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.

Treatment of recurrent aphtous stomatitis: A systematic review

“…-Inclusion and exclusion criteria The inclusion criteria were: clinical trials, articles written in Spanish or English and no more than 5 years since their publication. The exclusion criteria were: articles which were not available in English or Spanish, which Treatment of RAS, review -Studies features (Table 1) All the 17 articles included in this review were written in English and Spanish and were published between 2016 and 2021 (1)(2)(3)5,11,12,14,(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). Altogether there were 985 patients examined, divided in 505 cases and 480 controls.…”

“…4 published in Europe (2 from Italy, 1 from Denmark and 1 from Liechtenstein) (5,17,19,20). 3 published in Africa (all them from Egypt) (2,18,22). We divided the studies in the kind of treatment used and the patients were distributed in "cases" if they received the experimental treatment, and "controls" if they received a placebo or another treatment in order to compare their efficacy.…”

“…We divided the studies in the kind of treatment used and the patients were distributed in "cases" if they received the experimental treatment, and "controls" if they received a placebo or another treatment in order to compare their efficacy. According to that, we divided the treatments obtained in three categories: "food supplements" (3,17,18) with 65 cases and 65 controls, "topical treatments" (1,2,5,11,12,14,(19)(20)(21)(22)(23)(24)(25) which included 408 cases and 387 controls. Finally, the group of "systemic treatments" (26), with only one article with 32 cases and 28 controls.…”

“…On the 3 rd stage, we selected 28 articles for the revision of the whole text, we applied the eligibility criteria, inclusion and exclusion. Finally, we selected 17 articles that met the inclusion criteria for our revision (1)(2)(3)5,11,12,14,(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). This systematic review fulfill 21 of 27 items of PRISMA statement (15) and the degree of evidence is high (16).…”

“…-Summary of results Among all the pain scales, the majority of studies use VAS (Visual Analogic Scale). In that scale, the patient has to give a score of the pain from 0 (no pain) to 10 (maximum pain) (1)(2)(3)5,11,12,(17)(18)(19)(20)(21)(23)(24)(25)26). Ibrahim et al (22) use the scale OCMI (Oral Clinical Manifestations Index) which combines different factors, giving a score to every one of them.…”