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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
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TMJ Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 28, 2023
    Last Updated
    October 16, 2023
    Sponsor
    University of Nove de Julho
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    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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