Therapeutic Effects of “Ibuprofen, Diphenhydramine and Aluminium MgS” on Recurrent Aphthous Stomatitis: A Randomized Controlled Trial

OBJECTIVE: Recurrent aphthous stomatitis (RAS) is the most common and painful oral inflammatory lesion with an unknown etiology. This study aims to determine the therapeutic effects of ibuprofen, diphenhydramine and aluminum magnesium simethicone (AlMgS) syrup on reducing oral aphthous ulcer pain. MATERIALS AND METHODS: Thirty-one patients with RAS participated in this double-blind clinical trial. Subjects were randomly divided into two groups. The control group (n=14) received drug mixture as drug A (diphenhydramine and AlMgS) and the case group (n=17) received drug B (ibuprofen, diphenhydramine and AlMgS). Drugs were topically applied on ulcers by the patients three times a day for 3 days. Patients were re-examined for the symptoms on the fourth day following their first visits using VAS (Visual Analogue Scale) tool. Statistical analysis was performed using paired t-test, independent t-test and chi-square test. RESULTS: The mean of pain reduction was 3.17±2 (P<0.001) and 3.82±1.79 (P<0.001) in the case and control group, respectively. The difference in pain reduction between both groups was not statistically significant. In addition, no significant difference was detected between the two groups regarding the duration of pain or burning sensation (P=0.57). CONCLUSION: The results of this study demonstrate that in comparison with diphenhydramine and AlMgS syrup, the studied mixture did not effectively reduce the level of pain, duration and burning sensation.