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Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction

Effect of Photobiomodulation With LED Cluster on Pain and Mandibular and Cervical Mobility in Patients With Temporomandibular Dysfunction: Clinical, Randomized, Controlled and Blind Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06068959
Enrollment
32
Registered
2023-10-05
Start date
2024-02-29
Completion date
2024-08-10
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMJ Pain

Brief 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.

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.

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

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Pain BaselineBefore an interventionEvaluation of Pain using visual analogic scale in centimeters (0-10cm)
Final Pain2 weeks after treatmentEvaluation of Pain using visual analogic scale in centimeters (0-10cm)

Secondary

MeasureTime frameDescription
Cervical spine mobility baselineBefore an interventionEvaluation of cervical spine mobility using goniometer in degrees
Final Cervical spine mobility2 weeks after interventionEvaluation of cervical spine mobility using goniometer in degrees
Mandibular mobility baselineBefore an interventionEvaluation of mandibular mobility using caliper in millimeters
Final Mandibular mobility2 weeks after interventionEvaluation of mandibular mobility using caliper in millimeters

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026