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IRCT20200704047996N2 IRCT 2022-02-10 Esfahan University of Medical Sciences Evaluation of the effect of anatomical shaping of the nasal preform area in orthognathic patients Evaluation of changes in external airway resistance and basal alar size following Lefort 1 osteotomy with anatomical shaping of the nasal preform area in orthognathic surgery patients 2022-01-28 anticipated 30 Complete https://irct.ir/trial/61525 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Blinding description: In order to blind, the study of measurements is done by one person and then anonymous information will be provided to another person for examination. N/A Complications of orthognathic surgery. Intervention 1: Intervention group: A typical Le Fort I osteotomy is performed to separate the maxilla and correct its position. In the intervention group, to control the position of the nasal alar base, cutting and shaping the bone of the nasal cavity and preform is used to increase the space available for the nose. Cutting the bone of the nasal floor and the bone around the nose with a milling process will be 2 mm diameter. Intervention 2: Control group: A typical Le Fort I osteotomy is performed to separate the maxilla and correct its position. In the control group, the usual cinch suture is used to control the position of the alarms. 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 Due to the novelty of the method, the decision to publish it is still pending
public Ali kazemi
Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 4264 8448 alikazemi_dnt@yahoo.com Esfahan University of Medical Sciences scientific Ali kazemi
Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 4264 8448 alikazemi_dnt@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients undergoing orthodontic treatment and are candidates for maxillofacial surgery The amount of movement of the maxilla is less than 3 mm no limit no limit Both History of trauma and fracture in the middle of the face Patients with a history of congenital facial abnormalities (such as cleft palate) Prevention Prevention Intervention group: A typical Le Fort I osteotomy is performed to separate the maxilla and correct its position. In the intervention group, to control the position of the nasal alar base, cutting and shaping the bone of the nasal cavity and preform is used to increase the space available for the nose. Cutting the bone of the nasal floor and the bone around the nose with a milling process will be 2 mm diameter Control group: A typical Le Fort I osteotomy is performed to separate the maxilla and correct its position. In the control group, the usual cinch suture is used to control the position of the alarms Width of nasal alar base. Timepoint: 3 months before surgery and 3 months after surgery. Method of measurement: Soft tissue calipers. Respiratory function. Timepoint: 3 months before surgery and 3 months after surgery. Method of measurement: rhinometry test. Esfahan University of Medical Sciences Approved 2022-01-16 Ethics committee of isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar jerib St Isfahan Isfehan Iran (Islamic Republic of)