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Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction

Not Applicable
Not yet recruiting
Conditions
TMJ Pain
Interventions
Device: Photobiomodulation using LED
Device: Placebo
Registration Number
NCT06068959
Lead Sponsor
University of Nove de Julho
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
32
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PhotobiomodulationPhotobiomodulation using LEDPhotobiomodulation using a LED cluster
Placebo PhotobiomodulationPlaceboPlacebo Photobiomodulation with the equipment turned off
Primary Outcome Measures
NameTimeMethod
Pain BaselineBefore an intervention

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

Final Pain2 weeks after treatment

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

Secondary Outcome Measures
NameTimeMethod
Final Mandibular mobility2 weeks after intervention

Evaluation of mandibular mobility using caliper in millimeters

Final Cervical spine mobility2 weeks after intervention

Evaluation of cervical spine mobility using goniometer in degrees

Mandibular mobility baselineBefore an intervention

Evaluation of mandibular mobility using caliper in millimeters

Cervical spine mobility baselineBefore an intervention

Evaluation of cervical spine mobility using goniometer in degrees

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