Jung Ronald E, Windisch Simone I, Eggenschwiler Ariane M, Thoma Daniel S, Weber Franz E, Hämmerle Christoph H F
Clinic for Fixed and Removable Prosthodontics and Dental Material Science, University of Zurich, Zurich, Switzerland.
Clin Oral Implants Res. 2009 Jul;20(7):660-6. doi: 10.1111/j.1600-0501.2008.01648.x. Epub 2009 Mar 27.
The aim of this randomized-controlled clinical trial was to evaluate the long-term outcome of implants placed in bone augmented with a xenogenic bone substitute material and a collagen membrane with or without the addition of recombinant human bone morphogenetic protein-2 (rhBMP-2).
Eleven patients received a total of 34 implants placed into sites exhibiting lateral bone defects. In a split mouth design, the defects were randomly treated with the graft material and the collagen membrane either with (test) or without (control) rhBMP-2. The patients were examined 3 and 5 years after insertion of the prosthetic restoration. Student's paired t-test was performed to detect differences between the two groups.
The survival rate at 3 and 5 years was 100% for both groups. The peri-implant soft tissues were stable and healthy without any difference between the two groups. The prosthetic reevaluation demonstrated four loose prosthetic screws during the first 3 years and seven ceramic chippings after 3 and 5 years. The mean distance between the first bone to implant contact to implant abutment junction at 3 years was 1.37 mm (test), 1.22 mm (control), and 1.38 mm (test), and 1.23 mm (control) at 5 years. The difference of <0.2 mm between test and control implants was not statistically significant. The mean change of the marginal bone level between baseline and 5 years ranged from -0.07 mm (mesial, test), -0.11 mm (distal, test), -0.03 mm (mesial, control), to +0.13 mm (distal, control). No statistically significant differences were observed between test and control sites.
Implants placed in bone augmented with and without rhBMP-2 revealed excellent clinical and radiological outcomes after 3 and 5 years.
本随机对照临床试验的目的是评估在使用异种骨替代材料和胶原膜增强的骨中植入种植体，并添加或不添加重组人骨形态发生蛋白-2（rhBMP-2）的长期效果。
11名患者共接受了34颗种植体植入表现为侧方骨缺损的部位。采用分口设计，缺损部位随机使用含rhBMP-2（试验组）或不含rhBMP-2（对照组）的移植材料和胶原膜进行治疗。在植入修复体后3年和5年对患者进行检查。采用学生配对t检验检测两组之间的差异。
两组在3年和5年时的存活率均为100%。种植体周围软组织稳定且健康，两组之间无差异。修复体重新评估显示，在最初3年内有4颗修复螺丝松动，3年和5年后有7处陶瓷碎片。3年时，从首次骨与种植体接触到种植体基台连接处的平均距离，试验组为1.37mm，对照组为1.22mm；5年时，试验组为1.38mm，对照组为1.23mm。试验组和对照组种植体之间<0.2mm的差异无统计学意义。基线至5年期间，边缘骨水平的平均变化范围为-0.07mm（近中，试验组）、-0.11mm（远中，试验组）、-0.03mm（近中，对照组）至+0.13mm（远中，对照组）。试验组和对照组部位之间未观察到统计学上的显著差异。
在添加和未添加rhBMP-2的增强骨中植入种植体，在3年和5年后均显示出优异的临床和影像学效果。
