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具有内连接与外连接的牙种植体:一项实用多中心随机对照试验的加载后1年结果

Dental implants with internal versus external connections: 1-year post-loading results from a pragmatic multicenter randomised controlled trial.

作者信息

Esposito Marco, Maghaireh Hassan, Pistilli Roberto, Grusovin Maria Gabriella, Lee Sang Taek, Gualini Federico, Yoo Jungtaek, Buti Jacopo

出版信息

Eur J Oral Implantol. 2015 Winter;8(4):331-44.

Abstract

PURPOSE

To evaluate advantages and disadvantages of identical implants with internal or external connections.

MATERIALS AND METHODS

Two hundred patients with any type of edentulism (single tooth, partial and total edentulism) requiring one implant-supported prosthesis were randomly allocated in two equal groups to receive either implants with an external connection (EC) or implants of the same type but with an internal connection (IC) (EZ Plus, MegaGen Implant, Gyeongbuk, South Korea) at seven centres. Due to slight differences in implant design/components, IC implants were platform switched while EC were not. Patients were followed for 1 year after initial loading. Outcome measures were prosthesis/implant failures, any complication, marginal bone level changes and clinician preference assessed by blinded outcome assessors.

RESULTS

One hundred and two patients received 173 EC implants and 98 patients received 154 IC implants. Six patients dropped out with 11 EC implants and 3 patients with four IC implants, but all remaining patients were followed up to 1-year post-loading. Two centres did not provide any periapical radiographs. Two prostheses supported by EC implants and one supported by IC implants failed (P = 1.000, difference = -0.01, 95% CI: -0.05 to 0.04). Three EC implants failed in 3 patients versus two IC implants in 1 patient (P = 0.6227, difference = -0.02, 95% CI: -0.07 to 0.03). EC implants were affected by nine complications in 9 patients versus six complications of IC implants in 6 patients (P = 0.5988, difference = -0.02, 95% CI: -0.10 to 0.06). There were no statistically significant differences for prosthesis/implant failures and complications between the implant systems. One year after loading, there were no statistically significant differences in marginal bone level changes between the two groups (difference = 0.24, 95% CI: -0.01 to 0.50, P = 0.0629) and both groups lost bone from implant placement in a statistically significant manner: 0.98 mm for the EC implants and 0.85 mm for the IC implants. Five operators had no preference and two preferred IC implants.

CONCLUSIONS

Within the limitations given by the difference in neck design and platform switching between EC and IC implants, preliminary short-term data (1-year post-loading) did not show any statistically significant differences between the two connection types, therefore clinicians could choose whichever one they preferred.

摘要

目的

评估具有内部或外部连接的相同种植体的优缺点。

材料与方法

200例患有任何类型牙列缺失(单颗牙缺失、部分牙列缺失和全牙列缺失)且需要一个种植体支持修复体的患者被随机分为两组,每组人数相等,分别在七个中心接受外部连接(EC)种植体或相同类型但具有内部连接(IC)的种植体(EZ Plus,韩国庆尚北道MegaGen种植体公司)。由于种植体设计/部件存在细微差异,IC种植体采用了平台转换,而EC种植体未采用。患者在初次加载后随访1年。观察指标包括修复体/种植体失败情况、任何并发症、边缘骨水平变化以及由盲法结果评估者评估的临床医生偏好。

结果

102例患者接受了173颗EC种植体,98例患者接受了154颗IC种植体。6例患者(11颗EC种植体)和3例患者(4颗IC种植体)退出研究,但所有其余患者均随访至加载后1年。两个中心未提供任何根尖片。由EC种植体支持的两个修复体和由IC种植体支持的一个修复体失败(P = 1.000,差异=-0.01,95%可信区间:-0.05至0.04)。3例患者的3颗EC种植体失败,而1例患者的2颗IC种植体失败(P = 0.6227,差异=-0.02,95%可信区间:-0.07至0.03)。9例患者的EC种植体出现9种并发症,6例患者的IC种植体出现6种并发症(P = 0.5988,差异=-0.02,95%可信区间:-0.10至0.06)。两种种植体系统在修复体/种植体失败和并发症方面无统计学显著差异。加载1年后,两组之间边缘骨水平变化无统计学显著差异(差异=0.24,95%可信区间:-0.01至0.50,P = 0.0629),且两组均在种植体植入后出现有统计学显著意义的骨吸收:EC种植体为0.98 mm,IC种植体为0.85 mm。5名操作者无偏好,2名操作者更喜欢IC种植体。

结论

在EC和IC种植体颈部设计和平台转换差异所带来的局限性内,初步短期数据(加载后1年)未显示两种连接类型之间存在任何统计学显著差异,因此临床医生可选择他们更喜欢的任何一种。

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