Clinical Trial

Non-Thermal Plasma vs. Low-Level Laser Therapy for Recurrent Oral Ulcers

Completed
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Summary
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.
Trial Details
NCT Number NCT07322666
Lead Sponsor National Institute of Nuclear Research - Mexico
Collaborators: Autonomous University of the State of Mexico
Conditions Stomatitis, Aphthous Ulcer
Enrollment 50 participants
Start Date 2019-02-04
Primary Completion 2023-11-30 (estimated)
Study Completion 2024-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-01-07