The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis

Phase 4

Completed

• Conditions: Recurrent Aphthous Stomatitis
• Interventions: Drug: Epoetin 4000; Other: Placebo

• Registration Number: NCT06923605
• Lead Sponsor: Future University in Egypt

Brief Summary

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.

Detailed Description

Thirty 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.

Study Timeline

• Study Start: 2024-07-01
• Primary Completion: 2024-12-21
• Study Completion: 2025-02-27
• Study First Submitted: 2025-03-11
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All patients should be free from any systemic disease or Behcet syndrome.
• Patients ≥18 years of age, male or female are eligible.
• Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration.
• Patient has only aphthous ulcer and It should had not been passed more than 4 days from beginning of their ulcer.

Exclusion Criteria

• • Patients with poor oral hygiene or not willing to perform oral hygiene measures.

  • Smoking and alcohol use.
  • Pregnant and lactating females
  • Patients with history of any topical or systemic medication or steroid therapy 1 month prior to the investigation.
  • The vulnerable group; prisoners, mentally or physically disabled patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythropoietin/oral gel	Epoetin 4000	topical erythropoietin oral gel 4 times daily for 1 week
placebo	Placebo	isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily
Erythropoietin/mouthwash	Epoetin 4000	Erythropoietin mouthwash 4 times daily for 1 week

Primary Outcome Measures

Name	Time	Method
Pain visual analogue scale (P-VAS)	Reduction from baseline and after 1 week of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Size of the ulcer	change from baseline and after 1 week of treatment	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.

Trial Locations

Locations (1)

Future university in Egypt; 🇪🇬 New Cairo, Cairo, Egypt