CompletedPhase 2

Efficacy of 5% Chitosan Nanoparticle Paste in the Treatment of Recurrent Aphthous Stomatitis

30 participantsStarted 2009-04-21

Plain-language summary

The purpose of this study is to evaluate the therapeutic clinical efficacy of a synthesized 5 wt.% chitosan nanoparticle paste compared to a standard topical corticosteroid (triamcinolone acetonide 0.1% oral paste) in patients suffering from minor recurrent aphthous stomatitis. The study specifically monitors changes in clinical ulcer diameter and pain reduction.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients complaining of oral recurrent ulcers with signs of minor recurrent aphthous stomatitis. * History of oral recurrent ulcers with a recurrence rate of 2 to 3 times per year. * Ulcer diameter less than 1 cm at baseline. * Maximum of 4 days passed since the emergence of the current ulcer. * No use of any prior medications or treatment for the current ulcer. * Signed written informed consent. Exclusion Criteria: * Background of systemic diseases, including diabetes mellitus. * Connective tissue diseases such as Lupus. * Syndromes or diseases related to aphthous ulcers, such as cyclic neutropenia and Behcet's disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in clinical ulcer diameter

Timeframe: Days 0, 1, 6, and 10

Trial details

NCT IDNCT07702474

SponsorKerman University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11-03

View on ClinicalTrials.gov More Recurrent Aphthous Stomatitis trials