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IRCT20221109056454N1 IRCT 2023-11-21 Tehran University of Medical Sciences Evaluating the effect of celecoxib in comparison with acetaminophen on orthodontic pain management Evaluating the effect of celecoxib in comparison with acetaminophen on pain management after insertion of first orthodontic wire: a randomized, double-blind, controlled trial 2023-11-22 anticipated 70 Complete https://irct.ir/trial/66887 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients into two groups under study will be done by permutation block method with size 2x35. The list of random numbers will be prepared by the thesis statistics advisor and will be provided to pharmacist. The website https://www.sealedenvelope.com will be used to generate the list of random numbers. In order to conceal the allocation, the drugs (Celecoxib and Acetaminophen) with the same weight, appearance, color are prepared in identically packaged containers and are coded according to a list of random numbers and assigned to each patient who enters the study sequentially. is allocated and the drug container receives the corresponding code, Blinding description: This study will be double-blind and the statistician will be blind and does not know about the groups under study. Also, the patient will be blind and does not know what medicine he is taking. But in this study, there is no need to blind the dentist because he has no role in evaluating and measuring the outcome of the study and it is the patient who self-reports using the VAS index to measure pain at the considered times. Because in this study and in general, in the placement of orthodontic wire, the same brand of wire (which is American Orthodontics (AO)) is an important issue, and the performance of the clinician in this case will not be influential or confusing. N/A Pain after placing the first orthodontic wire. Intervention 1: Intervention group: The group that was prescribed celecoxib 200 mg 1 hour before and 6 hours after receiving the orthodontic wire. Intervention 2: Intervention group: The group that was prescribed 500 mg of acetaminophen 1 hour before and 6 hours after receiving the orthodontic wire. Yes - There is a plan to make this available What will be shared: All non-personally identifiable information When: 6 months after the results are published To whom: Researchers in academic and scientific institutions Conditions: In order to familiarize with the type of study for similar studies and judging Where to obtain: Project manager, Dr. Atefeh Safar Shahroudi a-shahroudi@tums.ac.ir How to obtain: Details of the requesting person and the relevant organization, the reason for the request and the process to be carried out Comments:
public Atefeh Saffar Shahroudi
Dr. Shahroudi's office, 1st floor, unit 2, Afra Building, , Itsar St., corner of Mehr Alley, Marzdaran Blvd.
Tehran Iran (Islamic Republic of) 1464643114 +98 21 4426 9453 a-shahroudi@tums.ac.ir Tehran University of Medical Sciences scientific Atefeh Saffar Shahroudi
Dr. Shahroudi's office, 1st floor, unit 2, Afra Building, , Itsar St., corner of Mehr Alley, Marzdaran Blvd.
Tehran Iran (Islamic Republic of) 1464643114 +98 21 4426 9453 a-shahroudi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) The patient's age is between 12 and 30 years The treatment plan for orthodontic patients should be fixed without tooth extraction. According to little's irregularity index, they should have a moderate rating. Orthodontic treatment should start with the lower jaw. 12 years 30 years Both Taking antibiotics and painkillers before orthodontic treatment Pregnant and lactating women Patients with history of allergy to celecoxib or acetaminophen Patients with a history of gastrointestinal or kidney ulcer and liver or cardiovascular failure History of drug addiction Not having written informed consent to participate in the study Patients with periodontal disease Z46.4 Encounter for fitting and adjustment of orthodontic device Treatment - Drugs Treatment - Drugs Intervention group: The group that was prescribed celecoxib 200 mg 1 hour before and 6 hours after receiving the orthodontic wire. Intervention group: The group that was prescribed 500 mg of acetaminophen 1 hour before and 6 hours after receiving the orthodontic wire. Overall pain score. Timepoint: 2 hours after wire placement, 6 hours after that, the first night of wire placement, 24 hours after the start, and finally on the second, third, and seventh day. Method of measurement: The patient's score on the severity of orthodontic pain in the general state with the VAS index. Pain score in chewing mode. Timepoint: 2 hours after wire placement, 6 hours after that, the first night of wire placement, 24 hours after the start, and finally on the second, third, and seventh day. Method of measurement: Patient's score of orthodontic pain severity in chewing state with VAS index. Pain score in biting position. Timepoint: 2 hours after wire placement, 6 hours after that, the first night of wire placement, 24 hours after the start, and finally on the second, third, and seventh day. Method of measurement: Patient score of orthodontic pain severity in biting state with VAS index. personal Approved 2023-10-21 Research Ethics Committees of School of Dentistry- Tehran University of Medical Sciences Tehran- Quds town (west)- between South Flamak and Zarafshan, Simai Iran street- Central headquarters of the Ministry of Health, Treatment and Medical Education, block A, 13th floor Tehran Tehran Iran (Islamic Republic of)