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Erythropoietin (EPO) exerts anti-inflammatory effects by inhibiting NF- kappa B-dependent formation of pro-inflammatory cytokines, thus it reduces local and circulating levels of these disease (recurrent aphthous stomatitis RAS) related cytokines. So, it is considered as a potent anti-inflammatory cytokine in inflammatory disorders and infectious disease. It also accelerates wound-healing and decreases the extent of apoptosis and the areas of the open wound. this drug seems to be a promising therapeutic option in oral lesions. the effectiveness of EPO oral gel and EPO mouth wash were compared on patients with recurrent aphthous stomatitis and investigated therapeutic mechanism by examining treatment effect on expression of IL-2 IN RAS.
Sixty patients with recurrent aphthous stomatitis were randomly assigned into three equal groups to receive topical Erythropoietin oral gel four times per day (after meals and at bedtime) (Group I).
Erythropoietin mouthwash 4 times per day (after meals and at bedtime) (Group II), and placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) (Group III).
All patients were followed up four 1 week, photographs were taken at the beginning and end of the treatment.
patients were assessed using pain visual analogue scale (PVAS), clinical assessments for the size of the ulcers and rate of their recurrence.
pretreatment and post treatment salivary samples were taken to detect the expression and levels of salivary IL-2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythropoietin/oral gel | Experimental | topical erythropoietin oral gel 4 times daily for 1 week |
|
| placebo | Experimental | isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily |
|
| Erythropoietin/mouthwash | Experimental | Erythropoietin mouthwash 4 times daily for 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin 4000 | Drug | Erythropoietin hormone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain visual analogue scale (P-VAS) | The pain VAS consisted of a 10-cm horizontal line marked 0-10 (0 no pain, 10 most severe pain experienced). Patients marked the scale at each visit, and the all P-VAS were included on one sheet of paper allowing the patient to think in terms of change instead of absolutes. The P-VAS was then scored by measuring from the patient's mark to the beginning of the scale in cm. | Reduction from baseline and after 1 week of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Size of the ulcer | The score corresponds to the average diameter of the ulcers in millimeters, that is, a patient having ulcers of average size of 5 mm would score 5. Patients indicated the average size of their ulcers on a diagram of different diameter circles. The maximum score was 20 to accommodate the small number of RAS cases in which ulcers are on average more than 10 mm in diameter. | change from baseline and after 1 week of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical analysis | Salivary IL-2 was detected by an Enzyme-Linked Immunosorbent Assay (ELISA). This sandwich kit is for the accurate quantitative detection of Human Interleukin 2 (also known as IL-2) in serum, plasma, cell culture supernates, Ascites, tissue homogenates or other biological fluids. | From baseline and after 1 week of treatment |
Inclusion Criteria:
Exclusion Criteria:
• Patients with poor oral hygiene or not willing to perform oral hygiene measures.
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| Name | Affiliation | Role |
|---|---|---|
| Mai T. assistant lecturer Mai T. Elgendi, Assistant lecturer | Faculty of oral medicine- Future University in Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Future university in Egypt | New Cairo | Cairo Governorate | 4710001 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41851196 | Derived | Elgendi MT, Hussein RR, Ragy N, El Hoffy NM, El Din NHK. Efficacy of topical erythropoietin gel and mouthwash for recurrent aphthous stomatitis in a randomized clinical trial. Sci Rep. 2026 Mar 18;16(1):9339. doi: 10.1038/s41598-026-40440-7. |
| Label | URL |
|---|---|
| Related Info | View source |
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the age and number of the participants
will be available in September 2025
other researchers in oral medicine will be able to access, when the experiment is published internationally
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Placebo | Other | isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily |
|