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NCT Number: NCT05916235

Photobiomodulation for Management of Temporomandibular Disorder Pain

Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.

Recruiting

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Key information

Conditions

Pain Related to TMD

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged 18 years and older
  • Meets the CATI pre-screening criteria during pre-screening visit [participant-reported facial pain for at least 3 months and an average pain intensity rating for the week preceding CATI of ≥30 on a numerical rating scale (NRS, 0-100)].
  • Willing to provide signed and dated informed consent
  • Willing to to comply with all study procedures and to be available for the duration of the study
  • Meets diagnostic criteria for TMD (Masticatory Muscle disorder, 1 A: Myalgia) during Visit 0
  • Completes a minimum of 4 of 7 daily symptom diary (DSD) entries prior to Visit 1 (Randomization visit), and the weekly average pain score on this DSD is ≥30 of 100

Exclusion criteria

  • Active rheumatologic disease
  • Has a medical condition, laboratory finding, or physical exam finding (e.g., renal failure or dialysis, uncontrolled diabetes mellitus, or uncontrolled seizures) that precludes participation as determined by the investigator
  • Initiated occlusal appliance therapy within 30 days prior to CATI
  • Initiated non-pharmacologic therapy, such as acupuncture, biofeedback, and/or TENS within 30 days prior to CATI
  • Is in active orthodontic treatment
  • Received any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 14 days prior to the CATI
  • Has a history of facial trauma or orofacial surgery within 6 weeks prior to CATI
  • Has a history of psychiatric hospitalization within one year prior to CATI
  • Currently pregnant or lactating
  • Has a known hypersensitivity to laser therapy
  • Currently being treated with chemotherapy or radiation therapy
  • Is undergoing treatment with another investigational drug or treatment initiated within 30 days prior to the Screening and Baseline Visit
  • Initiated a new daily prescribed or over-the counter medication for the management of pain within 30 days prior to Screening and Baseline Visit.
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study as determined by the investigator

Treatment and study plan

THOR® laser system

Device

We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation.

Primary outcomes

  1. Pain Level Change with PBM treatment using a Numerical Rating Scale

    Time frame: Through study completion; about 6 months

    The primary outcome measure will be the average of daily pain ratings on the numerical rating scale (0 = no pain, 100 = worst pain imaginable) from the Daily Symptom Diary. Daily pain ratings averaged over one week prior to randomization will be treated as the baseline variable. The average daily pain for one week prior to Visit 9 will be treated as the primary endpoint. This outcome measure averaged across multiple days provides a stable measure of pain that is less subject to recall bias.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Weber, CCRP

CONTACT

[email protected]

352-273-7802

Selenia Rubio, MD

CONTACT

[email protected]

352-273-5590

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Acronym: ULLTRA

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 23, 2023
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.