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IRCT20151123025202N7 IRCT 2020-06-13 Hamedan University of Medical Sciences Le Fort I osteotomy for transferring of anteroposterior position of maxilla Comparison of accuracy between standard surgical splint and modified interpretative adjustable splint in transferring of anteroposterior position of maxilla during Le Fort I osteotomy 2020-03-19 anticipated 20 Complete https://irct.ir/trial/43651 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We made 20 cards and write letter A on 10 for adjustable splint and on the other 10 letter S for the standard surgical splint group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the letters will be randomly selected and opened, based on selected letter ( A or S) patients will be assigned to adjustable surgical splint or standard surgical splint group. 2 Asymmetry of maxillary and mandibular. Intervention 1: Intervention group: In each patient, first the upper and lower jaw casts will be prepared and transferred to the articulator using Face bow. Then, based on the data obtained from the clinical analysis, photography and lateral cephalometry, the position of the upper and lower jaw is determined. Then, the patient's sergeant model is started and the upper jaw cast will be fixed at the designated position (position 0). For this purpose, first a standard (thin) wafer is made and then this wafer is removed and another wafer will be made using the made device (adjustable wafer). The upper jaw will be detached from the articulator base and fixed one millimeter stronger to the base (position 1-a) and a standard wafer and a thick adjustable wafer will be made for it. This process is in the position of two millimeters more anterior (position 2-a) and 3 mm more anterior (position 3-a), one millimeter more posterior (position 1-p), two millimeters more posterior (position 2-p) and three A more posterior millimeter (3-p position) will be repeated. In each case, a standard wafer and an adjustable wafer are made. During surgery, a horizontal osteotomy line is first marked on the bone with a milling cutter, and two vertical lines are drawn on the canine and molar teeth in the first area. An osteotomy is performed and the maxilla is broken down. At this time, the standard wafer will be placed first and the upper jaw will be moved upwards with the pressure of the hand so that the two pieces in the osteotomy line come together again and the amount of vertical line movement on the moving piece (Down fractured maxilla) The vertical line will be measured on the fixed piece. If this shift is to the front, it will be displayed with positive numbers, and if it is backwards, it will be displayed with negative numbers. Now the adjustable wafer is set and the displacement of the lower vertical line is measured relative to the upper. This process will be repeated with wafers made in positions 1-a, 2-a, 3-a, as well as 1-p, 2-p, and 3-p. If any error occurs, this error is the same on both devices. will be. Therefore, it will not affect the comparison of the two devices. In addition, all necessary measures are taken to control these rotations during operation. Intervention 2: Control group: The surgical procedure in this group is similar to the intervention group, except that a standard splint will be used instead of an adjustable splint to determine the maxillary position during the Lefort I osteotomy surgery. Yes - There is a plan to make this available What will be shared: All data can be shared except for authors names When: From 2021 onward it is permissible To whom: Researchers in all fields Conditions: To develop research and science Where to obtain: Correspond to the email address of the scientific responsible for the study How to obtain: Send and receive email Comments:
public Abbas Moradi
Hamedan shahid fahmideh street medicine school
Hamedan Iran (Islamic Republic of) 6517838736 +98 81 3838 0097 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Dr Mohammad Reza Jamalpour
Shahid Beheshti Blv
Hamadan Iran (Islamic Republic of) 6514845411 +98 81 3264 0030 Jamalpour_omfs@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Problem in sagittal dimension of Jaw Class 2 & 3 Jaw skeletal connection Need to change just in sagittal dimension no limit no limit Both Patients with previous history of orthognathic surgery Toothless patients Patients need vertical changes M26.11 Maxillary asymmetry Treatment - Devices Treatment - Devices Intervention group: In each patient, first the upper and lower jaw casts will be prepared and transferred to the articulator using Face bow. Then, based on the data obtained from the clinical analysis, photography and lateral cephalometry, the position of the upper and lower jaw is determined. Then, the patient's sergeant model is started and the upper jaw cast will be fixed at the designated position (position 0). For this purpose, first a standard (thin) wafer is made and then this wafer is removed and another wafer will be made using the made device (adjustable wafer). The upper jaw will be detached from the articulator base and fixed one millimeter stronger to the base (position 1-a) and a standard wafer and a thick adjustable wafer will be made for it. This process is in the position of two millimeters more anterior (position 2-a) and 3 mm more anterior (position 3-a), one millimeter more posterior (position 1-p), two millimeters more posterior (position 2-p) and three A more posterior millimeter (3-p position) will be repeated. In each case, a standard wafer and an adjustable wafer are made. During surgery, a horizontal osteotomy line is first marked on the bone with a milling cutter, and two vertical lines are drawn on the canine and molar teeth in the first area. An osteotomy is performed and the maxilla is broken down. At this time, the standard wafer will be placed first and the upper jaw will be moved upwards with the pressure of the hand so that the two pieces in the osteotomy line come together again and the amount of vertical line movement on the moving piece (Down fractured maxilla) The vertical line will be measured on the fixed piece. If this shift is to the front, it will be displayed with positive numbers, and if it is backwards, it will be displayed with negative numbers. Now the adjustable wafer is set and the displacement of the lower vertical line is measured relative to the upper. This process will be repeated with wafers made in positions 1-a, 2-a, 3-a, as well as 1-p, 2-p, and 3-p. If any error occurs, this error is the same on both devices. will be. Therefore, it will not affect the comparison of the two devices. In addition, all necessary measures are taken to control these rotations during operation. Control group: The surgical procedure in this group is similar to the intervention group, except that a standard splint will be used instead of an adjustable splint to determine the maxillary position during the Lefort I osteotomy surgery. Maxillary movement. Timepoint: before and after Surgery. Method of measurement: The measurement is made with a ruler. Maxilla displacement in sagittal dimension. Timepoint: before and after surgery. Method of measurement: The measurement is made with a ruler. Hamedan University of Medical Sciences Approved 2020-05-23 Ethics committee of Hamadan University of Medical Science Shahid Fahmideh Avenue Hamadan Hamadan Iran (Islamic Republic of)