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IRCT20230125057218N2 IRCT 2023-12-11 Mashhad University of Medical Sciences Effect of analgesics during pulp therapy of deciduous teeth. Effect of oral analgesic on patient’s reaction during pulpal exposure in children 5 to 8 years old a randomized clinical trial. 2024-01-05 anticipated 40 Complete https://irct.ir/trial/68320 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: In this study permuted block technique randomizes patients between groups within a set of study participants, called a block. For this purpose, random allocation sequence of people will be used using Random Allocation Software and block size of two. In this study there are two blocks of AB and BA. A represents placebo and B represents Acetaminophen syrup. One of these blocks is selected randomly and people will be allocated to AB or BA blocks accordingly. This process will be continued until all of the samples have been allocated, Blinding description: Participant is unaware which of the medical intervention or placebo they used due to the similarity of the shape of the bottles and the taste of medical intervention and placebo. Evaluator is unaware whether the drug or placebo used by denoting similar bottles in A and B (A and B are written on the bottom of the bottles). Data analyst becomes unaware which data belongs to each of the groups through coded group names (A and B). N/A The degree of discomfort or pain. Intervention 1: Intervention group 1: Behsa's corp. Acetaminophen syrup (120mg acetaminophen per 5cc) with the dose of 15mg acetaminophen per 1kg is given to the child one hour before the dental treatment on the first session and on the second session Shahredaru's corp. Mester Vit multivitamin syrup is given in the same amount as acetaminophen one hour before the dental treatment. Intervention 2: intervention group 2: Shahredaru's corp. Mester Vit multivitamin syrup is given in the same amount as acetaminophen one hour before the dental treatment on the first session and on the second sessionBehsa's corp. Acetaminophen syrup (120mg acetaminophen per 5cc) with the dose of 15mg acetaminophen per 1kg is given to the child one hour before the dental treatment. Yes - There is a plan to make this available What will be shared: The details of the participants, such as age, sex, and the teeth studied, will be published by hiding their identities. When: Access to information will be from 2025 onwards. To whom: Researchers working in academic and scientific institutions who require this information can have access to it. Conditions: Is allowed with citation. Where to obtain: They can refer to Mashhad dental school's library or Mashhad University of Medical Sciences library website. How to obtain: Information will be available in thesis format. Comments:
public Rasoul Sahebalam
Department of Pediatric Dentistry, Faculty of Dentistry, Vakil Abad Blvd.
MASHHAD Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 sahebalamr@mums.ac.ir Mashhad University of Medical Sciences scientific Rasoul sahebalam
Department of Pediatric Dentistry, Faculty of Dentistry, Vakil Abad Blvd.
MASHHAD Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 sahebalamr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients in need of bilateral pulp treatment of the first primary molar tooth of the upper jaw. 5 years 8 years Both Patients requiring antibiotic prophylaxis for dental treatments. Patients with cooperation problems. Prevention Prevention Intervention group 1: Behsa's corp. Acetaminophen syrup (120mg acetaminophen per 5cc) with the dose of 15mg acetaminophen per 1kg is given to the child one hour before the dental treatment on the first session and on the second session Shahredaru's corp. Mester Vit multivitamin syrup is given in the same amount as acetaminophen one hour before the dental treatment. intervention group 2: Shahredaru's corp. Mester Vit multivitamin syrup is given in the same amount as acetaminophen one hour before the dental treatment on the first session and on the second sessionBehsa's corp. Acetaminophen syrup (120mg acetaminophen per 5cc) with the dose of 15mg acetaminophen per 1kg is given to the child one hour before the dental treatment. Discomfort and pain. Timepoint: during pulpal exposure. Method of measurement: Behavioral assessment scale FLACC( Face, Legs, Activity, Cry, Consolability scale). Mashhad University of Medical Sciences Approved 2023-03-13 Ethics committee of Mashhad University of Medical Sciences Vakil Abad Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)