Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

British University In Egypt

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Aphthus Ulcer

Treatments: Drug: topical application of Triamcinolone acetonide gel; Drug: topical application of oxygenated gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06910579

britishUE1

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

control

Active Comparator group

Description:

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.

Treatment:

Drug: topical application of Triamcinolone acetonide gel

Oxygenated gel Group

Experimental group

Description:

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

Treatment:

Drug: topical application of oxygenated gel