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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
British University in Egypt
RECRUITING
Al Sherouk City
Time Frame
Start Date: 2025-03-15
Estimated Completion Date: 2026-04-12
Participants
Target number of participants: 30
Treatments
Active_comparator: control
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.
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: British University In Egypt

This content was sourced from clinicaltrials.gov