Buccal films as a dressing for the treatment of aphthous lesions

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The oral mucosa is prone to various disorders, of which one of the most commons are aphthous lesions 1. During the first days of the disease, aphthous lesions are usually extremely painful, often making eating and speaking difficult 2. Despite extensive efforts to reveal causes and factors influencing the development of aphthous lesions, the information is still limited, and the exact etiology and pathophysiology of aphthous lesions is poorly understood. Many factors have been suggested including hypersensitivity to food and drugs, trauma, hormonal changes, hematological deficiencies (particularly serum iron, folate, and vitamins B), cessation of smoking, immunological problems, environmental and psychological stresses, genetic factors, and viral infections 3. The most widely accepted mechanism of the development of aphthous lesions suggests a local immune dysfunction, in which T‐lymphocytes play a significant role.
However, as the exact causes of aphthous lesions are still uncertain and an effective therapy or prevention unknown, the treatment remains only symptomatic, focusing on the suppression of the local immune response, reduction in pain and discomfort, and on prevention of secondary infections and recurrence. Topical applications of antiseptics (chlorhexidine, triclosan, benzydamine hydrochloride, amlexanox), local anesthetics (lidocaine, dyclonine hydrochloride), or corticosteroids (triamcinolon, betamethasone) were proved to have positive effects during the treatment 4. In recalcitrant cases, administration of systemic corticosteroids also appears to have beneficial effects 8. The traditional surgical removal of aphthous lesions has been ineffective; however, a therapy involving the use of carbon dioxide lasers has been recently reported to be helpful in some cases of aphthous lesions 9. The use of thin mucoadhesive films designed for oral mucosa applications (buccal flexible films) is a novel, promising method of the treatment of aphthous lesions 11. They can be used as patches (dressings) designed to separate the mucosal lesion from the environment of the oral cavity, and thus to reduce the washout of any applied local treatment agent by saliva and to extend its effect from minutes to hours 10. This application can increase the duration of the contact between the active agent and the lesion and significantly improve the therapy effectiveness, reduce patients’ discomfort and bring relief more quickly than commonly used oral gels or solutions 7.
The buccal film should be flexible and adaptable to fit closely to the oral mucosa and be comfortable for the patient. At the same time, it must be durable enough to withstand the stress caused by the movements within the oral cavity 12.
Usually, the films consist of two layers, one of which is adhesive and the second is a covering (backing) layer protecting the first one against moisture and providing the film with mechanical durability 14. The adhesive layer may also contain a sorbent carrying an active agent 15, or, as in this study, the film can be used as a patch covering a lesion on which an active agent was applied.
The aim of this study was to compare the results of the treatment of aphthous lesions using a conventional local oral gel with the innovative approach to the treatment improved by the application of a buccal flexible film used as dressing covering the lesion. A promising statistical method, multivariate data analysis, was used to evaluate the obtained results.
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