University of Southern California, Los Angeles, California.
Private practice "de Mondhoek", Apeldoorn, The Netherlands.
Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.
The present multi-center randomized controlled clinical trial sought to compare the marginal bone level (MBL) changes and survival of 6- and 11-mm implants.
Ninety-five patients receiving a total of 209 dental implants were enrolled. Subjects were randomly allocated to two cohorts: test (4.0 × 6 mm; N = 108) or control (4.0 × 11 mm; N = 101) implant groups. To be randomized, all edentulous sites were anatomically qualified to receive 11 mm implant. Two to three implants were placed in maxillary or mandibular posterior regions and loaded with splinted provisional restoration after 6 weeks and definitive restoration 6 months thereafter. Test and control implants were followed by clinical and radiographic examinations on an annual basis up to 3 years.
Radiographic assessment of MBL 3 years after loading revealed the bone to be located at 0.27 mm (±0.40) and 0.44 mm (±0.74) apical to the implant platform in the test and control groups, respectively. During the 3 years of follow-up since loading, 0.04 mm (±0.43) MBL gain and 0.02 mm (±0.76) of MBL loss were observed in the 6-mm (test) and 11-mm (control) groups, respectively. The MBL's for test and control were significantly different (p = 0.000) in favor of short implants. The cumulative survival rates from placement after 3 years were 96% and 99% for the 6- and 11-mm implants, respectively, with no statistical significance.
Reconstruction of partially edentulous posterior maxilla or mandible with 6- or 11-mm implants led to stable marginal bone level and high implant survival rate after 3 years.
本多中心随机对照临床试验旨在比较 6 毫米和 11 毫米种植体的边缘骨水平（MBL）变化和存活率。
共纳入 95 名接受 209 枚牙种植体的患者。受试者被随机分为两组：试验组（4.0×6mm；N=108）和对照组（4.0×11mm；N=101）。为了进行随机分组，所有无牙颌部位在解剖学上都符合植入 11mm 种植体的条件。在 6 周后，将 2 到 3 枚种植体植入上颌或下颌后牙区，并使用夹板临时修复体进行负载，6 个月后再进行最终修复。试验组和对照组的种植体在 3 年内每年进行临床和影像学检查。
加载后 3 年的 MBL 放射学评估显示，试验组的骨位于种植体平台上方 0.27mm（±0.40）和 0.44mm（±0.74）处，对照组分别为 0.44mm（±0.74）和 0.44mm（±0.74）。在加载后 3 年的随访期间，6mm（试验组）和 11mm（对照组）组的 MBL 分别获得了 0.04mm（±0.43）和 0.02mm（±0.76）的增加，同时分别出现了 0.02mm（±0.76）和 0.02mm（±0.76）的丧失。试验组和对照组的 MBL 差异具有统计学意义（p=0.000），试验组有利于短种植体。3 年后种植体植入的累积存活率分别为 6mm 种植体 96%和 11mm 种植体 99%，无统计学差异。
在后牙区植入 6mm 或 11mm 种植体可稳定边缘骨水平，3 年后种植体存活率高。
