Aphthus Ulcer
Conditions
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).
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.
Sponsors
British University In Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed