Flores-Mir Carlos, Major Paul W
Orthodontic Graduate Program and Cranio-facial and Oral-health Evidence-based Group, Faculty of Medicine and Dentistry, University of Alberta, Canada.
Eur J Orthod. 2006 Dec;28(6):586-93. doi: 10.1093/ejo/cjl034. Epub 2006 Nov 9.
The objective of the present systematic review was to evaluate, through lateral cephalograms, facial soft tissue changes after the use of the Activator and Bionator appliances in Class II division 1 malocclusion subjects. Several electronic databases (PubMed, Medline, Medline In-Process and Other Non-Indexed Citations, Cochrane Database, Embase, Web of Sciences, and Lilacs) were searched with the assistance of a senior health sciences librarian. Abstracts, which appeared to fulfil the initial criteria, were selected by consensus. The original articles were then retrieved. Their references were also hand searched for possible missing articles. Clinical trials, which assessed facial soft tissue changes with the use of either an Activator or a Bionator appliance without any surgical intervention or syndromic characteristics, were considered. A comparable untreated control group was required to factor out normal growth changes. Five articles using the Activator and six using the Bionator fulfilled the selection criteria and quantified facial soft tissue changes. An individual analysis of these articles was undertaken and some methodological flaws were identified. Based on the available evidence, a significant amount of controversy regarding the soft tissue changes produced by the Activator and the Bionator exists. Soft tissue changes that were reported as being statistically significant were of questionable clinical significance. Long-term, double-blinded, prospective randomized clinical trials are needed to confirm the findings. Three-dimensional quantification is also required to overcome current limitations in our understanding of the soft tissue changes obtained with the use of removable functional appliances.
本系统评价的目的是通过头颅侧位片评估安氏Ⅱ类1分类错 畸形患者使用Activator矫治器和Bionator矫治器后面部软组织的变化。在一位资深健康科学图书馆员的协助下，检索了几个电子数据库（PubMed、Medline、Medline In-Process及其他未索引引文、Cochrane数据库、Embase、科学网和Lilacs）。通过共识选择了似乎符合初始标准的摘要。然后检索原始文章。还对其参考文献进行了手工检索以查找可能遗漏的文章。纳入的临床试验需评估使用Activator或Bionator矫治器且无任何手术干预或综合征特征时面部软组织的变化。需要一个未治疗的可比对照组以排除正常生长变化的影响。5篇使用Activator矫治器的文章和6篇使用Bionator矫治器的文章符合选择标准并对面部软组织变化进行了量化。对这些文章进行了单独分析并发现了一些方法学上的缺陷。基于现有证据，关于Activator和Bionator矫治器所产生的软组织变化存在大量争议。报告具有统计学意义的软组织变化的临床意义存疑。需要长期、双盲、前瞻性随机临床试验来证实这些发现。还需要进行三维量化以克服目前我们对使用可摘功能性矫治器所获得的软组织变化理解上的局限性。
