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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Feasibility - Patient recruitment rate
Timeframe: From the start of enrollment to the end of the recruitment period, an average of 1 month.
Feasibility - Patient adherence to the intervention protocol
Timeframe: From the first intervention to the last planned session for each participant.
Preliminary efficacy - Time to complete ulcer re-epithelialization
Timeframe: From baseline (day of intervention) until complete healing, assessed daily up to 30 days.
Preliminary efficacy - Change in pain intensity measured by a Visual Analogue Scale (VAS)
Timeframe: From baseline (pre-intervention) to 48 hours post-intervention