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IRCT201501189014N53 IRCT 2015-01-21 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of gel Benzocaine 18% versus gel Menthol 10% and 5% on local dentistry injection pain in children 3 to 6 years old Effect of gel Benzocaine 18% versus gel Menthol 10% and 5% on local dentistry injection pain in children 3 to 6 years old: a double-blind randomized clinical trial 2012-12-30 anticipated 180 Complete https://irct.ir/trial/9492 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomization: the patients will be randomly allocated to the intervention and control groups using random numbers table. Blinding: the gels stained with the anesthetic drugs will be put on the location of injection for 30 seconds by a physician. Then, the injection and measuring the pain will be done by another physician. Neither the patients not the second physician will be aware of the type of anesthetic drugs. Therefore, the trial will be run as double blinded. 2 Injection pain. Intervention 1: putting gel Menthol 10% on the location of injection for 30 seconds. Intervention 2: putting gel Menthol 5% on the location of injection for 30 seconds. Intervention 3: putting gel Benzocaine 18% on the location of injection for 30 seconds.
public Dr Fatemeh Zeraati
School of Pharmacy, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 1590 fatemez415@gmail.com School of Pharmacy scientific Roya Pahlavani
School of Dentistry, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) +98 81 3838 1059 zoyapah@yahoo.com School of Dentistry Iran (Islamic Republic of) Inclusion criteria: (a) age of 3 to 6 years; (b) the first dentistry local anesthesia injection; (c) require to repair the first or second molar of the maxilla. Exclusion criteria: (a) restless child; (b) history of previous dentistry injection; (c) contraindication for anesthesia; (d) absence of the first or second molar of the maxilla; (e) havinf systemic, psychological, or mental disorder, (f) presence of oral abscess or lesions. 3 years 6 years Both R52 Pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Other putting gel Menthol 10% on the location of injection for 30 seconds putting gel Menthol 5% on the location of injection for 30 seconds putting gel Benzocaine 18% on the location of injection for 30 seconds Measuring the pain severity. Timepoint: just after injection. Method of measurement: using VAS scale. Nothing. Timepoint: Nothing. Method of measurement: Nothing. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2012-04-22 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)