Analgesic Effects of LED Light on Temporomandibular Disorders.

Study Overview
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Brief Summary
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Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode) light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount.

Detailed Description
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Aims: Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode)light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount. Method: This study proposes an evaluation of analgesic effect in TMD (temporomandibular disorders) using two different LEDs systems, one emitting at the spectral band of red (630 +/-5 nm) and the other at infrared band (850 +/-5 nm), and compare the results with a laser treated control group (780nm diode laser using 105.7 J/cm2). Mandibular range of motion and report of pain were evaluated via appropriate equipment developed to do this end. Power output was 150mW, tip area was 0.5 cm² for both sources. Fluency or dose chosen was 18 J/cm² for each point of application, around the TMJ, on both sides. Five points were irradiated on TMJ, temporal and masseter muscles. Eight irradiation sessions were done and follow up was performed 7 and 30 days, after last session. Thirty patients were enrolled and they were selected randomly for each treatment, resulting in 10 patients per group (infrared LED, red LED and Control Group using infrared Laser).

Official Title
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COMPARATIVE CLINICAL STUDY OF LIGHT ANALGESIC EFFECT ON TEMPOROMANDIBULAR DISORDER (TMD) USING RED AND INFRARED LED-THERAPY

Conditions
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Temporomandibular Disorder

Intervention / Treatment
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* Radiation: Red LED
* Radiation: INFRARED LED
* Radiation: LASER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Thirty patients (from 18 to 50 years old) presenting signs and symptoms of TMD were selected to participate in the study. The patients received care at a private dental office in Ribeirao Preto, São Paulo, Brazil (NILO- Integrated Center for Laser in Dentistry). The patients´ age ranged from 18 to 40 years old, being 08 male and 22 female. The signs and symptoms evaluated by a trained professional were as follow: pain during palpation in the TMJ area, pain on associated muscles (masseter and temporal), and limited or painful jaw movement with impaired oral aperture. Exclusion Criteria: The exclusion criteria were patients whom where currently under orthodontic and/or orthopedic treatment, degenerative joint disease, patients who were under systemic medication with anti-inflammatory drugs, analgesic treatment, muscle relaxant and corticosteroids. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Red LED<br>Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point. | Radiation: Red LED<br>* Phototherapy with red LED on temporomandibular area<br>* Other names: Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.;|
| Experimental: infrared LED<br>Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point | Radiation: INFRARED LED<br>* Phototherapy with infrared LED on temporomandibular area<br>* Other names: Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point;|
| Active Comparator: LASER<br>Irradiation parameters: 780 nm, 60 sec and 105 J/cm² | Radiation: LASER<br>* Phototherapy with LASER INFRARED on temporomandibular area<br>* Other names: Irradiation parameters: 780 nm, 60 sec and 105 J/cm²;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationships between pain and range of motion | Pain score and mandibular range of motion | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Research Diagnostic Criteria(RDC)/Temporomandibular Disorders (DTM) | RDC/DTM diagnostic exam for research of arthralgia and chronic myofascial pain. The signs and symptoms evaluated by a trained professional were as follow: pain during palpation in the temporomandibular joint, pain on associated muscles (masseter and temporal), and limited or painful jaw movement with impaired oral aperture. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lasertherapy, Ledtherapy, TMJs, pain relief, oral aperture