Topical insulin-liposomal formulation in management of recurrent aphthous ulcers: A randomized placebo-controlled trial

Abstract

Aim: To evaluate the effectiveness of topical insulin-liposomal gel in aphthous ulcer treatment.

Methods: 80 participants with minor aphthous ulcers were randomly divided to receive either topical insulin-liposomal gel or placebo gel (once daily) for 6 days. Assessment of outcomes included visual analog scale (VAS) for pain (primary outcome), and secondary outcomes included ulcer duration and impact of treatment on quality of life using the Oral Health Impact Profile 14 (OHIP-14). Testing of the outcomes was carried out at 1, 2, 3, 4 and 6 days after treatment for VAS and at 6 days for OHIP-14.

Results: For pain scores, the test group showed a significant decrease by time, this was evident from day 1 (P < .001); at day 3, median and interquartile range (IQR) values were 0 (0-1). For the placebo group, a non-significant change by time was reported between baseline and day 1; at day 3, the median value was 7 (IQR, 7-9). The test group showed significantly lower mean duration than the placebo group (P < .001). OHIP-14 scores after 6 days showed that the test group had a significantly lower score than placebo (P < .001).

Conclusions: Topical insulin-liposomal formulation showed marked effectiveness in management of aphthous ulcers.