Luminance RED for Canker Sores

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Canker Sore
• Intervention / Treatment: Device: Luminance RED Low Level Laser Therapy Device

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew M Amsden; Phone Number: (888) 870-4189; Email: crew@proofpilot.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • ProofPilot Virtual Online Trial (https://proofpilot.com)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Luminance Red Treatment Arm	Device: Luminance 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Pain Scale	daily score of canker sore pain	Baseline to day 18
Change in Eating, drinking, and brushing teeth questionnaire	score calculated on daily discomfort with eating, drinking and brushing teath	Baseline to day 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device retention	Percentage of participants who decide to keep device	Day 21

Collaborators and Investigators

• Sponsor: ProofPilot
• Collaborators: Luminance RED
• Investigators: Principal Investigator: Matthew M Amsden, ProofPilot

Study record dates

Study Major Dates

• Study Start (Anticipated): June 21, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 28, 2021

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Stomatitis; Stomatitis, Aphthous
• Other Study ID Numbers: 2795 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No