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IRCT20191114045442N1 IRCT 2020-02-27 Esfahan University of Medical Sciences Effect of fentanyl on the success of anesthesia for painful teeth مطالعه بی حسی دندان و فنتانیل اصفهان Effect of fentanyl on the success of inferior alveolar nerve block for teeth with symptomatic irreversible pulpitis 2020-01-21 anticipated 100 Complete https://irct.ir/trial/43673 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization is based on block randomization using four blocks. 25 blocks of four quadrants will be selected randomly adopting random number table method. Patients under study will be assigned to one of two groups of intervention and control groups based on the order of blocks selection, Blinding description: Drugs used in similar cartridges are prepared. The mentioned drugs will be differentiated from each other based on a four-digit code that is pasted on them with the usage of a random number table method. There is no difference in terms of shape, size and other physical characteristics.Therefore, the patient and the individual assessing the impact of the intervention will not be able to detect the drug in the intervention and control groups. 2-3 Irreversible pulpitis. Intervention 1: Intervention group: 2 cartridges of 1.8 mL of 2% lidocaine with epinephrine each combined with 0.25 ml fentanyl 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 0.25 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 There is no further information
public Neda Shekarchizade
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 Neda_shekarchizade@yahoo.com Esfahan University of Medical Sciences scientific Neda Shekarchizade
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 Neda_shekarchizade@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 18 years of age up to 60 in good health(ASA I (classification of the American Society of Anesthesiologists)) having at least one mandibular molar tooth with 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 Taking any medications that might cause altered pain sensation Any swelling or sinus tract near the target tooth pregnant or nursing mothers 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 0.25 ml fentanyl 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 0.25 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). Esfahan University of Medical Sciences Approved 2019-10-08 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)