Treatment for recurrent mouth sores using a hydrogel film
Clinical Efficacy of α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS) Treatment
This study is testing a new hydrogel film made from mangosteen to see if it can help people with recurring mouth sores feel better and heal faster.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Universitas Padjadjaran Academic / other |
| Locations | 1 site (Bandung, Jawa Barat) |
| Trial ID | NCT06039774 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a hydrogel film containing α-Mangostin, derived from mangosteen rind, for treating recurrent aphthous stomatitis (RAS). The study aims to address the challenges of delivering topical medications effectively to the oral mucosa, which often face issues like saliva washout. By using a chitosan alginate base, the hydrogel film is designed to provide a protective barrier over the ulcers, prolonging drug effectiveness and alleviating pain. Participants will be compared against a placebo group to assess the treatment's impact.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-59 who do not have any existing mouth diseases and are not currently undergoing treatment for RAS.
Not a fit: Patients with existing mouth diseases, serious health conditions, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from recurrent mouth sores by providing effective pain relief and promoting healing.
How similar studies have performed: While topical treatments for RAS are common, the specific use of α-Mangostin in a hydrogel film is a novel approach that has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-59years * Healthy subjects without mouth diseases * Not using drugs for RAS therapy * Not involved with other clinical trials * Willing to participate Exclusion Criteria: * Have a mouth disease * Have other serious illnesses, including arrhythmia, uncontrolled hypertension, diabetes, hepatitis, and kidney failure * pregnant or lactating women, and women who wish to become pregnant during the study period * poor oral hygiene that requires treatment * chronic diseases requiring treatment with antibiotics, hormones, nonsteroidal anti-inflammatory drugs, immunosuppressants, immune enhancers, cytotoxic drugs, or cell cycle agents that affect the oral mucosa * mental illness or limited mental capacities
Where this trial is running
Bandung, Jawa Barat
- Padjadjaran University Dental and Oral Hospital — Bandung, Jawa Barat, Indonesia (Recruiting)
Study contacts
- Principal investigator: Indah Suasani Wahyuni, drg. — Faculty of Dentistry Universitas Padjadjaran Bandung
- Study coordinator: Cszahreyloren Vitamia, M.Si
- Email: cszahreyloren20001@mail.unpad.ac.id
- Phone: +6282120176639
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.