Abstract

Objective: Aphthous stomatitis (canker sore) is painful ulcerations of the oral mucosa that can affect the quality of life of affected people. The use of medical devices in gel, spray and mouth rinse form, has become a valuable alternative to drug-based approaches in the treatment of aphthous stomatitis (canker sores). The presented study aimed to investigate the filmogenic capability and the barrier retention of three sodium hyaluronate-based medical devices: a gel, a spray and a mouth rinse formulation, produced by BMG PHARMA.

Methods: To investigate their efficacy in forming and retaining a barrier effect over time, an in vitro approach based on the well-established Franz cell system was applied. In particular, the BMG gel (BMG0722) product was ccompared with two commercial formulations available on the Italian market, Alovex^® and Tantum^® Verde SOS Afte Gel.

Results: According to our results, the sodium hyaluronate-based gel of BMG products line showed a better barrier retention compared to the two commercial formulation: indeed, while the barrier efficacy for BMG gel medical device (BMG0722) was observed for up to 8 h, for the other two formulations the barrier efficacy lasted up to 6 h. Regarding the other formulations of BMG line, the mouth rinse (BMG0721) performance is compatible with BMG0722 gel formulation (8 h), while the spray formulation (BMG0723) loses part of its barrier retention starting from 3 h after application. All tested formulations readily form a barrier following application.

Conclusion: Within the limitation of our experimental design, it can be concluded that the barrier forming sodium hyaluronate-based formulations of BMG line are effective in the treatment of aphthous stomatitis, since they protect the aphthae from the oral environment for a long period following application, limiting their application frequency while increasing the patient’s compliance as a consequence.

Keywords: Aphthae; Aphthous stomatitis; Sodium hyaluronate; Gel; Spray; Rinse; Filmogenic capacity