Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Sandra Kalil Bussadori，University of Nove de Julho

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

April 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Range of motion[ Time Frame: Fourteen days. ]
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.
Electromyography[ Time Frame: Fourteen days. ]
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.

Descriptive Information

Brief Title ^ICMJE

Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction

Official Title ^ICMJE

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.

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
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.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Active Comparator: 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.
Placebo Comparator: Placebo group
For the placebo group, all measures described for the LED group will be adopted, however, the equipment will be switched off.
No Intervention: Control group
In this group, the participants will only be evaluated. No intervention will take place.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 30, 2019

Estimated Primary Completion Date

April 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Sandra Kalil Bussadori，University of Nove de Julho

Study Sponsor ^ICMJE

University of Nove de Julho

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of Nove de Julho

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名