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

Future University in Egypt

Status and phase: Completed; Phase 4

Conditions: Recurrent Aphthous Stomatitis

Treatments: Drug: Epoetin 4000; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06923605

FDAsu-Rec ID032209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Erythropoietin/oral gel

Experimental group

Description:

topical erythropoietin oral gel 4 times daily for 1 week

Treatment:

Drug: Epoetin 4000

placebo

Experimental group

Description:

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

Treatment:

Other: Placebo

Erythropoietin/mouthwash

Experimental group

Description:

Erythropoietin mouthwash 4 times daily for 1 week

Treatment:

Drug: Epoetin 4000