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IRCT20230313057710N1 IRCT 2023-04-27 Esfahan University of Medical Sciences Investigation of the Effect of topical application of amitriptyline and nortriptyline on irreversible pulpitis pain in teeth with failed pulpal anesthesia after a successful inferior alveolar nerve block Investigation of the Effect of topical application of amitriptyline and nortriptyline on irreversible pulpitis pain in teeth with failed pulpal anesthesia after a successful inferior alveolar nerve block 2019-07-13 anticipated 45 Complete https://irct.ir/trial/69175 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each patient will allocated a code and the patients assigned to three groups of 15 using a table of random numbers. In this way, intervention group 1 was assigned a two-digit code from 01 to 15, intervention group 2 was assigned a two-digit code from 16 to 30, and the control group was assigned a code from 31 to 45. Then, a number was randomly selected from the table of random numbers by placing a finger on it, and from the beginning of the selected number, the numbers were read in pairs in order. The numbers above 45 were removed, but the numbers between 01 and 45 were placed in one of 3 groups depending on the initial code assigned to each person in each group, Blinding description: Both patients and the dentist (researcher) were blind to the tube contents (double-blind design). Each Eppendorf tube was coded such that the dentist did not aware of its content. A coded Eppendorf tube was assigned to each patient by someone not involved in the study. After measuring the level of pain of patient during access cavity preparation and prior to pulp exposure, one Eppendorf tube randomly was assigned to each patient while the dentist did not aware of type of intervention. N/A Pulpitis. Intervention 1: Intervention group 1: The diagnosis of irreversible pulpitis was confirmed by the heat and cold tests and presence of signs and symptoms of irreversible pulpitis such as severe long-lasting pain response to cold test, and pain during access cavity preparation (prior to pulp exposure). Patients showed signs of successful anesthetic injection 15 minutes after the IAN block injection of 2% lidocaine and 1:80,000 epinephrine (Darupakhsh Company, Tehran, Iran). 10 mg of amitriptyline (daroupakhsh company, Tehran, Iran) was prescribed. The colored coating of the tablets was removed and each tablet was powdered and mixed with 2 cc saline in an Eppendorf tube until a homogenous solution was obtained. The tubes were coded such that the dentist was blinded to the contents of each tube. The tube content was applied on exposed dentin by a microbrush, and a cotton pellet was placed over it, followed by a cotton roll and then the patient was requested to bite on it for 3 minutes. After this time period, the dentist continued the process of access cavity preparation and the pain score was measured again. Pain was measured three times prior to the treatment onset, after the injection of anesthetic agent and initiation of access cavity preparation as the patient felt pain for the first time, and also after the application of medication using the McGill visual analog scale (VAS) and Wong-Baker Faces Pain Rating Scale (PRS). Intervention 2: Intervention group 2: 10 mg of Nortriptyline ( Sobhan darou company, Tehran, Iran) was prescribed. The method of prescribing, intervention and data measurement were the same as the intervention 1. Intervention 3: Control group: Placebo including 10 mg starch was prescribed. The method of prescribing, intervention and data measurement were the same as the first intervention. 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 Zahra Khosravani
Hezarjarib, the Endodontics Department, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
Isfehan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 z.khosravani@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Armita Vali Sichani
Hezarjarib Avenu, the Endodontics Department, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
Isfehan Iran (Islamic Republic of) 0098 3136680048 +98 81 7467 3461 a.valisichani@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients requiring endodontic treatment of mandibular first molars showing the signs and symptoms of irreversible pulpitis and required treatment. Who had evidence of successful IAN block. Age 10-68 years 10 years 68 years Both History of hypersensitivity to TCAs, lidocaine or epinephrine Lack of Systemic diseases (In according to self-report) Pregnancy and nursing mothers Patients who took systemic analgesics within 4-6 hours prior to dental visit, Patients with complete anesthesia and no pain. K04.0 Pulpitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: The diagnosis of irreversible pulpitis was confirmed by the heat and cold tests and presence of signs and symptoms of irreversible pulpitis such as severe long-lasting pain response to cold test, and pain during access cavity preparation (prior to pulp exposure). Patients showed signs of successful anesthetic injection 15 minutes after the IAN block injection of 2% lidocaine and 1:80,000 epinephrine (Darupakhsh Company, Tehran, Iran). 10 mg of amitriptyline (daroupakhsh company, Tehran, Iran) was prescribed. The colored coating of the tablets was removed and each tablet was powdered and mixed with 2 cc saline in an Eppendorf tube until a homogenous solution was obtained. The tubes were coded such that the dentist was blinded to the contents of each tube. The tube content was applied on exposed dentin by a microbrush, and a cotton pellet was placed over it, followed by a cotton roll and then the patient was requested to bite on it for 3 minutes. After this time period, the dentist continued the process of access cavity preparation and the pain score was measured again. Pain was measured three times prior to the treatment onset, after the injection of anesthetic agent and initiation of access cavity preparation as the patient felt pain for the first time, and also after the application of medication using the McGill visual analog scale (VAS) and Wong-Baker Faces Pain Rating Scale (PRS) Intervention group 2: 10 mg of Nortriptyline ( Sobhan darou company, Tehran, Iran) was prescribed. The method of prescribing, intervention and data measurement were the same as the intervention 1. Control group: Placebo including 10 mg starch was prescribed. The method of prescribing, intervention and data measurement were the same as the first intervention. [The outcome variable is Irreversible pulpitis. Timepoint: Pain will measure three times including: prior to the treatment onset, after the injection of anesthetic agent and initiation of access cavity preparation as the patient felt pain for the first time, and also after the application of medication. Method of measurement: McGill Visual Analogue Scale, Wong-Baker figure scale. Isfahan University of Medical Sciences Approved 2019-06-26 The ethics committee of Isfahan University of Medical Sciences Hazar Jarib Ave, Isfahan University of Medical Sciences, Faculty of Dentistry, Isfahan, Iran Isfehan Isfehan Iran (Islamic Republic of)