- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03696706
Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction
November 6, 2018 updated by: Sandra Kalil Bussadori, University of Nove de Julho
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.
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
33
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 01504-000
- Recruiting
- UniNove
-
Contact:
- Dowglas FM de Sousa
- Phone Number: +5511999531476
- Email: dowglas@un9.pro.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
In this group, the same procedures as the LED group will be made, but the device will be turned off.
|
No Intervention: Control group
In this group, the participants will only be evaluated.
No intervention will take place.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Fourteen days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Fourteen days.
|
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.
|
Fourteen days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2018
Primary Completion (Anticipated)
April 30, 2019
Study Completion (Anticipated)
August 30, 2019
Study Registration Dates
First Submitted
October 3, 2018
First Submitted That Met QC Criteria
October 3, 2018
First Posted (Actual)
October 5, 2018
Study Record Updates
Last Update Posted (Actual)
November 8, 2018
Last Update Submitted That Met QC Criteria
November 6, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dowglas
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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