Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction
Primary Purpose
TMJ Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photobiomodulation using LED
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for TMJ Pain
Eligibility Criteria
Inclusion Criteria: present TMD according Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I have all permanent teeth Exclusion Criteria: be undergoing orthodontic treatment be undergoing other treatment for TMD present dental caries or gingival disease. Initiate or use any type of medication during the phases of the study comorbidity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Photobiomodulation
Placebo Photobiomodulation
Arm Description
Photobiomodulation using a LED cluster
Placebo Photobiomodulation with the equipment turned off
Outcomes
Primary Outcome Measures
Pain Baseline
Evaluation of Pain using visual analogic scale in centimeters (0-10cm)
Final Pain
Evaluation of Pain using visual analogic scale in centimeters (0-10cm)
Secondary Outcome Measures
Cervical spine mobility baseline
Evaluation of cervical spine mobility using goniometer in degrees
Final Cervical spine mobility
Evaluation of cervical spine mobility using goniometer in degrees
Mandibular mobility baseline
Evaluation of mandibular mobility using caliper in millimeters
Final Mandibular mobility
Evaluation of mandibular mobility using caliper in millimeters
Full Information
NCT ID
NCT06068959
First Posted
September 28, 2023
Last Updated
October 16, 2023
Sponsor
University of Nove de Julho
1. Study Identification
Unique Protocol Identification Number
NCT06068959
Brief Title
Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction
Official Title
Effect of Photobiomodulation With LED Cluster on Pain and Mandibular and Cervical Mobility in Patients With Temporomandibular Dysfunction: Clinical, Randomized, Controlled and Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 29, 2023 (Anticipated)
Primary Completion Date
May 10, 2024 (Anticipated)
Study Completion Date
July 10, 2024 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.
Detailed Description
The term temporomandibular disorders (TMD), according to the American American Dental Association (ADA), refers to a group of disorders characterized by pain in the temporomandibular joint (TMD) in the periauricular area or in the masticatory muscles, in addition to TMD sounds during jaw function and deviation or restriction of jaw movements. Its multifactorial etiology is related to a heterogeneous group of functional, structural, and psychological factors, making it difficult to identify the association between a single etiological factor and the signs and symptoms of TMD. As a treatment option, it hasphotobiomodulation, using different light sources, alone or in combination. These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMJ Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photobiomodulation
Arm Type
Experimental
Arm Description
Photobiomodulation using a LED cluster
Arm Title
Placebo Photobiomodulation
Arm Type
Placebo Comparator
Arm Description
Placebo Photobiomodulation with the equipment turned off
Intervention Type
Device
Intervention Name(s)
Photobiomodulation using LED
Intervention Description
Photobiomodulation Using a Cluster of LEDs in the Red and Infrared Wavelengths in the Cervical Spine Region and Over the Masticatory Muscles
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Photobiomodulation Placebo
Primary Outcome Measure Information:
Title
Pain Baseline
Description
Evaluation of Pain using visual analogic scale in centimeters (0-10cm)
Time Frame
Before an intervention
Title
Final Pain
Description
Evaluation of Pain using visual analogic scale in centimeters (0-10cm)
Time Frame
2 weeks after treatment
Secondary Outcome Measure Information:
Title
Cervical spine mobility baseline
Description
Evaluation of cervical spine mobility using goniometer in degrees
Time Frame
Before an intervention
Title
Final Cervical spine mobility
Description
Evaluation of cervical spine mobility using goniometer in degrees
Time Frame
2 weeks after intervention
Title
Mandibular mobility baseline
Description
Evaluation of mandibular mobility using caliper in millimeters
Time Frame
Before an intervention
Title
Final Mandibular mobility
Description
Evaluation of mandibular mobility using caliper in millimeters
Time Frame
2 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
present TMD according Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I
have all permanent teeth
Exclusion Criteria:
be undergoing orthodontic treatment
be undergoing other treatment for TMD
present dental caries or gingival disease.
Initiate or use any type of medication during the phases of the study
comorbidity
12. IPD Sharing Statement
Learn more about this trial
Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction
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