Clinical evaluation of an oral mucoadhesive film containing chitosan for the treatment of recurrent aphthous stomatitis: a randomized, double-blind study.

Objective: To assess the efficacy and safety of an oral mucoadhesive film containing chitosan for the treatment of recurrent aphthous stomatitis (RAS).Methods: Seventy-two subjects with RAS were recruited to this randomized, parallel-controlled, double-blind clinical trial. The participants were randomly allocated to the test group or the control group. Demographic data were recorded at baseline. The use of the film was demonstrated. Pain score (visual analog scale), adverse effects, ulcer size were recorded on day 1 (baseline), day 2, day 4, and day 6.Results: The reduction in ulcer size was significantly greater (p<.05) in the treatment group (2.91 ± 3.66) than in the control group (1.10 ± 2.26) between days 4 and 6. There was no significant difference between the treatment and control groups in the pain score, ulcer size, or reduction in the pain score (p>.05). No obvious adverse effects were observed.Conclusions: The oral mucoadhesive film containing chitosan promotes oral ulcer healing and can be used as a drug carrier in treating oral ulcers.Trial registration number: ChiCTR-IOR-16008970.