Soft tissue changes with fixed functional appliances in Class II division 1.

OBJECTIVE: To evaluate facial soft tissue changes after the use of fixed functional appliances in Class II division 1 malocclusion cases using a systematic review of the literature.
MATERIALS AND METHODS: Several electronic databases (PubMed, Medline, Medline In-Process & Other Non-Indexed Citations, Cochrane Database, Embase, Web of Sciences, and Lilacs) were searched with the help of a senior Health Sciences librarian. Abstracts that appeared to fulfill the initial selection criteria were selected by consensus. The original articles were then retrieved. Their references were also hand-searched for possible missing articles. Clinical trials assessing facial soft tissue changes with the use of fixed functional appliances without any surgical intervention or syndromic characteristics were considered. A comparable untreated control group was required to factor out normal growth changes. Four articles using Herbst and one using Jasper Jumper fulfilled the selection criteria. An individual analysis of these articles was made and some methodological flaws were identified.
RESULTS: Although fixed functional appliances produce some significant statistical changes in the soft tissue profile, the magnitude of the changes may not be perceived as clinically significant.
CONCLUSIONS: The conclusions from this systematic review should be considered with caution because only a secondary level of evidence was found. Long-term double-blinded prospective randomized clinical trials are needed. Three-dimensional quantification of the soft tissue changes is required to overcome current limitations in our understanding of the soft tissue changes obtained with the use of fixed functional appliances.