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Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jan 30, 2026 → Jan 30, 2027
See other at-risk trials from British University In Egypt

Record History

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  1. Notable Primary completion pushed from Jan 30, 2026 to Jan 30, 2027
    • Study completion pushed from Apr 12, 2026 to Jul 12, 2027
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Notable Primary completion date: Jun 30, 2025 to Jan 30, 2026
    • Study completion date: Aug 12, 2025 to Apr 12, 2026
    v3
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06910579
Lead Sponsor British University In Egypt
Conditions
(from sponsor)
Aphthus Ulcer
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov