Division of Fixed Prosthodontics and Biomaterials, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland.
Research Unit in Periodontology and Periodontal Medicine, University of Florence, Florence, Italy.
Clin Oral Implants Res. 2023 May;34 Suppl 25:22-37. doi: 10.1111/clr.13926. Epub 2022 Jul 11.
To evaluate outcome measures, methods of assessment, and analysis in clinical studies on fixed single- and multiple-unit implant restorations.
Three independent electronic database searches (MEDLINE, EMBASE, and Cochrane) were done to identify prospective and retrospective clinical studies published from January 2011 up to June 2021 with ≥20 patients and minimum 1-year follow-up period on technical and clinical outcomes of implant-supported single crowns (SCs) and partial fixed dental prostheses (P-FDPs). An entire data extraction was performed to identify primarily the most reported outcome measures and later to define the choice of assessment methods of those outcome measures. The outcomes were analysed descriptively, and the strength of association was evaluated using the Pearson chi-square test (p ≤ .05).
In a total 531 studies, 368 on SCs (69.3%), 70 on P-FDPs (13.1%), and 93 on both restoration types (17.5%) were included; 56.3% of all studies did not clearly define a primary outcome. The most frequent primary outcome was marginal bone level (MBL) (55.2%) followed by implant survival (5.3%), professional aesthetic evaluation (3.4%), and technical complications (2.1%). Peri-implant indices were the most reported secondary outcome (55.1%), followed by implant survival (39.9%), MBL (36%), and implant success (26.4%). Prosthetic failure (seven studies [3.9%]) was one of the least reported outcome measures.
Outcome measures and their assessment methods showed high heterogeneity among studies. Primary outcomes were not often defined clearly, and the most frequently selected primary outcome was marginal bone loss. Prosthetic outcomes, implant survival, and patient-related outcomes were only infrequently reported.
评估固定单/多单位种植修复体临床研究中的结局测量指标、评估方法和分析方法。
对 2011 年 1 月至 2021 年 6 月期间发表的前瞻性和回顾性临床研究进行了三次独立的电子数据库检索(MEDLINE、EMBASE 和 Cochrane),纳入了至少 20 例患者且随访时间至少 1 年的研究,以评估种植体支持的单冠(SCs)和部分固定义齿(P-FDPs)的技术和临床结局。进行了全面的数据提取,首先确定报告最多的结局测量指标,然后定义这些结局测量指标的评估方法选择。对结局进行描述性分析,并使用 Pearson 卡方检验(p≤.05)评估关联强度。
共纳入 531 项研究,其中SCs 368 项(69.3%)、P-FDPs 70 项(13.1%)、两种修复体类型均有报道 93 项(17.5%);所有研究中有 56.3%未明确定义主要结局。最常见的主要结局是边缘骨吸收(MBL)(55.2%),其次是种植体存活率(5.3%)、专业美学评价(3.4%)和技术并发症(2.1%)。种植体周围指数是报告最多的次要结局(55.1%),其次是种植体存活率(39.9%)、MBL(36%)和种植体成功率(26.4%)。修复体失败(7 项研究[3.9%])是报告最少的结局之一。
研究之间结局测量指标及其评估方法存在高度异质性。主要结局未得到明确界定,最常选择的主要结局是边缘骨吸收。修复体结局、种植体存活率和患者相关结局的报告较少。