NCT07322666

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

Tissue Repair of Incisions for Biopsy and Mouth Ulcers Using Non-Thermal Plasma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Institute of Nuclear Research - Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stomatitis
• Aphthous Ulcer

Interventions

Type	Name	Description
DEVICE	Non-Thermal Plasma (NTP)	Topical application of cold (non-thermal) plasma to the oral ulcer using a plasma generator, with specific time and power parameters.
DEVICE	Low-Level Laser Therapy (LLLT)	Topical application of low-power laser radiation (low-level laser therapy) to the oral ulcer, following a standardized time and wavelength protocol.
PROCEDURE	Placebo	Simulation of the application procedure (e.g., turning on a device without active plasma or laser emission, or application with the device turned off) to mask group assignment.

Timeline

• Start date: 2019-02-04
• Primary completion: 2023-11-30
• Completion: 2024-02-28
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Mexico