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IRCT20221120056551N1 IRCT 2023-02-13 Babol University of Medical Sciences Comparison of obturation quality and root canal treatment time between Neolix and M3 Immatural rotary systems and hand instrument in primary mandibular molars Comparison of obturation quality and root canal treatment time between Neolix and M3 Immatural rotary systems and hand instrument in primary mandibular molars: a single blind randomized clinical trial 2023-01-21 anticipated 30 Complete https://irct.ir/trial/66959 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Children are selected by the available and improbable method, and among them, children who meet the eligible criteria will be selected. Then 30 children will be divided into three groups by random allocation method and using random numbers obtained from Excel software, and 10 people will be treated in each group, Blinding description: The assessment of obturation quality will be done by an endodontist who will be blinded to the type of instrumentation. 3 Necrosis of pulp. Intervention 1: Intervention group: Root canal instrumentation will be done using M3 Immatural (#20) rotary files. Intervention 2: Control group: Root canal preparation will be done using Hand K-files from #15 to #30 employing a quarter pull turn method. Intervention 3: Intervention group: Root canal instrumentation will be done using Neoniti A1 rotary files (#25). 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 Mostafa Abasirostami
Ganjafrooz Ave.
Babol Iran (Islamic Republic of) 4717647745 0098 11 2291408 mo.abbasi@mubabol.ac.ir Babol University of Medical Sciences scientific Efat Khodadadi
Ganjafrooz Ave.
Babol Iran (Islamic Republic of) 4717647745 0098 11 2291408 drekhodadadi@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Age 4 to 9 years. Vital or necrotic mandibular primary molars without sinus tract. Absence of internal or external pathological root resorption. At least two-thirds of remaining root length. Children exhibiting Frankl's behavior rating scale score of 3 and 4. Presence of adequate coronal tooth structure to receive Stainless Steel (SS) crown or amalgam restoration. Signature of consent form. 4 years 9 years Both Children with underlying systemic diseases and those with special healthcare needs. Children lacking cooperative ability. Teeth with more than one-third of pathological root resorption. Radiolucent area(s) in the radiography. Teeth that cannot be restored. K04.1 Necrosis of pulp Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: Root canal instrumentation will be done using M3 Immatural (#20) rotary files. Control group: Root canal preparation will be done using Hand K-files from #15 to #30 employing a quarter pull turn method. Intervention group: Root canal instrumentation will be done using Neoniti A1 rotary files (#25). Obturation quality. Timepoint: Immediately after root canal obturation. Method of measurement: The obturation quality will be graded as optimal fill, overfill, and underfill (by Coll JA and Sadrian R 1996). Treatment time. Timepoint: Time to prepare and obturate the root canal. Method of measurement: by stopwatch. Babol University of Medical Sciences Approved 2022-10-30 Ethics committee of Babol univercity of medical science Ganjafrooz Ave. Babol Mazandaran Iran (Islamic Republic of)