Efficacy of a Mucoadhesive Patch Compared with an Oral Solution for Treatment of Aphthous Stomatitis

Department of Dermatology, C. Sheba Medical Center, Ramat-Gan, Israel.
Drugs in R & D (Impact Factor: 1.71). 01/2008; 9(1):29-35. DOI: 10.2165/00126839-200809010-00003
Source: PubMed


The purpose of this study was to evaluate the efficacy and tolerability of a mucoadhesive patch compared with a pain-relieving oral solution for the treatment of aphthous stomatitis.
Patients with active aphthous stomatitis were randomly treated either once a day with a mucoadhesive patch containing citrus oil and magnesium salts (n = 26) or three times a day with an oral solution containing benzocaine and compound benzoin tincture (n = 22). All patients were instructed to apply the medication until pain had resolved, and completed a questionnaire detailing multiple clinical parameters followed by an evaluation of the treatment.
The mucoadhesive patch was found to be more effective than the oral solution in terms of healing time (mean +/- SD: 36.0 +/- 22.8 hours vs 134.7 +/- 57.7, p < 0.001) and pain intensity after 12 and 24 hours (3.7 +/- 2.8 vs 6.3 +/- 2.6, p = 0.003, and 2.3 +/- 2.7 vs 5.7 +/- 2.5, p < 0.001, respectively). Local adverse effects 1 hour after treatment were significantly (p < 0.01) less frequent among the mucoadhesive patch patients compared with the oral solution patients.
The mucoadhesive patch was found to be significantly more effective and better tolerated than the oral solution in the treatment of aphthous stomatitis.

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    • "Oral mucosal ulceration is a common condition with up to 50% of healthy adults suffering from recurrent minor mouth ulcers (aphthous stomatitis). Shermer[84] evaluated the efficacy and tolerability of a mucoadhesive patch compared with a pain-relieving oral solution for the treatment of aphthous stomatitis. The mucoadhesive patch was found to be more effective than the oral solution in terms of healing time and pain intensity after 12 and 24 h. "
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