Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-31 @ 1:17 AM
Study NCT ID:
NCT06923605
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2025-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis
Sponsor:
Future University in Egypt
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: