Department of Oral & Maxillofacial Surgery, Linköping University Hospital, Sweden.
Bone. 2012 May;50(5):1148-51. doi: 10.1016/j.bone.2012.02.001. Epub 2012 Feb 10.
Many surgical procedures use metal implants in bone. The clinical results depend on the strength of the bone holding these implants. Our objective was to show that a drug released from the implant surface can improve parameters reflecting the quality or amount of this bone. Sixteen patients received paired dental titanium implants in the maxilla, in a randomized, double-blinded fashion. One implant in each pair was coated with a thin fibrinogen layer containing 2 bisphosphonates. The other implant was untreated. Fixation was evaluated by measurement of resonance frequency (implant stability quotient; ISQ) serving as a proxy for stiffness of the implant-bone construct. Increase in ISQ at 6months of follow-up was the primary variable. None of the patients had any complications. The resonance frequency increased 6.9 ISQ units more for the coated implants (p=0.0001; Cohen's d=1.3). The average difference in increase in ISQ, and the effect size, suggested a clinically relevant improvement. X-ray showed less bone resorption at the margin of the implant both at 2months (p=0.012) and at 6months (p=0.012). In conclusion, a thin, bisphosphonate-eluting fibrinogen coating might improve the fixation of metal implants in human bone. This might lead to new possibilities for orthopedic surgery in osteoporotic bone and for dental implants.
许多外科手术都在骨骼中使用金属植入物。临床结果取决于支撑这些植入物的骨骼的强度。我们的目的是证明从植入物表面释放的药物可以改善反映骨质量或数量的参数。16 名患者在随机、双盲的情况下在上颌骨中接受了配对的牙科钛植入物。每对中的一个植入物用含有 2 种双膦酸盐的薄纤维蛋白原层包裹。另一个植入物未处理。通过测量作为植入物-骨结构刚度的替代物的共振频率（植入物稳定性商数；ISQ）来评估固定。6 个月随访时 ISQ 的增加是主要变量。没有患者出现任何并发症。涂层植入物的共振频率增加了 6.9 ISQ 单位（p=0.0001；Cohen's d=1.3）。ISQ 增加的平均差异和效应大小表明有临床相关的改善。X 射线显示在植入物边缘的骨吸收在 2 个月（p=0.012）和 6 个月（p=0.012）时均减少。总之，薄的、双膦酸盐洗脱纤维蛋白原涂层可能会改善金属植入物在人骨中的固定。这可能为骨质疏松性骨骼中的骨科手术和牙科植入物带来新的可能性。
