Esposito Marco, Dojcinovic Ivan, Buchini Sabrina, Péchy Péter, Aronsson Björn-Owe
Eur J Oral Implantol. 2017;10(1):43-54.
To evaluate the safety and clinical efficacy of a novel surface treatment (SurfLink, Nano Bridging Molecules, Gland, Switzerland) on titanium dental implants. SurfLink consists of a monolayer of permanently bound multiphosphonic acid molecules, which mimics the surface of naturally occurring hydroxyapatite.
Twenty-three patients requiring at least two single dental implants had their sites randomised according to a split-mouth design to receive one titanium grade 4 implant treated with SurfLink and one untreated control implant. Additional SurfLink-treated implants were placed if needed. Implants were submerged for 3 months in mandibles and 6 months in maxillae, then loaded with definitive metal-ceramic crowns and followed for 3 years after loading. Outcome measures were crown/implant failures, any complication, radiographic peri-implant marginal bone level changes and marginal bleeding.
Three patients dropped out but all remaining patients were followed up to 3-years post-loading. No implant failed. Complications were reported for three patients, affecting both types of implant in two patients and only SurfLink implant in one patient. No differences for complications between the two implant types was observed (McNemar test, P = 1, difference in proportions = -0.04, 95% CI: -0.22 to 0.14). No bleeding was observed when a periodontal probe was run in the peri-implant soft tissues around any of the implants, with the exception of three implants affected by peri-implantitis. There were no statistically significant differences in marginal bone level changes between the two groups (at 3 years post-loading P = 0.86, mean difference = -0.05; SD = 1.15; 95% CI: -0.56 to 0.47).
Medium-term data (3-years post-loading) of implants with a biomimetic monolayer of permanently bound multiphosphonic acid molecules (SurfLink surface treatment) presented no safety issues. Clinical healing in both control and SurfLink-treated implant groups was uneventful and did not differ significantly. More challenging clinical situations need to be investigated to evaluate the real effectiveness of this surface treatment. Conflict-of-interest statement: Marco Esposito and Ivan Dojcinovic declare that they have no conflict of interest, and they acted as consultants for Nano Bridging Molecules (NBM). Sabrina Buchini, Péter Péchy and Björn-Owe Aronsson are employed at NBM. NBM, the manufacturer of the SurfLink surface treatment, supported and carefully monitored this trial without interfering with the presentation of its results.
评估一种新型表面处理（SurfLink，纳米桥接分子，瑞士格兰德）应用于牙科钛种植体的安全性和临床疗效。SurfLink由一层永久结合的多膦酸分子单层组成，其模拟天然存在的羟基磷灰石表面。
23例至少需要植入两颗单颗牙种植体的患者，根据分口设计将其种植部位随机分组，分别植入一颗经SurfLink处理的4级钛种植体和一颗未处理的对照种植体。如有需要，额外植入经SurfLink处理的种植体。种植体在下颌骨中埋植3个月，在上颌骨中埋植6个月，然后安装最终的金属烤瓷冠，并在加载后随访3年。观察指标为牙冠/种植体失败、任何并发症、种植体周围影像学边缘骨水平变化以及边缘出血情况。
3例患者退出，但所有其余患者均随访至加载后3年。无种植体失败。3例患者报告有并发症，其中2例患者的两种种植体均受影响，1例患者仅SurfLink处理的种植体受影响。两种种植体类型之间并发症无差异（McNemar检验，P = 1，比例差异=-0.04，95%可信区间：-0.22至0.14）。除3颗受种植体周围炎影响的种植体外，在任何种植体周围的种植体周围软组织中使用牙周探针探查时均未观察到出血。两组之间边缘骨水平变化无统计学显著差异（加载后3年，P = 0.86，平均差异=-0.05；标准差=1.15；95%可信区间：-0.56至0.47）。
具有永久结合的多膦酸分子仿生单层（SurfLink表面处理）的种植体的中期数据（加载后3年）未显示安全问题。对照种植体组和经SurfLink处理的种植体组的临床愈合情况均顺利，且无显著差异。需要研究更具挑战性的临床情况，以评估这种表面处理的实际效果。利益冲突声明：马尔科·埃斯波西托和伊万·多伊契诺维奇声明他们没有利益冲突，并且他们担任纳米桥接分子（NBM）的顾问。萨布丽娜·布基尼、彼得·佩奇和比约恩-奥韦·阿隆松受雇于NBM。SurfLink表面处理的制造商NBM支持并仔细监测了该试验，但未干预试验结果的呈现。
