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IRCT201311069569N2 IRCT 2014-12-06 Vice chancellor for research of Tabriz university of medical sciences The effect of different loading times on loosening of miniscrews in orthodontic patients The Comparison of Clinical Success Rates of Orthodontic Miniscrews with three different loading times: immediately, six and fourteen weeks after miniscrew placement in orthodontic patients 2013-12-01 anticipated 180 Complete https://irct.ir/trial/10147 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This site has been used for randomization and allocation: http://www.graphpad.com/quick calcs/index.cfm . With attention to the patient age, stratified randomization will be done. Patients less than 16 years old randomly will settle in one of these three loading groups: loading immediately, loading 6 weeks after miniscrew placement and loading 14 weeks after miniscrew placement. Patients older than 16 years old also will settle randomly in one of these three loading groups. According to the previous study, 20 patients of 30 patients are older than 16 years old and 10 patients are under 16 years old. 2-3 Orthodontic Anchorage Procedures. Intervention 1: 180 miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 11mm will be inserted in 90 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. According to the age of patients, stratified randomization will be done. The patients randomly divided into 3 groups of loading time. In intervention group 1, miniscrews will be loaded after 6 weeks from minisrcrew insertion. Intervention 2: 180 miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 11mm will be inserted in 90 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. According to the age of patients, stratified randomization will be done. The patients randomly divided into 3 groups of loading time. In intervention group 2, miniscrews will be loaded after 14 weeks from minisrcrew insertion. Intervention 3: 180 miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 11mm will be inserted in 90 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. According to the age of patients, stratified randomization will be done. The patients randomly divided into 3 groups of loading time: control group and two intervention groups. In control group miniscrews will be loaded immediately.
public Amir Mohammadi
Department of orthodontics, Tabriz dental faculty, Tabriz university of medical sciences, Golgasht street
Tabriz Iran (Islamic Republic of) +98 413335596 amirortho@gmail.com Department of orthodontics of dental faculty of Tabriz university of medical sciences scientific Amir Mohammadi
Department of orthodontics, Tabriz dental faculty, Tabriz university of medical sciences, Golgasht street
Tabriz Iran (Islamic Republic of) +98 41 3329 4312 amirortho@gmail.com Department of orthodontics of dental faculty of Tabriz university of medical sciences Iran (Islamic Republic of) Inclusion criteria: A treatment plan to insert miniscrews on both sides of maxilla between the second premolar and the first molar for retraction of anterior teeth. Exclusion criteria: Any disease compromising bone quality like osteoporosis, osteomalasia, and osteopetrosis. 10 years 45 years Both Z45.8 Adjustment and management of other implanted devices Treatment - Other Treatment - Other Treatment - Other 180 miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 11mm will be inserted in 90 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. According to the age of patients, stratified randomization will be done. The patients randomly divided into 3 groups of loading time. In intervention group 1, miniscrews will be loaded after 6 weeks from minisrcrew insertion. 180 miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 11mm will be inserted in 90 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. According to the age of patients, stratified randomization will be done. The patients randomly divided into 3 groups of loading time. In intervention group 2, miniscrews will be loaded after 14 weeks from minisrcrew insertion. 180 miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 11mm will be inserted in 90 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. According to the age of patients, stratified randomization will be done. The patients randomly divided into 3 groups of loading time: control group and two intervention groups. In control group miniscrews will be loaded immediately. Mobility in the miniscrews. Timepoint: Three weeks after miniscrew placement, six weeks after miniscrew placement, ten weeks after miniscrew placement and then every 4 weeks. Method of measurement: By placing a calibrated probe on the miniscrew and lateral movement, if mobility is greater than 0.5 millimeter, the miniscrew is designated mobile. Mobility in two groups less than 16 years old and older than 16 years old. Timepoint: Three weeks after miniscrew placement, six weeks after miniscrew placement, ten weeks after miniscrew placement and then every 4 weeks. Method of measurement: By placing a calibrated probe on the miniscrew and lateral movement, if mobility is greater than 0.5 millimeter, the miniscrew is designated mobile. Amount of insertion torque of the miniscrews. Timepoint: during insertion of miniscrews. Method of measurement: Torque measurement device (Orthonia, JEIL Company). Vice chancellor for research of Tabriz university of medical sciences Approved 2014-08-11 Ethics committee of Tabriz University of Medical Sciences Ethics committee of Tabriz university of medical sciences, vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht street Tabriz Iran (Islamic Republic of)