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一项随机对照、分口试验的三年加载后结果,该试验比较了部分下颌后牙区无牙颌中具有不同修复界面和设计的种植体。

Three-year post-loading results of a randomised, controlled, split-mouth trial comparing implants with different prosthetic interfaces and design in partially posterior edentulous mandibles.

作者信息

Pozzi Alessandro, Tallarico Marco, Moy Peter K

出版信息

Eur J Oral Implantol. 2014 Spring;7(1):47-61.

Abstract

PURPOSE

To compare the clinical and radiological outcomes of two implant designs with different prosthetic interfaces and neck configurations.

MATERIALS AND METHODS

Thirty-four partially edentate patients randomly received at least one NobelActive implant (Nobel Biocare, Göteborg, Sweden) with back-tapered collar, internal conical connection and platform shifting design, and one NobelSpeedy implant (Nobel Biocare) with external hexagon and flat-to-flat implant-abutment interface according to a split-mouth design. Follow-up continued to 3 years post-loading. The primary outcome measures were the success rates of the implants and prostheses, and the occurrence of any surgical and prosthetic complications during the entire follow-up. Secondary outcome measures were: horizontal and vertical peri-implant marginal bone level (MBL) changes, resonance frequency analysis values at implant placement and loading (4 months), sulcus bleeding index (SBI) and plaque score (PS).

RESULTS

No drop-out occurred. No implants and prostheses failures were observed to the 3-year follow-up. MBL changes were statistically significant different with better results for the NobelActive implants for both horizontal and vertical measurements (P = 0.000). After 3 years post-loading, the NobelActive implants underwent a mean vertical bone resorption of 0.66 mm, compared with 1.25 mm for the NobelSpeedy Groovy implants (P = 0.000); the mean horizontal bone resorption was 0.19 mm for the NobelActive implants and 0.60 mm for the NobelSpeedy Groovy implants (P = 0.000). A high ISQ value was found for both implants, and no statistically significant difference was found for ISQ mean values between interventions (P = 0.941 at baseline; P = 0.454 at implantabutment connection; P = 0.120 at prosthesis delivery). All implants showed good periodontal health at the 3-year-in-function visit, with no significant differences between groups.

CONCLUSION

The results of this research suggest that in well-maintained patients, the MBL changes could be affected by the different implant design. After 4 months of unloaded healing, as well as after 3 years in function, both implants provided good results, however vertical and horizontal bone loss had statistically significant differences between the two groups (difference of 0.58 ± 0.10 mm for the vertical MBL, and 0.4 ± 0.05 mm for the horizontal MBL), with lower values in the Nobel Active implants, compared to the NobelSpeedy Groovy implants.

摘要

目的

比较两种具有不同修复界面和颈部结构的种植体设计的临床和影像学结果。

材料与方法

34例部分牙列缺损患者根据分口设计随机接受至少一枚带有后锥形颈部、内部锥形连接和平台转换设计的NobelActive种植体(诺贝尔生物科技公司,瑞典哥德堡),以及一枚带有外部六边形和种植体-基台平面到平面界面的NobelSpeedy种植体(诺贝尔生物科技公司)。随访持续至加载后3年。主要观察指标为种植体和修复体的成功率,以及整个随访期间任何手术和修复并发症的发生情况。次要观察指标为:种植体周围边缘骨水平(MBL)的水平和垂直变化、种植体植入时和加载时(4个月)的共振频率分析值、龈沟出血指数(SBI)和菌斑评分(PS)。

结果

无患者退出。至3年随访时未观察到种植体和修复体失败。MBL变化在统计学上有显著差异,NobelActive种植体在水平和垂直测量方面均有更好的结果(P = 0.000)。加载后3年,NobelActive种植体的平均垂直骨吸收为0.66 mm,而NobelSpeedy Groovy种植体为1.25 mm(P = 0.000);NobelActive种植体的平均水平骨吸收为0.19 mm,NobelSpeedy Groovy种植体为0.60 mm(P = 0.000)。两种种植体均发现较高的ISQ值,不同干预措施之间的ISQ平均值无统计学显著差异(基线时P = 0.941;种植体-基台连接时P = 0.454;修复体交付时P = 0.120)。在功能3年的随访中,所有种植体均显示出良好的牙周健康状况,组间无显著差异。

结论

本研究结果表明,在维护良好的患者中,MBL变化可能受不同种植体设计的影响。在4个月的无负载愈合期以及功能3年后,两种种植体均取得了良好的效果,然而两组之间的垂直和水平骨丢失在统计学上有显著差异(垂直MBL差异为0.58±0.10 mm,水平MBL差异为0.4±0.05 mm),与NobelSpeedy Groovy种植体相比,NobelActive种植体的值更低。

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