Effectiveness of a Uniquely Designed Oral Appliance on Obstructive Sleep Apnea Control: A Pilot Study.

OBJECTIVES: Obstructive sleep apnea is an inflammatory, chronic, and evolutive disease often needing adequate treatment and follow-up. The oral appliance (OA) is an accepted alternative therapy for obstructive sleep apnea (OSA) control. Due to greater adherence, OA with mandibular advancement (OAm) is being recommended treatment for patients who refuse or do not tolerate continuous positive airway pressure. The mode of action of OAm is to promote the advancement of the mandible or tongue with a subsequent increase in the tone of the pharyngeal muscles and the permeability of the upper airway, but most OAm use conventional models as reference, analogic, or digital, dissociating dental arches of the skull structures. MATERIALS AND METHODS: A retrospective longitudinal study of 33 OSA patient treated with a different OAm, that use Camper plane as reference with skull structures for dental arches disocclusion, where polysomnographic, cephalometric measures, and subjective data from questionnaires pre- and post-treatment were assessed and correlated. Descriptive analysis, correlated Chi-square tests, and basic statistics were used. Generalized linear mixed model for repeated measure and post hoc Tukey-Kramer test compares the variables pre- and post-treatment. Shapiro-Wilk test and Pearson's correlation coefficients were used. All statistical tests were set in 5% level of significance. RESULTS: Regarding polysomnography data, there was a significant association between apnea hypopnea index (AHI) with oxygen saturation, arousal index (AI) and the maximum heartbeats, and sleep improvement and health risk reduction. Additionally, from cephalometric data, it was found a significant association between the tongue posture with the soft palate, hioyd-C3 and, lower and posterior airway. When both parameters are correlated, there are a significant dependent association with hyoid bone position with AHI and AI. The limitation of this study was the two-dimensional image used without provide volumetric measurements, but this limitation was reduced with the follow-up polysomnography parameters. CONCLUSION: In this pilot study, DIORS OAm as an uniquely designed device using Camper plane as a reference for disocclusion was effective in the control of OSA.