A systematic review of cephalometric facial soft tissue changes with the Activator and Bionator appliances in Class II division 1 subjects.

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.