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IRCT20180526039847N1 IRCT 2019-06-19 Mashhad University of Medical Sciences The Effect of Folic Acid Mouthwash on Stomatitis Caused by Head and Neck radiotherapy The effect of folic acid mouthwash solution in prevention of head and neck radiotherapy –induced stomatitis 2018-06-10 anticipated 100 Complete https://irct.ir/trial/31454 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using a random number table with 0-9 assignment to two groups of intervention and control, then on the random numbers table, set the starting point to blinded and specify the sequences of the sequence of the group on the random numbers of the starting point with a blind eye And sequences of sequence numbers of the intervention and control group are determined, Blinding description: Mouthwashes of folic acid and magic in similar containers and dividing the dishes into two groups (a, b) and delivering mouthwash to the patients by clinical care will not be known to the researcher in the relationship to the type of mouthwash. 3 Stomatitis caused by radiotherapy for head and neck. Intervention 1: Intervention group: Combined folic acid solution containing (folic acid = 100 mg, NaHCO3=38 mg, propyl parahydroxybenzoate = 25 mg, methyl parahydroxy benzoate = 50 mg, conc peppermint water= 2 ml, distilled water = Up to 100 ml volume)(This mucosal formulation has been used in several cases for gingivitis, which was developed and used by the pharmacist's professor at the Pharmacy Lab of Mashhad University of Medical Sciences for this study) and each time 5 cc for 14 days in Garnish two minutes in the morning and at night and then routine mouthwash (Magic) at 15 minutes intervals. and they do not eat anything until 15 minutes later. Intervention 2: Control group: The routine oral mucosal control group (magic) with the combination (Aluminum MGS syrup, diphenhydramine syrup, lidocaine ampoules, dexamethasone ampoules, nystatin drops) 2 times more than 15 minutes for 14 days, twice a day for one minutes and they do not eat anything until 15 minutes later. The mouths of patients are examined on the first, seventh and fourteenth days. Yes - There is a plan to make this available What will be shared: Only the original outcome information When: Starting the access period from 1399 To whom: Only for researchers working in academic and scientific institutions Conditions: Analysis of delivered data is allowed Where to obtain: Zahra gholami Gholamiz932@mums.ac.ir How to obtain: In less than one month, information is provided to the applicant by email. Comments:
public Seyyed Mousa Mahdizadeh
Faculty of Nursing and Midwifery of Mashhad Crossroad of the Doctora., Mashhad city
Mashhad Iran (Islamic Republic of) 91388-13944 +98 51 3859 1511 MahdizadehM@mums.ac.ir Mashhad University of Medical Sciences scientific Seyyed Mousa Mahdizadeh
Crossroad of the Doctora., Mashhad city
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3859 1511 MahdizadehM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Satisfied to participate in the study The mucous membrane is healthy and free from mucosal lesions and oral and dental problems Age of 18 to 60 years Receive external radiotherapy and radiation at a dose of 180 CGy per day for one hour During the study, do not use any mouthwash and other medication for oral ulcers Not having dentures 18 years 60 years Both Having immunodeficiency disease and having leukopenia and leukocytosis Having underlying illness (diabetes, kidney disease, liver disease) There is a history of tobacco use, including smoking, hookah, and narcotics in the last month Chemotherapy drugs receive simultaneous radiotherapy during the study Receives sedative During the study, do not use any mouthwash and other medication for oral ulcers K12.3 Oral mucositis (ulcerative) Prevention Prevention Intervention group: Combined folic acid solution containing (folic acid = 100 mg, NaHCO3=38 mg, propyl parahydroxybenzoate = 25 mg, methyl parahydroxy benzoate = 50 mg, conc peppermint water= 2 ml, distilled water = Up to 100 ml volume)(This mucosal formulation has been used in several cases for gingivitis, which was developed and used by the pharmacist's professor at the Pharmacy Lab of Mashhad University of Medical Sciences for this study) and each time 5 cc for 14 days in Garnish two minutes in the morning and at night and then routine mouthwash (Magic) at 15 minutes intervals. and they do not eat anything until 15 minutes later. Control group: The routine oral mucosal control group (magic) with the combination (Aluminum MGS syrup, diphenhydramine syrup, lidocaine ampoules, dexamethasone ampoules, nystatin drops) 2 times more than 15 minutes for 14 days, twice a day for one minutes and they do not eat anything until 15 minutes later. The mouths of patients are examined on the first, seventh and fourteenth days. The incidence of stomatitis. Timepoint: Before the start of the first and seventh and fourteenth days of Radiotherapy, the incidence of stomatitis, pain, mouth ulcers in patients' records. Method of measurement: The World Health Organization standard tool for measuring stomatitis, pain visual analog scale (Visual Analogue Scale), measuring instruments sores (oral mucositis assessment scale). Mashhad University of Medical Sciences Approved 2017-11-24 Ethics committee of Mashhad University of Medical Sciences Crossroad of the Doctora., Mashhad city Mashhad Razavi Khorasan Iran (Islamic Republic of)