Oral gel treatment for canker sores

Devintec OR-AT0222 Oral Gel for the Treatment of Canker Sores: A Double Blind, Randomized, Placebo Controlled Clinical Investigation

This study is testing a new oral gel to see if it can help people with recurring canker sores feel less pain and heal faster.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Devintec Sagl (industry)
• Locations: 1 site (Rome)
• Trial ID: NCT05959824 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the efficacy of Devintec OR-AT0222, an oral gel, in treating recurrent canker sores, also known as aphthous ulcers. A total of 46 participants will be randomly assigned to receive either the active gel or a placebo for seven days, applying the treatment three times daily. Participants will assess their pain levels using a visual analogue scale and will be monitored for safety and tolerability throughout the study. The primary outcomes include pain reduction and complete healing of the ulcers as confirmed by clinical examination.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a recent onset of one or more canker sores.

Not a fit: Patients with hypersensitivity to the gel's ingredients or those who have used other ulcer treatments recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief from the pain and discomfort associated with canker sores.

How similar studies have performed: While there are various treatments for canker sores, the specific approach of using OR-AT0222 gel is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. \>18 years (male and females)
2. Patients have one oral canker sore, at least. Onset within 48 hours
3. Patients in good condition with no serious systemic disease

Exclusion Criteria:

1. Hypersensitivity to any OR-AT0222 ingredients
2. Use of any medication to treat the ulcers the previous week before ORAT0222 gel use started or use of local medication or systemic drug during the treatment with OR-AT0222 gel.
3. Underlying systemic disease(s) or a history of immunologic disorder(s);
4. Taking immunomodulatory agents or systemic nonsteroidal antiinflammatory drugs \< 1 month before study commencement;
5. Smokers;
6. Could not provide written informed consent

Where this trial is running

Rome

• Policlinico "Umberto I" - U.O.C. di Odontoiatria Pediatrica ed Odontostomatologia — Rome, Italy (RECRUITING)

Study contacts

• Study coordinator: Umberto Romeo

Conditions: Recurrent Aphthous Ulcer, aphthous ulcer, canker sores, aphthous stomatitis, Topical oral gel