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IRCT20180519039722N3 IRCT 2020-06-11 Islamic Azad University Evaluation the effect of pre cooling , topical anesthesia gel on the pain of palatal injection in children Evaluation the effect of pre-cooling , topical anesthesia gel and placebo on the pain of palatal injection in children 2020-06-09 anticipated 112 Complete https://irct.ir/trial/45524 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly divided into 4 groups using Balanced block randomization using quadratic blocks using Randomization software.(Balanced block randomization), Blinding description: Anesthesia will be injected by the first surgeon (pediatric dentist) using an anesthetic. The second practitioner, who is blind to the selected topical anesthetic and has been present since the start of the injection, will examine the child's behavior during the SEM (sound, eye, and motor) scale. At the end of each injection, the child is asked to rate the amount of pain felt by selecting a face based on the Wong-Baker Faces scale. N/A Evaluation the effect of pre-cooling , topical anesthesia gel and placebo on the pain of palatal injection in children. Intervention 1: Intervention group: In the topical anesthesia gel group, the injection will be performed for 1 minute after drying the tissue with a cotton swab and applying ear cleaner impregnated with 20% prime gel of benzocaine 20% topical anesthesia gel. Intervention 2: Intervention group: Injection in the pre cooling group, after drying the tissue with cotton and placing ice carpool for 1 minute (to prepare the ice packs, lidocaine cartridges are emptied and filled with water and then placed in the freezer Took). Intervention 3: Intervention group: In the placebo group, after drying the tissue with a cotton swab and placing a vaseline for 1 minute at the injection site. Intervention 4: Control group: The injection will be given alone and without any 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 Will be announced at the end of the study.
public Taban Ahadi
No73,Habibnezhad Ave,Estakhr Ave,Tehranpars,Tehran
Tehran Iran (Islamic Republic of) 1656945812 +98 21 7734 4758 tabanahadi96@gmail.com Islamic Azad University scientific Saba Aghaei
No.9, Ninth Neyestan, Pasdaran Ave, Tehran
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 s_aghaei@dentaliau.ac.ir Islamic Azad University Iran (Islamic Republic of) Co-operative children (Frankl's rating scales III and IV) Requiring bilateral palatal injection for routine dental work such as extraction, dental preparation for stainless steel crown (SSC), pulpotomy and pulpectomy 7 years 10 years Both History of systemic diseases Allergy to dental anesthesia Any phobias from injections and dental work Having abscess and toothache at the injection site Treatment - Drugs Treatment - Other Placebo N/A Intervention group: In the topical anesthesia gel group, the injection will be performed for 1 minute after drying the tissue with a cotton swab and applying ear cleaner impregnated with 20% prime gel of benzocaine 20% topical anesthesia gel Intervention group: Injection in the pre cooling group, after drying the tissue with cotton and placing ice carpool for 1 minute (to prepare the ice packs, lidocaine cartridges are emptied and filled with water and then placed in the freezer Took) Intervention group: In the placebo group, after drying the tissue with a cotton swab and placing a vaseline for 1 minute at the injection site. Control group: The injection will be given alone and without any intervention Determination of pain. Timepoint: Immediately after the end of each injection, the child is asked to rate the amount of pain felt. Method of measurement: Image of Wonge-Baker Faces Pain Rating Scale. Determination of pain. Timepoint: The pediatric dentist during the injection will examine the child's behavior with the SEM scale (sound, eyes and motion). Method of measurement: Sound-Eye-Motor behavioral evaluation scale. Islamic Azad University Approved 2020-02-01 Ethics committee of Tehran Islamic Azad University of Dental Branch of Medical Sciences No.9, Ninth Neyestan, Pasdaran Ave, Tehran Tehran Tehran Iran (Islamic Republic of)