BACKGROUND: To evaluate the efficacy of a new bioadhesive patch, Aloe vera hydrogel, for the treatment of aphthous stomatitis. METHODS: An open, not controlled study was performed in 31 pediatric out-patients, aged 6-14 years, affected by mouth ulcers were enrolled consecutively in the 3 Gps Depts+ of San Marino Republic. For each case, data on case history and clinical profile, patterns of the lesion, presence of spontaneous or provoked pain were collected at baseline, and a bioadhesive patch ("Alovex patch") was administered on the basis of a daily regimen of < or = 3 patches for 4 days. Data on modification of the above-mentioned parameters, with patients and physicians opinion on the therapeutical efficacy, were collected during a control visit (4 days later). Moreover, by means of a daily diary, patients recorded information on the course of the symptoms during the 4 days and were also asked to compare the current treatment with other previous therapies. RESULTS: At the control visit 77% of the patients have shown a marked resolution of spontaneous pain, while in the other patients, pain was significantly decreased to a "mild" or "moderate" level. No one child declared to suffer from severe pain. Also provoked pain resulted to be significantly decreased after treatment Global efficacy was judged positively, being the therapeutical effect in more than 80% of cases "evident or of absolute improvement" both by physicians and patients opinion. A positive improvement of symptomatology started within the 2nd day of treatment in 74% of the patients. The compliance (adhesivity, acceptability and palatability) of the formulation was judged largely favourable in more than 90% of the patients. CONCLUSIONS: The results of this study underline the good efficacy and compliance of the patch for the treatment of the aphtous stomatitis; also the limit of topical available therapies, linked to the "contact time", to develop their therapeutical action, seems not to be evinced on the basis of this study, so the application of this patch seems to be more easy and beneficial.