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IRCT20210928052625N1 IRCT 2021-12-22 Islamic Azad University Evaluation of changes in nasal profile after Lefort 1 with and without ANS reduction Evaluation of changes in nasal profile after Lefort 1 osteotomy (maxillary advancement) with and without ANS reduction in class III skeletal patients referred to Buali and Farhikhtegan Hospital in Tehran in 1400 and 1401: A Randomized Clinical Trial 2022-01-21 anticipated 26 Complete https://irct.ir/trial/59171 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups using balanced block randomization with a sample size of 4 samples in each block and random allocation of samples in both groups with the help of Rand software, Excell software. The result of random allocation is done by a person other than the surgeon and evaluator (consultant of methodology and study statistics) and the type of allocation treatment is recorded on paper and each sample is placed in a separate package with a sample order code. When surgery is performed, clinicians who do not know the outcome of the allocation process in each sample until the time of surgery will open the packages, Blinding description: The result of random allocation is done by a person other than the surgeon and evaluator (consultant of methodology and study statistics) and the type of allocation treatment is recorded on paper and each sample is placed in a separate package with a sample order code. When surgery is performed, clinicians who do not know the outcome of the allocation process in each sample until the time of surgery will open the packages. N/A Skeletal Deformity of Jaws. Intervention 1: Intervention group: Lefort 1 osteotomy with ANS reduction. Intervention 2: Control group: Lefort 1 osteotomy without ANS reduction. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Need to thoroughly review medical ethics
public Hosein Rastegarmoghadam Shaldouzi
9th Neyestan, Pasdaran
Tehran Iran (Islamic Republic of) 1946853314 +98 26 3425 8913 dr.rastegarmoghaddam@hotmail.com Islamic Azad University scientific Hosein Rastegarmoghadam Shaldouzi
9th Neyestan, Pasdaran
Tehran Iran (Islamic Republic of) 1946853314 +98 26 3425 8913 dr.rastegarmoghaddam@hotmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) History of maxillofacial surgery History of Rhinoplasty Surgery The amount of maxillary advancement should be more than 3 mm 18 years no limit Both History of Maxillofacial or Rhinoplasty surgery The amount of maxillary advancement is less than 3 M26.213 Malocclusion, Angle's class III Treatment - Surgery Treatment - Surgery Intervention group: Lefort 1 osteotomy with ANS reduction Control group: Lefort 1 osteotomy without ANS reduction Nasolabial Angle. Timepoint: Pre Op and 3 moths Post Op. Method of measurement: Lateral Cephalometric analysis of measurements. Upper lip length. Timepoint: Pre Op and 3 moths Post Op. Method of measurement: Lateral Cephalometric analysis of measurements. Islamic Azad University Approved 2021-06-09 National Committee for ethics in biomedical research 13th floor, Block A, Ministry of Health and Medical Education, Simaye Iran Ave, South Falamak, Shahrake Gharb Tehran Tehran Iran (Islamic Republic of)