Tissue Repair of Incisions for Biopsy and Mouth Ulcers Using Non-Thermal Plasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility - Patient recruitment rate
研究概览
简要总结
The goal of this clinical trial (pilot study) is to evaluate the feasibility and preliminary effectiveness of Non-Thermal Plasma (NTP) in treating pain and accelerating healing in 50 patients with Recurrent Oral Ulcers (ROUs). The main questions it aims to answer are:
Is the study design feasible for a future large-scale trial?
Does NTP show promising preliminary results in reducing ulcer size and healing time compared to standard laser therapy and placebo?
Does NTP provide superior pain relief compared to standard laser therapy and placebo?
Researchers will compare the NTP group (n=20) to the Low-Level Laser Therapy (LLLT) group (n=20) and the placebo group (n=10) to see if NTP is more effective in accelerating healing and reducing pain.
Participants will:
Be randomly assigned to one of three treatment groups (NTP, LLLT, or placebo).
Receive their assigned treatment for their oral ulcers.
Undergo measurements of their ulcer size, report their pain perception using a visual analog scale (VAS), and have their time to complete healing recorded.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Patients of both sexes
- •Patients with recurrent oral ulcers (ROU)
- •Patients without oral soft tissue diseases
- •Patients with at least one recurrent ulcer
排除标准
- •Patients under 18 years of age
- •Patients with ROU of more than 48 hours' duration
- •Patients with gingivitis and/or periodontitis
- •Patients undergoing maxillofacial orthopedic and/or orthodontic treatment
- •Patients with ill-fitting dentures
结局指标
主要结局
Feasibility - Patient recruitment rate
时间窗: From the start of enrollment to the end of the recruitment period, an average of 1 month.
Proportion of the target sample size successfully recruited within the recruitment period. Unit of Measure: Percentage (%)
Feasibility - Patient adherence to the intervention protocol
时间窗: From the first intervention to the last planned session for each participant.
Proportion of prescribed treatment sessions completed by enrolled participants. Unit of Measure: Percentage (%)
Preliminary efficacy - Time to complete ulcer re-epithelialization
时间窗: From baseline (day of intervention) until complete healing, assessed daily up to 30 days.
Number of days required for the ulcer to achieve complete re-epithelialization (visual absence of ulcer crater) confirmed by clinical examination. Unit of Measure: Days
Preliminary efficacy - Change in pain intensity measured by a Visual Analogue Scale (VAS)
时间窗: From baseline (pre-intervention) to 48 hours post-intervention
The Visual Analogue Scale (VAS) is a 0 to 10 scale, where "0" represents "no pain" and "10" represents "the worst pain". A higher score indicates worse pain. The change score (post-intervention minus baseline) will be calculated. Unit of Measure: 0-10 VAS
次要结局
- Change in ulcer surface area(From baseline (day of intervention) to days 1, 2, 3, 5, and 7 post-intervention)
- Safety - Incidence and severity of treatment-related adverse events(From the first intervention until the end of the follow-up period (up to 7 days post-intervention))
- Cumulative use of rescue analgesic medication(From baseline to complete healing or up to 30 days, whichever comes first)
研究者
Benjamín Gonzalo Rodríguez Méndez
Professional B, Level 19
National Institute of Nuclear Research - Mexico