COMPARATIVE EFFICACY AND SAFETY OF STOMAREGEN IN A RABBIT MODEL OF STOMATITIS: A RANDOMISED CONTROLLED TRIAL

Abstract

This preclinical study compared the efficacy and safety of a new multicomponent formulation, StomaRegen (containing lactoferrin, propolis, hyaluronic acid and zinc citrate), with Miramistin (0.01%) and Chlorhexidine (0.05%) in a rabbit model of chemical stomatitis induced by 50% acetic acid. Forty Chinchilla rabbits were divided into four groups (n=10 each): placebo (saline), Miramistin, Chlorhexidine, and StomaRegen. Treatment was applied twice daily for 14 days. Ulcer area dynamics (photoplanimetry), time to complete epithelialisation, clinical signs (salivation, pain behaviour), haematological and biochemical parameters, as well as local tolerability and acute toxicity were assessed. By day 7, the ulcer area in the StomaRegen group had decreased by 89.7% from baseline, significantly outperforming Miramistin (58.2%, p<0.01) and Chlorhexidine (63.5%, p<0.01). Complete epithelialisation occurred at 8.2±1.1 days in the StomaRegen group versus 12.3±1.7 days for Miramistin and 11.8±1.5 days for Chlorhexidine (p<0.01). StomaRegen provided faster resolution of salivation and pain, as well as normalisation of leukocytosis (9.4±1.3×10⁹/L vs. 16.8±2.1×10⁹/L in placebo, p<0.001). Biochemical markers (ALT, AST, creatinine, urea) showed no differences from controls, confirming the absence of hepato‑ and nephrotoxicity. In the acute toxicity test (10‑fold dose), no mortality or neurological disturbances were recorded. The local irritation index of StomaRegen (0.8±0.3) was lower than that of Chlorhexidine (1.8±0.6, p=0.03). StomaRegen demonstrated statistically significant superiority over Miramistin and Chlorhexidine in ulcer healing rate, anti‑inflammatory and regenerative activity, while having a favourable safety profile. These results justify clinical trials of StomaRegen in patients with various forms of stomatitis, especially recurrent aphthous stomatitis.