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IRCT20190716044230N1 IRCT 2020-04-21 Shahid Beheshti University of Medical Sciences Analgesic Efficacy of Ketoprofen Transdermal Patch Versus Ibuprofen Tablet on Post-Endodontic Pain Analgesic Efficacy of Ketoprofen Transdermal Patch Versus Ibuprofen Tablet on Post-Endodontic Pain in Patients with Irreversible Pulpitis – A Randomized Clinical Trial 2020-09-22 anticipated 54 Complete https://irct.ir/trial/45695 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, teeth(first molar/second molar) Tools used in randomization: sealed envelops How the random sequence was built: permutation Allocation concealment: all the drugs are packed in same unclear sealed envelops which is not distinguishable for the researcher. This process is done by a third person that is unaware of the object and protocol of the study, Blinding description: Dentist: he is not aware of the randomization and can not distinct drug packs because of their same appearance. principal investigator and data collectors: are not aware of the randomization. Outcome assessors: are not aware of the randomization. 3 Irreversible pulpitis (dental). Intervention 1: First Intervention group: Name of the drug: Ketoprofen, How to use: Skin patch (patches with the trademark Ketoclin from Sinsin pharm company), Patch concentration: 60 mg, Frequency: Every 6 hours, Duration: 24 hours. Additional Description: Patch Placement: Hairless areas on the arm or forearm. Intervention 2: Second Intervention group: Name of the drug: Ibuprofen, How to use: Oral tablets (Made by Tehran chemie company), Tablet concentration: 400 mg, Frequency: Every 6 hours, Duration: 24 hours. 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 since the study drug is evaluated for the first time in endodontics, we decided to publish the article first.
public Saeede Zadsirjan
Shahid Beheshti Dental school, Daneshjou blvd, Velenjak
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2241 3896 S_sirjani@yahoo.com Shahid Beheshti University of Medical Sciences scientific Saeede Zadsirjan
Shahid Beheshti Dental school, Daneshjou blvd, Velenjak
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2241 3896 S_sirjani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients whom their physical status is classified as ASA I Mandibular first/second molar diagnosed as irreversible pulpitis with moderate to severe pain Positive response to electric pulp test, lingering pain to cold test which validate the diagnosis of irreversible pulpitis for each tooth 18 years 65 years Both Having any systemic disorders, gastrointestinal disease or allergy which interfere with NSAIDS Allergy to local anesthesia drugs or sulfite Teeth that are not appropriate to be restorated or teeth with severe periodontal disease which are not suitable for endodontic treatment Patients with swelling or fistula Using any analgesic drug in the past 12 hours Spontaneous pain which requires emergency treatment Not being able to give informed consent or not being able to read and write Pregnant or breastfeeding women Exit criteria include disability (for any reason) in patient's fallow-up, inappropriate endodontic treatment or a two visit treatment and using other analgesics along with the study drugs. K04.99 Other diseases of pulp and periapical tissues Treatment - Drugs Treatment - Drugs First Intervention group: Name of the drug: Ketoprofen, How to use: Skin patch (patches with the trademark Ketoclin from Sinsin pharm company), Patch concentration: 60 mg, Frequency: Every 6 hours, Duration: 24 hours. Additional Description: Patch Placement: Hairless areas on the arm or forearm Second Intervention group: Name of the drug: Ibuprofen, How to use: Oral tablets (Made by Tehran chemie company), Tablet concentration: 400 mg, Frequency: Every 6 hours, Duration: 24 hours. Pain intensity after root canal treatment. Timepoint: Pain measurement immediately after root canal treatment and 2, 4, 8,12, 24 and 48 hours after treatment. Method of measurement: Numerical rating scale (NRS). Shahid Beheshti University of Medical Sciences Approved 2020-01-28 Ethics committee of Shahid Beheshti university of medical sciences Shahid Beheshti Dental school, Daneshjou blvd, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)