OBJECTIVE: 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. METHODS: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. RESULTS: 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. CONCLUSIONS: The mucoadhesive patch was found to be significantly more effective and better tolerated than the oral solution in the treatment of aphthous stomatitis.
RCT Entities:
OBJECTIVE: 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. METHODS: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. RESULTS: 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. CONCLUSIONS: 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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