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

NCT ID: NCT06923605

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-02-27

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

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.

Conditions

Recurrent Aphthous Stomatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Erythropoietin/oral gel

topical erythropoietin oral gel 4 times daily for 1 week

Group Type: EXPERIMENTAL

Epoetin 4000

Intervention Type: DRUG

Erythropoietin hormone

placebo

isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily

Erythropoietin/mouthwash

Erythropoietin mouthwash 4 times daily for 1 week

Group Type: EXPERIMENTAL

Epoetin 4000

Intervention Type: DRUG

Erythropoietin hormone

Interventions

Epoetin 4000

Erythropoietin hormone

Intervention Type: DRUG

Placebo

isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) 4 times daily

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Future University in Egypt

OTHER

Sponsor Role: lead

Responsible Party

Mai Talaat Mohamed

lecturrer assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mai T. assistant lecturer Mai T. Elgendi, Assistant lecturer

Role: STUDY_DIRECTOR

Faculty of oral medicine- Future University in Egypt

Locations

Future university in Egypt

New Cairo, Cairo Governorate, Egypt

Countries

Egypt

Related Links

https://pubmed.ncbi.nlm.nih.gov

Related Info

Other Identifiers

FDAsu-Rec ID032209

Identifier Type: -

Identifier Source: org_study_id