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IRCT20221203056693N1 IRCT 2023-03-02 Shahid Beheshti University of Medical Sciences Comparison of Neurosensory disturbance following the inferior alveolar nerve block Comparison of Neurosensory disturbance following the inferior alveolar nerve block in the extraction of the third molars. 2023-01-21 anticipated 1000 Complete https://irct.ir/trial/67158 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The names of the patients were put in a pocket in separate papers and were taken out blindly and were devided into two groups alternatively, Blinding description: The labels of the anesthetic cartridges were removed and marked by numbers 1 and 2. the cartridges were applicated neither the dentist nor the patient knowing the type of anesthetic solution. The patients were consented to participate in the study but not aware of the type of anesthetics. Evaluation of the neurosensory disturbances was done by an epidemiologist and the researcher to define statistical and clinical significance of difference, while both were unaware of the type of the anesthetic solution. In this study, patients, dentists, the data analyst, and the researcher were blind. 3 Neurosensory disturbance of inferior alveolar nerve. Intervention 1: Control group: Lidocaine 0.2% with epinephrine 1:80000 (Perzocaine - E, Darupakhsh, Tehran, Iran). For each patient, two 1.8 cc carpule were injected for inferior alveolar nerve block, each one in 45 seconds period. patients were undergone the procedure only once during the study. Intervention 2: Intervention group: Articaine 4% with epinephrine 1:200000 (Dentacaine, Exir, Tehran, Iran).For each patient, two 1.8 cc carpule were injected for inferior alveolar nerve block, each one in 45 seconds period. patients were undergone the procedure only once during the study. 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 data exists
public Amir Mazidi Sharafabadi
Daneshjou Blvd, District 1, Tehran, Tehran Province,
Tehran Iran (Islamic Republic of) 1983969411 +98 912 623 4656 amir.mazidi@ymail.com Shahid Beheshti University of Medical Sciences scientific Reza Tbrizi
Daneshjou Blvd, District 1, Tehran, Tehran Province,
Tehran Iran (Islamic Republic of) 1983969411 +98 912 585 0829 tabmed@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who are in normal healthy status Patients who need to remove mandibular third molars Patients with a sufficient distance between the third molars root and the inferior alveolar nerve 18 years 70 years Both Patients with disturbed inferior alveolar nerve Patients with a history of fracture or trauma to mandible Patients with history of surgery Patients with a history of surgery of a mandibular pathologic lesion Patients who have done cosmetic surgery or augmentation at mandible Patients taking psychologic medications G50.9 disorder of trigeminal nerve, unspecified Prevention Prevention Control group: Lidocaine 0.2% with epinephrine 1:80000 (Perzocaine - E, Darupakhsh, Tehran, Iran). For each patient, two 1.8 cc carpule were injected for inferior alveolar nerve block, each one in 45 seconds period. patients were undergone the procedure only once during the study. Intervention group: Articaine 4% with epinephrine 1:200000 (Dentacaine, Exir, Tehran, Iran).For each patient, two 1.8 cc carpule were injected for inferior alveolar nerve block, each one in 45 seconds period. patients were undergone the procedure only once during the study. Incidence of neurosensory disturbance. Timepoint: Evaluation of the neurosensory disturbance 24 hours, 1 week, 2 weeks, one and 4 months after the extraction. Method of measurement: Neurosensory evaluation was performed by brush test. Patients' eyes were covered and the chin area were brushed and the patients were asked about the direction of the brushing. the results were recorded as true or false. Shahid Beheshti University of Medical Sciences Approved 2020-08-22 Ethics committee of Shahid Beheshti University of Medical Sciences Tehran Province, Tehran، Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave Tehran Tehran Iran (Islamic Republic of)