Luminance RED for Canker Sores

NCT04914533 | Withdrawn FDA Device

• 1 other identifier: 2795
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Canker Sore

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Device retention

  Day 21

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Luminance Red Treatment Arm

Device: Luminance RED Low Level Laser Therapy Device

Interventions

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ProofPilot: lead

Study Sites (1)

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

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Matthew M Amsden

  ProofPilot

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm trial

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: June 21, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 28, 2021
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

US (1)