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IRCT20221011056145N1 IRCT 2022-10-30 Rasht University of Medical Sciences Comparative study of pre-medication with paracetamol, Ibuprofen and placebo on post operative pain following pulpotomy in 6-12 years old children A split‐mouth randomized controlled trial: Comparative study of pre-medication with paracetamol, Ibuprofen and placebo on post operative pain following pulpotomy in 6-12 years old children 2022-10-21 anticipated 27 Complete https://irct.ir/trial/66345 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random block of 3 was used for randomization.For this reason, based on the following randomization list, patients will receive the following treatments in the order of entering the study.Group A paracetamol, group B ibuprofen and group C placebo.In the same way, in the second measurement based on random selection using a coin, the group receiving paracetamol will receive placebo;The group receiving ibuprofen received paracetamol and the group receiving placebo received ibuprofen.In the last round, any treatment group that did not receive it will receive it. Randomization was done with SAS software version 9, Blinding description: Participants of this study have no information of their consuming syrup. The therapist has no knowledge of the syrup consumed by the patients. The statistics analyst does not know about the syrup consumed by the patients. N/A Pulpotomy. Intervention 1: Intervention group: Ibuprofen. Ibuprofen suspension 100 mg/5 ml (Iran, Tehran, Hakim) is given 45 minutes before treatment based on the weight of each child. Intervention 2: Intervention group: Paracetamol. Paracetamol syrup 120 mg/5 ml (Tehran, Iran, Korizan) is given 45 minutes before treatment based on the weight of each child. Intervention 3: placebo suspension is given to children 45 minutes before treatment. Yes - There is a plan to make this available What will be shared: Only part of the data is shared, such as information on pain reduction after pulpotomy When: After printing the results To whom: Dentists, pediatricians, researchers working in academic and scientific institutions Conditions: Using pre-treatments such as ibuprofen, paracetamol and placebo to reduce pain after pulpotomy. Where to obtain: Gilan University of Medical Sciences Library How to obtain: Refer to the website of the library of Gilan Faculty of Dentistry and search in defended theses and approved research projects from 2021 onwards. Comments:
public Seyedeh Hedyeh Daneshvar
Complex of Gilan University of Medical Sciences.,Saravan beltway to Foman
Rasht Iran (Islamic Republic of) 73774 41941 +98 13 3348 6406 dr.daneshvar@gums.ac.ir Rasht University of Medical Sciences scientific seyedeh Hedyeh Daneshvar
Complex of Gilan University of Medical Sciences.,Saravan beltway to Foman
Rasht Iran (Islamic Republic of) 4194173774 +98 13 3348 6406 dr.daneshvar@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) The children be 6-12 years old Each patient must have at least 3 teeth for Pulpotomy and SSC in lower jaw Parents' consent to perform the treatment 6 years 12 years Both Not reaching hemostasis Not reaching adequate anesthesia Any kind of systemic disease that is in contrast to conservative pulp treatment Any radiographic findings including:internal and external resorption, PDL Widening,furcation and periapical radiolucency,root canal calcification Patients with any history of allergy to analgesics or any drugs used in the study Patients are not reachable through phone call Patients with Gastrointestinal problems, Favism, GERD,Active asthma Patients with prolonged bleeding history Presence of abscess or sinus tract K04.0 Inflammation of the dental pulp, usually due to bacterial infection in dental caries, tooth fracture, or other conditions causing exposure of the pulp to bacterial invasion. Chemical irritants, thermal factors, hyperemic changes, and other factors may als Treatment - Drugs Treatment - Drugs Placebo Intervention group: Ibuprofen. Ibuprofen suspension 100 mg/5 ml (Iran, Tehran, Hakim) is given 45 minutes before treatment based on the weight of each child. Intervention group: Paracetamol. Paracetamol syrup 120 mg/5 ml (Tehran, Iran, Korizan) is given 45 minutes before treatment based on the weight of each child. placebo suspension is given to children 45 minutes before treatment. Examining the type of drug on pain after pulpotomy treatment. Timepoint: The treatments are done with an interval of one week, and the child is asked to paint the face that is most similar to his feeling about the treated tooth in the intervals of 24, 48, 72 hours after the treatment. Method of measurement: comparative investigation of pre-treatment with paracetamol, ibuprofen and placebo on pain after pulpotomy treatment in children 6-12 years old" the way of measuring the outcome variable is "Wong-Baker scale". Examining the age variable on pain after treatment. Timepoint: In the initial treatment session, the age is asked and recorded for each child. Method of measurement: In the initial treatment session, the age is asked and recorded for each child. Examining the gender variable on pain after treatment. Timepoint: In the initial treatment session, the gender of the child is asked and noted. Method of measurement: In the initial treatment session, the gender of the child is asked and noted. Rasht University of Medical Sciences Approved 2022-04-20 Ethics committee of gilan university of medical Sciences Gilan Province, Fouman - Saravan Rd, Guilan Academic Complex of Medical Sciences Rasht Guilan Iran (Islamic Republic of)