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IRCT20221018056224N1 IRCT 2023-05-25 Semnan University of Medical Sciences The effect of using local anesthetic gel on the amount of anesthetic injection pain The effect of using local anesthesia gel on the amount of pain during dental anesthesia injection 2023-05-21 anticipated 30 Complete https://irct.ir/trial/69453 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are divided into two groups using blocks of six prepared by SPSS statistical software: in the first group, the first injection of anesthesia is performed on the right side of the jaw, and in the second group, the first injection of anesthesia is performed on the left side of the jaw. All injections will be performed by a maxillofacial surgeon in a room with an assistant. The use or non-use of anesthetic gel in the first injection will be randomly selected, Blinding description: First, SPSS statistical software randomly selects which side of the jaw of the local anesthetic is applied first in each patient. Therefore, it is determined which side is selected as the control group and which side is the case group, and the anesthetic gel is applied. Based on the injection site, we define two areas and place the desired anesthesia at that point. Due to the fact that a placebo is used in the control group, the patient will be blinded to the use or non-use of local anesthetic gel. 3 Pain during local anesthetic injection. Intervention 1: Intervention group: injection of local anesthesia along with the use of local anesthetic gel. First, SPSS statistical software randomly selects which side of the jaw of the local anesthetic is applied first in each patient. Therefore, it is determined which side is selected as the control group and which side is the case group, and the anesthetic gel is applied. As a result, in the intervention group, after placing the local anesthetic gel, anesthesia injection is performed. Local anesthetic gel containing 20% ​​lidocaine from Prodofix brand and then injection of 2% Xylopen anesthetic containing 20 mg lidocaine and 12.5 mg epinephrine. The interval between 2 intervention and control sessions will be 2 weeks. Intervention 2: Control group: injection of local anesthesia using placebo. First, SPSS statistical software randomly selects which side of the jaw of the local anesthetic is applied first in each patient. Therefore, it is determined which side is selected as the control group and which side is the case group, and the anesthetic gel is applied. As a result, in the control group, anesthesia injection is performed after placing the placebo substance. Vaseline petroleum jelly is used as a placebo, and then the injection of 2% xylopen anesthetic containing 20 mg of lidocaine and 12.5 mg of epinephrine is performed. The interval between 2 intervention and control sessions will be 2 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is not more information
public Seyed Vahid Dehnad
Faculty of Dentistry., Semnan University of Medical Sciences., 17 shahrivar blvd., Semnan.
Semnan Iran (Islamic Republic of) ۳۵۱۸۷۹۴۴۳۱ +98 23 3332 1026 s.vahid-dehnad@gmail.com Semnan University of Medical Sciences scientific Seyed Vahid Dehnad
Faculty of Dentistry., Semnan University of Medical Sciences., 17 shahrivar blvd., Semnan.
Semnan Iran (Islamic Republic of) ۳۵۱۸۷۹۴۴۳۱ +98 23 3332 1026 s.vahid-dehnad@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Full consent to participate in this study Patients without systemic disease Patients without epinephrine, lidocaine and benzocaine allergy Patients who need tooth extraction and there is a tooth corresponding to the intervention tooth on the opposite side of the jaw arch as a reference tooth no limit no limit Both Pregnant patients Lactating patients Patients who have taken systemic painkillers 4-6 hours before surgery Patients with localized abscess G89 Pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: injection of local anesthesia along with the use of local anesthetic gel. First, SPSS statistical software randomly selects which side of the jaw of the local anesthetic is applied first in each patient. Therefore, it is determined which side is selected as the control group and which side is the case group, and the anesthetic gel is applied. As a result, in the intervention group, after placing the local anesthetic gel, anesthesia injection is performed. Local anesthetic gel containing 20% ​​lidocaine from Prodofix brand and then injection of 2% Xylopen anesthetic containing 20 mg lidocaine and 12.5 mg epinephrine. The interval between 2 intervention and control sessions will be 2 weeks. Control group: injection of local anesthesia using placebo. First, SPSS statistical software randomly selects which side of the jaw of the local anesthetic is applied first in each patient. Therefore, it is determined which side is selected as the control group and which side is the case group, and the anesthetic gel is applied. As a result, in the control group, anesthesia injection is performed after placing the placebo substance. Vaseline petroleum jelly is used as a placebo, and then the injection of 2% xylopen anesthetic containing 20 mg of lidocaine and 12.5 mg of epinephrine is performed. The interval between 2 intervention and control sessions will be 2 weeks. Pain during local anesthetic injection. Timepoint: Immediately after the injection of anesthesia in each session, we ask the patient to express the amount of pain felt based on the Visual Analogue Scale chart, from one to ten. The interval between the first and second session is 2 weeks. Method of measurement: Visual Analogue Scale. Semnan University of Medical Sciences Approved 2022-10-10 Ethics Committee of Semnan University of Medical Sciences Semnan University of Medical Sciences and Health Services Headquarters., Basij Blvd. Semnan Semnan Iran (Islamic Republic of)