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IRCT20111219008458N3 IRCT 2021-08-03 Esfahan University of Medical Sciences Effect of "External Cold and Vibration" on Maxilla Infiltration injection Evaluation of effectiveness of using "external cold and vibration" in contrast with control group on amount of pain caused by infiltration injection in 6-12 years old children: randomized clinical trial 2021-08-20 anticipated 30 Complete https://irct.ir/trial/55201 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Random Sampling: Simple randomization using google's online coin flipper. First, each group will be assigned to a coin flip result. Thereafter, a coin flip will be performed using google's online coin flipper, for each individual, and it will be decided whether the participant is in the Case or Control group, Blinding description: Participants will not know whether they participate in case or control group. Participants will then be assigned with identifiers, generated with an online number generator software (numbergenerator.org). Therefor, the putcome assessors, and the manuscript writers will be blind to the identity of participants in both Case and Control groups. 3 Pain When Injecting Maxillary Infiltration. Intervention 1: Hold the Buzzy(external cold and vibration) on the mucosa of the injection site for two minutes and inject the anesthetic (1.8 ml 2% lidocaine with 1: 100000 epinephrine using a 27 gauge and short needle).The device should be in place while injecting. Intervention 2: Control group: Benzocaine 20% Dentotix (North Carolina) topical anesthetic gel is applied and injected for 30 seconds. Yes - There is a plan to make this available What will be shared: Evaluation of external cold and vibration in contrast with topical anesthesia gel in amount of pain perceived by children during infiltration injection When: Not decided To whom: Researchers working in academic and scientific institutions Conditions: Not decided Where to obtain: Not decided How to obtain: Not dicided Comments:
public Sanaz Ziaei
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave
Isfahan Iran (Islamic Republic of) 8164986744 +98 31 3663 0106 sanaz20_2005@yahoo.com Esfahan University of Medical Sciences scientific Sanaz Ziaei
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave
Isfahan Iran (Islamic Republic of) 8157895561 +98 31 3792 3120 sanaz20_2005@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children referred to the School of Dentistry of Isfahan University of Medical Sciences Be mentally and physically healthy They do not take analgesics or sedatives Be positive or completely positive in terms of Frankl division Have no previous dental history Do not have toothache when referred Need deep restoration of D or E teeth on both sides of the maxilla Willing to participate in the study 6 years 12 years Both Treatment - Devices Treatment - Devices Hold the Buzzy(external cold and vibration) on the mucosa of the injection site for two minutes and inject the anesthetic (1.8 ml 2% lidocaine with 1: 100000 epinephrine using a 27 gauge and short needle).The device should be in place while injecting Control group: Benzocaine 20% Dentotix (North Carolina) topical anesthetic gel is applied and injected for 30 seconds. Heart rate during infiltration injection on maxillary teeth. Timepoint: 5 minutes before injection, during injection, 5 minutes after injection. Method of measurement: Pulse Oxymeter. Esfahan University of Medical Sciences Approved 2021-03-17 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)