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IRCT20241008063291N1 IRCT 2025-04-19 Mashhad University of Medical Sciences Comparing the Efficacy of Maxillary Total Arch Distalization Using Zygomatic Mini-screw vs. Palatal Mini-screw Comparing the Efficacy of Maxillary Total Arch Distalization Using Zygomatic Mini-screw vs. Palatal Mini-screw: A Randomized Clinical Trial 2025-05-20 anticipated 20 Complete https://irct.ir/trial/79415 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To facilitate randomization of participants into two groups, the Sealed Envelope software will be utilized, employing combined blocks of four and two. In this type of assignment, blocks of four letters long consisting of the letters A and B are used, so that each block contains two letters A and two letters B. Also, blocks of two are used randomly. Therefore, 20 combinations of the letters A and B are generated, which are placed in a matte envelope in the order they are generated by the sealedenvelope software and its number is written on the envelope. The first person takes envelope number 1, the envelope is opened and assigned to the relevant group. Then the second person takes envelope number 2 and so on until envelope number 20. 2 Class II skeletal patients. Intervention 1: First Intervention group: In the first group, for distalization of the maxillary arch, Jeil JS 2mm×12mm mini screws (Korea, Seoul) are used, which are placed in the infrazygomatic crest on both sides of the arch, and a power arm of appropriate length is used on the archwire so that the line of force action passes through the center of resistance of the maxillary dentition. Anatomically, the infrazygomatic crest is a bony prominence of the zygomatic process that gradually fades towards the buccal region of the maxilla, and clinically, it is a bony ridge that is palpable in the curvature between the alveolar and zygomatic processes of the maxilla. To place the infrazygomatic mini-screw, first penetrate the cortical bone by 1mm perpendicular to the longitudinal axis of the adjacent teeth in the attached gingiva, and then gradually and continuously change the direction of the screw driver by 60 to 70 degrees relative to the occlusal plane and onto the frontal plane so that the mini-screw is placed in the maximum bone thickness of the buccal area of ​​the molar teeth without damaging their roots. The force is applied by a Niti closed coil spring 150gr on each side and patients are seen at 3-week intervals. Changes are evaluated after achieving a class I molar relationship. Intervention 2: Second Intervention group: In the second group, two Jeil G2 1.6mm×8mm palatal mini-screws (Korea, Seoul) will be used in the interdental area of ​​the second premolar and first molar (one on each side) along with the palatal arch to retract the entire maxillary dental arch. The force applied by Niti closed coil spring 150gr on each side is applied to the palatal arch hooks and the patients are visited at 3-week intervals. After reaching a class I molar relationship, the changes are evaluated. 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 There is no further information.
public Peyman Zamanipour
No. 74, 24th Daneshjoo Ave., Daneshjoo Blvd.
Mashhad Iran (Islamic Republic of) 9188354376 +98 51 3864 9855 zmppeyman@gmail.com Mashhad University of Medical Sciences scientific Peyman Zamanipour
No. 74, 24th Daneshjoo Ave., Daneshjoo Blvd.
Mashhad Iran (Islamic Republic of) 9188354376 +98 51 3864 9855 zmppeyman@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Individuals exhibiting a mild Class 1 or Class 2 skeletal relationship with an overjet ranging from 4 to 6 mm and an A point - Nasion - B point angle (ANB) between 1 and 5 degrees Class 2 canine relationship and Class 2 half cusp molar relationship bilaterally Aged between 14 to 25 years With a crowding measurement of less than 5 mm indicating the suitability for a non-extraction treatment plan All permanent teeth fully erupted, excluding the wisdom teeth Frankfort-Mandibular plane angle (FMA) between 22 and 28 degrees 14 years 25 years Both Systemic disease or the use of pharmacological agents influencing bone metabolism Complications such as posterior crossbite, dental anomalies, skeletal asymmetry, and syndromic conditions Improper oral hygiene Prior history of orthodontic intervention Smoker M26.212 Malocclusion, Angle's class II Treatment - Devices Treatment - Devices First Intervention group: In the first group, for distalization of the maxillary arch, Jeil JS 2mm×12mm mini screws (Korea, Seoul) are used, which are placed in the infrazygomatic crest on both sides of the arch, and a power arm of appropriate length is used on the archwire so that the line of force action passes through the center of resistance of the maxillary dentition. Anatomically, the infrazygomatic crest is a bony prominence of the zygomatic process that gradually fades towards the buccal region of the maxilla, and clinically, it is a bony ridge that is palpable in the curvature between the alveolar and zygomatic processes of the maxilla. To place the infrazygomatic mini-screw, first penetrate the cortical bone by 1mm perpendicular to the longitudinal axis of the adjacent teeth in the attached gingiva, and then gradually and continuously change the direction of the screw driver by 60 to 70 degrees relative to the occlusal plane and onto the frontal plane so that the mini-screw is placed in the maximum bone thickness of the buccal area of ​​the molar teeth without damaging their roots. The force is applied by a Niti closed coil spring 150gr on each side and patients are seen at 3-week intervals. Changes are evaluated after achieving a class I molar relationship. Second Intervention group: In the second group, two Jeil G2 1.6mm×8mm palatal mini-screws (Korea, Seoul) will be used in the interdental area of ​​the second premolar and first molar (one on each side) along with the palatal arch to retract the entire maxillary dental arch. The force applied by Niti closed coil spring 150gr on each side is applied to the palatal arch hooks and the patients are visited at 3-week intervals. After reaching a class I molar relationship, the changes are evaluated. Maxillary first molar position measurements. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the treatment. Method of measurement: Dolphin Imaging 11.8 Premium software. Occlusal plane angle. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the treatment. Method of measurement: Dolphin Imaging 11.8 Premium software. Maxillary central incisor angle. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the treatment. Method of measurement: Dolphin Imaging 11.8 Premium software. Mashhad University of Medical Sciences Approved 2024-10-12 Ethics committee of Mashhad University of Medical Sciences Vakilabad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)