Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: topical application of oxygenated gel, topical application of Triamcinolone acetonide gel.
- Who it may be relevant to
- Registry conditions: Aphthus Ulcer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers: A Randomized Controlled Clinical Trial
Overview
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).
Interventions
- Drug topical 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 - Drug topical 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.
Primary outcome measures
- Pain intensity [Time frame: 10 days]
Secondary outcome measures (3)
- Size of ulcers (in mm) [Time frame: 10 days]
- Complete healing duration [Time frame: 10 days]
- OHIP-14 [Time frame: 10 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- British University in Egypt — Al Sherouk City
Identifiers
NCT: NCT06910579 · britishUE1