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Not yet recruiting NCT06622213

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

Phase II Interventional Aphthous Stomatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mucoadhesive film with Acmella oleracea extract, Triamcinolone Acetonide 0.1% Oromucosal Paste, mucoadhesive film without Acmella oleracea extract.
Who it may be relevant to
Registry conditions: Aphthous Stomatitis. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other mucoadhesive film with Acmella oleracea extract
    Apply 1 patch on ulcer 3 times per day (after meals)
  • Drug Triamcinolone Acetonide 0.1% Oromucosal Paste
    Apply ¼ inch on ulcer 3 times per day (after meals)
  • Other mucoadhesive film without Acmella oleracea extract
    Apply 1 patch on ulcer 3 times per day (after meals)

Primary outcome measures

  • Reduction of ulcer size after using product [Time frame: Base line, day4, day7, day10 and day 14]
  • Pain score [Time frame: Base line, day4, day7, day10 and day 14]
Secondary outcome measures (2)
  • Satisfaction score [Time frame: Day 14]
  • Quality of life score [Time frame: base line and day 14]

Eligibility criteria

Inclusion criteria

  • Healthy participants aged 18-50 years without any underlying diseases.
  • Participants are voluntary and have signed the informed consent.
  • Participants are literate.
  • Participants can follow the treatment guidelines and follow up.
  • 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.
  • If an ulcer is caused by a denture or orthodontic appliance, the cause must be eliminated before participation.
  • Participants must not be currently participating in any other clinical studies about oral ulcer

Exclusion criteria

  • Participants with allergies to herbal extracts, Acmella oleracea, or steroids.
  • Participants with chronic underlying diseases.
  • Participants with underlying diseases that may affect wound healing.
  • Participants receiving anti-analgesic drug, systemic steroids, antibiotics, hormones, NSAIDS, or any drugs that affect the oral mucosa.
  • Oral ulcer lesion larger than 10 mm or lesions resembling herpetic form of aphthous ulcers.
  • Oral ulcers are caused by infection or associated with systemic diseases.
  • Participants with poor oral hygiene requiring emergency treatment.
  • Participants who smoke or consume alcohol regularly.
  • Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 28160585
  • 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.

Identifiers

NCT: NCT06622213 · KKUHE671243 · D43DE032294

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗