Investigating the effectiveness of ibuprofen mucoadhesive gel on minor recurrent aphthous stomatitis: a randomized double-blind clinical trial.

OBJECTIVE

Recurrent aphthous stomatitis (RAS) is the most common form of oral mucosal lesions. This preliminary study investigated the effectiveness of ibuprofen mucoadhesive gel on minor aphthous lesions.

STUDY

DESIGN

In this randomized double-blind clinical trial, 44 participants, 22 in each intervention and control groups, used mucoadhesive gels 6 times a day. On days 0 (baseline), 3, 5, and 7, the lesion diameter was measured. Pain intensity was recorded using a visual numerical scale (VNS). Independent t-test, Friedman, generalized estimating equation (GEE), Mann-Whitney, and Chi-square tests were used to analyze data. Data analysis was performed using SPSS 22.

RESULTS

Comparison of the difference in mean lesion diameter between the 2 groups on measurement days and the baseline showed significant results (P < .05). The reduction in lesion diameter was greater in the intervention group. The mean pain intensity of the intervention group on days 4 (1.31 ± 2.56), 5 (0.91 ± 1.00), and 6 (0.69 ± 0.39) was significantly lower than that of the control group on days 4 (3.91 ± 2.36), 5 (2.61 ± 2.36), and 6 (1.52 ± 1.60) (P < .05).

CONCLUSION

The ibuprofen mucoadhesive gel resulted in a greater reduction in lesion diameter when comparing the results with the baseline and compared to the control group. Its analgesic effect was confined to days 4 to 6 of the study.

CLINICAL TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials (IRCT20241208063987N1).