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IRCT20180429039468N1 IRCT 2018-07-16 Qazvin University of Medical Sciences Efficacy of Race rotary files in root canal preparation of primary molars Efficacy evaluation of manual and Race rotary files in root canal preparation of primary molars: an in vivo study 2018-10-06 anticipated 20 Complete https://irct.ir/trial/32468 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will select upon nonrandomization simple sampling (convenience sample), between those referred for primary molars pulpectomy to the pediatric dentistry department of Qazvin dental university. With Win Pepi software they will be randomly allocated into two stratifies, 5< up to 7 years and 7< up to 9 years, Blinding description: After the description of intervention methods to parents/guardians, the kind of instrument will specify for the operator, upon software allocation. The operator won't be blind, due to the different types of instrument. Via lack of awareness of the investigation's aims, the child and the collector of time will be considered blind. The evaluator and collector of microbiologic data will be blind, through coded samples. By overlaying the monitor, the evaluator and collector of cooperation data will be blind. The analyzer will be blind, on coded patients. N/A infectious necrotic primary molars. Intervention 1: Intervention group: Canal preparation through Race rotary file 2% tapered. Intervention 2: Control group: Canal preparation through manual instrument 2% tapered. 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 No more information
public Seyedeh Fatemeh Pachenari
Unit 34,floor 3, west building, Aseman towers,maskan 1 St., felestin cross,
Qazvin Iran (Islamic Republic of) 3413941613 +98 28 3332 3283 pachenari.dds@gmail.com Qazvin University of Medical Sciences scientific Anita Ebrahimi Khanghah
Shahid Bahonar Blvd,Qazvin university of medical sciences
Qazvin Iran (Islamic Republic of) 3419915315 +98 28 3333 6001 anita.ebrahimi@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) healthy child none of a history of the chronic systemic disease the cooperation basis on frankle criteria ( 3 and 4 groups) the restorable tooth with the suitable structure for rubber dam caries with the history of spontaneous and night pain at least two-thirds of the root present normal morphology moderate root angulation (root curvature radius 10-20m, the angle of the curvature 25-39 degrees) radiographic signs of pulp complication, consist of thin trabeculae, radiolucency of furcation and PDL widening acute alveolar abscess and fistulae 5 years 9 years Both physical or mental disability of the child antibiotic receipt in two last weeks former pulp therapy inadequate root length obstructed and calcified canal fractured root pathological internal or external root resorption internal or external furcation perforation severe bone resorption, affecting the permanent tooth crypt type II canals presence of two distally canals in mandibular molars K04.1 Necrosis of pulp Treatment - Devices Treatment - Devices Intervention group: Canal preparation through Race rotary file 2% tapered Control group: Canal preparation through manual instrument 2% tapered Change of the microbial load of canal following instrumentation by manual or rotary file. Timepoint: Sampling before and after chemomechanical preparation of canal at the same session. Method of measurement: Count of colony forming units after aerobic and anaerobic bacterial culture. Instrumentation time throughout the manual or rotary file. Timepoint: At the period of canal preparation by the manual or rotary file. Method of measurement: Chronometer. Cooperation scale of the child throughout instrumentation. Timepoint: At the period of canal preparation by the manual or rotary file. Method of measurement: Ohio state university behavioral rating scale(OSUBRS). Qazvin University of Medical Sciences Approved 2017-08-18 Ethics committee of Qazvin University of Medical Sciences Shahid Bahonar Blvd Qazvin Qazvin Iran (Islamic Republic of)