The aim of this intervention study is to compare the effect of topical Rebamipide (regular and nanoparticulated) to topical Clobetasol propionate in management of Methotrexate induced oral mucositis in patients with rheumatoid arthritis.
A random sample of patients diagnosed with rheumatoid arthritis attending at the Rheumatology clinic in faculty of Medicine, Cairo University Hospital, will be enrolled by the investigator in the study in a consecutive order after being examined for methotrexate induced oral ulceration by means of history and clinical examination. Since oral mucositis associated with Methotrexate include production of free radicals, increase of inflammatory cytokines, and alteration of intracellular signal transduction, this suggests that Rebamipide should be useful for its treatment and prevention. Thus, this RCT will be the first to evaluate the treatment of Methotrexate-induced oral mucositis using Rebamipide and Rebamipide nanoparticles in patients with rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer.
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology.
A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration.
Cairo University
Cairo, Egypt
RECRUITINGchange in the Clinical improvement of oral ulcers
Will be assessed using World Health Organization (WHO) grading of mucositis
Time frame: assessment will be at baseline, 2 weeks and 4 weeks
Subjective degree of pain
All patients were introduced to the Numerical Rating Scale (NRS) and learnt how to express their pain through it, patients were instructed to fill the scale paper at the first visit \[baseline\], this procedure was repeated for each follow-up visit.
Time frame: Pain assessment will be daily for the first week then at 2 weeks and 4 weeks.
size of oral ulcer
The ulcer size was determined by measuring the distance between two opposite edges of the ulcer border, using a periodontal probe in millimeters.
Time frame: assessment at 0, 2 weeks and 4 weeks
healing time of the ulcer
The total healing time of oral ulcers Will be recorded in days for all the patients.
Time frame: assessment at 0, 2 weeks and 4 weeks
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