Patient selection
herpetiform, allergy, Triadent®, blindness
SYSTEMIC DISEASE, BLINDNESS, ALLERGY, BLIND, APHTHOUS ULCERS
This study was performed in the Dentistry school of the Medical University of Isfahan. Patients with confirmed RAS aged 18–50 were included in this study. Exclusion criteria were pregnant or lactating women, history of allergy to herbal products, history of a systemic disease, history of using anti-inflammatory or corticosteroids, presence of herpetiform and major aphthous ulcers, and presence of lesions for more than 48 h. With a standard deviation of 1.67, absolute precision of 1.2, an α of 0.95, and a β of 0.2, the sample size was calculated as 30 persons in each group. Accordingly, 60 eligible patients were recruited for the study, and after giving the necessary explanations about the study, informed consent was obtained from all patients before inclusion in the study. For the blindness of the study, a code (“A” or “B”) was assigned to each patient randomly to determine the patient’s drug. One of the codes belonged to triamcinolone acetonide (Triadent®, Raha Pharmaceutical Company, Isfahan, Iran), and the other belonged to Salvizan gel (Goldaru Herbal Pharmaceutical Company, Isfahan, Iran). Both are drugs introduced for the treatment of aphthous ulcers. Each patient was assigned to one group with a random process performed by a third person. This study had a parallel arm design. The drugs were randomly defined as “A” and “B”. Then 60 drug tubes were coded and divided into groups of A (n = 30) and B (n = 30) with an allocation ratio of 1:1. The relevant tube was given to each patient, with a covered tube, so the researchers were blind to the treatment of each group until the end of the study. The person who analyzed the results was also blind to the groups. At the end of the study, experiment and control groups were indicated using these codes.