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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Reduction of ulcer size after using product
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will not know which treatment each participant will receive (single blinding). Participants will know the type of treatment they received.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
mucoadhesive film with Acmella oleracea extract
Participants received mucoadhesive film with Acmella oleracea extract.
干预措施: mucoadhesive film with Acmella oleracea extract (Other)
Triamcinolone acetonide
Participants received 0.1% Triamcinolone acetonide.
干预措施: Triamcinolone Acetonide 0.1% Oromucosal Paste (Drug)
mucoadhesive film without Acmella oleracea extract
Participants received mucoadhesive film without Acmella oleracea extract.
干预措施: mucoadhesive film without Acmella oleracea extract (Other)
结局指标
主要结局
Reduction of ulcer size after using product
时间窗: 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
时间窗: 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.
次要结局
- Satisfaction score(Day 14)
- Quality of life score(base line and day 14)
研究者
Kemporn Kitsahawong
Principle investigator
Khon Kaen University