Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

Phase 2

Recruiting

• Conditions: Aphthus Ulcer
• Interventions: Drug: topical application of Triamcinolone acetonide gel; Drug: topical application of oxygenated gel

• Registration Number: NCT06910579
• Lead Sponsor: British University In Egypt

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-15
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	topical application of Triamcinolone acetonide gel	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.
Oxygenated gel Group	topical application of oxygenated gel	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

Primary Outcome Measures

Name	Time	Method
Pain intensity	10 days	Visual Analog Scale (0-10), which measured a range of "no pain" to "unbearable pain" on a 100 mm horizontal line \[10\]. to determine the intensity of pain on day 0, day 3, day 5, day 7, and day 10

Secondary Outcome Measures

Name	Time	Method
Size of ulcers (in mm)	10 days	after starting treatment, ulcer size was recorded on day 0, day 3, day 5, day 7, and day 10 using a calibrated dental probe with millimeter marking
Complete healing duration	10 days	the duration till complete healing is achieved is recorded in days
OHIP-14	10 days	has been assessed 1 week after intervention. OHIP-14 utilizes a scale with five categories (1 = never, 2 = hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often). A lower score in any of the five categories indicates higher satisfaction

Trial Locations

Locations (1)

British University in Egypt; 🇪🇬 Al Sherouk City, Cairo, Egypt