CAD CAM Oral Appliances for Treatment of Obstructive Sleep apnea Hypopnea Syndrome - Trial PACTR201806003371275

Timeline & Enrollment

Summary

Background: Obstructive sleep apnea (OSA) is a condition in which there is repetitive and intermittent occlusion of the upper airway during sleep. If repetitive apnea occurs in a patient, many times a night, for years together, there will be considerable changes in the nervous system, myocardial and cerebral circulation, pulmonary and systemic circulation. Treatment for OSA can be; continuous positive airway pressure (CPAP), surgery, or oral appliances. Mandibular Advancement Appliance (MAA) is considered a valid alternative, which can be the first choice in simple snorers, mild OSA patients, mild-moderate OSA. MAA can be either customed or non-customed, one-piece or two-pieces, titratable or non-titratable. While Monoblock designs permit no mouth opening, Two-piece appliances vary in permissible lateral jaw movement and in the coupling mechanisms which attach the two plates together. The use of rigid mandibular advancement appliance restricts mandibular movement and this immobility sometimes produces discomfort, including temporomandibular disorders.The aim of the study is to assess the influence of a new design of two pieces (Biblock) mandibular advancement appliance (MAA) fabricated by CAD/CAM additive manufacturing for treatment of obstructive sleep apnea hypopnea syndrome and to compare the influence of Biblock with Monoblock MAA design to improve the patient's sleep quality by reducing or eliminating snoring and respiratory pauses during sleep.

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