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.
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- University of Nove de Julho
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control group
In this group, the participants will only be evaluated. No intervention will take place.
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.
Intervention: LED photobiomodulation (Radiation)
Placebo group
For the placebo group, all measures described for the LED group will be adopted, however, the equipment will be switched off.
Intervention: Placebo LED photobiomodulation (Radiation)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS)
Time Frame: Fourteen days.
VAS is an instrument that allows easy measurement of pain intensity, and consists of a straight line 10 cm long, whose extremities have a verbal description (no pain and worse pain already felt, respectively), in which the participants will be asked to perform a perpendicular trait between the two extremes that represents the level of pain he/she presents at that moment. This will be evaluated at baseline, immediately after treatment and at the end of the treatment.
Secondary Outcomes
- Range of motion(Fourteen days.)
- Electromyography(Fourteen days.)
Investigators
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho