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IRCT20200622047887N1 IRCT 2020-09-06 Rasht University of Medical Sciences Comparison of the anesthetic efficacy of Articaine infiltration versus Lidocaine inferior alveolar nerve block in children pulpotomy Comparison of the anesthetic efficacy of 4% Articaine infiltration versus 2% Lidocaine inferior alveolar nerve block in pulp therapy of mandibular primary second molars in 5-8 years old children 2020-07-31 anticipated 40 Complete https://irct.ir/trial/49157 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use block randomization with size of 10 to randomize treatment for the patients. According to the comparison of the two types of anesthetics, at first, the subjects were divided into two groups, A and B, based on which treatment they received in the first session.in each block of 10, 5 people randomly receive A treatment and 5 people receive B treatment. Randomization was performed using version 9 of SAS software.Based on this, considering that the sample size is 40, we had 4 blocks of 10. In order to randomly assign the treatment to the patients right or left, a 10-shift permutation randomization was used again, considering that we indicated the right and left with letters C and D. in the previous randomization, we specified which anesthesia each person would receive. in this randomization, we specified which direction the anesthesia would be injected. based on this, we had random blocks of 10 that identified 5 on the right and 5 on the left, Blinding description: All injections will be performed by a pediatric dentist who is not aware of anesthetic drug type and study method.Dentist will receive anesthetic drugs in the same boxes without name and will be marked as A and B. In this way, dentist and patient will not be aware of treatment type. 3 Anesthesia in pediatric pulpotomy. Intervention 1: Intervention group: In this group patients will receive 1.8 ml Articaine 4% infiltration injection in mandibular primary second molar and their tooth anesthesia during the pulp therapy will be evaluated. Tehran Daru Pakhsh will provide the drug. Intervention 2: Control group: In this group patients will receive 1.8 ml Lidocaine 2% Inferior alveolar nerve block injection and their anesthesia during the pulp therapy of mandibular primary second molar will be evaluated. Tehran Daru Pakhsh will provide the drug. Yes - There is a plan to make this available What will be shared: Data are shareable after making them unidentifiable When: accessibility starts from 6 month after being published To whom: The data will be available to researchers working in academic and scientific institutions Conditions: Researchers can use them by citing references. Where to obtain: Dr. seyed hedyeh daneshvar dr.daneshvar@gums.ac.ir How to obtain: There is no special process. Comments:
public Dr. Seyed Hedyeh Daneshvar
Dentistry faculty, Guilan medical sciences complex, Fuman_Saravan Highway
Rasht Iran (Islamic Republic of) 41941-73774 +98 13 3348 6406 dr.daneshvar@gums.ac.ir Rasht University of Medical Sciences scientific Dr. Seyed Hedyeh Daneshvar
Dentistry faculty, guilan medical sciences complex, Fuman_Saravan Highway
Rasht Iran (Islamic Republic of) 41941-73774 +98 13 3348 6406 dr.daneshvar@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) 5-8 years healthy children who require pulp therapy of mandibular primary second molar in both sides appropriate cooperation of child for dental treatment under local anesthesia(class of 3 or 4 Frunkle scale) parents' consent for study entrance 5 years 8 years Both Presence of any inflammation or infection of soft tissue near the injection area Presence of any Allergic reaction to anesthetic soluble Children communication problem with others Presence of a systemic problems that interferes with the use of epinephrine containing anesthetics Using any drug within last 24 hours which interfere with pain evaluation presence of any systemic diseases and mental disorders patients with hypermic primary second molars which require pulpectomy Treatment - Drugs Treatment - Drugs Intervention group: In this group patients will receive 1.8 ml Articaine 4% infiltration injection in mandibular primary second molar and their tooth anesthesia during the pulp therapy will be evaluated. Tehran Daru Pakhsh will provide the drug. Control group: In this group patients will receive 1.8 ml Lidocaine 2% Inferior alveolar nerve block injection and their anesthesia during the pulp therapy of mandibular primary second molar will be evaluated. Tehran Daru Pakhsh will provide the drug. Facial Image Scale(FIS). Timepoint: Immediately after pulp exposure. Method of measurement: facial image scale graph. Sound , Eye & Motor scale (SEM). Timepoint: Immediately after pulp exposure. Method of measurement: patient behavior objective evaluation. Rasht University of Medical Sciences Approved 2020-07-29 Ethics Committee of Guilan University of Medical Sciences Deputy of Research and Technology, In front of 17 Sharivar Hospital, Shahid Siadati Ave., Namjo Ave. Rasht Guilan Iran (Islamic Republic of)