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IRCT20190915044771N2 IRCT 2024-03-04 Rasht University of Medical Sciences Analgesic efficacy of transdermal patches versus oral tablets on pain control of orthodontic patients Analgesic efficacy of diclofenac and ketoprofen transdermal patches versus ibuprofen oral tablets on pain control after initial arch wire placement in orthodontic patients -a randomized clinical trial study 2024-03-05 anticipated 48 Complete https://irct.ir/trial/75633 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization: block Unit of randomization: stratified Randomization strata: sex, drug How the random sequence was built: permutation Allocation concealment: all the drugs will be packed in same unclear sealed envelops which is not distinguishable for the researcher. This process will be done by a third person that is unaware of the object and protocol of the study. complete explanation of Randomization: Based on Stratified Permuted Blocks, all the patients who agreed to participate in the research will be randomly assigned a drug envelope that contains the studied drugs and their usage method. This operation will be performed by the therapist's assistant. Since 48 patients will enter the randomization process and the variables of gender and type of drug are considered as criteria for classification, the patients will divided into 3 groups of 16 (8 males and 8 females). A, B, C will be labeled on the envelopes. 48 envelopes will divided into two groups, blue and red. If the client is a woman, the red envelope will pickup, and if the client is a man, the blue envelope will be prescribed. The envelopes will be filled with drugs and how to use them according to the order of the following three-number blocks based on the sequence of simple randomization. Blue envelopes: ABC, ACB, BAC, BCA, CBA, CAB, ABC, ACB Red envelopes: CAB, CBA, ABC, ACB, BAC, BCA, ABC, ACB In order to hide the random allocation, the method of Sequentially numbered, sealed opaque envelopes which is abbreviated as SNOSE will be used, Blinding description: Patients do not become blind due to the prescription of different drugs; But since they do not meet each other, they will not understand the difference of prescription drugs. In this study, the therapist (orthodontist), researcher and statistical analyst will not be aware of randomization and the drugs prescribed for the patients. Only the therapist's assistant (allocating samples to groups) is aware of the prescription drug by coding the drug packages and registering them. Patients will communicate only with the therapist's assistant, they will send him their pain level form after taking the drugs and ask him any questions. 4 pain after initial arch wire placement in orthodontic patients. Intervention 1: Intervention group1: Name of the drug: Ketoprofen, How to use: Skin patch (patches with the trademark Kefentech from jeil health science company), Patch concentration: 30 mg, Frequency:3 times every 12 hours, Duration: 24 hours. Additional Description: Patch Placement: Hairless areas on the arm or forearm. Intervention 2: Intervention group2: Name of the drug: Diclofenac, How to use: Skin patch (patches with the trademark Flector EP tissugel from Altergon Italia Srl company), Patch concentration: 1.3 percent Diclofenac epolamine( including 1%diclofenac equal to 15mg), Frequency:3 times every 12 hours, Duration: 24 hours. Additional Description: Patch Placement: Hairless areas on the arm or forearm. Intervention 3: Control group: Name of the drug: Ibuprofen, How to use: Oral tablets (Made by Raha pharmaceutical company), Tablet concentration: 400 mg, Frequency:4 times Every 8 hours, Duration: 24 hours. Yes - There is a plan to make this available What will be shared: All data in this study can be shared. When: The beginning of the access period is after 1403 To whom: The data of this study will be available for use by other researchers. Conditions: In the case of using the results and methods of this study, the source should be mentioned. Where to obtain: Dr. Yasamin Babaee Hemmati, Guilan dental school How to obtain: Review and satisfaction of the person responsible for the implementation of this study. Comments:
public Dr. Yasamin Babaee Hemmati
Guilan dental school, Rasht
Rasht Iran (Islamic Republic of) 4144693358 +98 13 3348 6406 yasi.10482@gmail.com Rasht University of Medical Sciences scientific Dr. Yasamin Babaee Hemmati
Guilan dental school, Rasht
Rasht Iran (Islamic Republic of) 4144693358 +98 13 3348 6406 yasi.10482@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients who want to start fixed orthodontic treatment of 2 jaws. Patients should be in the age range of 18 to 30 years. Patients should be healthy in terms of physical condition, without any systemic disease and according to the classification of the American Society of Anesthesiology should be in ASA I group. Based on Little's Irregularity Index, patients should have 3-6 mm of crowding in both upper and lower jaws and do not need tooth extraction. Patients should not take any medication at the moment. Patients should not report a history of bleeding or gastrointestinal discomfort or any allergies after taking Asprin-like drugs such as ibuprofen, and should not have any problems using ketoprofen, diclofenac, and ibuprofen. 18 years 30 years Both Patients who have taken any painkiller within 24 hours before treatment. Patients who cannot give informed consent. Patients who are illiterate. Patients who need restoration, root canal treatment or extraction of their teeth. Patients who have spontaneous pain in their teeth or periodontal problems do not allow to start orthodontic treatment. Patients who are pregnant or breastfeeding their babies. Patients who have a history of liver or kidney diseases or take drugs that affect these 2 organs. Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: Name of the drug: Ketoprofen, How to use: Skin patch (patches with the trademark Kefentech from jeil health science company), Patch concentration: 30 mg, Frequency:3 times every 12 hours, Duration: 24 hours. Additional Description: Patch Placement: Hairless areas on the arm or forearm Intervention group2: Name of the drug: Diclofenac, How to use: Skin patch (patches with the trademark Flector EP tissugel from Altergon Italia Srl company), Patch concentration: 1.3 percent Diclofenac epolamine( including 1%diclofenac equal to 15mg), Frequency:3 times every 12 hours, Duration: 24 hours. Additional Description: Patch Placement: Hairless areas on the arm or forearm Control group: Name of the drug: Ibuprofen, How to use: Oral tablets (Made by Raha pharmaceutical company), Tablet concentration: 400 mg, Frequency:4 times Every 8 hours, Duration: 24 hours. Pain intensity after initial arch wire placement in orthodontic patients. Timepoint: Immediately after arch wire placement and 2, 6 hours later, while sleeping, 24, 48 hours, 3 and 7 days after treatment. Method of measurement: Numerical rating scale (NRS). Rasht University of Medical Sciences Approved 2024-01-31 Research Ethics Committees of Guilan university of medical sciences No. 20, Faraz building, Fajr Alley, Namjoo Ave Rasht Guilan Iran (Islamic Republic of)