Neutral supporting mandibular advancement device with tongue bead for passive myofunctional therapy: a long term follow-up study.

Backgrounds: Myofunctional therapy has been reported to be a valid adjunct treatment to OSA, but compliance was mentioned as an issue. We performed a prospective study on age matched randomized children submitted to myofunctional therapy (MFT) or to a functional device used during sleep (passive MFT).

Methods: 110 children 4 to 16 were recruited for the study, 54 children were in the MFT group [A] while 56 were in the "nocturnal device" group [B]. Clinical evaluation, polysomnography and cephalometric X-Rays were performed at baseline, 6 months and 12 months, with clinical follow-up at 3 months.

Results: MFT group show very important absence of compliance, at six months only 23 subjects participated and only 10/23 had been compliant with treatment. None came back for research investigation at 12 months. 48/56 of passive MFT children ended the research protocol at 12 months. Comparison of baseline to 6 and 12 months data showed that all children with passive MFT improved (PSG and cephalometrics) and had nasal breathing during sleep at 1 year, and no negative effect of device were noted. The 10 children compliant with MFT showed clear improvement of sleep related breathing with also changes at cephalometric -X-rays.

Conclusion: Compliance is a major problem of MFT, and MFT will have to take into consideration the absolute need to have continuous parental involvement in the procedure. Passive MFT gives many more positive results, but potential negative effects of device on other jaw will have to be continuously evaluated.