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种植体表面对种植体失败和种植体周围炎影响的三年评估:一项采用双侧随机对照试验和分口设计的临床试验。

Three-Year Evaluation of the Influence of Implant Surfaces on Implant Failure and Peri-implantitis: A Double-Blind Randomized Controlled Trial with Split-Mouth Design.

出版信息

Int J Oral Maxillofac Implants. 2021 Mar-Apr;36(2):e23-e30. doi: 10.11607/jomi.8538.

DOI:10.11607/jomi.8538
PMID:33909728
Abstract

PURPOSE

To compare the onset of peri-implantitis, incidence of failure, and peri-implant marginal bone level changes between implants with a roughened surface and those with a machined/turned surface.

MATERIALS AND METHODS

All patients needing two dental implants of the same size on the left and right sides of the same arch, and not scheduled for immediate loading, were enrolled between October 2012 and February 2016. The patients were randomly allocated either to Nobel Biocare MKIII or Sweden & Martina Outlink2. Rough-surface implants and machined-surface implants were used from each company. After the preparation of two identical implant sites, each implant (rough or machined of the same group) was randomly allocated to the right and left sides of the same patient, following a split-mouth design. Outcome measures were peri-implantitis onset, incidence of failure, and peri-implant marginal bone level changes. Patients were followed up for 3 years after loading.

RESULTS

One hundred fourteen patients were enrolled and treated; nine patients dropped out. Following an intent-to-treat analysis to avoid overestimation, proportions are given related to the initial number of 114 patients. Peri-implantitis incidence was 4.39% for machined implants (5/114), 0.88% for rough implants (1/114), 1.75% in the Nobel Biocare group (2 cases), and 3.51% in the Sweden & Martina group (4 cases). The failure rate was 1.75% in machined implants (2/114), 0.88% in rough implants (1/114), 0.98% in the Nobel Biocare group (1/114), and 1.85% in the Sweden & Martina group (1/114). No statistically significant differences in marginal bone loss were found comparing different surfaces, while marginal bone loss was significantly lower in Nobel Biocare than in Sweden & Martina implants.

CONCLUSION

Based on the results of this study, no significant differences can be demonstrated in either peri-implantitis or failure rate or in marginal bone loss between rough and machined implants. Marginal bone loss was significantly worse in machined-surface Sweden & Martina than in rough-surface Nobel Biocare implants.

摘要

目的

比较粗糙表面种植体和机械加工/车削表面种植体的种植体周围炎发病情况、失败率和种植体边缘骨水平变化。

材料和方法

所有需要在同一弓的左右两侧植入两颗相同尺寸的牙种植体且不计划即刻负载的患者,于 2012 年 10 月至 2016 年 2 月间入组。患者随机分配到 Nobel Biocare MKIII 或 Sweden & Martina Outlink2 组。每个公司使用粗糙表面种植体和机械加工/车削表面种植体。在准备好两个相同的种植体部位后,根据分组,将每个种植体(同组的粗糙或机械加工)随机分配到同一患者的右侧和左侧,采用分侧设计。主要结局指标为种植体周围炎发病、失败率和种植体边缘骨水平变化。患者在负载后随访 3 年。

结果

114 例患者入组并接受治疗,9 例患者脱落。为避免高估,采用意向治疗分析,给出与最初 114 例患者相关的比例。机械加工种植体的种植体周围炎发生率为 4.39%(5/114),粗糙种植体为 0.88%(1/114),Nobel Biocare 组为 1.75%(2 例),Sweden & Martina 组为 3.51%(4 例)。机械加工种植体的失败率为 1.75%(2/114),粗糙种植体为 0.88%(1/114),Nobel Biocare 组为 0.98%(1/114),Sweden & Martina 组为 1.85%(1/114)。不同表面之间的边缘骨丧失无统计学显著差异,而 Nobel Biocare 种植体的边缘骨丧失明显低于 Sweden & Martina 种植体。

结论

根据本研究结果,粗糙表面和机械加工表面种植体在种植体周围炎或失败率或边缘骨丧失方面无显著差异。机械加工表面的 Sweden & Martina 种植体的边缘骨丧失明显比粗糙表面的 Nobel Biocare 种植体差。

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