PACTR201806003371275

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

Efficacy of Two CAD CAM Oral Appliances for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (Randomized Controlled Clinical Trial)
Faculty of Dentistry, Alexandria University.·Not Applicable·Pan Africa Clinical Trials Registry·device·Device trialNot yet recruiting
Study focus
Disease/Condition
Respiratory; Other
Intervention type
device
Sponsor & location
Primary sponsor
Faculty of Dentistry, Alexandria University.
Location
Egypt
Timeline & enrollment
Phase
Not Applicable
Start date
May 15, 2018
End date
May 15, 2019
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.

ICD-10 classifications
Other specified respiratory disordersOther respiratory disordersOther diseases of the respiratory systemOther postprocedural respiratory disordersOther respiratory conditions due to chemicals, gases, fumes and vapours
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR201806003371275
Type
Device Trial
About this record

Access comprehensive clinical trial information for PACTR201806003371275 through Pure Global AI's free database. This Not Applicable trial is sponsored by Faculty of Dentistry, Alexandria University. and is currently Not yet recruiting. The study focuses on Respiratory; Other.

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