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Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction

Primary Purpose

Temporomandibular Disorder

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
LED photobiomodulation
Placebo LED photobiomodulation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UniNoveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

LED group

Placebo group

Control group

Arm Description

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.

For the placebo group, all measures described for the LED group will be adopted, however, the equipment will be switched off.

In this group, the participants will only be evaluated. No intervention will take place.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 3, 2018
Last Updated
November 6, 2018
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT03696706
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LED group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
For the placebo group, all measures described for the LED group will be adopted, however, the equipment will be switched off.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In this group, the participants will only be evaluated. No intervention will take place.
Intervention Type
Radiation
Intervention Name(s)
LED photobiomodulation
Intervention Description
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 Type
Radiation
Intervention Name(s)
Placebo LED photobiomodulation
Intervention Description
In this group, the same procedures as the LED group will be made, but the device will be turned off.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
Fourteen days.
Secondary Outcome Measure Information:
Title
Range of motion
Description
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.
Time Frame
Fourteen days.
Title
Electromyography
Description
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.
Time Frame
Fourteen days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
UniNove
City
São Paulo
State/Province
SP
ZIP/Postal Code
01504-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dowglas FM de Sousa
Phone
+5511999531476
Email
dowglas@un9.pro.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
35751005
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.
Results Reference
derived

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Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction

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