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IRCT20091004002541N7 IRCT 2018-05-17 Vice chancellor for research, Isfahan University of Medical Sciences Anesthetic efficacy of Dexamethasone added to Lidocaine for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis Anesthetic efficacy of Dexamethasone added to Lidocaine for inferior alveolar nerve block in patients with symptomatic irreversible pulpitis 2016-08-01 anticipated 100 Complete https://irct.ir/trial/30971 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients choose the envelope with simple random sampling protocol to determine which anesthetic solution will be administered, Blinding description: Five-digit random numbers are being generated by using computer random numbers and they are written on a label on the anesthetic solutions. Each random number will be kept in a separate sealed opaque envelope. All these procedures is done by a third person who has no clue and has not involved in the rest of the study and only the random number is used on the data collection sheets to further blind the experiment. 2-3 Irreversible pulpitis. Intervention 1: Intervention group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.2 ml dexamethasone applied by using conventional inferior alveolar nerve block injection technique. Intervention 2: Control group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.2 ml sterile distilled water applied by using conventional inferior alveolar nerve block injection technique. 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 No more information available
public Masoud Saatchi
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 2822 saatchi@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Masoud Saatchi
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. P.O.Box: 81744-176
isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 2822 saatchi@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Eighteen years of age and over Being in good health condition Having a mandibular molar tooth with symptomatic irreversible pulpitis Normal periapical radiographic appearance (except for a widened periodontal ligament) Not having severe periodontal problem No history of allergy to local anesthesia or sulfite 18 years 60 years Both Pregnancy or lactation Taking any medications that might cause altered pain sensation ِAny swelling or sinus tract near the target tooth Active sites of pathosis in the area of injection Inability of the patient to give an informed consent Lack of lip numbness within 15 minutes after injection K04.0 Pulpitis Treatment - Drugs Placebo Intervention group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.2 ml dexamethasone applied by using conventional inferior alveolar nerve block injection technique. Control group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.2 ml sterile distilled water applied by using conventional inferior alveolar nerve block injection technique. Pain. Timepoint: Before treatment and after initiating root canal therapy. Method of measurement: Heft-Parker visual analog scale (VAS). Post pain. Timepoint: During procedure. Method of measurement: Heft-Parker visual analog scale (VAS). Vice chancellor for research, Isfahan University of Medical Sciences Approved 2016-07-01 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)