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IRCT20191002044953N1 IRCT 2019-12-26 Yazd University of Medical Sciences Maxillary Primary Molars Anaesthesia Comparison of Effectiveness of Articaine and Lidocaine on Depth of Anaesthesia in Maxillary Primary Molars Teeth 2019-12-22 anticipated 30 Complete https://irct.ir/trial/42668 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method was blocked. Randomization unit was individual. Randomization tool was sealed envelops. For allocation concealment, two sealed envelops were used for every patient in the first appointment; one determined extraction side and another was for drug type, Blinding description: The principle investigator who is aware of type of intervention would inject and extract tooth. The blinded dentist would collect the data. Considering blinding of data collector and the patient in every appointment, this study is double blinded. Also, the statistics analyst is not aware of type of intervention for each patient. 3 Effectiveness of articaine in comparison to lidocaine during maxillary primary molars extraction. Intervention 1: Intervention group: Injection of 1.8 ml of 4% articaine with 1:100000 epinephrine in buccal infiltration. Intervention 2: Control group: Injection of 1.8 ml of 2% lidocaine with 1:100000 epinephrine in buccal and palatal infiltration. Yes - There is a plan to make this available What will be shared: Undetectable information such as age, sex, type of tooth under extraction (first or second molar), amount of root length remaining to be extracted, and previous dental treatments history will be published. Study outcomes will also be published, including changes in blood pressure, pulse rate, Wong-Baker Facial Pain Scale and Face Leg Activity Cry Consolability Scale. When: Starting 9 months after publication. To whom: The data are only available for people working in academic institutions. Conditions: Use of this data is permitted for systematic review and meta-analysis. Similar clinical trials can also use the data to criticize the present study and its results in their Discussion. Where to obtain: 1. Send an email to nahidmaghsoodi@yahoo.com 2. Send an email to zbahrololoom@yahoo.com 3. Telephone Call with Dr. Zahra Bahrololoomi, No. 983536214257. How to obtain: After the request via one of the three methods listed above, if the request matches the sharing information mentioned before, this information will be available to the applicant within one month. Comments:
public Nahid Maghsoudi
No. 1, Imam Reza Blvd., Imam Reza Square., Yazd, Iran
Yazd Iran (Islamic Republic of) 89148-15669 +98 35 3621 4257 nahidmaghsoodi@yahoo.com Yazd University of Medical Sciences scientific Nahid Maghsoudi
No. 1, Imam Reza Blvd., Imam Reza Square., Yazd, Iran
Yazd Iran (Islamic Republic of) 89148-15669 +98 35 3621 4257 nahidmaghsoodi@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Children who require bilateral extraction of primary maxillary molars Children with grade 3 or 4 of frankl behavior rating scale Unrestorable primary maxillary molars primary maxillary molars with at least one third of the root length Children without systemic disease or drug allergy Children with ability of communication in persian language Children without learning disability 6 years 9 years Both Uncooperative children Teeth with acute abscess Use of analgesics before treatment Failure in complete anaesthesia after injection Treatment - Drugs Treatment - Drugs Intervention group: Injection of 1.8 ml of 4% articaine with 1:100000 epinephrine in buccal infiltration Control group: Injection of 1.8 ml of 2% lidocaine with 1:100000 epinephrine in buccal and palatal infiltration Score of self-reported pain by children during maxillary primary molars extraction based on Wong Baker Facial Pain Scale after anaesthesia with lidocaine or articaine. Timepoint: After tooth exrtraction. Method of measurement: Wong Baker Facial Pain Scale. Calculated score of child pain by investigator during maxillary primary molars extraction based on Face Leg Activity Cry Consolability Scale after anaesthesia with lidocaine or articaine. Timepoint: During tooth exrtraction. Method of measurement: Face Leg Activity Cry Consolability Scale. Blood pressure changes before and after tooth extraction. Timepoint: before and after tooth extraction. Method of measurement: Blood prassure monitor. Pulse rate changes before and after tooth extraction. Timepoint: Before and after tooth extraction. Method of measurement: Pulse Oximeter. Yazd University of Medical Sciences Approved 2019-09-17 Ethics Committee of Shahid Sadoughi University of Medical Sciences Dahe Fajr Ave , Imam Reza Square , Dentistry Faculty Yazd Yazd Iran (Islamic Republic of)