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IRCT20210815052196N1 IRCT 2021-09-04 Esfahan University of Medical Sciences Effect of cold and external vibration in local anesthesia Comparative evaluation of effectiveness of using “external cold and vibration” and “cold” on amount of pain caused by maxillary infiltration in 6-12 year-old children 2021-08-25 anticipated 30 Complete https://irct.ir/trial/58150 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The randomization method is done by sealing the envelope. The randomization unit is individual. There are two envelopes, one with the word buzzy and the other with the word control. We ask the child to choose an envelope at the beginning of the session. The package that will be chosen will be the treatment method in the first session, Blinding description: The analyzer does not know the data related to intervention and control. Also, in the control session for blinding the participant, the device is placed off on the child's face. N/A A child has deep caries in the maxillary D and E teeth that requires local anesthesia.. Intervention 1: Intervention group: The parent places the Buzzy on the skin of the injection site and holds it for two minutes. The dentist applies surface anesthesia gel to the mucusa of the injection site with an ear cleaner, and after 30 seconds of injection, performs the infiltration anesthesia for one minute. The device should be in place during the application of the superficial anesthetic gel and the injection. Intervention 2: Control group: only cold and surface anesthesia gel are used. To blind the baby, we put the Buzzy on the baby's face without turning on the vibration and cold wings, and after two minutes, the surface anesthetic gel is applied by the ear cleaner for 30 seconds and the injection is done. Yes - There is a plan to make this available What will be shared: Age and gender, Frankel classification, fear score, children's heart rate after non-identification When: Access starts one month after publication To whom: General dentists and pediatric dentists , researchers working in academic institutions can apply for it. Conditions: The use of data for systematic review and meta analysis will be allowed. Where to obtain: Dr. Reyhane Faghihian reyhane.fgh@gmail.com Fateme shadmanfar. fatemeshd@yahoo.com How to obtain: The applicant must submit their application via email. The email must state the reason for the request and the use of it. Data will be sent up to one month after the request is submitted. Comments:
public Dr Reyhane Faghihian
9th floor, Block 4, Doctors Building, Aref St., Third Moshtaq, Esfahan.
Esfahan Iran (Islamic Republic of) 8158184959 +98 31 3263 8163 Reyhane.fgh@gmail.com Esfahan University of Medical Sciences scientific Dr Reyhane Faghihian
9th floor, Block 4, Doctors Building, Aref St., Third Moshtaq, Esfahan.
Esfahan Iran (Islamic Republic of) 8158184959 +98 31 3263 8163 Reyhane.fgh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children who are physically and mentally healthy, they have no underlying disease they are not currently taking painkillers or sedatives Children should be positive or completely positive about Frankl's behavioral classification during the dental examination he child should have no history of previous dental treatment and toothache at the time of referral they require deep D or E tooth restorations on both sides of the maxilla they are willing to participate in the study 6 years 12 years Both Have a history of hospitalization due to dental surgery children with chronic illnesses (such as asthma, allergies, diabetes, sickle cell disease, cystic fibrosis, dermatitis) children with behavioral problems (such as autism, ADHD, learning disabilities) patients with mental health problems, patients Congenital disorders, hearing and speech disorders are also not included in the study The child will be excluded from the study if the area to be implanted has pathology or if there is inflammation at the injection site non-working children will not participate in the study. K02 Dental caries Treatment - Devices Treatment - Devices Intervention group: The parent places the Buzzy on the skin of the injection site and holds it for two minutes. The dentist applies surface anesthesia gel to the mucusa of the injection site with an ear cleaner, and after 30 seconds of injection, performs the infiltration anesthesia for one minute. The device should be in place during the application of the superficial anesthetic gel and the injection. Control group: only cold and surface anesthesia gel are used. To blind the baby, we put the Buzzy on the baby's face without turning on the vibration and cold wings, and after two minutes, the surface anesthetic gel is applied by the ear cleaner for 30 seconds and the injection is done. Pain index. Timepoint: Measure of pain index immediately after injection. Method of measurement: Wong-baker index, FLACC index. Heart rate. Timepoint: 5 minutes before injection, during injection, 5 minutes after injection. Method of measurement: Pulse oximeter. Esfahan University of Medical Sciences Approved 2021-08-22 Ethics committee of Esfahan University of Medical Sciences Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St, Esfahan Esfahan Isfehan Iran (Islamic Republic of)