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

National Institute of Nuclear Research - Mexico

Status: Completed

Conditions: Stomatitis; Aphthous Ulcer

Treatments: Procedure: Placebo; Device: Low-Level Laser Therapy (LLLT); Device: Non-Thermal Plasma (NTP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07322666

CEICIEAO-2018-001

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

Treatment with Non-Thermal Plasma (NTP)

Experimental group

Treatment:

Device: Non-Thermal Plasma (NTP)

Treatment with Low-Level Laser Therapy (LLLT)

Active Comparator group

Treatment:

Device: Low-Level Laser Therapy (LLLT)

Treatment with Placebo

Placebo Comparator group

Treatment:

Procedure: Placebo