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IRCT20120215009014N479 IRCT 2023-08-01 Hamedan University of Medical Sciences Comparison of the stability of Iranian mini-screw with Korean mini-screw Comparison of the stability of Iranian mini-screw with Korean mini-screw as an orthodontic anchorage: a double-blind randomized clinical trial 2023-08-11 anticipated 76 Complete https://irct.ir/trial/71583 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The shape, length and diameter of the mini-screws will be the same. Therefore, patients will be unaware of the type of intervention. The person who performs the randomization will be different from the person who examines the patients, so the person who examines the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 3 Orthodontic mini-screw device. Intervention 1: Intervention group 1: Inserting the Iranian mini-screw made by Pouyan Teb Co. with a length of 8 mm and a diameter of 1.6 mm perpendicular to the bone using a manual driver in a predetermined place, then applying force immediately after loading the mini-screw with a force equivalent to 100 to 150 grams. Intervention 2: Intervention group 2: Inserting the Korean mini-screw JEIL brand with a length of 8 mm and a diameter of 1.6 mm perpendicular to the bone using a manual driver in a predetermined place, then applying force immediately after loading the mini-screw with a force equivalent to 100 to 150 grams. 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 It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Anahita Morovat
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 anahita.morovat@gmail.com Hamedan University of Medical Sciences scientific Dr. Nasrin Fahadian Langroodi
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 nasrinne@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 15 to 30 years In need of orthodontic treatment Indications for the use of mini-screw 15 years 30 years Both Pregnancy Being a smoker Z46.4 Encounter for fitting and adjustment of orthodontic device Treatment - Devices Treatment - Devices Intervention group 1: Inserting the Iranian mini-screw made by Pouyan Teb Co. with a length of 8 mm and a diameter of 1.6 mm perpendicular to the bone using a manual driver in a predetermined place, then applying force immediately after loading the mini-screw with a force equivalent to 100 to 150 grams. Intervention group 2: Inserting the Korean mini-screw JEIL brand with a length of 8 mm and a diameter of 1.6 mm perpendicular to the bone using a manual driver in a predetermined place, then applying force immediately after loading the mini-screw with a force equivalent to 100 to 150 grams. The degree of stability of Iranian and Korean mini-screws. Timepoint: In the first week and then the first, second and third month after treatment. Method of measurement: By clinical examination. Hamedan University of Medical Sciences Approved 2023-05-06 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)