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

NCT ID: NCT07322666

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Stomatitis Aphthous Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment with Non-Thermal Plasma (NTP)

Group Type EXPERIMENTAL

Non-Thermal Plasma (NTP)

Intervention Type DEVICE

Topical application of cold (non-thermal) plasma to the oral ulcer using a plasma generator, with specific time and power parameters.

Treatment with Low-Level Laser Therapy (LLLT)

Group Type ACTIVE_COMPARATOR

Low-Level Laser Therapy (LLLT)

Intervention Type DEVICE

Topical application of low-power laser radiation (low-level laser therapy) to the oral ulcer, following a standardized time and wavelength protocol.

Treatment with Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age
* Patients of both sexes
* Patients with recurrent oral ulcers (ROU)
* Patients without oral soft tissue diseases
* Patients with at least one recurrent ulcer

Exclusion Criteria

* Patients under 18 years of age
* Patients with ROU of more than 48 hours' duration
* Patients with gingivitis and/or periodontitis
* Patients undergoing maxillofacial orthopedic and/or orthodontic treatment
* Patients with ill-fitting dentures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Autonomous University of the State of Mexico

UNKNOWN

Sponsor Role collaborator

National Institute of Nuclear Research - Mexico

OTHER

Sponsor Role lead

Responsible Party

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Benjamín Gonzalo Rodríguez Méndez

Professional B, Level 19

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Plasma Physics Laboratory, National Institute of Nuclear Research

Ocoyoacac, State of Mexico, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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CEICIEAO-2018-001

Identifier Type: -

Identifier Source: org_study_id

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