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Procedure

THOR® laser system for Temporomandibular Disorder (PBM Trial)

N/A
Waitlist Available
Led By Margarete Ribeiro-Dasilva, DDS, MS, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 10 weeks
Awards & highlights

PBM Trial Summary

This trial will test if a certain type of light therapy can help with pain related to TMJ disorders.

Eligible Conditions
  • Temporomandibular Disorder (TMD)

PBM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable

PBM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active PBMExperimental Treatment1 Intervention
PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD.
Group II: Sham PBMPlacebo Group1 Intervention
When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment.

Find a Location

Who is running the clinical trial?

National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,598 Total Patients Enrolled
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,691 Total Patients Enrolled
Margarete Ribeiro-Dasilva, DDS, MS, PhDPrincipal InvestigatorUniversity of Florida

Media Library

THOR® laser system (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04415281 — N/A
Temporomandibular Disorder Research Study Groups: Active PBM, Sham PBM
Temporomandibular Disorder Clinical Trial 2023: THOR® laser system Highlights & Side Effects. Trial Name: NCT04415281 — N/A
THOR® laser system (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04415281 — N/A
Temporomandibular Disorder Patient Testimony for trial: Trial Name: NCT04415281 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research project accepting new participants at this time?

"According to the information housed on clinicaltrials.gov, this medical study is not presently enrolling patients; however, it was initially posted in April 2021 and amended as recently as May 2022. At present there are 45 other trials actively recruiting participants across different therapeutic areas."

Answered by AI

What qualifications must potential participants fulfill to be accepted into this research?

"This medical investigation is recruiting 28 participants with temporomandibular joint disorders aged 18 to 65. To be eligible, all applicants must meet the following criteria: Being of legal age (regardless of gender or ethnicity), having dealt with facial pain for 3 months prior to application and reporting an average pain intensity rating over the past week on a numerical scale of 30 or above at screening and baseline visits."

Answered by AI

Has the THOR® laser system received FDA certification?

"After assessing THOR® laser system, our team at Power assigned it a score of 2 due to the fact that there is only some evidence suggesting its safety as this is still an early phase trial and no data has yet been found in relation to efficacy."

Answered by AI

Does this investigation accept participants above the age of seventy-five?

"Eligible participants must meet the age-range of 18 to 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am out of options.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Photobiomodulation for the Management of Temporomandibular Disorder Pain
2021. "Photobiomodulation for the Management of Temporomandibular Disorder Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04415281.
~4 spots leftby Apr 2025
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