Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction
NCT02839967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-01-28
Summary
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%.
Conditions
- Temporomandibular Disorders
Interventions
- OTHER
-
Photobiomodulation
Intraoral photobiomodulation is applied in the temporal, medial and lateral pterygoid, bilateral, totaling 4 points of application of phototherapy. The researcher who will perform the treatments will receive the equipment with the stylus activates and pre-programmed dose, an eye protection (glasses, opaque) will be used by the participants, to protect the eyes, because the same does not cause any sensation to volunteer. The technique is used, contact an area. The individual is positioned supine on a stretcher, with the legs supported on a foam roller 20 cm in diameter, the head supported on a pillow, to accommodate her comfortably in a resting posture, prompted the opening of the mouth and placing the tip of photobiomodulation in sections as described below, with 2 minutes interval between one application and another for rest with the mouth closed.
- OTHER
-
Photobiomodulation placebo
The volunteers will be subjected to the same Group intervention, Photobiomodulation and the researcher will receive the equipment unaware if the pen that will apply the phototherapy is active or placebo, only the research coordinator will have this knowledge, and for this group the researcher will receive placebo pen. Fits the caveat that, when the voluntary participation, will be held with the active pen treatment.
Sponsors & Collaborators
-
University of Nove de Julho
lead OTHER
Principal Investigators
-
Daniela ap Biasotto-Gonzalez, Phd · University of Nove de Julho
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-25
- Primary Completion
- 2017-05-10
- Completion
- 2018-01-20
Countries
- Brazil
Study Locations
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