Department of Oral & Maxillofacial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Clin Oral Implants Res. 2010 May;21(5):520-6. doi: 10.1111/j.1600-0501.2009.01889.x. Epub 2010 Mar 11.
This clinical trial aimed (1) to evaluate the predictability of the osteotome sinus floor elevation (OSFE) technique, (2) to study the influence of simultaneous grafting on the clinical success of placing dental implants in the posterior maxilla using OSFE and (3) to observe the bone changes in the elevated space with OSFE without grafting.
Two hundred and eighty Straumann implants were placed in the posterior maxillae of 202 patients using OSFE. One hundred and ninety-one implants were placed in 125 patients without grafting. The implants were allowed to heal for 3-4 months for non-grafted implants and for 6-8 months for grafted cases. For radiographic analyses, periapical and panoramic radiographs were taken of 30 implants at 3 and 9 months to assess the bone changes for the elevated sites without grafting.
Two hundred and sixty-eight of 280 implants fulfilling the survival criteria represented a cumulative survival rate of 95.71%. The residual bone height (RBH) was 5.6+/-2.5 mm for the non-grafted group and 4.7+/-2.1 mm for the grafted group. The perforation rate was 4.29%. No significant differences were found between the two groups in RBH, survival rate or membrane perforation rate. The radiographic analyses demonstrated that new bone formation in the elevated sinus was visible and the endo-sinus bone gain was 2.26+/-0.92 mm and 2.66+/-0.87 mm at 3- and 9- month follow-up, respectively. Crestal bone loss (CBL) was 0.89+/-0.5 and 1.2+/-0.48 mm at 3 and 9 months. For the two test groups, RBH did not have a significant influence on the survival of the implants. At the 9-month follow-up, the endo-sinus bone gain and CBL were not significantly correlated to RBH. The implant protrusion length was significantly correlated to the endo-sinus bone gain.
The findings of this study indicated that uneventful osseointegration may be predictable on applying OSFE whether with or without grafting in atrophic posterior maxilla. Spontaneous new bone formation seemed to be expected with implants placed using OSFE without simultaneous grafting.
本临床试验旨在（1）评估骨凿鼻窦提升术（OSFE）的可预测性，（2）研究同期植骨对使用 OSFE 在后上颚放置牙种植体的临床成功率的影响，以及（3）观察无植骨的 OSFE 提升空间的骨变化。
202 名患者的后上颚共植入 280 颗 Straumann 种植体。191 颗种植体植入 125 名患者，未进行植骨。非植骨组植入物愈合 3-4 个月，植骨组愈合 6-8 个月。对于影像学分析，在 3 个月和 9 个月时，对 30 个种植体进行根尖和全景 X 线片拍摄，以评估无植骨的提升部位的骨变化。
符合生存标准的 280 个种植体中的 268 个代表了 95.71%的累积生存率。非植骨组的残余骨高度（RBH）为 5.6+/-2.5mm，植骨组为 4.7+/-2.1mm。穿孔率为 4.29%。两组在 RBH、生存率或膜穿孔率方面均无显著差异。影像学分析显示，在提升的窦内可见新骨形成，在 3 个月和 9 个月的随访中，窦内骨增加分别为 2.26+/-0.92mm 和 2.66+/-0.87mm。牙槽嵴骨丢失（CBL）分别为 0.89+/-0.5mm 和 1.2+/-0.48mm。对于两个测试组，RBH 对种植体的存活率没有显著影响。在 9 个月的随访中，窦内骨增加和 CBL 与 RBH 无显著相关性。种植体突出长度与窦内骨增加呈显著正相关。
本研究结果表明，在后上颚萎缩的情况下，无论是否同时进行植骨，应用 OSFE 都可能实现无并发症的骨整合，具有可预测性。在不进行同期植骨的情况下，使用 OSFE 放置种植体时，似乎会自发形成新骨。
