Evaluation of Topical Rebamipide Versus Topical Betamethasone for Treatment of Oral Aphthous Ulcers

Summary

The goal of this randomized clinical trial is to to compare the effect of topical rebamipide to topical betamethasone on pain intensity in patients having recurrent oral aphthous ulcers. The main question it aims to answer is : What is the effect of topical Rebamipide mouthwash compared to topical betamethasone mouthwash on pain reduction in patients with oral aphthous ulcers? Participants will will be divided randomly into the two groups and the following outcomes will be measured: Pain associated with oral ulcers Number of oral ulcers Diameter of oral ulcers Healing time of oral ulcers

Timeline

Start

2026-07-01

Primary completion

2027-04

Completion

2027-06

Publications

• Background Ma Y, Yang M, Sun J, Qu X, Qu Z, Qu W. The effectiveness of lower-level laser therapy on the treatment of minor recurrent aphthous ulcers: a systematic review and meta-analysis. Lasers Med Sci. 2025 Nov 25;40(1):493. doi: 10.1007/s10103-025-04700-8.
• Background Parra-Moreno FJ, Egido-Moreno S, Schemel-Suarez M, Gonzalez-Navarro B, Estrugo-Devesa A, Lopez-Lopez J. Treatment of recurrent aphtous stomatitis: A systematic review. Med Oral Patol Oral Cir Bucal. 2023 Jan 1;28(1):e87-e98. doi: 10.4317/medoral.25604.
• Background Rogulj AA, Z Alajbeg I, Brailo V, Skrinjar I, Zuzul I, Vucicevic-Boras V, Alajbeg I. Topical NAVS naphthalan for the treatment of oral lichen planus and recurrent aphthous stomatitis: A double blind, randomized, parallel group study. PLoS One. 2021 Apr 8;16(4):e0249862. doi: 10.1371/journal.pone.0249862. eCollection 2021.
• Background Manfredini M, Guida S, Giovani M, Lippolis N, Spinas E, Farnetani F, Dattola A, Di Matteo E, Pellacani G, Giannetti L. Recurrent Aphthous Stomatitis: Treatment and Management. Dermatol Pract Concept. 2021 Sep 1;11(4):e2021099. doi: 10.5826/dpc.1104a99. eCollection 2021 Sep.
• Background Alsahaf S, Alkurdi KA, Challacombe SJ, Tappuni AR. Topical betamethasone and systemic colchicine for treatment of recurrent aphthous stomatitis: a randomised clinical trial. BMC Oral Health. 2023 Oct 3;23(1):709. doi: 10.1186/s12903-023-03335-x.
• Background Akagi S, Fujiwara T, Nishida M, Okuda A, Nagao Y, Okuda T, Tokuda H, Takayanagi K. The effectiveness of rebamipide mouthwash therapy for radiotherapy and chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a systematic review and meta-analysis. J Pharm Health Care Sci. 2019 Jul 25;5:16. doi: 10.1186/s40780-019-0146-2. eCollection 2019.
• Background Kudur MH, Hulmani M. Rebamipide: A Novel Agent in the Treatment of Recurrent Aphthous Ulcer and Behcet's Syndrome. Indian J Dermatol. 2013 Sep;58(5):352-4. doi: 10.4103/0019-5154.117298.
• Background Matsuda T, Ohno S, Hirohata S, Miyanaga Y, Ujihara H, Inaba G, Nakamura S, Tanaka S, Kogure M, Mizushima Y. Efficacy of rebamipide as adjunctive therapy in the treatment of recurrent oral aphthous ulcers in patients with Behcet's disease: a randomised, double-blind, placebo-controlled study. Drugs R D. 2003;4(1):19-28. doi: 10.2165/00126839-200304010-00002.
• Background Nagai N, Seiriki R, Deguchi S, Otake H, Hiramatsu N, Sasaki H, Yamamoto N. Hydrogel Formulations Incorporating Drug Nanocrystals Enhance the Therapeutic Effect of Rebamipide in a Hamster Model for Oral Mucositis. Pharmaceutics. 2020 Jun 9;12(6):532. doi: 10.3390/pharmaceutics12060532.
• Background Quijano D, Rodriguez M. [Topical corticosteroids in recurrent aphthous stomatitis. Systematic review]. Acta Otorrinolaringol Esp. 2008 Jun-Jul;59(6):298-307. Spanish.

Drugs

Indications