Clinical trial NCT02839967: Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction
Official title: Influence of Intraoral Photobiomodulation on Pain, Joint Mobility, Functionality and Quality of Life in Individuals With Temporomandibular Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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%.


Eligibility criteria: 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.

Primary outcomes:
measure: Intensity of pain as measured by Visual analogue scale
timeFrame: five minutes
measure: Measured by joint mobility
timeFrame: ten minutes
Secondary outcomes:
measure: Functional as measured by Patient specific Functional scale
timeFrame: ten minutes
measure: quality of life measured by questionnaire (WHOQOL-BREF)
timeFrame: ten minutes
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Nove de Julho
state: São Paulo
Study officials:
affiliation: University of Nove de Julho
name: Daniela ap Biasotto-Gonzalez, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herpich CM, Leal-Junior ECP, Politti F, de Paula Gomes CAF, Dos Santos Gloria IP, de Souza Amaral MFR, Herpich G, de Azevedo LMA, de Oliveira Gonzalez T, Biasotto-Gonzalez DA. Intraoral photobiomodulation diminishes pain and improves functioning in women with temporomandibular disorder: a randomized, sham-controlled, double-blind clinical trial : Intraoral photobiomodulation diminishes pain in women with temporomandibular disorder. Lasers Med Sci. 2020 Mar;35(2):439-445. doi: 10.1007/s10103-019-02841-1. Epub 2019 Jul 19.