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NCT Number: NCT06910579

Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers

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).

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Key information

Conditions

Aphthus Ulcer

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

British University in Egypt

Al Sherouk City, Cairo Governorate, 11837, Egypt

Location status: Recruiting

Location contact

Hamdy

CONTACT

ahmed hamdy, phd

CONTACT

[email protected]

+201061112512

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain intensity

    Time frame: 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 outcomes

  1. Size of ulcers (in mm)

    Time frame: 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

  2. Complete healing duration

    Time frame: 10 days

    the duration till complete healing is achieved is recorded in days

  3. OHIP-14

    Time frame: 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

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

Efficacy of Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers: A Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.