Clinical trial NCT06622213: Mucoadhesive Film With/without Acmella Oleracea &amp; Triamcinolone Acetonide for Aphthous Ulcers
Official title: Comparison of the Efficacy of Mucoadhesive Film with and Without Acmella Oleracea Extract and 0.1% Triamcinolone Acetonide for Treatment of Aphthous Ulcers: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Aphthous Stomatitis
Keywords: Oral ulcer
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2024-10-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1: mucoadhesive film with Acmella oleracea extract, group 2: 0.1% triamcinolone acetonide, and group 3: mucoadhesive film without Acmella oleracea extract.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of mucoadhesive film with or without Acmella oleracea extract compared to standard treatment by using 0.1% triamcinolone acetonide in pain relief, promoting wound healing, healing time and satisfaction in 3 aspects included taste, product used and quality of life after using the product.

Detailed description: Participants who consent and meet the inclusion criteria will be allocated into 3 groups using block randomization: group 1: mucoadhesive film with Acmella oleracea extract, group 2: 0.1% triamcinolone acetonide, and group 3: mucoadhesive film without Acmella oleracea extract.

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.

Primary outcomes:
measure: Reduction of ulcer size after using product
timeFrame: Base line, day4, day7, day10 and day 14
measure: Pain score
timeFrame: Base line, day4, day7, day10 and day 14
Secondary outcomes:
measure: Satisfaction score
timeFrame: Day 14
measure: Quality of life score
timeFrame: base line and day 14
Other outcomes:
Locations:
Study officials:
affiliation: KhonKaen university
name: Kemporn Kitsahawong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ofluoglu D, Ergun S, Warnakulasuriya S, Namdar-Pekiner F, Tanyeri H. An evaluation of the efficacy of a topical gel with Triester Glycerol Oxide (TGO) in the treatment of minor recurrent aphthous stomatitis in a Turkish cohort: A randomized, double-blind, placebo-controlled clinical trial. Med Oral Patol Oral Cir Bucal. 2017 Mar 1;22(2):e159-e166. doi: 10.4317/medoral.21469.
citation: Chatalongkorn, S. (2017). Psychometric Properties of Thai Version of The Oral Health Impact Profile (OHIP-14 Thai). J Prapokklao Hosp Clin Med Educat Center, 34(3), 158-170.