An interventional study of Non-Thermal Plasma (NTP) and Low-Level Laser Therapy (LLLT) in Stomatitis and Aphthous Ulcer, sponsored by National Institute of Nuclear Research - Mexico. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by National Institute of Nuclear Research - Mexico · Not applicable, Interventional, and Treatment
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 50 is above the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →National Institute of Nuclear Research - Mexico is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Stomatitis, Aphthous, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stomatitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: Non-Thermal Plasma (NTP)
Device: Low-Level Laser Therapy (LLLT)
Procedure: Placebo
Topical application of cold (non-thermal) plasma to the oral ulcer using a plasma generator, with specific time and power parameters.
Topical application of low-power laser radiation (low-level laser therapy) to the oral ulcer, following a standardized time and wavelength protocol.
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.
Feasibility - Patient recruitment rate
Proportion of the target sample size successfully recruited within the recruitment period. Unit of Measure: Percentage (%)
Time frame: 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 (%)
Time frame: 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
Time frame: 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
Time frame: From baseline (pre-intervention) to 48 hours post-intervention
Change in ulcer surface area
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)
Time frame: From baseline (day of intervention) to days 1, 2, 3, 5, and 7 post-intervention
Safety - Incidence and severity of treatment-related adverse events
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.
Time frame: From the first intervention until the end of the follow-up period (up to 7 days post-intervention)
Cumulative use of rescue analgesic medication
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
Time frame: From baseline to complete healing or up to 30 days, whichever comes first
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2019 to primary completion in Nov 2023, 57 months.
Of 13 interventional studies with no phase under Stomatitis, Aphthous, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's 57 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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National Institute of Nuclear Research - Mexico