drugset / Trial / NCT06910579
Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blue®m | Unknown | 1 ml | Topical |
| Subject | Blue®m | Unknown | 2 ml | Topical |
| Comparator | Triamcinolone Acetonide | Other / unclassified | 0.1 % | Topical |