Felice Pietro, Pistilli Roberto, Piattelli Maurizio, Soardi Elisa, Barausse Carlo, Esposito Marco
Eur J Oral Implantol. 2014 Spring;7(1):65-75.
To compare the efficacy of 1-stage versus 2-stage lateral maxillary sinus lift procedures.
Sixty partially edentulous patients requiring 1 to 3 implants and having 1 to 3 mm of residual bone height and at least 5 mm bone width below the maxillary sinus, as measured on CT scans were selected. They were randomised according to a parallel group study design into two equal arms to receive either a 1-stage lateral window sinus lift with simultaneous implant placement or a 2-stage procedure with implant placement delayed by 4 months, using a bone substitute in three different centres. Implants were submerged for 4 months, loaded with reinforced provisional prostheses, which were replaced, after 4 months, by definitive prostheses. Outcome measures, assessed by masked assessors, were: augmentation procedure failures; prosthesis failures and implant failures; complications; and marginal peri-implant bone level changes. Patients were followed up to 1 year after loading. Only data of implants placed in 1 to 3 mm of bone height were reported.
Two patients dropped out from the 1-stage group and none from the 2-stage group. No sinus lift procedure failed in the 1-stage group but one failed in the 2-stage group, the difference being not statistically significant (P = 1.00). Two prostheses failed or could not be placed in the planned time in the 1-stage group and one in the 2-stage group, the difference being not statistically significant (P = 0.51). Three implants failed in three patients of the 1-stage group, versus one implant in the 2-stage group, the difference being not statistically significant (P = 0.28). Two complications occurred in the 1-stage group and one in the 2-stage group, the difference being not statistically significant (P = 0.61). One year after loading, 1-stage treated patients lost an average of -1.01 mm (SD: 0.56) of peri-implant bone and 2-stage sites about -0.93 mm (SD: 0.40). There were no statistically significant differences in bone level change between groups 1 year after loading (-0.08 mm 95%CI: -0.33 to 0.18 P = 0.56).
No statistically significant differences were observed between implants placed according to 1- or 2-stage sinus lift procedures. However this study may suggest that in patients having residual bone height between 1 to 3 mm below the maxillary sinus, there might be a slightly higher risk for implant failures when performing a 1-stage lateral sinus lift procedure.
比较上颌窦外侧壁提升一期手术与二期手术的疗效。
选取60例部分牙列缺损患者，这些患者需要植入1至3颗种植体，经CT扫描测量，上颌窦下方剩余骨高度为1至3毫米，骨宽度至少为5毫米。根据平行组研究设计将他们随机分为两组，每组人数相等，分别在三个不同中心接受一期外侧开窗上颌窦提升同期种植体植入术，或二期手术（种植体植入延迟4个月），术中均使用骨替代材料。种植体植入后埋入4个月，之后安装加强型临时修复体，4个月后更换为最终修复体。由盲法评估者评估的结果指标包括：上颌窦提升手术失败情况；修复体失败和种植体失败情况；并发症；以及种植体周围边缘骨水平变化。患者在修复体加载后随访1年。仅报告骨高度为1至3毫米处植入种植体的数据。
一期手术组有2例患者退出，二期手术组无患者退出。一期手术组的上颌窦提升手术均未失败，二期手术组有1例失败，差异无统计学意义（P = 1.00）。一期手术组有2个修复体失败或未能在计划时间内安装，二期手术组有1个，差异无统计学意义（P = 0.51）。一期手术组3例患者的种植体失败，二期手术组有1例种植体失败，差异无统计学意义（P = 0.28）。一期手术组发生2例并发症，二期手术组发生1例，差异无统计学意义（P = 0.61）。修复体加载1年后，一期手术治疗的患者种植体周围骨平均吸收-1.01毫米（标准差：0.56），二期手术部位约吸收-0.93毫米（标准差：0.40）。修复体加载1年后，两组之间的骨水平变化无统计学显著差异（-0.08毫米，95%置信区间：-0.33至0.18，P = 0.56）。
根据一期或二期上颌窦提升手术植入的种植体之间未观察到统计学显著差异。然而，本研究可能表明，在上颌窦下方剩余骨高度为1至3毫米的患者中，进行一期外侧上颌窦提升手术时种植体失败的风险可能略高。
