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NCT Number: NCT06622213

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mucoadhesive film with Acmella oleracea extract

Other

Apply 1 patch on ulcer 3 times per day (after meals)

Triamcinolone Acetonide 0.1% Oromucosal Paste

Drug

Apply ¼ inch on ulcer 3 times per day (after meals)

Other names: Trinolone oral paste

mucoadhesive film without Acmella oleracea extract

Other

Apply 1 patch on ulcer 3 times per day (after meals)

Primary outcomes

  1. Reduction of ulcer size after using product

    Time frame: Base line, day4, day7, day10 and day 14

    Reduction of ulcer size will be evaluated by measuring the diameter of ulcers size using a periodontal probe and photograph on the first day and each follow up visit.

  2. Pain score

    Time frame: Base line, day4, day7, day10 and day 14

    The pain score will be assessed by using a visual analogue scale (VAS) which is a 10-cm line on that was labeled from "no pain"(0) to "worst pain" (10).The pain level will be recorded on the first day. The participants will then reassess their pain score again after receiving the intervention, which will be evaluated at each follow up visit.

Secondary outcomes

  1. Satisfaction score

    Time frame: Day 14

    Participants' satisfaction after using product will be assessed using a visual analogue scale (VAS) which is a 10-cm line on that was labeled from "unsatisfied" (0) to "most satisfied" (10). Satisfaction will be evaluated on the last day of follow-up.

  2. Quality of life score

    Time frame: base line and day 14

    Oral health impact on quality of life will be evaluated using the Thai version of the Oral Health Impact Profile-14 (OHIP-14). The survey classified into 7 dimensions with 2 items per dimension included functional limitation, painful, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Participants must choose the answer based on the frequency of problem occurrence. The frequency level is divided into 5 level: never= 0 point, rarely = 1 point, sometimes = 2 points, often = 3 points, always = 4 points. Total scores in each person range are between 0 to 56 points.The quality of life will be survey on the first and the last day of follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Kemporn Kitsahawong, Ph.D

CONTACT

[email protected]

(+66)91-4442699

Porntip Phajongviriyatorn, MsC.

CONTACT

[email protected]

(+66)86-7165260

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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