时P = 0.22)。PBM组的BSV/TV随时间保持稳定,6周和12周时分别为10.1±9%(最小值3.3%,最大值27.6%)和16.5±12.9%(最小值1%,最大值32.7%)(P = 0.72)。PBM组的BSV/TV与不同粒径Bio-Oss((R))颗粒的结果相当(弗里德曼检验;6周时P = 0.0503;12周时P = 0.56)。

结论

这项临床前研究的结果表明,PBM具有骨传导性并能维持增加的体积,与商业Bio-Oss((R))相似。这些数据表明,Bio-Oss((R))在较小粒径且存在载体的情况下仍保持骨传导特性。

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