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Recruiting Phase 2, Phase 3 NCT06910579

Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

Trial Parameters

Condition Aphthus Ulcer
Sponsor British University In Egypt
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 30
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2025-03-15
Completion 2026-01-30
Interventions
topical application of oxygenated geltopical application of Triamcinolone acetonide gel

Brief 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 Criteria

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

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