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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • topical application of oxygenated gel

    Drug

    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

  • topical application of Triamcinolone acetonide gel

    Drug

    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 groups

30 Participants
are divided into 2 treatment groups
Group A: controlActive comparator 1 intervention
Group B: Oxygenated gel GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

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

Time frame
10 days

Secondary outcomes

1

Size of ulcers (in mm)

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

Time frame
10 days
2

Complete healing duration

the duration till complete healing is achieved is recorded in days

Time frame
10 days
3

OHIP-14

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

Time frame
10 days

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

British University in EgyptRecruiting11837, Al Sherouk City, Cairo GovernorateEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British University In Egypt

Lead sponsor

Source ClinicalTrials.gov
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