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Randomized Controlled Trial
. 2025 Feb 1;29(2):106.
doi: 10.1007/s00784-025-06159-x.

Rebamipide for management of methotrexate-induced oral ulcers: a three-arm randomized clinical trial

Amira Abdelaziz  1 , Rehab Nabil Shamma  2 , Hala Lotfy Fayed  3 , Shereen Ali  4   5
Affiliations
Randomized Controlled Trial

Rebamipide for management of methotrexate-induced oral ulcers: a three-arm randomized clinical trial

Amira Abdelaziz et al. Clin Oral Investig. .

Abstract

Objectives: This RCT aimed to evaluate the effect of topical Rebamipide (regular and nanoparticulated) in comparison to topical Clobetasol propionate in the management of methotrexate-induced oral ulcers in rheumatoid arthritis patients.

Materials and methods: Patients were divided randomly into three parallel arms: 1% Rebamipide; 1% nanoparticulated Rebamipide, Clobetasol propionate. The outcome measures included WHO oral mucositis grading, pain (NRS), ulcer size, and healing time. The data was analyzed for any statistical significance.

Results: Intragroup comparisons of mucositis grade improvement and pain reduction revealed significant differences in all the groups. All intergroup comparisons demonstrated non-significant difference, yet nanoparticulated Rebamipide was leading, and all group participants achieved complete healing earlier than the other groups.

Conclusion: Rebamipide, regular and nanoparticulated forms, showed comparable results to potent Corticosteroid, Clobetasol propionate in management of the oral ulcers.

Clinical relevance: Rebamipide is an efficient promising alternative modality for management of methotrexate-induced oral ulcers in rheumatoid arthritis patients.

Keywords: Corticosteroid; Methotrexate; Nanoparticles; Oral ulcers; Rebamipide; Rheumatoid arthritis.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests.

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