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.
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 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.
Parallel
mucoadhesive film with Acmella oleracea extract
Other interventionApply 1 patch on ulcer 3 times per day (after meals)
Triamcinolone Acetonide 0.1% Oromucosal Paste
DrugApply ¼ inch on ulcer 3 times per day (after meals)
mucoadhesive film without Acmella oleracea extract
Other interventionApply 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.
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.
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.
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.
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Khon Kaen University
Lead sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator
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