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IRCT20190710044168N1 IRCT 2019-08-02 Kermanshah University of Medical Sciences Investigating the effect of micro-osteoperforation on the rate of tooth movements Investigating the effect of alveolar bone micro-osteoperforation on the rate of orthodontic tooth movements 2019-09-23 anticipated 40 Complete https://irct.ir/trial/40888 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: split mouth design, Randomization description: The randomization would be accomplished by using simple randomization method. The intervention will be randomly allocated to either the right or left side with a 1:1 allocation ratio. Each patient will be asked to pick a sealed envelope which includes a letter A or B (A: right B: left) to assign the intervention to either the right or left side, Blinding description: Blinding of either patient or clinician is not possible. Blinding would be accomplished at the data collection stage, in which the outcome assessor is blinded to where the micro-osteoperforation will be applied. Also, statistical analysis will be performed by an expert who is blind to the intervention. N/A Orthodontic tooth movement. Intervention 1: Intervention group: Five micro-osteoperforations (3 micro-osteoperforations (MOP)s in buccal plate and 2 MOPs in palatal plate) will be made using Orthonia, Jail company with DC 2.4 v handpiece and straight type driveholder at 3 mm distal to canine. Perforations will have 1.6 mm width and 3-4 mm depth. The process will be done under local anesthesia (lidocaine with 1:100000 epinephrine 2%). Acetaminophen will be advised to control the pain. The maxillary canine will be retracted by using Closed coil spring (150 g, 6 mm) connecting the maxillary canine bracket to the miniscrews between the maxillary second premolar and first molar. Intervention 2: Control group: The maxillary canine will be retracted by using Closed coil spring (150 g, 6 mm) spring connecting the maxillary canine bracket to the miniscrews between the maxillary second premolar and first molar. 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 more information.
public Parzhin Moradi
Across from the post office, above Shora st, Dr Shariati st
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3722 2400 parzhin.moradi@kums.ac.ir Kermanshah University of Medical Sciences scientific Dr. Amin Golshah
Across from the post office, above Shora st, Dr Shariati st
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3722 2400 amin.golshah@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Class II division I malocclusion 16-25 years of age Female patients 16 years 25 years Female Craniofacial disorders Systemic disorders Smoking Poor oral hygiene High buccal frenum Lack of adequate attached gingiva Gingivitis Insufficient distance between roots M26.4 Malocclusion, unspecified Treatment - Other Treatment - Other Intervention group: Five micro-osteoperforations (3 micro-osteoperforations (MOP)s in buccal plate and 2 MOPs in palatal plate) will be made using Orthonia, Jail company with DC 2.4 v handpiece and straight type driveholder at 3 mm distal to canine. Perforations will have 1.6 mm width and 3-4 mm depth. The process will be done under local anesthesia (lidocaine with 1:100000 epinephrine 2%). Acetaminophen will be advised to control the pain. The maxillary canine will be retracted by using Closed coil spring (150 g, 6 mm) connecting the maxillary canine bracket to the miniscrews between the maxillary second premolar and first molar. Control group: The maxillary canine will be retracted by using Closed coil spring (150 g, 6 mm) spring connecting the maxillary canine bracket to the miniscrews between the maxillary second premolar and first molar. Rate of canine movement. Timepoint: Right before retraction, 1, 2, 3, 4 and 5 months after canine retraction. Method of measurement: The digital models at first, second, third, fourth and fifth months will be superimposed on the baseline 3D model and the distance between the middle projection from the distal surface of canine in baseline model and the middle projection from distal surface of the models at month 1, 2, 3, 4 and 5 will be measured using Ceramill software. Kermanshah University of Medical Sciences Approved 2019-06-22 Ethics Committee of Kermanshah University of Medical Sciences Ethics Committee, Vice Chancellor for Research and Technology, Building No.2, Kermanshah University of Medical Sciences, Shahid Beheshti Boulverd Kermanshah Kermanshah Iran (Islamic Republic of)