Esposito M, Coulthard P, Thomsen P, Worthington H V
Department of Biomaterials and Department of Prosthetic Dentistry/Dental Material Sciences, Sahlgrenska Academy at Goteborg University, PO Box 412, Medicinaregatan 8B, Goteborg, Sweden, SE-405 30.
Cochrane Database Syst Rev. 2005 Jan 25(1):CD003815. doi: 10.1002/14651858.CD003815.pub2.
Dental implants are available in different materials, shapes and with different surface characteristics. In particular, numerous implant surface modifications have been developed for enhancing clinical performances.
To test the null hypothesis of no difference in clinical performance between various root-formed osseointegrated dental implant types.
We searched the Cochrane Oral Health Group's Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Handsearching included several dental journals. We checked the bibliographies of relevant clinical trials and review articles for studies outside the handsearched journals. We wrote to authors of the identified randomised controlled trials (RCTs), to more than 55 oral implant manufacturers; we used personal contacts and we asked on an internet discussion group in an attempt to identify unpublished or ongoing RCTs. No language restriction was applied. The last electronic search was conducted on 28 June 2004.
All RCTs of oral implants comparing osseointegrated implants with different materials, shapes and surface properties having a follow up of at least 1 year.
Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in duplicate and independently by two reviewers. Results were expressed as random effects models using weighted mean differences for continuous outcomes and relative risk for dichotomous outcomes with 95% confidence intervals.
Thirty-one different RCTs were identified. Twelve of these RCTs, reporting results from a total of 512 patients, were suitable for inclusion in the review. Twelve different implant types were compared with a follow up ranging from 1 to 5 years. All implants were made in commercially pure titanium and had different shapes and surface preparations. On a 'per patient ' rather than 'per implant' basis no significant differences were observed between various implant types for implant failures. There were statistically significant differences for peri-implant bone level changes on intraoral radiographs in three comparisons in two trials. In one trial there was more bone loss only at 1 year for IMZ implants compared to Branemark (mean difference 0.60 mm; 95% CI 0.01 to 1.10) and to ITI implants (mean difference 0.50 mm; 95% CI 0.01 to 0.99). In the other trial Southern implants displayed more bone loss at 5 years than Steri-Oss implants (mean difference -0.35 mm; 95% CI -0.70 to -0.01). However this difference disappeared in the meta-analysis. More implants with rough surfaces were affected by perimplantitis (RR 0.80; 95% CI 0.67 to 0.96) meaning that turned implant surfaces had a 20% reduction in risk of being affected by perimplantitis over a 3-year period.
AUTHORS' CONCLUSIONS: Based on the available results of RCTs, there is limited evidence showing that implants with relatively smooth (turned) surfaces are less prone to loose bone due to chronic infection (perimplantitis) than implants with rougher surfaces. On the other hand, there is no evidence showing that any particular type of dental implant has superior long-term success. These findings are based on a few RCTs, often at high risk of bias, with few participants and relatively short follow-up periods. More RCTs should be conducted, with follow up of at least 5 years including a sufficient number of patients to detect a true difference if any exists. Such trials should be reported according to the CONSORT recommendations (http://www.consort-statement.org/).
牙科种植体有不同的材料、形状和表面特征。特别是,已经开发出多种种植体表面改性方法以提高临床性能。
检验不同类型的根形骨结合牙科种植体在临床性能上无差异的无效假设。
我们检索了Cochrane口腔健康组试验注册库、Cochrane对照试验中央注册库(CENTRAL)、MEDLINE和EMBASE。手工检索包括几种牙科杂志。我们检查了相关临床试验和综述文章的参考文献,以查找手工检索杂志之外的研究。我们写信给已识别的随机对照试验(RCT)的作者、55多家口腔种植体制造商;我们利用个人关系,并在一个互联网讨论组中询问,试图识别未发表或正在进行的RCT。未设语言限制。最后一次电子检索于2004年6月28日进行。
所有比较不同材料、形状和表面特性的骨结合种植体且随访至少1年的口腔种植体RCT。
两名评价员独立重复进行合格研究的筛选、试验方法学质量评估和数据提取。结果以随机效应模型表示,连续结局采用加权均数差,二分结局采用相对危险度,并给出95%置信区间。
共识别出31项不同的RCT。其中12项RCT报告了总共512例患者的结果,适合纳入本综述。比较了12种不同类型的种植体,随访时间为1至5年。所有种植体均由商业纯钛制成,具有不同的形状和表面处理。在“ per patient”而非“per implant”的基础上,不同类型种植体在种植失败方面未观察到显著差异。在两项试验中的三次比较中,口腔内X线片上种植体周围骨水平变化存在统计学显著差异。在一项试验中,与Branemark种植体相比,IMZ种植体仅在1年时有更多的骨吸收(均数差0.60 mm;95%CI 0.01至1.10),与ITI种植体相比也有更多骨吸收(均数差0.50 mm;95%CI 0.01至0.99)。在另一项试验中,Southern种植体在5年时的骨吸收比Steri-Oss种植体更多(均数差-0.35 mm;95%CI -0.70至-0.01)。然而,在荟萃分析中这种差异消失了。更多表面粗糙的种植体受到种植体周围炎的影响(RR 0.80;95%CI 0.67至0.96),这意味着经过3年,经过车削处理的种植体表面受种植体周围炎影响的风险降低了20%。
基于RCT的现有结果,有限的证据表明,与表面较粗糙的种植体相比,表面相对光滑(经过车削处理)的种植体因慢性感染(种植体周围炎)导致骨松动的可能性较小。另一方面,没有证据表明任何特定类型的牙科种植体具有更优的长期成功率。这些发现基于少数RCT,这些研究往往存在较高的偏倚风险,参与者较少且随访期相对较短。应进行更多的RCT,随访至少5年,纳入足够数量的患者,以检测是否存在真正的差异。此类试验应按照CONSORT建议(http://www.consort-statement.org/)进行报告。