Canullo Luigi, Sisti Angelo
University of Bonn, Germany.
Eur J Oral Implantol. 2010 Spring;3(1):59-69.
self-supported study, no conflict of interest to declare
This 2-year prospective multi-centre study aimed to evaluate the survival of implants loaded 14 weeks after vertical ridge augmentation (VRA).
Twenty consecutive patients scheduled for VRA around implants were selected for this study in three private centres. Nano-structured Mg-enriched hydroxyapatite (Mg-e HAP) was used as the only augmentation filler material. It was covered with a titanium reinforced extended polytetrafluoroethylene (e-PTFE) membrane (Gore-Tex). A total of 42 rough-surface implants were inserted in the same surgical session. Healing abutments 2 mm long were used instead of cover screws to optimise aesthetics. All patients underwent a second surgery after 3 months. Thereafter, definitive restorations were seated within 2 weeks using a platform-switching concept. Outcome measures were amount of vertical bone gain, prosthesis and implant success, complications and radiographic marginal bone level changes assessed at 12 and 24 months of prosthetic loading. Frequency resonance analysis expressed using ISQ (implant stability quotient) values was performed at implant insertion (T0), when definitive restoration was seated (T1) and after 24 months of prosthetic loading (T2).
At the end of the study, no patient dropped out, all implants were clinically stable and no prosthesis failed. Initial clinical evaluations showed an average defect height of 4.1 mm. Only one late membrane exposure was registered. Complete bone filling of the regeneration volume was obtained in 19 out of 20 cases. The mean bone height gain was 5.6 mm. Radiographic assessments of inter-implant regenerated bone levels after 24 months of loading presented a mean value of 1.0 mm (SD 0.48 mm), stable compared to the same analysis at the 12-month follow-up. A statistically significant loss of peri-implant bone level occurred over time. Mean peri-implant bone levels were 0.3 mm at the time of prosthetic loading, 0.90 mm after 1 year and 0.98 after 2 years. ISQ values statistically significantly increased over time. At implant placement the mean ISQ value was 49.3, at delivery of the final restoration it was 63.9 and after 2 years of loading it was 73.6.
This clinical study suggests that VRA around rough-surface implants using e-PTFE membrane and nano-structured Mg-e HAP can be successful even in cases with early loading.
自筹研究，无利益冲突声明
这项为期2年的前瞻性多中心研究旨在评估垂直牙槽嵴增高术（VRA）后14周植入种植体的存留情况。
在三个私立中心，选取20例计划在种植体周围进行VRA的连续患者参与本研究。纳米结构富镁羟基磷灰石（Mg-e HAP）被用作唯一的增高填充材料。其表面覆盖有钛增强型聚四氟乙烯（e-PTFE）膜（戈尔特斯）。在同一次手术中总共植入了42枚粗面种植体。使用2mm长的愈合基台而非覆盖螺丝以优化美观效果。所有患者在3个月后接受第二次手术。此后，在2周内采用平台转换理念进行最终修复。观察指标包括垂直骨增量、修复体和种植体成功率、并发症以及在修复体加载12个月和24个月时评估的影像学边缘骨水平变化。在种植体植入时（T0）、最终修复体就位时（T1）以及修复体加载24个月后（T2），使用种植体稳定性商数（ISQ）值进行频率共振分析。
研究结束时，无患者退出，所有种植体临床稳定，无修复体失败。初始临床评估显示平均缺损高度为4.1mm。仅记录到1例晚期膜暴露。20例中有19例再生区域实现了完全骨填充。平均骨高度增量为5.6mm。加载24个月后种植体间再生骨水平的影像学评估均值为1.0mm（标准差0.48mm），与12个月随访时的相同分析相比保持稳定。种植体周围骨水平随时间出现统计学上显著的降低。修复体加载时平均种植体周围骨水平为0.3mm，1年后为0.90mm，2年后为0.98mm。ISQ值随时间在统计学上显著增加。种植体植入时平均ISQ值为49.3，最终修复体就位时为63.9，加载2年后为73.6。
本临床研究表明，即使在早期加载的情况下，使用e-PTFE膜和纳米结构Mg-e HAP对粗面种植体周围进行VRA也可能成功。
