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IRCT20130812014333N150 IRCT 2020-05-26 Kermanshah University of Medical Sciences Designing and fabricating oral Bioadhesive from Onosma Bulbotricum and study of its therapeutic effect on the patient with Recurrent Aphthous Stomatitis (RAS) Designing and fabricating oral Bioadhesive from Onosma Bulbotricum and study of its therapeutic effect on the patient with Recurrent Aphthous Stomatitis (RAS) 2020-05-21 anticipated 120 Complete https://irct.ir/trial/48000 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random number table. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group. 2-3 recurrent aphthous stomatitis. Intervention 1: The intervention group will receive oral Bioadhesive extracted from Onosma Bulbotricum (from borage species) topically for 3 days (several times a day) for a week. Intervention 2: The control group will receive 1% triamcinolone topical gel (with trademarked of Teriadent) three days a week (several times a day) for one week. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared. When: 6 months To whom: If requested, results will be made available to other academic researchers Conditions: Collected data is confidential and will not be shared with anyone else Where to obtain: Send E-mail to the responsible for the update to get the documentation How to obtain: Documentation will be emailed within a 15-day timeframe Comments:
public Dr. Reza Tahvilian
Shariati Ave, Faculty of Dentistry
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 rtahvilian@kums.ac.ir Kermanshah University of Medical Sciences scientific Dr. Masoome Eivazi
Shariati Ave, Faculty of Dentistry
Kermanshah Iran (Islamic Republic of) 6713954658 +98 83 3729 6591 masoomeeivazi@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Aphthous stomatitis occurs at least three times a year Age between 18 and 60 years 18 years 60 years Both pregnant women K12.0 Recurrent oral aphthae Treatment - Drugs Treatment - Drugs The intervention group will receive oral Bioadhesive extracted from Onosma Bulbotricum (from borage species) topically for 3 days (several times a day) for a week. The control group will receive 1% triamcinolone topical gel (with trademarked of Teriadent) three days a week (several times a day) for one week. Pain. Timepoint: The second day after starting treatment as every other day for one week. Method of measurement: Based on a visual pain scale (VAS). Number of oral lesions. Timepoint: The second day after starting treatment as every other day for one week. Method of measurement: By a specialist in oral, maxillofacial and facial diseases. The average diameter of oral lesions. Timepoint: The second day after starting treatment as every other day for one week. Method of measurement: Using a ruler. Kermanshah University of Medical Sciences Approved 2020-02-04 Ethics committee of Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)