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| ID | Type | Description | Link |
|---|---|---|---|
| D43DE032294 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mucoadhesive film with Acmella oleracea extract | Experimental | Participants received mucoadhesive film with Acmella oleracea extract. |
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| Triamcinolone acetonide | Active Comparator | Participants received 0.1% Triamcinolone acetonide. |
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| mucoadhesive film without Acmella oleracea extract | Placebo Comparator | Participants received mucoadhesive film without Acmella oleracea extract. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mucoadhesive film with Acmella oleracea extract | Other | Apply 1 patch on ulcer 3 times per day (after meals) |
|
| 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 |
| 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 |
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Inclusion Criteria:
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.
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kemporn Kitsahawong, Ph.D | Contact | (+66)91-4442699 | kkempo@kku.ac.th | |
| Porntip Phajongviriyatorn, MsC. | Contact | (+66)86-7165260 | ppornt@kku.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| Kemporn Kitsahawong, Ph.D | KhonKaen university | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28160585 | Background | 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. | |
| 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. |
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group 1: mucoadhesive film with Acmella oleracea extract, group 2: 0.1% triamcinolone acetonide, and group 3: mucoadhesive film without Acmella oleracea extract.
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Outcome assessor will not know which treatment each participant will receive (single blinding). Participants will know the type of treatment they received.
| Triamcinolone Acetonide 0.1% Oromucosal Paste | Drug | Apply ΒΌ inch on ulcer 3 times per day (after meals) |
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| mucoadhesive film without Acmella oleracea extract | Other | Apply 1 patch on ulcer 3 times per day (after meals) |
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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 |
| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| D019226 | Oral Ulcer |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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