Albrektsson Tomas, Gottlow Jan, Meirelles Luiz, Ostman Per-Olov, Rocci Antonio, Sennerby Lars
Department of Biomaterials, Institute for Clinical Sciences, Sahlgrenska Academy, University of Göteborg, Göteborg, Sweden.
Clin Implant Dent Relat Res. 2007 Jun;9(2):65-70. doi: 10.1111/j.1708-8208.2007.00054.x.
A recently introduced implant, the NobelDirect (Nobel Biocare AB, Göteborg, Sweden), has previously been documented with substantial bone resorption in a large number of operated cases.
The aim of this study was to evaluate the failure rate of NobelDirect implants in a retrospective multicenter survey.
A total of 550 NobelDirect implants consecutively placed in over 269 patients at 18 centers were evaluated with regard to failure rate after an average follow-up of about 1 year.
The overall failure percentage was 10.9% (59 failures). The 58 implants not loaded directly showed only one failure (1.7%) versus 58 failures (11.8%) of those implants that were loaded directly. A chemical x-ray photoelectron spectroscopy analysis of an implant from the original batch showed up to 3.5% silicon at parts of the implants. A retrieval analysis of one implant removed at 2 years after placement demonstrated bone resorption down to the level of the fifth thread.
It is concluded that the NobelDirect implant, if placed with a punch procedure, ground down in situ, and loaded directly, shows an unusually high failure rate at 1 year.
最近推出的一种种植体NobelDirect（诺贝尔生物保健公司，瑞典哥德堡），此前已有大量手术病例记录显示其存在大量骨吸收现象。
本研究的目的是在一项回顾性多中心调查中评估NobelDirect种植体的失败率。
在18个中心，对连续植入269例以上患者的550颗NobelDirect种植体进行了评估，平均随访约1年后观察其失败率。
总体失败率为10.9%（59例失败）。未直接加载的58颗种植体仅出现1例失败（1.7%），而直接加载的种植体有58例失败（11.8%）。对原始批次的一颗种植体进行化学X射线光电子能谱分析显示，种植体部分区域硅含量高达3.5%。对一颗植入后2年取出的种植体进行的取出分析表明，骨吸收至第五螺纹水平。
得出结论，NobelDirect种植体如果采用打孔程序植入、原位磨平并直接加载，在1年时显示出异常高的失败率。
