Luminance RED for Canker Sores

Sponsor

ProofPilot (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04914533

Collaborator

Luminance RED (Other)

Enrollment

Location

Arm

3.3

Anticipated Duration (Months)

18.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Canker Sore	Device: Luminance RED Low Level Laser Therapy Device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single arm trialSingle arm trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 21, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 28, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Device retention [Day 21]
Percentage of participants who decide to keep device

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProofPilot Virtual Online Trial (https://proofpilot.com)	New York	New York	United States	10003

Sponsors and Collaborators

ProofPilot
Luminance RED

Investigators

Principal Investigator: Matthew M Amsden, ProofPilot

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ProofPilot

ClinicalTrials.gov Identifier:

NCT04914533

Other Study ID Numbers:

2795

First Posted:

Jun 4, 2021

Last Update Posted:

Jun 4, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Stomatitis, Aphthous

Study Results

No Results Posted as of Jun 4, 2021