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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rebamipide | Experimental | The enrolled subjects will be treated with Rebamipide in mucoadhesive gel for 2 weeks or until complete healing. |
|
| Nanoparticulated Rebamipide | Experimental | The enrolled subjects will be treated with nanoparticulated Rebamipide in mucoadhesive gel for 2 weeks or until complete healing. |
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| Clobetasol | Active Comparator | The enrolled subjects will be treated with Clobetasol in mucoadhesive gel for 2 weeks or until complete healing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebamipide | Drug | A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in the Clinical improvement of oral ulcers | Will be assessed using World Health Organization (WHO) grading of mucositis | assessment will be at baseline, 2 weeks and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pain assessment will be daily for the first week then at 2 weeks and 4 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | Egypt |
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| Nanoparticulated Rebamipide | Drug | A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology. |
|
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| Clobetasol Propionate | Drug | A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration. |
|
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| 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. | 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. | assessment at 0, 2 weeks and 4 weeks |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C052785 | rebamipide |
| D002990 | Clobetasol |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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