Evaluation of caffeic acid mucoadhesive tablets on minor recurrent aphthous stomatitis: a randomized, double-blind, placebo-controlled clinical trial

Abstract

Abstract Background Oral aphthous stomatitis is a chronic inflammatory condition. Numerous medications have been investigated to treat the symptoms of the disease. However, these days patients prefer herbal medicines due to lower side effects. Considering the anti-inflammatory, analgesic, and anti-oxidant properties of Caffeic acid and its few side effects, the aim of this study was to assess the impact of Caffeic acid on recurrent aphthous stomatitis (RAS). investigating the effect of caffeic acid mucoadhesive tablets on the size and pain intensity of the aphthous lesions. Methods in this double-blinded clinical trial study, 47 patients who met the inclusion criteria were selected by convenient sampling method. The patients were assigned to two groups randomly; the control group (placebo recipients) and the intervention group (Caffeic acid recipients). Patients were followed up for 7 days following the intervention. The diameter of the inflammatory lesion was measured in millimeters, and the pain intensity was recorded based on the VAS scale (Visual Analogue Scale). This trial was approved by the medical ethics committee of Mazandaran University of Medical Sciences (Ethical code: IR.MAZUMS.REC.1401.261) and received IRCT code of IRCT20220815055700N1on 03/09/2022. Results the diameter of the lesion in both groups decreased over time, and there was no significant difference between the intervention and control groups, except on the fifth day when the diameter of the lesion was significantly greater in the control group (P = 0.012). From the second day, the control group’s average pain intensity was significantly higher than the intervention group’s pain intensity (P < 0.05). Conclusions when comparing mucoadhesive tablets containing Caffeic acid and placebo, the findings demonstrated that Caffeic acid has a significant efficacy in reducing aphthous lesions’ diameter and pain intensity of the patients and are suggested for palliative oral aphthous lesions treatment since they showed significant anti-inflammatory and analgesic effects on recurrent aphthous stomatitis.