Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers
ConditionAphthus Ulcer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBritish University In Egypt
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Treatments tested in this trial
- topical application of oxygenated gel
- topical application of Triamcinolone acetonide gel
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
British University in EgyptRecruiting11837, Al Sherouk City, Cairo Governorate
Egypt
EgyptSponsors and collaborators
Source ClinicalTrials.gov