Evaluation of zinc sulfate mucoadhesive formulation on recurrent aphthous stomatitis: a randomized double-blind, placebo-controlled clinical trial

Abstract

Background: Recurrent aphthous stomatitis (RAS) is a common lesion that affects the oral mucosa. There are several methods to treat RAS, including systemic and topical formulations. This study was conducted to evaluate the anti-inflammatory effect of topical zinc sulfate and its efficacy in the treatment of RAS. Methods: A double-blind randomized clinical trial was conducted on 46 patients with RAS. They were randomly assigned into two groups to receive a zinc sulfate mucoadhesive tablet or placebo for 7 days. The pain severity was measured at baseline and daily while the diameter of the lesion was measured at baseline and on days 3, 5, and 7. The obtained data were analyzed in SPSS V.16. Results: There was no significant difference in the mean diameter of lesions and pain at baseline between the two groups (P = 0.643 and P = 0.842, respectively). However, on the third, fifth, and seventh days of the study, the diameter of the lesion significantly reduced in the intervention group (P = 0.001) and the pain intensity became significantly different between groups from the fourth day of the study (P = 0.001). Conclusion: Zinc sulfate mucoadhesive tablet was effective in recovery and reducing the pain and diameter of the aphthous lesion and could be considered for the treatment of RAS. Trial registration: Evaluation of the effectiveness of zinc sulfate mucoadhesive tablet in the improvement of recurrent aphthous stomatitis (RAS), IRCT20151109024975N9.

Recurrent aphthous stomatitis: A comprehensive review and recommendations on therapeutic options

“…Zinc sulfate has also been shown to treat RAS. One double‐blind randomized control trial (RCT) of 46 patients with RAS found a significant reduction in the diameter of lesions after 3, 5, and 7 days of the study and significant reduction in pain starting the fourth day of the study when treated with a zinc sulfate mucoadhesive tablet for 7 days compared to placebo 15 …”

“…One double-blind randomized control trial (RCT) of 46 patients with RAS found a significant reduction in the diameter of lesions after 3, 5, and 7 days of the study and significant reduction in pain starting the fourth day of the study when treated with a zinc sulfate mucoadhesive tablet for 7 days compared to placebo. 15 Vitamin D deficiency also seems to be associated with RAS. A systematic review and meta-analysis of five case-control, pooled studies reported statistically significant lower levels of vitamin D in RAS patients.…”

Recent Advances in Oral Mucoadhesive Drug Delivery

“…In the study of Anahita Ghorbani et al mucoadhesive tablets were prepared which contained carbopol 940, sodium alginate, zinc sulfate and starch. Results showed clinically and statistically the effectiveness of zinc mucoadhesive tablets as a topical drug delivery system, on decreasing pain, the diameter of the wound, and length of the recovery period of recurrent aphthous stomatitis compared to the control group (108). Another study by Perioli et al sustained-release mucoadhesive bilayered tablets were designed by mixing mucoadhesive polymers and an inorganic matrix (hydrotalcite) to apply flurbiprofen in oral cavity.…”

Efficacy of Topical Intervention for Recurrent Aphthous Stomatitis: A Network Meta-Analysis

“…Data from 36 RCTs [20,22,24,26,[28][29][30][40][41][42]47,48,50,53,54,[63][64][65]70,71,[75][76][77]80,82,83,[85][86][87][88][89][92][93][94][95][96] with 32 pairwise comparisons among 22 interventions were pooled. In terms of possible adverse events, triamcinolone performed better, with none occurring in 259 subjects, compared to amlexanox, chitosan, dexamethasone, doxycycline, penicillin and placebo.…”