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

NCT07322666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Autonomous University of the State of Mexico

    collaborator UNKNOWN

  • National Institute of Nuclear Research - Mexico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2023-11-30
Completion
2024-02-28

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07322666 on ClinicalTrials.gov