Non-Thermal Plasma vs. Low-Level Laser Therapy for Recurrent Oral Ulcers
NCT ID: NCT07322666
Last Updated: 2026-01-07
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-02-04
2024-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment with Non-Thermal Plasma (NTP)
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.
Treatment with Low-Level Laser Therapy (LLLT)
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.
Treatment with Placebo
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Autonomous University of the State of Mexico
UNKNOWN
National Institute of Nuclear Research - Mexico
OTHER
Responsible Party
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Benjamín Gonzalo Rodríguez Méndez
Professional B, Level 19
Locations
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Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, State of Mexico, Mexico
Countries
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Other Identifiers
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CEICIEAO-2018-001
Identifier Type: -
Identifier Source: org_study_id
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