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

Phase 2

Not yet recruiting

• Conditions: Aphthous Stomatitis
• Interventions: Other: mucoadhesive film with Acmella oleracea extract; Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste; Other: mucoadhesive film without Acmella oleracea extract

• Registration Number: NCT06622213
• Lead Sponsor: Khon Kaen University

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-29
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Study Start: 2024-10-15
• Primary Completion: 2025-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mucoadhesive film with Acmella oleracea extract	mucoadhesive film with Acmella oleracea extract	Participants received mucoadhesive film with Acmella oleracea extract.
Triamcinolone acetonide	Triamcinolone Acetonide 0.1% Oromucosal Paste	Participants received 0.1% Triamcinolone acetonide.
mucoadhesive film without Acmella oleracea extract	mucoadhesive film without Acmella oleracea extract	Participants received mucoadhesive film without Acmella oleracea extract.

Primary Outcome Measures

Name	Time	Method
Reduction of ulcer size after using product	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.
Pain score	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 Outcome Measures

Name	Time	Method
Satisfaction score	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.
Quality of life score	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.