Efficacy of Oral Mucoadhesive N-acetylcysteine Tablets in Treatment of Recurrent Aphthous Stomatitis: A Randomized Double-Blind, Placebo-Controlled Clinical Trial

Gohar Eslami; Anahita Ghorbani; Jafar Akbari; Ali Farmoudeh; Fereshteh Faghih; Minoo Moghimi

doi:10.18502/fid.v20i18.12824

Gohar Eslami Cardiovascular Research Center, Mazandaran University of Medical Sciences, Sari, Iran
Anahita Ghorbani Department of Oral Medicine, Faculty of Dentistry, Mazandaran University of Medical Sciences, Sari, Iran
Jafar Akbari Department of Pharmaceuticals, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
Ali Farmoudeh Department of Pharmaceuticals, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
Fereshteh Faghih Department of Oral Medicine, Faculty of Dentistry, Mazandaran University of Medical Sciences, Sari, Iran
Minoo Moghimi Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran

DOI: https://doi.org/10.18502/fid.v20i18.12824

Keywords: Acetylcysteine; Stomatitis, Aphthous; Visual Analog Scale

Abstract

Objectives: This study aimed to assess the efficacy of oral mucoadhesive N-acetylcysteine (NAC) tablets for treatment of recurrent aphthous stomatitis (RAS).

Materials and Methods: Forty-nine patients with RAS were randomized to receive mucoadhesive NAC tablets (n=25) or placebo (n=24). Tablets were prescribed three times a day for 7 days in each group. Pain intensity was evaluated with visual analog scale (VAS) three times a day from day 1 to day 7. Also, patients were clinically examined on days 0 (before entering the study), 3, 5, and 7 using a metal caliper to measure the diameter of the lesions. The data were statistically analyzed and P<0.05 was considered statistically significant.

Results: Regarding the VAS score, all participants in the treatment group showed complete recovery on day 7 (P<0.01). Also, the diameter of the lesions was significantly smaller in the treatment group than the placebo group at the end of the study (P<0.001).

Conclusion: The results of this clinical trial showed for the first time that mucoadhesive NAC tablets can significantly decrease pain and the diameter of RAS lesions without any systemic complications.