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CompletedNCT06068959Updated Jul 29, 2026

Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction

An interventional study of Photobiomodulation using LED and Placebo in TMJ Pain, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.

Read the detailed description

The term temporomandibular disorders (TMD), according to the American American Dental Association (ADA), refers to a group of disorders characterized by pain in the temporomandibular joint (TMD) in the periauricular area or in the masticatory muscles, in addition to TMD sounds during jaw function and deviation or restriction of jaw movements. Its multifactorial etiology is related to a heterogeneous group of functional, structural, and psychological factors, making it difficult to identify the association between a single etiological factor and the signs and symptoms of TMD. As a treatment option, it hasphotobiomodulation, using different light sources, alone or in combination. These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.

02

Conditions studied

  • TMJ Pain
03

In context

Lead sponsor

University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • present TMD according Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I
  • have all permanent teeth

Exclusion criteria

Exclusion Criteria:

  • be undergoing orthodontic treatment
  • be undergoing other treatment for TMD
  • present dental caries or gingival disease.
  • Initiate or use any type of medication during the phases of the study
  • comorbidity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Photobiomodulation

    Photobiomodulation using a LED cluster

    Device: Photobiomodulation using LED

  • Placebo comparator
    Placebo Photobiomodulation

    Placebo Photobiomodulation with the equipment turned off

    Device: Placebo

Interventions

  • DevicePhotobiomodulation using LED

    Photobiomodulation Using a Cluster of LEDs in the Red and Infrared Wavelengths in the Cervical Spine Region and Over the Masticatory Muscles

  • DevicePlacebo

    Photobiomodulation Placebo

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What researchers measure

Primary outcomes

  1. Pain Baseline

    Evaluation of Pain using visual analogic scale in centimeters (0-10cm)

    Time frame: Before an intervention

  2. Final Pain

    Evaluation of Pain using visual analogic scale in centimeters (0-10cm)

    Time frame: 2 weeks after treatment

Secondary outcomes

  1. Cervical spine mobility baseline

    Evaluation of cervical spine mobility using goniometer in degrees

    Time frame: Before an intervention

  2. Final Cervical spine mobility

    Evaluation of cervical spine mobility using goniometer in degrees

    Time frame: 2 weeks after intervention

  3. Mandibular mobility baseline

    Evaluation of mandibular mobility using caliper in millimeters

    Time frame: Before an intervention

  4. Final Mandibular mobility

    Evaluation of mandibular mobility using caliper in millimeters

    Time frame: 2 weeks after intervention

07

Study locations

1 site
  • Kristiane Porta Santos Fernandes
    São Paulo, São Paulo 01525-000, Brazil
08

References and documents

Publications

  • Trindade LP, Urruty MJ, Bruno LH, Todeschini F, Moya LEP, Lestido V, Dos Santos Malavazzi TC, Motta LJ, Bussadori SK, Fernandes KPS, Horliana ACRT, Mesquita-Ferrari RA. LED Photobiomodulation for Pain Reduction in Temporomandibular Disorder: A Randomized, Controlled, and Blinded Clinical Trial. J Biophotonics. 2026 Mar;19(3):e70243. doi: 10.1002/jbio.70243. PubMed 41792959 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06068959
Lead sponsor
University of Nove de Julho
Responsible party
Anna Carolina Ratto Tempestini Horliana (Principal investigator, University of Nove de Julho) — Principal investigator
First posted
Oct 5, 2023
Start date
Feb 29, 2024
Primary completion
Jul 10, 2024
Completion
Aug 10, 2024
Last update
Jul 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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