Eckert Steven E, Choi Yong-Geun, Sánchez Andrés R, Koka Sreenivas
Mayo Medical School, Division of Prosthodontics, Mayo Clinic, Rochester, Minnesota 55905, USA.
Int J Oral Maxillofac Implants. 2005 May-Jun;20(3):406-15.
This literature review was conducted to evaluate the quality of current evidence of clinical performance provided by American Dental Association-certified dental implant manufacturers and manufacturers with strong market penetration in the United States. The study also compared the clinical performance of different dental implant systems.
A letter was sent to 6 implant manufacturers requesting 10 references each that validated the manufacturer's implant system in a variety of clinical applications. References were reviewed and classified relative to strength of evidence. Data extraction was then performed. Comparisons of implant survival data from 5-year studies were made, and data were pooled to establish an overall 5-year survival rate with confidence intervals (CIs).
A total of 69 references were provided by the 6 implant manufacturers (Astra Tech, Centerpulse, Dentsply/Friadent, Implant Innovations, Nobel Biocare, and Straumann) but only 59 articles were available for review. Of those references, most were level-4 (case series) or level-5 (expert opinion) articles. Five-year survival data were extracted from 17 articles demonstrating overlap of CIs from the weighted average of the pooled data from each specific manufacturer; substantial equivalence of all implant systems was demonstrated based upon survival alone at 5 years. When all data were pooled, the 5-year survival rate of 96% (CI: 93% to 98%) was observed for a total of 7,398 implants.
No obvious differences in implant survival were observed when comparing implant systems.
The evidence supporting implant therapy is generally derived from level-4 case series rather than higher-level cohort or controlled clinical trials. Articles that directly compared different implant systems were not found. Five-year implant survival rates easily exceeded the minimums recommended by the American Dental Association certification program. (More than 50 references.)
进行本系统文献综述以评估美国牙科协会认证的牙科种植体制造商以及在美国市场占有率高的制造商所提供的临床性能现有证据的质量。本研究还比较了不同牙科种植系统的临床性能。
向6家种植体制造商致函，每家索要10篇能在各种临床应用中验证该制造商种植体系统的参考文献。对参考文献进行评审并根据证据强度分类。随后进行数据提取。对来自5年研究的种植体存留数据进行比较，并汇总数据以确定总体5年存留率及置信区间（CI）。
6家种植体制造商（Astra Tech、Centerpulse、登士柏/弗瑞德曼、种植体创新公司、诺贝尔生物保健公司和士卓曼公司）共提供了69篇参考文献，但仅有59篇文章可供评审。在这些参考文献中，大多数为4级（病例系列）或5级（专家意见）文章。从17篇文章中提取了5年存留数据，这些数据显示各特定制造商汇总数据的加权平均值的CI存在重叠；仅基于5年时的存留情况就表明所有种植体系统具有实质等效性。当汇总所有数据时，共7398颗种植体的5年存留率为96%（CI：93%至98%）。
比较种植体系统时未观察到种植体存留在明显差异。
支持种植治疗的证据通常来自4级病例系列，而非更高级别的队列研究或对照临床试验。未找到直接比较不同种植体系统的文章。种植体5年存留率轻松超过了美国牙科协会认证计划推荐的最低标准。（参考文献超过50篇。）
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