Stafford Gary L
Department of General Dental Sciences, Marquette University School of Dentistry, Milwaukee, Wisconsin, USA.
Evid Based Dent. 2013 Dec;14(4):109-10. doi: 10.1038/sj.ebd.6400967.
The Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, and Embase databases were searched. Reference lists of identified articles were also scanned for relevant papers. There were no restrictions on language or date of publication.
Randomised controlled trials (RCTs) of parallel group design and of split-mouth design including root-form osseointegrated dental implants having a follow-up of four months to one year after loading were included.
Data were independently extracted, in duplicate, by at least two review authors. The outcome measures were prosthesis and implant failures and radiographic marginal bone level changes. Risk of bias was assessed for each trial by at least two review authors. Results were combined using fixed-effect models with mean differences (MD) for continuous outcomes and risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI).
Twenty-six trials involving a total of 1217 participants and 2120 implants were included. The risk of bias was low in three trials, high in 12 and unclear for the remaining eleven. In nine studies there were no prosthetic failures within the first year, with no implant failures in seven studies and the mean rate of implant failure in all 26 trials was a low 2.5%. From 15 RCTs comparing immediate with conventional loading there was no evidence of a difference in either prosthesis failure (RR 1.87; 95% CI 0.70 to 5.01; 8 trials) or implant failure (RR 1.65; 95% CI 0.68 to 3.98; 10 trials) in the first year. However, there is some evidence of a small reduction in bone loss favouring immediate loading (MD -0.10 mm; 95% CI -0.20 to -0.01; P = 0.03; 9 trials), but this very small difference may not be clinically important. From three RCTs which compared early loading with conventional loading, there is insufficient evidence to determine whether or not there is a clinically important difference in prosthesis failure, implant failure or bone loss. Six RCTs compared immediate and early loading and found insufficient evidence to determine whether or not there is a clinically important difference in prosthesis failure, implant failure or bone loss. From the two trials that compared occlusal loading with non-occlusal loading there is insufficient evidence to determine whether there is a clinically important difference in the outcomes of prosthesis failure, implant failure or bone loss. No trials were identified which evaluated progressive loading of implants.
Overall there was no convincing evidence of a clinically important difference in prosthesis failure, implant failure or bone loss associated with different loading times of implants. More well-designed RCTs are needed and should be reported according to the CONSORT guidelines.
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数据库。还对已识别文章的参考文献列表进行了扫描以查找相关论文。对语言或发表日期没有限制。
纳入平行组设计和分口设计的随机对照试验(RCT),包括根形骨结合牙种植体,加载后随访4个月至1年。
数据由至少两名综述作者独立提取,一式两份。结局指标为修复体和种植体失败以及影像学边缘骨水平变化。至少两名综述作者对每项试验进行偏倚风险评估。使用固定效应模型合并结果,连续结局采用均数差(MD),二分结局采用风险比(RR),并给出95%置信区间(CI)。
纳入26项试验,共1217名参与者和2120颗种植体。3项试验偏倚风险低,12项试验偏倚风险高,其余11项试验偏倚风险不明确。9项研究中第一年无修复体失败,7项研究中无种植体失败,所有26项试验中种植体失败的平均发生率较低,为2.5%。在15项比较即刻加载与传统加载的RCT中,没有证据表明第一年修复体失败(RR 1.87;95%CI 0.70至5.01;8项试验)或种植体失败(RR 1.65;95%CI 0.68至3.98;10项试验)存在差异。然而,有一些证据表明即刻加载有利于骨吸收略有减少(MD -0.10 mm;95%CI -0.20至-0.01;P = 0.03;9项试验),但这种非常小的差异可能在临床上并不重要。在3项比较早期加载与传统加载的RCT中,没有足够的证据来确定修复体失败、种植体失败或骨吸收在临床上是否存在重要差异。6项RCT比较了即刻加载和早期加载,没有足够的证据来确定修复体失败、种植体失败或骨吸收在临床上是否存在重要差异。在2项比较咬合加载与非咬合加载的试验中,没有足够的证据来确定修复体失败、种植体失败或骨吸收的结局在临床上是否存在重要差异。未识别出评估种植体渐进性加载的试验。
总体而言,没有令人信服的证据表明种植体不同加载时间与修复体失败、种植体失败或骨吸收在临床上存在重要差异。需要更多设计良好的RCT,并应根据CONSORT指南进行报告。