StomatitisNCT07322666
Non-Thermal Plasma vs. Low-Level Laser Therapy for Recurrent Oral Ulcers
A study testing Non-Thermal Plasma (NTP) and Low-Level Laser Therapy (LLLT) in people with Stomatitis and Aphthous Ulcer, run by National Institute of Nuclear Research - Mexico at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomatitis, Aphthous Ulcer
- What is being tested?
- Non-Thermal Plasma (NTP) and Low-Level Laser Therapy (LLLT)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 4 Feb 2019to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Plasma Physics Laboratory, National Institute of Nuclear Research
Ocoyoacac, State of Mexico, 52750
About this study
Official title: Tissue Repair of Incisions for Biopsy and Mouth Ulcers Using Non-Thermal Plasma
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?
Read more
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
- Being tested
- Non-Thermal Plasma (NTP), Low-Level Laser Therapy (LLLT), Placebo
- Keywords
- Oral Ulcers, Non-Thermal Plasma, Low-Level Laser Therapy, Placebo, Healing, Pain
- Medical subject headings
- Stomatitis, Stomatitis, Aphthous, Oral Ulcer, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Non-Thermal Plasma (NTP) | Experimental | Not described Receives: Device: Non-Thermal Plasma (NTP) |
| Treatment with Low-Level Laser Therapy (LLLT) | Active comparator | Not described Receives: Device: Low-Level Laser Therapy (LLLT) |
| Treatment with Placebo | Placebo comparator | Not described Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Patient recruitment rate
Proportion of the target sample size successfully recruited within the recruitment period. Unit of Measure: Percentage (%)
Measured: 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 (%)
Measured: 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
Measured: 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
Measured: From baseline (pre-intervention) to 48 hours post-intervention
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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
Measured: From baseline to complete healing or up to 30 days, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start4 Feb 2019
- Primary completion30 Nov 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nuclear Research - Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Autonomous University of the State of Mexico
- Responsible party
- Principal investigator, Benjamín Gonzalo Rodríguez Méndez, National Institute of Nuclear Research - Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322666
- Sponsor's protocol ID
- CEICIEAO-2018-001
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Repair of Incisions for Biopsy and Mouth Ulcers Using Non-Thermal Plasma
- ClinicalTrials.gov ID
- NCT07322666
- Acronym / sponsor ID
- CEICIEAO-2018-001
- Conditions
- Stomatitis, Aphthous Ulcer
- Keywords
- Oral Ulcers, Non-Thermal Plasma, Low-Level Laser Therapy, Placebo, Healing, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Institute of Nuclear Research - MexicoUniversity, hospital or other
- Collaborators
- Autonomous University of the State of Mexico
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment with Non-Thermal Plasma (NTP) |
| 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. | Device | Treatment with Low-Level Laser Therapy (LLLT) |
| PlaceboSimulation 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. | Procedure or surgery | Treatment with Placebo |
Primary outcome
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 (%)
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 (%)
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
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
3 secondary outcomes
Change in ulcer surface area
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
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
Time frame: From baseline to complete healing or up to 30 days, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Thermal Plasma (NTP) and Low-Level Laser Therapy (LLLT) in people with Stomatitis and Aphthous Ulcer, run by National Institute of Nuclear Research - Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Patient recruitment rate (time frame: From the start of enrollment to the end of the recruitment period, an average of 1 month.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.