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IRCT20200303046685N3 IRCT 2022-04-11 Esfahan University of Medical Sciences Comparison of Adhesive Pharmacological Form of Achillea Millefolium with Triamcinolone Acetonide Effects in Treating the Symptoms and Reducing Period of Recurrent Aphthous Stomatitis Comparison of Achillea Millefolium with Triamcinolone Acetonide Mucoadhesive Film Effects in Treating the Symptoms and Reducing Period of Recurrent Minor Aphthous Stomatitis 2021-11-22 anticipated 60 Complete https://irct.ir/trial/59724 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among patients suffering from minor aphthous stomatitis who refereed to dentistry department of isfahan medical univeristy, 60patients who have been examined by supervisor and have met the eligibility criteria, will enter the study and a number will be assigned to every patient. Then they will be divided into two intervention groups using block randomization (block size=30) through the random allocation service software. For allocation concealment, sealed coded boxes with randomized sequence with the same size and weight will be used, Blinding description: Both the participant and the investigator are not aware of the administered medication because of the similarity of the films In appearance, color and smell provided to the participants. 3 Recurrent minor Aphthous stomatitis. Intervention 1: First intervention group: Achillea millefolium adhesive film, every day after every meal and before bed, the duration of treatment for a week or until the lesions heal, whichever occurs sooner. Intervention 2: second intervention group: : Triamcinolone acetonide adhesive film with 1mg active ingredient, made by Dr Saniee Pharmaceutical Company, every day after every meal and before bed, the duration of treatment for a week or until the lesions heal, whichever occurs sooner. Yes - There is a plan to make this available What will be shared: Only information such as main consequence or the like can be shared. When: Access to the results immediately after publication To whom: Open access Conditions: Access to data is possible only after formal permission from corresponding author Where to obtain: Corresponding author How to obtain: Formal letter or email Comments:
public Fahimeh Pakravan
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
Isfahan Iran (Islamic Republic of) 817473461 +98 31 3436 8793 pakravan@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Fahimeh Pakravan
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
Isfahan Iran (Islamic Republic of) 817473461 +98 31 3792 5515 Pakravan@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) patients in the age group of 16 to 50 years with a minor oral stomititis that has been diagnosed by an oral disease specialist. No more than 24 hours after the onset of the minor oral stomatitis. 16 years 50 years Both Pregnancy and lactation concomitant treatment with other drugs allergy to herbs or triamcinolone immunodeficiency current and past head and neck radiotherapy and current chemotherapy neuropsychiatric disorders and lack of cooperation systemic steroid, Immune regulators and non-steroidal anti-inflammatory drugs users Patients with a history of ulcerative colitis Behcet's disease, severe anemia and Crohn's disease K12.0 Recurrent oral aphthae Treatment - Drugs Treatment - Drugs First intervention group: Achillea millefolium adhesive film, every day after every meal and before bed, the duration of treatment for a week or until the lesions heal, whichever occurs sooner second intervention group: : Triamcinolone acetonide adhesive film with 1mg active ingredient, made by Dr Saniee Pharmaceutical Company, every day after every meal and before bed, the duration of treatment for a week or until the lesions heal, whichever occurs sooner Pain. Timepoint: Days two, four and six of the study. Method of measurement: VAS ( visual analogue scale). The size of the aphthous lesion. Timepoint: Days two, four and six of the study. Method of measurement: ruler (millimeter). Esfahan University of Medical Sciences Approved 2021-08-23 Ethics committee of Isfahan University of Medical Sciences Hezarjerib Ave, Isfahan University of Medical Sciences,Isfahan,Iran Isfahan Isfehan Iran (Islamic Republic of)