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IRCT20240126060812N1 IRCT 2024-02-19 Zahedan University of Medical Sciences Copmparsion the effect of olive oil and coconut in preventing mucosities induced by chemotherapy Comparing the impact of using olive and coconut oils in preventing of chemotherapy induced mucositis in children with leukemia 2024-02-20 anticipated 100 Complete https://irct.ir/trial/75194 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization, block In order to randomly select patients using the block randomization method, with a total sample size of 13, we will have 8 blocks of size 8. After the first patient visits, one of these blocks will be randomly selected, and the patient will be assigned to the corresponding group based on that block, Blinding description: Sampling is random and purpose-based, and the double-blind study is easy and accessible. Allocation method of blocks of 8 will be used according to the total number of samples. In order to randomly select patients using the block randomization method, with a total sample size of 13, we will have 8 blocks of size 8. After the first patient visits, one of these blocks will be randomly selected, and the patient will be assigned to the corresponding group based on that block. 3 Leukemia. Intervention 1: Intervention group: In this group, olive oil (Farabakr Company, Rudbar, Iran), which is stored in dark glass containers at room temperature, is used to prevent mucositis. Intervention 2: Intervention group:In this group, coconut oil (DR-GEORGE, Germany) stored in metal cans at room temperature is used to prevent mucositis. Intervention 3: Control group:In this group, chlorhexidine mouthwash (0.2% chlorhexidine mouthwash, Najo, Iran) is used as a positive control group to prevent mucositis. Intervention 4: Control group:In this group, normal saline mouthwash (Darupakhsh, Iran) is used as a negative control group. Yes - There is a plan to make this available What will be shared: Information regarding the primary outcomes and group comparisons will be published two months after the study concludes When: Two months after the study's completion To whom: Dental students and researchers Conditions: will be provided with information about the mucositis developed following chemotherapy treatment Where to obtain: dr.mahsamoradi.pediatric@gmail.com Dr.mahsa moradi How to obtain: by sending an email to the email address of the responsible person for the research project Comments:
public Dr Mahsa Moradi
No19,Janbazan 1,Janbazan Blvd,
Zahedan Iran (Islamic Republic of) 9816833750 +98 54 3345 0105 dr.mahsamoradi.pediatric@gmail.com Zahedan University of Medical Sciences scientific Forough Amirabadi
Pedodontics Department,School of Dentistry.,Azadegan Blvd.
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3345 0105 dr.mahsamoradi.pediatric@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Children 1-14 years old Not receiving any type of treatment in the past Healthy mucosa at the beginning of treatment By obtaining the informed consent of the patient and the patient's parents Children who have not undergone radiotherapy and surgery in addition to chemotherapy. 1 year 14 years Both Children who have undergone chemotherapy, radiotherapy, and surgery Children who, in addition to leukemia, also suffer from other systemic or malignant disorders Children who have received any anti-fungal or anti-viral drug or any substance that is effective on oral mucositis before entering the study. C91.0 Acute lymphoblastic leukemia [ALL] Prevention Prevention Prevention Prevention Intervention group: In this group, olive oil (Farabakr Company, Rudbar, Iran), which is stored in dark glass containers at room temperature, is used to prevent mucositis. Intervention group:In this group, coconut oil (DR-GEORGE, Germany) stored in metal cans at room temperature is used to prevent mucositis. Control group:In this group, chlorhexidine mouthwash (0.2% chlorhexidine mouthwash, Najo, Iran) is used as a positive control group to prevent mucositis. Control group:In this group, normal saline mouthwash (Darupakhsh, Iran) is used as a negative control group. Prevention of mucusitis. Timepoint: In the first days, the first week, and the fourth week after the intervention. Method of measurement: Assessed based on the classification of the World Health Organization and clinical examination of the mucosal status. Zahedan University of Medical Sciences Approved 2023-12-24 Ethics committee of Zahedan University of Medical Sciences Pedodontics Department,School of Dentistry.,Azadegan Blvd. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)