]>
IRCT20190108042293N1 IRCT 2021-07-31 Dental Research Institute of Tehran University of Medical Sciences The Effect of Combination of Micro-osteoperforation and a Vibration Device on Orthodontic Tooth Movement The Effect of Combination of Micro-osteoperforation and a Vibration Device on Orthodontic Tooth Movement : A Prospective Randomized Clinical trial 2021-07-31 anticipated 20 Complete https://irct.ir/trial/53415 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the "Balanced Block Randomization" method will be used. In this method, 4 blocks (envelopes) of equal size are prepared. In each block, sheets are randomly assigned to the control group (B) and/or the intervention group (A) using the RAND option of Excel software. The randomization process will be performed by the Methodology and Research Consultant of the study and the clinical researcher will not be aware of the type of intervention until the study begins (allocation concealment). The person performing the randomization process, places the letters A as the intervention group and the letters B as the control group on sheets inside the sealed envelopes. These envelopes will be numbered from 1 to 4 . At the beginning of the study and the arrival of patients (participants), envelope 1 to envelope 4 will be used, respectively, and when working on the patient, the envelope will be opened and the type of intervention will be determined. Randomization unit: Individual Randomization tool: Excel software, Blinding description: Patients (participants) blinding is not possible because one of the study interventions is vibration that is perceived by the patients. Blinding the clinical researcher is also not possible. Because the responsible persons for data collection and outcome evaluation are different from the practitioner (clinical researcher) and while collecting data and evaluating the outcome, they do not know which control and / or intervention group the patient belongs to, blinding of the persons responsible for data collection and outcome evaluation is possible. N/A Orthodontic Treatment. Intervention 1: The intervention group: receives micro-osteoperforations on both sides (right and left) of the maxilla along with using a C-shaped vibration device (Vpro5, Propel Orthodontics). Intervention 2: The control group: receives micro-osteoperforations on both sides (right and left) of the maxilla without using a vibration device. Yes - There is a plan to make this available What will be shared: Individual unidentifiable data of the participants including age, sex, type of malocclusion and data obtained from the study such as the effect of intervention on the rate of orthodontic tooth movement. When: Access period starts 6 months after the results are published. To whom: Faculty members of the universities of medical sciences Conditions: Using data for systematic review Where to obtain: Applicants can refer to the corresponding author " Dr. Sarvin Sarmadi" to get the study data. Postal address: Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, North Karegar St., Tehran, Iran. Postal code: 1439955991 Email : sarmadis@sina.tums.ac.ir Phone : 0098 21 88015801 How to obtain: After receiving the request of an applicant and consulting the first and the corresponding authors of the article, the documents will be delivered to the applicant within 1 working month. Comments:
public Sarvin Sarmadi
Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, North Karegar St, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۳۹۹۵۵۹۹۱ +98 21 8801 5801 sarmadis@sina.tums.ac.ir Tehran University of Medical Sciences scientific Sarvin Sarmadi
Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, North Karegar St, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۳۹۹۵۵۹۹۱ +98 21 8801 5801 sarmadis@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age range : 18 to 45 years Maxillary canine teeth fully erupted Need to extract both first maxillary premolars Existence of 3 mm space after initial alignment Good oral hygiene 18 years 45 years Both Systemic diseases affecting bone metabolism Take any medication Periodontal disease Smoking Pregnancy Treatment - Devices Treatment - Devices The intervention group: receives micro-osteoperforations on both sides (right and left) of the maxilla along with using a C-shaped vibration device (Vpro5, Propel Orthodontics). The control group: receives micro-osteoperforations on both sides (right and left) of the maxilla without using a vibration device. Rate of orthodontic tooth movement. Timepoint: At the beginning of the study, immediately before canine retraction, and 28 days after the onset of canine retraction. Method of measurement: Digital caliper with an accuracy of 0.01 millimeter and dental casts. The level of pain caused by micro-osteoperforation. Timepoint: The day of appliance placement , the day of canine retraction, and subsequently at 24 hours, 7 days, and 28 days after canine retraction. Method of measurement: Numerical rating scale. The level of patient's drooling caused by micro-osteoperforation and the use of a vibration device. Timepoint: The day of appliance placement , the day of canine retraction, and subsequently at 24 hours, 7 days, and 28 days after canine retraction. Method of measurement: Numerical rating scale. Dental Research Institute of Tehran University of Medical Sciences Approved 2019-12-18 Ethics committee of Tehran University of Medical Sciences North Karegar St , Tehran , Iran Tehran Tehran Iran (Islamic Republic of)