Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-08-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

In the placebo group, the same procedures of the LED group will be made, but the device will be turned off. Participants will not know whether they are in the active or placebo group.

The investigator will not know to which group the participants belong, only the care provider.

Study Groups

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LED group

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.

Group Type ACTIVE_COMPARATOR

LED photobiomodulation

Intervention Type RADIATION

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.

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo LED photobiomodulation

Intervention Type RADIATION

In this group, the same procedures as the LED group will be made, but the device will be turned off.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LED photobiomodulation

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.

Intervention Type RADIATION

Placebo LED photobiomodulation

In this group, the same procedures as the LED group will be made, but the device will be turned off.

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No