Tissue Repair of Incisions for Biopsy and Mouth Ulcers Using Non-Thermal Plasma
Abstract
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.
Conditions: Stomatitis, Aphthous Ulcer.
Primary outcome: Feasibility - Patient recruitment rate; Feasibility - Patient adherence to the intervention protocol; Preliminary efficacy - Time to complete ulcer re-epithelialization; Preliminary efficacy - Change in pain intensity measured by a Visual Analogue Scale (VAS).
Enrollment: 50 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
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