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Recruiting Phase 2/3

Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

NCT06910579 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 2/3
Started
2025-03-15
Last updated
2026-10-15

Condition(s) studied

Aphthus Ulcer

Investigational drug(s) / intervention(s)

topical application of oxygenated geltopical application of Triamcinolone acetonide gel

topical application of oxygenated gel: patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days

topical application of Triamcinolone acetonide gel: patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group.

Study summary

Interventions of both groups:

Oxygenated gel Group: 15 patients who used oxygenated gel (Blue®m, Wijhe, Netherlands) were trained by the co-investigator (A.H) through real demonstration for topical application of the gel on aphthous ulcers, which entails the application of 1-2 ml of oxygenated gel directly to the ulcer two times per day and this was repeated for 7 days.

Triamcinolone acetonide Group: 15 patients were treated with Kenalog in orabase (Triamcinolone acetonide 0.1% oral paste 5g), four times (i.e., at 8 am, 12 noon, 4 pm, and 8 pm) a day for 7 days at intervention group.

Patients in both groups were reexamined after treatment at different intervals (day 3, day 5, day 7, and day 10).

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Clinically diagnosed patients with chronic aphthous stomatitis measuring ≤6 mm in size in the oral cavity and who gave written consent for participation. * Only single ulcers were considered for the study. * Systemically healthy patients. Exclusion Criteria: * The study excluded patients with a history of associated systemic disease. * Cases of chronic aphthous stomatitis (major), lesions of herpetic form, numerous aphthae, and smoking. * Patients with a history of hypersensitivity to the used agents. * Pregnancy and lactation

Primary outcome measure(s)

  • Pain intensity — 10 days
    Visual Analog Scale (0-10), which measured a range of "no pain" to "unbearable pain" on a 100 mm horizontal line \[10\]. to determine the intensity of pain on day 0, day 3, day 5, day 7, and day 10

Trial sites (1)

FacilityCityRegionStatus
British University in Egypt Al Sherouk City Cairo Governorate Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06910579 on ClinicalTrials.gov ↗ ← All trials in Egypt