Wennström Jan L, Ekestubbe Annika, Gröndahl Kerstin, Karlsson Stig, Lindhe Jan
Department of Periodontology, Faculty of Odontology, The Sahlgrenska Academy of Göteborg University, Göteborg, Sweden.
J Clin Periodontol. 2004 Sep;31(9):713-24. doi: 10.1111/j.1600-051X.2004.00568.x.
Comparatively few studies with at least 5 years of follow-up are available that describe the use of implants in prosthetic rehabilitation of partially edentulous patients. Randomized, controlled clinical studies that evaluated the effect of different surface designs of screw-shaped implants on the outcome of treatment are also sparse.
To determine, in a prospective randomized, controlled clinical trial, the outcome of restorative therapy in periodontitis-susceptible patients who, following basic periodontal therapy, had been restored with implants with either a machined- or a rough-surface topography.
Fifty-one subjects (mean age, 59.5 years), 20 males and 31 females who, following treatment of moderate-to-advanced chronic periodontitis, required implant therapy for prosthetic rehabilitation were recruited. Seventeen of the patients were current smokers. Following the active treatment, all subjects were included in an individually designed maintenance program. A total of 56 fixed partial dentures (FPDs) and a total of 149 screw-shaped, and self-tapping implants (Astra Tech implants) -- 83 in the maxilla and 66 in the mandible -- were installed in a two-stage procedure. Each patient received a minimum of two implants and by randomization every second implant that was installed had been designed with a machined surface and the remaining with a roughened Tioblast surface. Abutment connection was performed 3-6 months after implant installation. Clinical and radiographical examinations were performed following FPD connection and once a year during a 5-year follow-up period. The analysis of peri-implant bone-level alterations was performed on subject, FPD and implant levels.
Four patients and four FPDs were lost to the 5 years of monitoring. One implant (machined surface) did not properly integrate (early failure), and was removed at the time of abutment connection. Three implants were lost during function and a further eight implants could not be accounted for at the 5-year follow-up examination. The overall failure rate at 5 years was 5.9% (subject level), 5.3% (FPD level) and 2.7% (implant level). Radiographic signs of loss of osseointegration were not found at any of the implants during the 5-year observation period. During the first year in function there was on average 0.33 (SD, 0.61) mm loss of peri-implant marginal bone on the subject and FPD levels and 0.31 (0.81) mm on the implant level. During the subsequent 4 years, the peri-implant bone-level alterations were small. The calculated annual change in peri-implant bone level was -0.02 (0.15) on subject and FPD levels and -0.03 (0.20) on the implant level. Thus, the mean total bone-level change over the 5-year interval amounted to 0.41 mm on all three levels of analysis. In the interval between baseline and 5 years, the machined and the Tioblast implants lost on average 0.33 and 0.48 mm, respectively (p>0.05).
The present randomized, controlled clinical trial that included partially edentulous periodontitis-susceptible subjects demonstrated that bone loss (i) during the first year of function as well as annually thereafter was small and (ii) did not vary between implants with machined- or rough-surface designs.
关于部分牙列缺损患者修复性种植治疗的研究中，随访至少5年的相对较少。评估不同表面设计的螺旋形种植体对治疗效果影响的随机对照临床研究也很匮乏。
在一项前瞻性随机对照临床试验中，确定在接受基础牙周治疗后，使用机械加工表面或粗糙表面种植体修复的牙周炎易感患者的修复治疗效果。
招募了51名受试者（平均年龄59.5岁），其中男性20名，女性31名，这些患者在接受中重度慢性牙周炎治疗后需要种植治疗进行修复。17名患者为现吸烟者。在积极治疗后，所有受试者都纳入了个性化设计的维护计划。通过两阶段手术共植入了56个固定局部义齿（FPD）和149个螺旋形自攻种植体（Astra Tech种植体），其中上颌83个，下颌66个。每位患者至少植入2个种植体，通过随机分组，每第二个植入的种植体设计为机械加工表面，其余为粗糙的Tioblast表面。种植体植入后3 - 6个月进行基台连接。在连接FPD后以及5年随访期间每年进行临床和影像学检查。对种植体周围骨水平变化的分析在受试者、FPD和种植体水平上进行。
在5年的监测中，4名患者和4个FPD失访。1个种植体（机械加工表面）未正常愈合（早期失败），在基台连接时被取出。3个种植体在功能期丢失，在5年随访检查时另有8个种植体无法找到。5年时的总体失败率在受试者水平为5.9%，FPD水平为5.3%，种植体水平为2.7%。在5年观察期内，任何种植体均未发现骨结合丧失的影像学迹象。在功能期的第一年，受试者和FPD水平上种植体周围边缘骨平均丧失0.33（标准差0.61）mm，种植体水平上为0.31（0.81）mm。在随后的4年中，种植体周围骨水平变化较小。计算得出的种植体周围骨水平的年变化在受试者和FPD水平上为 - 0.02（0.15），在种植体水平上为 - 0.03（0.20）。因此，在所有三个分析水平上，5年期间骨水平的平均总变化为0.41 mm。在基线至5年的间隔期内，机械加工表面种植体和Tioblast种植体平均分别丧失0.33和0.48 mm（p>0.05）。
本项纳入部分牙列缺损牙周炎易感受试者的随机对照临床试验表明，（i）在功能期的第一年以及此后每年，骨丧失量较小；（ii）机械加工表面或粗糙表面设计的种植体之间骨丧失量无差异。
