BACKGROUND Aim was to systematically search the literature and assess the available evidence regarding the clinical effectiveness of the Invisalign® system. METHODS Electronic database searches of published and unpublished literature were performed. The reference lists of all eligible articles were examined for additional studies. Reporting of this review was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS Three RCTs, 8 prospective, and 11 retrospective studies were included. In general, the level of evidence was moderate and the risk of bias ranged from low to high, given the low risk of bias in included RCTs and the moderate (n = 13) or high (n = 6) risk of the other studies. The lack of standardized protocols and the high amount of clinical and methodological heterogeneity across the studies precluded a valid interpretation of the actual results through pooled estimates. However, there was substantial consistency among studies that the Invisalign® system is a viable alternative to conventional orthodontic therapy in the correction of mild to moderate malocclusions in non-growing patients that do not require extraction. Moreover, Invisalign® aligners can predictably level, tip, and derotate teeth (except for cuspids and premolars). On the other hand, limited efficacy was identified in arch expansion through bodily tooth movement, extraction space closure, corrections of occlusal contacts, and larger antero-posterior and vertical discrepancies. CONCLUSIONS Although this review included a considerable number of studies, no clear clinical recommendations can be made, based on solid scientific evidence, apart from non-extraction treatment of mild to moderate malocclusions in non-growing patients. Results should be interpreted with caution due to the high heterogeneity.

中文翻译：

---

Invisalign®正畸治疗的临床有效性：系统评价。

背景技术目的是系统地搜索文献并评估有关Invisalign®系统临床有效性的可用证据。方法对已发表和未发表的文献进行电子数据库检索。检查了所有符合条件的文章的参考文献清单，以进行其他研究。该评价的报告基于系统评价和荟萃分析的首选报告项目（PRISMA）指南。结果纳入了3项RCT，8项前瞻性研究和11项回顾性研究。一般而言，鉴于纳入的随机对照试验的偏倚风险较低，而其他研究的偏中风险（n = 13）或较高（n = 6），证据水平为中度，偏倚风险的范围从低到高。由于缺乏标准化的研究方案，而且整个研究中临床和方法学的异质性很高，因此无法通过汇总估算值有效解释实际结果。但是，在研究中，Invisalign®系统是常规正畸治疗的一种可行替代方案，可用于矫正不需要摘除的非成长型患者的轻度至中度错牙合畸形，这在研究之间具有相当的一致性。此外，Invisalign®对准器可预见地使牙齿平整，倾斜和旋转（尖牙和前磨牙除外）。另一方面，通过身体的牙齿移动，拔牙间隙的闭合，咬合的矫正以及前后和垂直的较大差异，在牙弓扩张中发现的疗效有限。结论尽管该评价包括大量研究，根据可靠的科学证据，除了未拔除未成年患者的轻度至中度错牙合畸形外，没有明确的临床建议。由于高度的异质性，应谨慎解释结果。