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

NCT06622213 | Not Yet Recruiting Phase 2

• 2 other identifiers: KKUHE671243D43DE032294
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aphthous Stomatitis

Keywords

Oral ulcer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Satisfaction score

  Day 14

• Quality of life score

  base line and day 14

Study Arms (3)

mucoadhesive film with Acmella oleracea extract

EXPERIMENTAL

Participants received mucoadhesive film with Acmella oleracea extract.

Other: mucoadhesive film with Acmella oleracea extract

Triamcinolone acetonide

ACTIVE COMPARATOR

Participants received 0.1% Triamcinolone acetonide.

Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste

mucoadhesive film without Acmella oleracea extract

PLACEBO COMPARATOR

Participants received mucoadhesive film without Acmella oleracea extract.

Other: mucoadhesive film without Acmella oleracea extract

Interventions

mucoadhesive film with Acmella oleracea extract OTHER

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

mucoadhesive film with Acmella oleracea extract

Triamcinolone Acetonide 0.1% Oromucosal Paste DRUG

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

Also known as: Trinolone oral paste

Triamcinolone acetonide

mucoadhesive film without Acmella oleracea extract OTHER

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

mucoadhesive film without Acmella oleracea extract

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Related Publications (2)

• 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 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Stomatitis, Aphthous; Oral Ulcer

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Kemporn Kitsahawong, Ph.D

  KhonKaen university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kemporn Kitsahawong, Ph.D

CONTACT

(+66)91-4442699; kkempo@kku.ac.th

Porntip Phajongviriyatorn, MsC.

CONTACT

(+66)86-7165260; ppornt@kku.ac.th

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will not know which treatment each participant will receive (single blinding). Participants will know the type of treatment they received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: group 1: mucoadhesive film with Acmella oleracea extract, group 2: 0.1% triamcinolone acetonide, and group 3: mucoadhesive film without Acmella oleracea extract.

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: October 15, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share