Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
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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