Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction

University of Nove de Julho

Status and phase: Unknown; Phase 2

Conditions: Temporomandibular Disorder

Treatments: Radiation: LED photobiomodulation; Radiation: Placebo LED photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03696706

Dowglas

Details and patient eligibility

About

Temporomandibular Dysfunction - TMD is considered the main cause of orofacial pain of non-dental origin, and a public health problem. Due to their complexity there are already treatments using various forms of therapy. Photobiomodulation using different light sources, in a single or combined form, makes it possible to use it as another therapeutic resource to be explored. The objective of this study will be to evaluate the effects of photobiomodulation with simultaneous use of light emitting diodes (LEDs), red and infrared, on clinical aspects in individuals with TMD. A randomized, controlled and blind clinical trial is proposed, which will involve 33 individuals (n = 11 per group) of both genders, aged 18-45 years in three groups: Group 1 - LED; Group 2 - placebo and Group 3 - control, submitted to 6 nonconsecutive sessions of photobiomodulation totaling 2 weeks of treatment. The Research Diagnostic Criteria for Temporomandibular Disorders - RDC/TMD will be used to determine the TMD and evaluate the participants. Pain will be assessed using the visual analog scale (VAS), mandibular range of motion will be determined with the aid of a digital caliper, and the electrical activity of the masticatory muscles will be verified by electromyography. A mixed plate of 18 red LEDs - 660 nm and 18 infrared LEDs - 850 nm with power of 3.5 mW per LED, 4.45 mW/cm2, radiant exposure of 5,35 J/cm2, irradiated area of 14.13 cm2, and energy of 75.6 J, in the temporomandibular joint (TMJ) region and in the masseter and temporal muscles, bilateral in 6 sessions. Participants from all groups will be reassessed after the first therapeutic intervention, and again at the end, following the same evaluation procedures used initially.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present TMD;
• Complete dentition (except third molars);
• Present mandibular deviation and/or deflection.

Exclusion criteria

• Occlusal changes;
• Use of any type of dental prosthesis;
• Current orthodontic or physiotherapeutic treatment;
• Use of any type of medication during the phases of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 3 patient groups, including a placebo group

LED group

Active Comparator group

Description:

LED photobiomodulation will be applied at 36 points, bilaterally, in the temporomandibular joint regions, around these joints, and in the regions of the masseter muscles and anterior part of the temporal muscles, three times a week, totaling 6 treatment sessions, in 2 weeks. The LED apparatus is composed of a flexible rectangular plate (10cm/12cm), which adapts to the format of the area to be treated containing 18 red LEDs - 660 nm and 18 infrared LEDs - 850 nm, with a power of 3.5 mW by LED, 4.45 mW/cm2, radiant exposure of 5.35 J/cm2, radiated area of 14.13 cm2, and energy of 75.6 J.

Treatment:

Radiation: LED photobiomodulation

Placebo group

Placebo Comparator group

Description:

For the placebo group, all measures described for the LED group will be adopted, however, the equipment will be switched off.

Treatment:

Radiation: Placebo LED photobiomodulation

Control group

No Intervention group

Description:

In this group, the participants will only be evaluated. No intervention will take place.