Luminance RED for Canker Sores

Canker Sore Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04914533
• Other study ID #: 2795
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 21, 2021
• Est. completion date: September 28, 2021

Study information

• Verified date: May 2021
• Source: ProofPilot
• Contact: Matthew M Amsden
• Phone: (888) 870-4189
• Email: crew[@]proofpilot.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 28, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Canker Sore
• Stomatitis, Aphthous

Intervention

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.

Locations

Country	Name	City	State
United States	ProofPilot Virtual Online Trial (https://proofpilot.com)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
ProofPilot	Luminance RED

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analog Pain Scale	daily score of canker sore pain	Baseline to day 18
Primary	Change in Eating, drinking, and brushing teeth questionnaire	score calculated on daily discomfort with eating, drinking and brushing teath	Baseline to day 18
Secondary	Device retention	Percentage of participants who decide to keep device	Day 21