Mucoadhesive Film With/without Acmella Oleracea & Triamcinolone Acetonide for Aphthous Ulcers

Launched by KHON KAEN UNIVERSITY · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for painful mouth sores known as aphthous ulcers. Researchers want to see if a special film that sticks to the mouth lining, with or without an ingredient from a plant called Acmella oleracea, works better than the standard treatment, which is a steroid medication. The trial will look at how well these treatments relieve pain, help the sores heal, and improve overall quality of life for participants.

To join the study, you must be between 18 and 50 years old and healthy, meaning you don't have any serious health issues. You should have one painful mouth sore that is less than 10 mm in size and has appeared within the last 48 hours. Participants will be asked to follow some treatment guidelines and attend follow-up appointments. It's important to note that if you have allergies to certain herbal extracts or steroids, or if you smoke or drink alcohol regularly, you won't be able to participate. The study is not yet recruiting participants, but it aims to provide new insights into better treatments for mouth sores.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy participants aged 18-50 years without any underlying diseases.
• • 2. Participants are voluntary and have signed the informed consent.
• • 3. Participants are literate.
• • 4. Participants can follow the treatment guidelines and follow up.
• • 5. Participants have one untreated oral ulcer lesion.
• • An ulcer has occurred within 48 hours.
• • The ulcer size is less than 10 mm.
• • The ulcer is clearly visible and located on non-keratinized oral mucosa such as buccal mucosa, labial mucosa, alveolar mucosa, or buccal vestibule.
• • The ulcer must be painful.
• • 6. If an ulcer is caused by a denture or orthodontic appliance, the cause must be eliminated before participation.
• • 7. Participants must not be currently participating in any other clinical studies about oral ulcer
• Exclusion Criteria:
• • 1. Participants with allergies to herbal extracts, Acmella oleracea, or steroids.
• • 2. Participants with chronic underlying diseases.
• • 3. Participants with underlying diseases that may affect wound healing.
• • 4. Participants receiving anti-analgesic drug, systemic steroids, antibiotics, hormones, NSAIDS, or any drugs that affect the oral mucosa.
• • 5. Oral ulcer lesion larger than 10 mm or lesions resembling herpetic form of aphthous ulcers.
• • 6. Oral ulcers are caused by infection or associated with systemic diseases.
• • 7. Participants with poor oral hygiene requiring emergency treatment.
• • 8. Participants who smoke or consume alcohol regularly.
• • 9. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.