Clinical trial NCT06923605: The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis
Official title: The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis: A Randomized Controlled Clinical Study With Biochemical Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Aphthous Stomatitis
Keywords: Erythropoietin
IL-2
Recurrent aphthous stomatitis
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain visual analogue scale (P-VAS)
timeFrame: Reduction from baseline and after 1 week of treatment
Secondary outcomes:
measure: Size of the ulcer
timeFrame: change from baseline and after 1 week of treatment
Other outcomes:
measure: Biochemical analysis
timeFrame: From baseline and after 1 week of treatment
Locations:
city: New Cairo
country: Egypt
facility: Future university in Egypt
state: Cairo
Study officials:
affiliation: Faculty of oral medicine- Future University in Egypt
name: Mai T. assistant lecturer Mai T. Elgendi, Assistant lecturer
role: STUDY_DIRECTOR
References: