Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT05916235

Photobiomodulation for Management of Temporomandibular Disorder Pain

Led by University of Florida · Updated on 2025-10-24

130

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

N

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Photobiomodulation for Management of Temporomandibular Disorder Pain

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 18 years and older
  • Has had facial pain for at least 3 months with an average pain score of 30 or higher on a 0-100 scale in the week before screening
  • Willing to provide signed and dated informed consent
  • Willing to follow all study procedures and be available for the study duration
  • Meets diagnostic criteria for temporomandibular disorder (Masticatory Muscle disorder, 1 A: Myalgia)
  • Completes at least 4 out of 7 daily symptom diary entries before randomization with an average pain score of 30 or higher
Not Eligible

You will not qualify if you...

  • Has active rheumatologic disease
  • Has medical or physical conditions that prevent safe participation as judged by the investigator
  • Started occlusal appliance therapy within 30 days before screening
  • Started non-drug therapy like acupuncture, biofeedback, or TENS within 30 days before screening
  • Is currently undergoing orthodontic treatment
  • Received injection therapy for pain management within 14 days before screening
  • Had facial trauma or orofacial surgery within 6 weeks before screening
  • Had psychiatric hospitalization within one year before screening
  • Is currently pregnant or breastfeeding
  • Has a known sensitivity to laser therapy
  • Currently receiving chemotherapy or radiation therapy
  • Participating in another investigational drug or treatment study started within 30 days before screening
  • Started a new daily pain medication (prescription or over-the-counter) within 30 days before screening
  • Has any condition that increases risk or prevents full participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

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Research Team

S

Selenia Rubio, MD

CONTACT

E

Eric Weber, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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