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IRCT20181021041405N1 IRCT 2019-03-28 Islamic Azad University Effect of Naproxen and Ketrolac on local anesthesia and post operative pain The comparison of three oral prophylactic drugs on success of inferior alveolar nerve block and post operative pain in patient with symptomatic irreversible pulpitis. 2018-12-06 anticipated 80 Complete https://irct.ir/trial/35225 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method is used to divide the subject into subgroups called blocks, then the individuals in each block are randomly assigned to treatment conditions. In this type of sampling, each member of the defined community There is an equal and independent chance to be present in the sample, meaning that independence is not the choice of a member in any way in choosing other members of the community. In this method, first we get the list of all the members, then we assign a score to each of them and use the random number table to select the required number. In the random numbers table, the random numbers of the randomly assigned drugs are categorized in each group. The randomization unit in this study is individual. To avoid the bias, cryptographic selection is used to prevent selected bias. In this study, for the patient to be blind, the capsules that are in shape, color, size, and weight are each other and the same as those of the placebo group, are used to both patient and patient of the contents of the capsules. Treatment applied and taken bias does not exist, Blinding description: This is a double blind clinical trial. In this study, patients are blinded to practitioners of capsules that are in shape, color, size, and weight of each other and are similar to those of the placebo group, so that both the patient and the patient do not know the content of the capsules. Then, from the random numbers table, we put the drugs in different groups, and the four drugs are coded by the person not in the research, and the codes are not determined until the end of the study. So far, each drug has a code that is unknown to the patient and the content of the capsule, but the person outside the study knows that each code is the drug. After this stage, the assessor and, with the corresponding code, will be evaluated and analyzed. Their statistics. In the end, after obtaining information about each code and its alignment with drugs, information on the effects of each drug is identified. 1. researcher who prescribes drugs is blinded to the case & placebo medications due to all medications are encapsulated in identical size & shape capsules. 2. Patient is also blinded due to who does not know about the containing capsules. 3. outcome assessor is the main researcher who does not know about the prescribed medications. 4. statistician is absolutely blinded to prescription and assessment. 3 Local anesthesia in Root canal therapy and post Root canal therapy pain. Intervention 1: Intervention group 1: Naproxen 500 mg, non steroidal anti-inflammatory drugs prescribe 1 hour before intervention. Intervention 2: Intervention group 2: Ketrolac 10 mg, non steroidal anti-inflammatory drugs prescribe 1 hour before intervention. Intervention 3: Intervention group 3: ibuprofen 400 mg, non steroidal anti-inflammatory drugs prescribe 1 hour before intervention. Intervention 4: Control group: The placebo, which is color and shape and weight, is the same as the original medicine and contains a small amount of glucose that is given 1 hour before the start of the intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Peyman Mehrvarzfar
No.4, Neyestan 9 Alley, Pasdaran Street
Tehran Iran (Islamic Republic of) 19585175 +98 21 2256 4571 p_mehrvarzfar@dentaliau.ac.ir Islamic Azad University scientific Peyman Mehrvarzfar
No.4, Neyestan 9 Alley, Pasdaran Street
Tehran Iran (Islamic Republic of) 19585175 +98 21 2256 4571 p_mehrvarzfar@dentaliau.ac.ir Islamic Azad University Iran (Islamic Republic of) symptomatic irreversible pulpitis Healthy participant First & second molar of mandible People between 18 and 65 years old 18 years 65 years Both Systematic disease Pregnancy and lactation Taking analgesics in the last 12 hours Allergic drugs History of RCT Periodontitis & PDL widening more than 1mm K04.0 Pulpitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Naproxen 500 mg, non steroidal anti-inflammatory drugs prescribe 1 hour before intervention. Intervention group 2: Ketrolac 10 mg, non steroidal anti-inflammatory drugs prescribe 1 hour before intervention. Intervention group 3: ibuprofen 400 mg, non steroidal anti-inflammatory drugs prescribe 1 hour before intervention. Control group: The placebo, which is color and shape and weight, is the same as the original medicine and contains a small amount of glucose that is given 1 hour before the start of the intervention. Pain severity. Timepoint: Measurement of pain severity before intervention, after access cavity preparation, after pulpotomy, pulpectomy and 6, 12, 24, 48, 72 hours after finish the intervention. Method of measurement: Heft Parker visual analog scale(VAS) (0_170 mm). Islamic Azad University Approved 2018-04-22 Ethics committee of Tehran Medical science Branch, Islamic Azad university No. 4, Neyestan 9 Alley, Pasdaran Street Tehran Tehran Iran (Islamic Republic of)