Aphthous StomatitisPhase 2NCT06622213
Mucoadhesive Film With/without Acmella Oleracea & Triamcinolone Acetonide for Aphthous Ulcers
A Phase 2 study testing mucoadhesive film with Acmella oleracea extract, Triamcinolone Acetonide 0.1% Oromucosal Paste and mucoadhesive film without Acmella oleracea extract in people with Aphthous Stomatitis, run by Khon Kaen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphthous Stomatitis
- What is being tested?
- mucoadhesive film with Acmella oleracea extract, Triamcinolone Acetonide 0.1% Oromucosal Paste and mucoadhesive film without Acmella oleracea extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Aphthous Stomatitis
- Being tested
- mucoadhesive film with Acmella oleracea extract, Triamcinolone Acetonide 0.1% Oromucosal Paste, mucoadhesive film without Acmella oleracea extract
- Keywords
- Oral ulcer
- Medical subject headings
- Stomatitis, Aphthous, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mucoadhesive film with Acmella oleracea extractOther
Apply 1 patch on ulcer 3 times per day (after meals)
Triamcinolone Acetonide 0.1% Oromucosal PasteDrug
Also called Trinolone oral paste
Apply ¼ inch on ulcer 3 times per day (after meals)
mucoadhesive film without Acmella oleracea extractOther
Apply 1 patch on ulcer 3 times per day (after meals)
| Study group | Role | What they receive |
|---|---|---|
| mucoadhesive film with Acmella oleracea extract | Experimental | Participants received mucoadhesive film with Acmella oleracea extract. Receives: Other: mucoadhesive film with Acmella oleracea extract |
| Triamcinolone acetonide | Active comparator | Participants received 0.1% Triamcinolone acetonide. Receives: Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste |
| mucoadhesive film without Acmella oleracea extract | Placebo comparator | Participants received mucoadhesive film without Acmella oleracea extract. Receives: Other: mucoadhesive film without Acmella oleracea extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Base line, day4, day7, day10 and day 14
Secondary outcomes (2)
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.
Measured: 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.
Measured: base line and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aphthous StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1: mucoadhesive film with Acmella oleracea extract, group 2: 0.1% triamcinolone acetonide, and group 3: mucoadhesive film without Acmella oleracea extract.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Kemporn Kitsahawong, Khon Kaen University
- Investigators
- Kemporn Kitsahawong, Ph.D, Principal investigator, KhonKaen university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622213
- Sponsor's protocol ID
- KKUHE671243
- Other IDs
- D43DE032294
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28160585Chatalongkorn, 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 at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06622213
- Acronym / sponsor ID
- KKUHE671243
- Conditions
- Aphthous Stomatitis
- Keywords
- Oral ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- group 1: mucoadhesive film with Acmella oleracea extract, group 2: 0.1% triamcinolone acetonide, and group 3: mucoadhesive film without Acmella oleracea extract.
| Arm | Type | Receives |
|---|---|---|
| mucoadhesive film with Acmella oleracea extract | Experimental | Other: mucoadhesive film with Acmella oleracea extractParticipants received mucoadhesive film with Acmella oleracea extract. |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone Acetonide 0.1% Oromucosal PasteParticipants received 0.1% Triamcinolone acetonide. |
| mucoadhesive film without Acmella oleracea extract | Placebo comparator | Other: mucoadhesive film without Acmella oleracea extractParticipants received mucoadhesive film without Acmella oleracea extract. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mucoadhesive film with Acmella oleracea extractApply 1 patch on ulcer 3 times per day (after meals) | Other | mucoadhesive film with Acmella oleracea extract |
| Triamcinolone Acetonide 0.1% Oromucosal PasteAlso: Trinolone oral pasteApply ¼ inch on ulcer 3 times per day (after meals) | Drug | Triamcinolone acetonide |
| mucoadhesive film without Acmella oleracea extractApply 1 patch on ulcer 3 times per day (after meals) | Other | mucoadhesive film without Acmella oleracea extract |
Primary outcome
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.
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.
2 secondary outcomes
Satisfaction score
Time frame: Day 14
Quality of life score
Time frame: base line and day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Background: PubMed 28160585Ofluoglu 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.
- BackgroundChatalongkorn, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kemporn Kitsahawong, Ph.D principal investigator
KhonKaen university
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mucoadhesive film with Acmella oleracea extract, Triamcinolone Acetonide 0.1% Oromucosal Paste and mucoadhesive film without Acmella oleracea extract in people with Aphthous Stomatitis, run by Khon Kaen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kemporn Kitsahawong, Ph.D ((+66)91-4442699, kkempo@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of ulcer size after using product (time frame: Base line, day4, day7, day10 and day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06622213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.