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
About this trial
This is an interventional treatment trial for Temporomandibular Disorder
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).
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
NCT ID
NCT03005730
First Posted
December 26, 2016
Last Updated
January 25, 2018
Sponsor
University of Nove de Julho
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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