Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction

Temporomandibular Disorder Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03696706
• Other study ID #: Dowglas
• Status: Recruiting
• Phase: Phase 2
• Start date: October 15, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2018
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: August 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Radiation:
• LED photobiomodulation
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.
• Placebo LED photobiomodulation
In this group, the same procedures as the LED group will be made, but the device will be turned off.

Locations

Country	Name	City	State
Brazil	UniNove	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	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.	Fourteen days.
Secondary	Range of motion	A digital Starrett® caliper will be used to assess mandibular range of motion (in millimeters), that is, measure mouth opening, lateral deviations (right and left) and protrusion. This procedure composes the clinical evaluation of RDC/TMD. This will be evaluated at baseline, immediately after treatment and at the end of the treatment.	Fourteen days.
Secondary	Electromyography	The electrical signals of the right and left masseters and anterior temporal muscles will be captured. We will use an EMG System do Brasil® signal conditioning module, with eight channels (module 830 C), using frequency bandpass filter between 20-1000 Hz, common mode rejection index> 120 db. All data will be collected and processed using a 16-bit analog / digital converter (EMG System do Brasil®). This will be evaluated at baseline, immediately after treatment and at the end of the treatment.	Fourteen days.