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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aphthous Stomatitis
• Intervention / Treatment: Other: mucoadhesive film with Acmella oleracea extract; Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste; Other: mucoadhesive film without Acmella oleracea extract

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kemporn Kitsahawong, Ph.D; Phone Number: (+66)91-4442699; Email: kkempo@kku.ac.th
• Study Contact Backup: Name: Porntip Phajongviriyatorn, MsC.; Phone Number: (+66)86-7165260; Email: ppornt@kku.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mucoadhesive film with Acmella oleracea extract; Participants received mucoadhesive film with Acmella oleracea extract.	Other: mucoadhesive film with Acmella oleracea extract; Apply 1 patch on ulcer 3 times per day (after meals)
Active Comparator: Triamcinolone acetonide; Participants received 0.1% Triamcinolone acetonide.	Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste; Apply ¼ inch on ulcer 3 times per day (after meals); Other Names: Trinolone oral paste
Placebo Comparator: mucoadhesive film without Acmella oleracea extract; Participants received mucoadhesive film without Acmella oleracea extract.	Other: mucoadhesive film without Acmella oleracea extract; Apply 1 patch on ulcer 3 times per day (after meals)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of ulcer size after using product	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.	Base line, day4, day7, day10 and day 14
Pain score	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.	Base line, day4, day7, day10 and day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction score	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.	Day 14
Quality of life score	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.	base line and day 14

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Kemporn Kitsahawong, Ph.D, KhonKaen university

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Oral ulcer
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Stomatitis; Stomatitis, Aphthous; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: KKUHE671243; D43DE032294 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No