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IRCT20220509054789N2 IRCT 2022-07-23 Tabriz University of Medical Sciences Comparing the effectiveness of mouthwashes containing betamethasone and dexamethasone in improving oral lichen planus Comparison of the effectiveness of mouthwashs containing betamethasone with dexamethasone in the improvement of oral lichen planus lesions: A randomized double blind placebo controlled trial 2022-07-23 anticipated 60 Complete https://irct.ir/trial/64602 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups A and B. Sealed envelopes will be used for this purpose. They will be sealed by writing group A or B inside the envelopes. The envelopes are then mixed and the first envelope is removed at each patient's visit and assigned to the group inside the envelope. The examining dentist does not know which group A and B each belong to, Blinding description: he double-blind method will be implemented, In this way, the patient, researcher and data analyzer will not be aware of the contents of the bottles. Sampling and assignment of individuals to each group will remain secret for the patient and the researcher until the end of the study. Bottles with similar appearance will be divided into two categories. 3 Lichen planus. Intervention 1: Intervention group: 15 cc long-acting betamethasone (Kimia Drug Co.) in combination with 200 cc of AlMg stomach syrup, 3 times a day, 5 cc each time for 30 seconds, for 6 weeks. Patients will be instructed to gargle 5 cc each time for 30 seconds with betamethasone mouthwash inside their mouths, and to avoid eating and drinking for half an hour. In order to know about consumption or forgetting, the patients are asked to keep a diary and tick the consumption or non-consumption and hand it over to the researcher. This treatment will last up to 6 weeks. Then, after 6 weeks, the diameter of the lesions will be measured again. Intervention 2: Control group: 15 cc long-acting Dexamethasone (Kimia Drug Co.) in combination with 200 cc of AlMg stomach syrup, 3 times a day, 5 cc each time for 30 seconds, for 6 weeks. Patients will be instructed to gargle 5 cc each time for 30 seconds with dexamethasone mouthwash inside their mouths, and to avoid eating and drinking for half an hour. In order to know about consumption or forgetting, the patients are asked to keep a diary and tick the consumption or non-consumption and hand it over to the researcher. This treatment will last up to 6 weeks . Then, after 6 weeks, the diameter of the lesions will be measured again. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Sahar Khademnezhad
ّFaculty of dentistry, Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3333 6097 khademnezhad@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Sahar Khademnezhad
ّFaculty of dentistry, Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3333 6097 khademnezhad@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with OLP who have not received treatment so far. Confirmation of OLP diagnosis by histological sampling Age above 18 years 18 years no limit Both Pregnancy Having uncontrolled diabetes Stomach ulcer Having high blood pressure Suffering from a systemic disease for which corticosteroid administration is contraindicated Age below 18 years Observation of dysplasia in histopathological view Get other treatments for OLP L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: 15 cc long-acting betamethasone (Kimia Drug Co.) in combination with 200 cc of AlMg stomach syrup, 3 times a day, 5 cc each time for 30 seconds, for 6 weeks. Patients will be instructed to gargle 5 cc each time for 30 seconds with betamethasone mouthwash inside their mouths, and to avoid eating and drinking for half an hour. In order to know about consumption or forgetting, the patients are asked to keep a diary and tick the consumption or non-consumption and hand it over to the researcher. This treatment will last up to 6 weeks. Then, after 6 weeks, the diameter of the lesions will be measured again. Control group: 15 cc long-acting Dexamethasone (Kimia Drug Co.) in combination with 200 cc of AlMg stomach syrup, 3 times a day, 5 cc each time for 30 seconds, for 6 weeks. Patients will be instructed to gargle 5 cc each time for 30 seconds with dexamethasone mouthwash inside their mouths, and to avoid eating and drinking for half an hour. In order to know about consumption or forgetting, the patients are asked to keep a diary and tick the consumption or non-consumption and hand it over to the researcher. This treatment will last up to 6 weeks . Then, after 6 weeks, the diameter of the lesions will be measured again. Lesions size. Timepoint: Before and 6 weeks after the intervention. Method of measurement: Using the Thongprasom scoring system. Tabriz University of Medical Sciences Approved 2022-06-27 Research ethics comittees of Tabriz university of medical sciences Research Vice- Chancellor, Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz, Iran, , Tabriz East Azarbaijan Iran (Islamic Republic of)