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

NCT07322666 | Completed

• 1 other identifier: CEICIEAO-2018-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral Ulcers; Non-Thermal Plasma; Low-Level Laser Therapy; Placebo; Healing; Pain

Outcome Measures

Primary Outcomes (4)

• Feasibility - Patient recruitment rate

  Proportion of the target sample size successfully recruited within the recruitment period. Unit of Measure: Percentage (%)

  From the start of enrollment to the end of the recruitment period, an average of 1 month.

• Feasibility - Patient adherence to the intervention protocol

  Proportion of prescribed treatment sessions completed by enrolled participants. Unit of Measure: Percentage (%)

  From the first intervention to the last planned session for each participant.

• Preliminary efficacy - Time to complete ulcer re-epithelialization

  Number of days required for the ulcer to achieve complete re-epithelialization (visual absence of ulcer crater) confirmed by clinical examination. Unit of Measure: Days

  From baseline (day of intervention) until complete healing, assessed daily up to 30 days.

• Preliminary efficacy - Change in pain intensity measured by a Visual Analogue Scale (VAS)

  The Visual Analogue Scale (VAS) is a 0 to 10 scale, where "0" represents "no pain" and "10" represents "the worst pain". A higher score indicates worse pain. The change score (post-intervention minus baseline) will be calculated. Unit of Measure: 0-10 VAS

  From baseline (pre-intervention) to 48 hours post-intervention

Secondary Outcomes (3)

• Change in ulcer surface area

  From baseline (day of intervention) to days 1, 2, 3, 5, and 7 post-intervention

• Safety - Incidence and severity of treatment-related adverse events

  From the first intervention until the end of the follow-up period (up to 7 days post-intervention)

• Cumulative use of rescue analgesic medication

  From baseline to complete healing or up to 30 days, whichever comes first

Study Arms (3)

Treatment with Non-Thermal Plasma (NTP)

EXPERIMENTAL

Device: Non-Thermal Plasma (NTP)

Treatment with Low-Level Laser Therapy (LLLT)

ACTIVE COMPARATOR

Device: Low-Level Laser Therapy (LLLT)

Treatment with Placebo

PLACEBO COMPARATOR

Procedure: Placebo

Interventions

Non-Thermal Plasma (NTP) DEVICE

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

Treatment with Non-Thermal Plasma (NTP)

Low-Level Laser Therapy (LLLT) 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 Low-Level Laser Therapy (LLLT)

Placebo 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.

Treatment with Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Nuclear Research - Mexico: lead
• Autonomous University of the State of Mexico: collaborator

Study Sites (1)

Plasma Physics Laboratory, National Institute of Nuclear Research

Ocoyoacac, State of Mexico, 52750, Mexico

Location

MeSH Terms

Conditions

Stomatitis; Stomatitis, Aphthous; Oral Ulcer; Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professional B, Level 19

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 7, 2026
• Study Start: February 4, 2019
• Primary Completion: November 30, 2023
• Study Completion: February 28, 2024
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)