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Luminance RED for Canker Sores

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04914533
Enrollment
0
Registered
2021-06-04
Start date
2021-06-21
Completion date
2021-09-28
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Canker Sore

Brief summary

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.

Interventions

DEVICELuminance RED Low Level Laser Therapy 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.

Sponsors

ProofPilot
Lead SponsorINDUSTRY
Luminance RED
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single arm trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Visual Analog Pain ScaleBaseline to day 18daily score of canker sore pain
Change in Eating, drinking, and brushing teeth questionnaireBaseline to day 18score calculated on daily discomfort with eating, drinking and brushing teath

Secondary

MeasureTime frameDescription
Device retentionDay 21Percentage of participants who decide to keep device

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMatthew M Amsden

ProofPilot

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026