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IRCT20210803052059N1 IRCT 2022-03-07 Tabriz University of Medical Sciences Effect of preemptive ibuprofen analgesic compared to placebo on pain perception associated with the placement of temporary anchorage devices (TADs), A double blinded randomised clinical trial RCT Effect of preemptive ibuprofen analgesic compared to placebo on pain perception associated with the placement of temporary anchorage devices (TADs), A double blinded randomised clinical trial 2022-02-09 anticipated 46 Complete https://irct.ir/trial/57878 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Each individual represents a unit in the randomization method (46 individuals = 46 units), patients are randomly allocated in to blocks thus in to one of the arms using simple random sampling by using a computer softwarethe (Randlist v1.5), the two arms in the trial were placebo group and ibuprofen group and the block size was fixed to 6 individuals per block. The seed for random generator was (1786741248), then after the list was generated allocation concelment was carried out, Blinding description: Both Ibuprofen and Placebo will be packed in unclear packages and will be given to the patient by the assistance without the patient or the orthodontist knowing witch medication are in the package, for identifying the group no. 1 and 2 was written on the packages. 3 Malocclusion, Dental crowding.. Intervention 1: Intervention group: 25 participants, the medication (400 mg Ibuprofen (Advil، Pfizer Inc.)) will be given to the first groups thirty minutes before the TAD placement. Intervention 2: Control group: 25 participants, the medication (Placebo) will be given to the second groups thirty minutes before the TAD placement. 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 Arman Mohammadi Shayan
No 111, Niavaran 6 Building, Kaj Street, Roshdiyeh
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3661 4341 mohammadishayan@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Arman Mohammadi Shayan
No 111, Niavaran 6 Building, Kaj Street, Roshdiyeh
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3661 4341 mohammadishayan@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients treated with fixed orthodontic appliances Patients that only need one TAD in the posterior part of the maxilla Patients that will agree to participate in the clinical trial 13 years no limit Both Patients with poor oral hygiene or severe gingivitis Patients with systemic diseases Patients who currently are using other pain killer medications Patients who are allergic to any of TAD, Ibuprofen, or Placebo medication Patients who can not swallow M26 Anomalies of dental relationship Prevention Placebo Intervention group: 25 participants, the medication (400 mg Ibuprofen (Advil، Pfizer Inc.)) will be given to the first groups thirty minutes before the TAD placement. Control group: 25 participants, the medication (Placebo) will be given to the second groups thirty minutes before the TAD placement. Severity and type of pain during different times. Timepoint: severity and type of pain will be recorded at the following times: immediately after TAD placement (T1), 1 hour after TAD placement (T2), 12 hours after TAD placement (T3), 24 hour after TAD placement (T4). Method of measurement: The patients will be asked to fill a questionnaire form, this form is consisted of a Persian translated copy of short form of McGill Pain questionnaire (SF-MPQ). Tabriz University of Medical Sciences Approved 2021-10-25 Ethics committee of Tabriz University of Medical Sciences Central building of Tabriz medical university / gulgasht st. / Azadi st. / Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)