Comparison of HATAKABB® Anti-Cough Mouth Spray and 0.1% Triamcinolone Acetonide Mouth Spray in Treatment of Recurrent Aphthous Stomatitis

Recurrent Aphthous Stomatitis (RAS) is a common oral mucosal condition that adversely affects patients’ quality of life. Although its exact etiology remains unclear, current management primarily focuses on symptomatic relief and promotion of ulcer healing. This randomized, double-blind, controlled trial aimed to compare the clinical efficacy of HATAKABB® Anti-Cough Mouth Spray (HTK) with 0.1% Triamcinolone Acetonide Mouth Spray (TA) in patients with RAS. A total of 64 participants were randomly assigned to receive either HTK or TA three times daily for 7 days. Outcome measures included ulcer size, pain intensity assessed using a visual analog scale (VAS), healing time, and salivary tumor necrosis factor-alpha (TNF-α) levels, evaluated at baseline and after treatment. Baseline characteristics did not differ significantly between groups (P > 0.05). Both treatments resulted in significant reductions in ulcer size after 7 days (P < 0.001). Between-group comparison showed a greater reduction in ulcer size in the HTK group, and non-inferiority analysis confirmed that HTK was not inferior to TA in reducing ulcer size. No significant differences were observed between groups in healing time or VAS scores. Salivary TNF-α levels were significantly reduced in TA after treatment (P < 0.001), and the reduction in TNF-α (ΔTNF-α) was significantly greater in TA than HTK (P = 0.013), consistent with the known anti-inflammatory mechanism of corticosteroids. In conclusion, HTK may represent an effective non-steroidal topical alternative for reducing ulcer size in patients with RAS, particularly for individuals seeking options other than corticosteroid therapy.