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IRCT20191114045442N2 IRCT 2021-06-19 Esfahan University of Medical Sciences Evaluation of vibratory stimulation efficacy on pain during needle insertion and local anesthesia injection in anterior maxilla Evaluation of vibratory stimulation and cooling and topical anesthesia efficacy on pain during needle insertion and local anesthesia injection in anterior maxilla: a randomized clinical trial 2021-07-23 anticipated 200 Complete https://irct.ir/trial/55376 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method of randomization is based on block randomization using eight blocks. 25 blocks of eight 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: One person will do all the injections, which will show how people are assigned to the four intervention groups, and the other person will not know what group everyone is in, and will receive pain scores from patients.The person for whom blinding is performed in this study is responsible for evaluating patients' pain after the intervention. 3 Asymptomatic irreversible pulpitis, normal periapical. Intervention 1: Intervention group 1:Before injection, a cold spray-soaked ear cleaner is placed in the buccal vestibule area for one minute. Intervention group 2: Before injection, a vibrating device is placed in the area of ​​the buccal vestibule for one minute. Intervention group 3: Before injection, a topical gel is placed in the buccal vestibule area for one minute. Intervention 2: Control group: without any intervention (cold-spray, vibration and topical gel), local anesthetic injection is performed with infiltration technique in the buccal vestibule area of ​​the anterior teeth. Yes - There is a plan to make this available What will be shared: All data can be shared after unidentified individuals. When: starting 6 months after publication To whom: additional supporting information/documents will be shared only for people working in academic institutions Conditions: Any analysis of the data is allowed. Where to obtain: Dr Neda Shekarchizade Email: Neda_shekarchizade@yahoo.com How to obtain: It takes about a month for the documentation to reach the applicant. Comments:
public Neda Shekarchizade
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran.
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.
اصفهان Iran (Islamic Republic of) 8173638896 +98 31 3792 2822 Neda_shekarchizade@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) (ASA I) American Society of Anesthesiologists I Teeth with anterior maxillary root canal treatment with asymptomatic irreversible pulpitis, and normal periapical No periodontal disease Teeth adjacent to the target tooth should not have any infection or swelling Have not taken medications that change the perception of pain (such as painkillers, opioids, antidepressants, anti-anxiety drugs, alcohol) in the last 2 weeks No addiction Do not have pain or dental infection 18 years 60 years Both Patients who do not want to continue cooperating during the tests pulpitis K04.0 Prevention N/A Intervention group 1:Before injection, a cold spray-soaked ear cleaner is placed in the buccal vestibule area for one minute. Intervention group 2: Before injection, a vibrating device is placed in the area of ​​the buccal vestibule for one minute. Intervention group 3: Before injection, a topical gel is placed in the buccal vestibule area for one minute. Control group: without any intervention (cold-spray, vibration and topical gel), local anesthetic injection is performed with infiltration technique in the buccal vestibule area of ​​the anterior teeth. Pain. Timepoint: Pain when inserting a needle and pain during injecting of anesthtesia solution in the anterior region of the maxilla. Method of measurement: Heft-Parker visual analog scale (VAS). Esfahan University of Medical Sciences Approved 2021-03-17 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran. isfahan Isfehan Iran (Islamic Republic of)