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IRCT20150613022697N11 IRCT 2021-02-23 Mashhad University of Medical Sciences Evaluation of the effect of mandibular setback surgery on Apnea-hypopnea Index with ApneaLink device. Evaluation of apnea-hypopnea index change and the incidence of obstructive sleep apnea in patients with class III skeletal deformity, after mandibular setback surgery with ApneaLink device. 2021-02-19 anticipated 10 Complete https://irct.ir/trial/53895 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Blinding description: In this study, the outcome assessor and data analyzer will not know about the study groups. Regarding the assessor, who is a pulmonologist will not be aware of the surgical intervention and the amount of mandibular movement in millimeters. The data analyzer will be blinded and all data will be provided in the form of coding to him. N/A Obstructive sleep apnea. The intervention in this study is mandibular setback surgery by bilateral sagittal split osteotomy (BSSO) and maxillary advancement using Lefort 1 osteotomy.. Yes - There is a plan to make this available What will be shared: All collected data would be shared for all researchers after the participants were unidentified. When: The access to data will be started 6 months after publication To whom: The data would only be available for people working in academic institutions. Conditions: It is allowed to use the data for meta-analysis and systematic reviews. Where to obtain: The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad). E-mail: samieerads@mums.ac.ir How to obtain: The new research proposal and the processes details should be e-mailed to the corresponding researcher in order to get the access permission Comments:
public Sahand Samieerad
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 samieerads@mums.ac.ir Mashhad University of Medical Sciences scientific Sahand Samieerad
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 samieerads@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Non-smoker patients between the ages of 18 and 40 Patients with skeletal class 3 deformity who are candidates for orthognathic mandibular setback surgery by bilateral sagittal split osteotomy (BSSO) BMI less than 30 kg/m2 ASA 1,2 18 years 30 years Both Patients with a history of respiratory diseases like rhinitis, asthma, bronchitis. Patients with a history of maxillofacial congenital syndromes . G47.33 Obstructive sleep apnea (adult) (pediatric) Treatment - Surgery The intervention in this study is mandibular setback surgery by bilateral sagittal split osteotomy (BSSO) and maxillary advancement using Lefort 1 osteotomy. Apnea-hypopnea Index. Timepoint: Before surgery, one month and three months after surgery. Method of measurement: ApneaLink device. Obstructive Sleep apnea recovery. Timepoint: Before surgery, one month and three months after surgery. Method of measurement: En Apnea link device measurement. Mashhad University of Medical Sciences Approved 2020-12-16 Ethics commitee of Mashhad university of medical sciences Ghoreishi building, Daneshghah avenue. Mashhad Razavi Khorasan Iran (Islamic Republic of)