Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction

University of Nove de Julho

Status: Completed

Conditions: Temporomandibular Disorders

Treatments: Other: Photobiomodulation; Other: Photobiomodulation placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02839967

PHOTOBIOMODULATION DTM INT.

Details and patient eligibility

About

According to the International Association for the Study of Pain (IASP), the temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular joints. Pain is considered one of the most common and limiting clinical manifestations. One of the most used resources to treat muscle pain is the low-level laser therapy (LLLT), However, the mechanisms responsible for the effects observed in clinical trials remain poorly elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some advantages, among them the larger area radiation point and low cost. However, its effects remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid muscle. Assuming that there is need to investigate therapeutic resources that combine not only different wavelengths as well as different light sources (LED and LLLT), this study aims to evaluate the effect of photobiomodulation with a combination of different light sources on pain, joint mobility, equity and quality of jaw movements after treatment in patients with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 2 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols will be used in a 6 sessions and will be evaluated in four different moments. The analyses of the data will be performed by adopting a significance level of 5%.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with disfunction temporomandibular.
• Limitation of mandibular opening below 40 mm.
• score of masticatory muscle pain greater than 3 cm in accordance with EVA.

Exclusion criteria

• women who have dental failures, total or partial prosthesis.
• systemic diseases .
• history of trauma to the face and or ATMor the ATM dislocation history.
• orthodontic treatment and/or medicated that affects the musculoskeletal system.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Photobiomodulation group

Experimental group

Description:

For the purposes of photobiomodulation is used a portable cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), and 1 905 nm diode LASER, 4 875 nm LED diodes and 4 670 nm diodes LED, 4 cm2 beam, emitting an energy of 39.27 J.

Treatment:

Other: Photobiomodulation

Photobiomodulation placebo group

Placebo Comparator group

Description:

To provide the "blinding" of the participants of the study we will use two identical photobiomodulation equipment supplied by the manufacturer, being an active and another a placebo, but both have identical light and sound device (do not send energy and heat, non-coherent light without biological effect). The devices are named in X and Y for a researcher who does not participate in treatment and assessments.

Treatment:

Other: Photobiomodulation placebo