Formulation and clinical evaluation of Myrtus Mucoadhesive paste in the treatment of recurrent aphthous stomatitis

Recurrent aphthous stomatitis (RAS) is an oral lesion with high prevalence. Its management is directed toward treatment of symptoms. Myrtle is an herbal drug that has been used for RAS treatment during last years. Its essential oil has antiseptic and antimicrobial properties. One of the best factors in the treatment of aphthous lesion is, remaining of drug in location, so, a dosage form was tried to design that can hold the drug for a long time in location. For this purpose mucoadhesive drug delivery system was selected. Methods & Materials: This study was a double blind randomized clinical trial. The essential oil was extracted from myrtle leaf by using water in Clevenger apparatus. Oral mucoadhesive paste was prepared by compounding of sodium carboxy methyl cellulose, pectin and gelatin in plastibase. The best formulations were selected for clinical trial. In this double blind clinical trial, individuals were divided into two groups, A and B that received Mocuadhesive paste containing myrtle essence and mucoadhesive paste without drug as placebo, respectively. The size of lesions was measured by periodontal probe at 1, 2, 6 and 10 days. Also by use of VAS scale, daily pain was measured at 10 days period.

The time of burning sensation relief in A and B groups were 1.64±0.74 and 4.91±1.30 days respectively, which there was significant difference between the two groups (P<0.001). The mean of lesion size in group A were 0.14±0.36 and in group B 2.73±1.68 (mm) in sixth day (P<0.001).

The Mocuadhesive paste containing myrtle essential oil is a suitable formulation for treatment of recurrent aphthous stomatitis, with regard to its adhesive properties, the reduced time of burning sensation and the reduced size of lesion, significantly.