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RecruitingPhase 2Phase 3NCT06910579

Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

Efficacy of Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers: A Randomized Controlled Clinical Trial

Sponsor

British University In Egypt

Enrollment

30 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

Aphthus Ulcer

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

Inclusion Criteria3

  • 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 Criteria4

  • 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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Interventions

DRUGtopical 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

DRUGtopical 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.

Locations(1)

British University in Egypt

Al Sherouk City, Cairo Governorate, Egypt

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NCT06910579