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NCT Number: NCT04914533

Luminance RED for Canker Sores

Canker sores, also called aphthous ulcers, are small, shallow lesions that develop on the soft tissues in your mouth or at the base of your gums. Unlike cold sores, canker sores don't occur on the surface of your lips and they aren't contagious. They can be painful, however, and can make eating and talking difficult. Recurrent aphthous ulcer stomatitis (RAS) is characterized by recurrent bouts of solitary or multiple shallow painful ulcers, at intervals of a few months to a few days in patients who are otherwise well.

Low Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The light triggers biochemical changes within cells and can be compared to the process of photosynthesis in plants, where the photons are absorbed by cellular photoreceptors, which trigger chemical changes.

The main medical usage of LLLT is for pain and inflammation reduction, promoting the regeneration of different tissues and preventing damage to tissues. With the use of the appropriate power (from 5 to 200mW) and wavelength (600-900nm), the therapy brings anti-inflammatory and analgesic results aiding in wound healing. The mechanism of action of LLLT may be very beneficial in the treatment of oral erosions and ulcers, however, very few studies have been performed on the treatment of RAS with LLLT. There are few reports on accelerated healing in erosive mucocutaneous disorders and they are often presented as a case series rather than large randomized clinical trials. The effects on skin wound healing and periodontal inflammation management with laser biostimulation suggest that this treatment modality may also be useful for oral erosive conditions.

This clinical trial aims to evaluate the effect of the Luminance RED device on the management of RAS.

Why the study stopped: did not launch
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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ProofPilot Virtual Online Trial (https://proofpilot.com)

New York, 10003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
  • 18 years and older.
  • Self report canker sore outbreaks once every 30 days or more frequent
  • Understands and is willing, able and likely to comply with all study procedures and restrictions.
  • No previous experience of LLLT.
  • United States resident.
  • Willingness and ability to submit a $49 deposit using a credit card for the device.

Exclusion criteria

  • Patients with a known systemic disease that predisposes them to RAS (e.g., Behçet disease) or undergoing systemic treatment for RAS.
  • The presence of a serious medical condition.
  • Currently known to be pregnant or breastfeeding
  • Patients treated with topical or systemic medication for RAS, such as corticosteroid therapy, antibiotics or analgesics during the previous month.

Treatment and study plan

Luminance RED Low Level Laser Therapy Device

Device

Low Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The Luminance RED Device is specifically designed to make it easy to issue LLLT to canker sores.

Primary outcomes

  1. Change in Visual Analog Pain Scale

    Time frame: Baseline to day 18

    daily score of canker sore pain

  2. Change in Eating, drinking, and brushing teeth questionnaire

    Time frame: Baseline to day 18

    score calculated on daily discomfort with eating, drinking and brushing teath

Secondary outcomes

  1. Device retention

    Time frame: Day 21

    Percentage of participants who decide to keep device

Sponsors and collaborators

Lead sponsor

ProofPilot

Industry

Collaborators

  • Luminance RED

Registry information

Official study title

Exploratory Real-world Study Examining the Effect of the Luminance RED Device on Recurrent Aphthous Ulcer Stomatitis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2021
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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