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IRCT20231021059788N1 IRCT 2024-01-16 Islamic Azad University Comparison of the effect of V-One mouthwash (ginger) and Irsha mouthwash (ginger and yarrow) and nystatin in the treatment of denture osteomatitis type 2 Comparison of V-One mouthwash (ginger); Irsha (ginger and yarrow) and nystatin on the amount of oral mucosal erythema in people with denture stomatitis type 2: a clinical trial 2024-01-20 anticipated 54 Complete https://irct.ir/trial/73269 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Bottles that are completely similar in appearance to each other, are poured by one of the three drugs that is going to be examined in the study. For each drug there will be 18 bottles and each bottle suffices for use of a patient during one week and after one week it must be refilled. The bottles are numbered randomly from 1 to 54 and the characteristics of bottles are recorded in the database. A simple randomization method will be used. During the delivery of the medicine to the patient, random number generation software (Microsoft Excel 2013) will be used to assign a random number from 1 to 54 to each patient, and the person receives a bottle containing medicine with the corresponding number. Because it takes time to find related people to enter the study and their visit to the clinic for initial examination and required documentation and signing informed consent is done on different days, therefore, the people participating in the study do not have any contact with each other and hence allocation concealment is implemented in practice, Blinding description: Bottles containing mouthwash are already filled and numbered by the supervisor. The specifications of the mouthwash are recorded and kept by him in the sheet. The bottles containing the mouthwashes are completely similar in appearance and the contents of the bottles are not visible from the outside. 3 Denture Stomatitis. Intervention 1: Intervention group 1: use of Irsha's ginger and yarrow mouthwash. The concentration of effective ingredients is 25%. Five ml of mouthwash is swirled in the mouth 4 times a day for 3 minutes each time and then thrown away. Produced by Shafa Pharmaceutical Laboratory - Tehran - Iran. Intervention 2: Intervention group 2: use of ginger mouthwash V One. The concentration of effective ingredients is 25%. 5 ml of mouthwash is swirled in the mouth 4 times a day for 3 minutes each time and then thrown away. Produced by Rojin company. Tehran Iran. Intervention 3: Intervention group: Use of nystatin suspension. 100000 units. 5 ml of mouthwash is swirled in the mouth 4 times a day for 3 minutes each time and then thrown away. Produced by Jaber Bin Hayan Company - Tehran - Iran. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Seyed Mohammad Zamaan Mousavi Kaani
No. 4; Nistan Dahom; Pasdaran street
Tehran Iran (Islamic Republic of) 19585/175 +98 21 2256 4571 m.mousavik@gmail.com Islamic Azad University scientific Seyed Mohammad Zaamaan mousavi
No. 4; Nistan Dahom; Pasdaran street
Tehran Iran (Islamic Republic of) 19585/175 +98 21 2256 4571 m.mousavik@gmail.com Islamic Azad University Iran (Islamic Republic of) The presence of symptoms of oral candidiasis in the patient's palate Being literate in reading and writing Being able to use mouthwash 18 years no limit Both Individuals who are allergic to ginger, yarrow and/or nystatin mouthwash Individuals who have a diet rich in ginger having diabetes Having hypoparathyroidism History of chemotherapy and radiotherapy Use of antibiotics and antifungals during the last 4 weeks K12 Stomatitis and related lesions Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: use of Irsha's ginger and yarrow mouthwash. The concentration of effective ingredients is 25%. Five ml of mouthwash is swirled in the mouth 4 times a day for 3 minutes each time and then thrown away. Produced by Shafa Pharmaceutical Laboratory - Tehran - Iran Intervention group 2: use of ginger mouthwash V One. The concentration of effective ingredients is 25%. 5 ml of mouthwash is swirled in the mouth 4 times a day for 3 minutes each time and then thrown away. Produced by Rojin company. Tehran Iran Intervention group: Use of nystatin suspension. 100000 units. 5 ml of mouthwash is swirled in the mouth 4 times a day for 3 minutes each time and then thrown away. Produced by Jaber Bin Hayan Company - Tehran - Iran The area of erythema in the mucosa. Timepoint: Measurement of mucosal erythema area at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of mouthwash use. Method of measurement: Area measurement module in ImageJ image processing software. by myself Approved 2023-10-14 Ethics Committee of Faculty of Dentistry, Tehran Islamic Azad University of Medical Sciences No. 4; Nistan Dahom; Pasdaran street Tehran Tehran Iran (Islamic Republic of)