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IRCT20201031049199N1 IRCT 2020-11-17 Esfahan University of Medical Sciences Addition of clinidine to articaine solution in pain relief after root canal treatment IANB The Addition of Clonidine to the Articaine/Epinephrine for Inferior Alveolar Nerve Block Reduces Postoperative Pain of Patients with Irreversible Pulpitis: A Randomized Clinical Trial 2017-10-12 anticipated 100 Complete https://irct.ir/trial/51958 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The clonidine-containing and non-clonidine cartridges were labelled No. 1 and No. 2, respectively. The solutions were prepared daily under aseptic conditions .Immediately before the injection, the endodontist, who was unaware of the contents of the cartridges, threw a dice. A No. 1 cartridge was used when an odd number came out and a No. 2 cartridge was used with an even number. Therefore, both the patient and the investigator were not aware of the content of the injected solution, Blinding description: the anesthetic solutions were prepared and encoded by a dental student who was not involved in the study. Endodontist used a dice to choose which vial to use. The content of each number was not explained untill the data analysis was done. 3 Post operative pain. Intervention 1: Intervention group: The clonidine group (Articaine + Epinephrine + Clonidine, n = 50) received an IANB with 0.2 ml clonidine (Catapressan amp., 150 µg/ml; BoehringerIngelheim, Ingelheim am Rhein, Germany) in addition to 1.8 ml of 4% articaine (Daropakhsh, Tehran, Iran) with 1:100,000 epinephrine. Intervention 2: Control group: The control group (Articaine + Epinephrine, n = 50) received an IANB with 0.2 ml distilled water in addition to 1.8 ml 4% articaine with 1:100,000 epinephrine (Daropakhsh, Tehran, Iran). Yes - There is a plan to make this available What will be shared: VAS pain score and hemodynamic factors are shareable When: Access period starts 6 months after the results are published To whom: The data will be available to researchers working in scientific institutes. Conditions: Data can be used if it is not in conflict with interests. Where to obtain: Sara Hashemi 09134205038 Sara_hsh76@yahoo.com No. 32, 3rd Alley, 3rd Alley, South Resalat St., Sheikh Kolini St., Isfahan, Iran Postal Code: 8168964333 How to obtain: Email official documents related to the data requirements for a scientific project. Will be answered in a week. Comments:
public Dr.Elham Shadmehr
Hezar jarib St
Isfahan Iran (Islamic Republic of) 87986546 +98 31 3440 8524 elham.shadmer@gmail.com Esfahan University of Medical Sciences scientific Dr.Elham Shadmehr
Dentistry faculty of Isfahan University of Medical Sciences, Hezar jarib St
Isfahan Iran (Islamic Republic of) 87986546 +98 31 3440 8524 elham.shadmer@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Aged 15-60 ASA grade I Have symptomatic irreversible pulpitis in a mandibular posterior tooth 15 years 60 years Both necessity for multi-visit treatments consumption of analgesics or opioids in a week periodontal problems underlying diseases such as diabetes, hypertension or other cardiovascular diseases an allergy or contraindication to clonidine, articaine, or epinephrine active signs of oral infection or inflammation Pregnant or lactating mothers drug abusers, and patients taking a β-blocker G89.18 Other acute postprocedural pain Prevention Placebo Intervention group: The clonidine group (Articaine + Epinephrine + Clonidine, n = 50) received an IANB with 0.2 ml clonidine (Catapressan amp., 150 µg/ml; BoehringerIngelheim, Ingelheim am Rhein, Germany) in addition to 1.8 ml of 4% articaine (Daropakhsh, Tehran, Iran) with 1:100,000 epinephrine. Control group: The control group (Articaine + Epinephrine, n = 50) received an IANB with 0.2 ml distilled water in addition to 1.8 ml 4% articaine with 1:100,000 epinephrine (Daropakhsh, Tehran, Iran) Pain score. Timepoint: 12 h after- 24 h after-36 h after- 48 h after-72 h after procedure. Method of measurement: Heft- parker visual analog scale. Heart rate. Timepoint: Immediately Before administration- 5 minutes after administration. Method of measurement: digital blood pressure monitor (M3, Omron, omron healthcare co MTD, japan). Esfahan University of Medical Sciences Approved 2017-10-02 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib St., Isfahan University of Medical Sciences, Building No. 4 - Vice Chancellor for Research and Technology Isfahan Isfehan Iran (Islamic Republic of)