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NCT Number: NCT07322666

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

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.

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Key information

Conditions

Stomatitis Aphthous Ulcer Mouth Diseases Neurologic Manifestations Oral Ulcer Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatitis, Aphthous Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plasma Physics Laboratory, National Institute of Nuclear Research

Ocoyoacac, State of Mexico, 52750, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Feasibility - Patient recruitment rate

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

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

  2. Feasibility - Patient adherence to the intervention protocol

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

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

  3. Preliminary efficacy - Time to complete ulcer re-epithelialization

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

    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

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

    Time frame: From baseline (pre-intervention) to 48 hours post-intervention

    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

Secondary outcomes

  1. Change in ulcer surface area

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

    Ulcer size will be measured by calculating the surface area from perpendicular diameters (length and width in millimeters) using a standard periodontal probe or digital caliper. Unit of Measure: Square millimeters (mm²)

  2. Safety - Incidence and severity of treatment-related adverse events

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

    All adverse events and local reactions (e.g., erythema, edema, pain exacerbation) will be recorded and graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or a similar standardized scale. The relationship to the intervention will be assessed. Unit of Measure: Number of participants with adverse events, and severity grade.

  3. Cumulative use of rescue analgesic medication

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

    The total amount of rescue analgesic medication (e.g., acetaminophen/paracetamol) consumed by each participant, recorded in a daily diary. Unit of Measure: Milligrams (mg) of medication

Sponsors and collaborators

Lead sponsor

National Institute of Nuclear Research - Mexico

Other

Collaborators

  • Autonomous University of the State of Mexico

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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