Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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TMJ Pain

Intervention / Treatment
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* Device: Photobiomodulation using LED
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photobiomodulation<br>Photobiomodulation using a LED cluster | Device: Photobiomodulation using LED<br>* Photobiomodulation Using a Cluster of LEDs in the Red and Infrared Wavelengths in the Cervical Spine Region and Over the Masticatory Muscles<br>|
| Placebo Comparator: Placebo Photobiomodulation<br>Placebo Photobiomodulation with the equipment turned off | Device: Placebo<br>* Photobiomodulation Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Baseline | Evaluation of Pain using visual analogic scale in centimeters (0-10cm) | Before an intervention | 
| Final Pain | Evaluation of Pain using visual analogic scale in centimeters (0-10cm) | 2 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical spine mobility baseline | Evaluation of cervical spine mobility using goniometer in degrees | Before an intervention | 
| Final Cervical spine mobility | Evaluation of cervical spine mobility using goniometer in degrees | 2 weeks after intervention | 
| Mandibular mobility baseline | Evaluation of mandibular mobility using caliper in millimeters | Before an intervention | 
| Final Mandibular mobility | Evaluation of mandibular mobility using caliper in millimeters | 2 weeks after intervention |