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Photobiomodulation In the Masseter and Temporal In Patients With Temporomandibular Joint Dysfunction

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phototherapy
phototherapy 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 Temporomandibular Disorder

Eligibility Criteria

1 Year - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All volunteers will have a diagnosis of myogenous TMD based on the RDC/TMD with moderate to severe pain in the masseter and temporal muscles rated by an expert dentist. To standardize the sample, the body mass index of all participants must be less than 25 kg/m2, as the amount of adipose tissue between the electrode and surface of the muscle can affect that reading of the electromyographic (EMG) signal. All volunteers must also have an initial pain score greater than 3 points on the VAS.

Exclusion Criteria:

  • The exclusion criteria will be missing teeth, the use of dentures, systemic or neuromuscular diseases, a history of trauma to the face or temporomandibular joint, history of temporomandibular joint luxation, currently undergoing orthodontic treatment, or currently undergoing medicinal treatment that can affect the musculoskeletal system (analgesic, anti-inflammatory agent or muscle relaxant).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    Submitted to a session of phototherapy with 39,27 Joules per point in muscle masseter and temporal bilateral.

    Submitted to a session of phototherapy placebo with 0,0 Joules per point in muscle masseter and temporal bilateral.

    Outcomes

    Primary Outcome Measures

    Visual analog scale
    A Visual analog scale allows the quantification of pain intensity. This scale consists of a straight line measuring 10 cm in length, with "absence of pain" written at one end and "worst pain ever felt" written at the other end. The volunteer will be instructed to make a perpendicular line between the two extremes that represents the pain level he/she is feeling at the time

    Secondary Outcome Measures

    Range of motion
    We used a Starrett digital caliper ® to assess the breadth of mandibular movement (in mm), that is, the opening of the mouth was measured according to the RDC/TMD, and right and left lateral excursions.

    Full Information

    First Posted
    December 26, 2016
    Last Updated
    January 25, 2018
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03005730
    Brief Title
    Photobiomodulation In the Masseter and Temporal In Patients With Temporomandibular Joint Dysfunction
    Official Title
    Influence of Photobiomodulation In The Masseter and Temporal On Pain, Joint Mobility In Individuals With Temporomandibular Joint Dysfunction: Clinical Trial Randomised, Placebo-Controlled And Double-Blind
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 10, 2016 (Actual)
    Primary Completion Date
    May 10, 2017 (Actual)
    Study Completion Date
    January 20, 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Background: According to the International Association for the Study of Pain (IASP), the term temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck on one or both sides as well as joint sounds, limited mandibular movements or mandibular deviation and difficulties chewing. Phototherapy, such as low level laser therapy (LLLT) and light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain. Thus, there is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (LLLT and LED) in the same apparatus. Question: The aim of the proposed study is to evaluate the effects of phototherapy on pain, activity of the masticatory muscles (masseter and anterior temporal bilaterally) and joint mobility in individuals with temporomandibular disorder (TMD). A further aim is to determine the cumulative effect 24 and 48 hours after a six session. Methods/Design: A placebo-controlled, double-blind, randomized, clinical trial will be carried out involving 30 women between 18 and 40 years of age with a diagnosis of myogenous TMD. The participants will then be randomly allocated to two groups totaling 15 individuals per group. Group 1 submitted to a session of phototherapy with 39,27 Joules per point one group will receive placebo therapy (0 Joules). The following assessment tools will be administered on four separate occasions (baseline and immediately after, 24 h after and 48 h after phototherapy). Pain intensity will be assessed using the visual analog scale for pain, meter for range of movement, and electromyographic EMG analysis on the masseter and anterior temporal muscles. Discussion: The study will support the practice of evidence-based to the use of phototherapy in individuals with a myogenous TMD. Data will be published after the study is completed.

    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
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Submitted to a session of phototherapy with 39,27 Joules per point in muscle masseter and temporal bilateral.
    Arm Title
    Group 2
    Arm Type
    Placebo Comparator
    Arm Description
    Submitted to a session of phototherapy placebo with 0,0 Joules per point in muscle masseter and temporal bilateral.
    Intervention Type
    Other
    Intervention Name(s)
    phototherapy
    Intervention Description
    The portable PainAway® nine-diode cluster (Multi Radiance Medical®, Solon, OH, USA) will be employed. This system has one 905 nm laser diode, four 875 nm LED diodes and four 670 nm LED diodes. The aperture size of device is 4 cm2.
    Intervention Type
    Other
    Intervention Name(s)
    phototherapy placebo
    Intervention Description
    The placebo portable. The aperture size of device is 4 cm2 .
    Primary Outcome Measure Information:
    Title
    Visual analog scale
    Description
    A Visual analog scale allows the quantification of pain intensity. This scale consists of a straight line measuring 10 cm in length, with "absence of pain" written at one end and "worst pain ever felt" written at the other end. The volunteer will be instructed to make a perpendicular line between the two extremes that represents the pain level he/she is feeling at the time
    Time Frame
    5 min
    Secondary Outcome Measure Information:
    Title
    Range of motion
    Description
    We used a Starrett digital caliper ® to assess the breadth of mandibular movement (in mm), that is, the opening of the mouth was measured according to the RDC/TMD, and right and left lateral excursions.
    Time Frame
    10 min

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All volunteers will have a diagnosis of myogenous TMD based on the RDC/TMD with moderate to severe pain in the masseter and temporal muscles rated by an expert dentist. To standardize the sample, the body mass index of all participants must be less than 25 kg/m2, as the amount of adipose tissue between the electrode and surface of the muscle can affect that reading of the electromyographic (EMG) signal. All volunteers must also have an initial pain score greater than 3 points on the VAS. Exclusion Criteria: The exclusion criteria will be missing teeth, the use of dentures, systemic or neuromuscular diseases, a history of trauma to the face or temporomandibular joint, history of temporomandibular joint luxation, currently undergoing orthodontic treatment, or currently undergoing medicinal treatment that can affect the musculoskeletal system (analgesic, anti-inflammatory agent or muscle relaxant).

    12. IPD Sharing Statement

    Learn more about this trial

    Photobiomodulation In the Masseter and Temporal In Patients With Temporomandibular Joint Dysfunction

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