A Phase 2 interventional study of mucoadhesive film with Acmella oleracea extract and Triamcinolone Acetonide 0.1% Oromucosal Paste in Aphthous Stomatitis, sponsored by Khon Kaen University. Not yet recruiting. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Khon Kaen University · Phase 2, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's planned enrollment of 72 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Khon Kaen University is the lead sponsor of 161 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants have one untreated oral ulcer lesion.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received mucoadhesive film with Acmella oleracea extract.
Other: mucoadhesive film with Acmella oleracea extract
Participants received 0.1% Triamcinolone acetonide.
Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste
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)
Apply ¼ inch on ulcer 3 times per day (after meals)
Also known as: Trinolone oral paste
Apply 1 patch on ulcer 3 times per day (after meals)
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.
Time frame: 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.
Time frame: Base line, day4, day7, day10 and day 14
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.
Time frame: 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.
Time frame: base line and day 14
No study locations are listed for this record.
Plan to share: No
Start is estimated for Oct 2024; primary completion for May 2025, 7 months later.
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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