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| Name | Class |
|---|---|
| Autonomous University of the State of Mexico | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Non-Thermal Plasma (NTP) | Experimental |
| |
| Treatment with Low-Level Laser Therapy (LLLT) | Active Comparator |
| |
| Treatment with Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From baseline (day of intervention) to days 1, 2, 3, 5, and 7 post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plasma Physics Laboratory, National Institute of Nuclear Research | Ocoyoacac | State of Mexico | 52750 | Mexico |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D013281 | Stomatitis, Aphthous |
| D019226 | Oral Ulcer |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| 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. |
|
| 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. |
| 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 | From baseline to complete healing or up to 30 days, whichever comes first |
| D013568 |
| Pathological Conditions, Signs and Symptoms |