Clinical trial NCT03696706: Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction
Official title: Effects of Photobiomodulation With Simultaneous Use in a Same LED Device (Red and Infrared) on Clinical Aspects in Individuals With Temporomandibular Dysfunction: Clinical, Randomized, Controlled and Blind Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Temporomandibular Disorder
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Fourteen days.
Secondary outcomes:
measure: Range of motion
timeFrame: Fourteen days.
measure: Electromyography
timeFrame: Fourteen days.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UniNove
state: SP
Study officials:
References:
citation: de Sousa DFM, Malavazzi TCDS, Deana AM, Horliana ACRT, Fernandes KPS, Bussadori SK, Mesquita-Ferrari RA. Simultaneous red and infrared light-emitting diodes reduced pain in individuals with temporomandibular disorder: a randomized, controlled, double-blind, clinical trial. Lasers Med Sci. 2022 Dec;37(9):3423-3431. doi: 10.1007/s10103-022-03600-5. Epub 2022 Jun 24.