drugset / Trial / NCT06910579

Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

NCT06910579

Phase 2/3 Recruiting 30 enrolled British University In Egypt
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2025-03-15
Primary completion
2026-01-30
Completion
2026-04-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Blue®m Unknown 1 ml Topical
Subject Blue®m Unknown 2 ml Topical
Comparator Triamcinolone Acetonide Other / unclassified 0.1 % Topical

Indications