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Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction

Primary Purpose

Temporomandibular Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photobiomodulation
Photobiomodulation 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 Disorders

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with disfunction temporomandibular.
  • Limitation of mandibular opening below 40 mm.
  • score of masticatory muscle pain greater than 3 cm in accordance with EVA.

Exclusion Criteria:

  • women who have dental failures, total or partial prosthesis.
  • systemic diseases .
  • history of trauma to the face and or ATMor the ATM dislocation history.
  • orthodontic treatment and/or medicated that affects the musculoskeletal system.

Sites / Locations

  • University of Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Photobiomodulation group

Photobiomodulation placebo group

Arm Description

For the purposes of photobiomodulation is used a portable cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), and 1 905 nm diode LASER, 4 875 nm LED diodes and 4 670 nm diodes LED, 4 cm2 beam, emitting an energy of 39.27 J.

To provide the "blinding" of the participants of the study we will use two identical photobiomodulation equipment supplied by the manufacturer, being an active and another a placebo, but both have identical light and sound device (do not send energy and heat, non-coherent light without biological effect). The devices are named in X and Y for a researcher who does not participate in treatment and assessments.

Outcomes

Primary Outcome Measures

Intensity of pain as measured by Visual analogue scale
Visual analogue scale is a tool which allows easy measurement of the intensity of the pain, and consists of a straight line of 10 cm in length, the ends have a verbal description (without pain and worst pain ever felt, respectively), in which the volunteers will be directed to make a perpendicular dash between the two extremes that represents the level of pain she presented at that time.
Measured by joint mobility
Will be used a digital meter to assess the breadth of mandibular movement (in mm), i.e. will be measured the opening of the mouth, sides (right and left) and protrusion.

Secondary Outcome Measures

Functional as measured by Patient specific Functional scale
Patient specific Functional scale is a global scale, so it can be used for any region of the body. The patient is asked to identify up to 3 activities that are unable to perform or presents any difficulty and may incorporate issues that were not addressed in a generic scale but it's important for the patient's problem. The measurement is made by Likert-type scales of 11 points for each activity, and the higher the average score (0-10) the better the patient's ability to perform the activities.
quality of life measured by questionnaire (WHOQOL-BREF)

Full Information

First Posted
September 29, 2015
Last Updated
January 24, 2019
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02839967
Brief Title
Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction
Official Title
Influence of Intraoral Photobiomodulation on Pain, Joint Mobility, Functionality and Quality of Life in Individuals With Temporomandibular Joint Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 25, 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
According to the International Association for the Study of Pain (IASP), the temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular joints. Pain is considered one of the most common and limiting clinical manifestations. One of the most used resources to treat muscle pain is the low-level laser therapy (LLLT), However, the mechanisms responsible for the effects observed in clinical trials remain poorly elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some advantages, among them the larger area radiation point and low cost. However, its effects remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid muscle. Assuming that there is need to investigate therapeutic resources that combine not only different wavelengths as well as different light sources (LED and LLLT), this study aims to evaluate the effect of photobiomodulation with a combination of different light sources on pain, joint mobility, equity and quality of jaw movements after treatment in patients with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 2 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols will be used in a 6 sessions and will be evaluated in four different moments. The analyses of the data will be performed by adopting a significance level of 5%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation group
Arm Type
Experimental
Arm Description
For the purposes of photobiomodulation is used a portable cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), and 1 905 nm diode LASER, 4 875 nm LED diodes and 4 670 nm diodes LED, 4 cm2 beam, emitting an energy of 39.27 J.
Arm Title
Photobiomodulation placebo group
Arm Type
Placebo Comparator
Arm Description
To provide the "blinding" of the participants of the study we will use two identical photobiomodulation equipment supplied by the manufacturer, being an active and another a placebo, but both have identical light and sound device (do not send energy and heat, non-coherent light without biological effect). The devices are named in X and Y for a researcher who does not participate in treatment and assessments.
Intervention Type
Other
Intervention Name(s)
Photobiomodulation
Intervention Description
Intraoral photobiomodulation is applied in the temporal, medial and lateral pterygoid, bilateral, totaling 4 points of application of phototherapy. The researcher who will perform the treatments will receive the equipment with the stylus activates and pre-programmed dose, an eye protection (glasses, opaque) will be used by the participants, to protect the eyes, because the same does not cause any sensation to volunteer. The technique is used, contact an area. The individual is positioned supine on a stretcher, with the legs supported on a foam roller 20 cm in diameter, the head supported on a pillow, to accommodate her comfortably in a resting posture, prompted the opening of the mouth and placing the tip of photobiomodulation in sections as described below, with 2 minutes interval between one application and another for rest with the mouth closed.
Intervention Type
Other
Intervention Name(s)
Photobiomodulation placebo
Intervention Description
The volunteers will be subjected to the same Group intervention, Photobiomodulation and the researcher will receive the equipment unaware if the pen that will apply the phototherapy is active or placebo, only the research coordinator will have this knowledge, and for this group the researcher will receive placebo pen. Fits the caveat that, when the voluntary participation, will be held with the active pen treatment.
Primary Outcome Measure Information:
Title
Intensity of pain as measured by Visual analogue scale
Description
Visual analogue scale is a tool which allows easy measurement of the intensity of the pain, and consists of a straight line of 10 cm in length, the ends have a verbal description (without pain and worst pain ever felt, respectively), in which the volunteers will be directed to make a perpendicular dash between the two extremes that represents the level of pain she presented at that time.
Time Frame
five minutes
Title
Measured by joint mobility
Description
Will be used a digital meter to assess the breadth of mandibular movement (in mm), i.e. will be measured the opening of the mouth, sides (right and left) and protrusion.
Time Frame
ten minutes
Secondary Outcome Measure Information:
Title
Functional as measured by Patient specific Functional scale
Description
Patient specific Functional scale is a global scale, so it can be used for any region of the body. The patient is asked to identify up to 3 activities that are unable to perform or presents any difficulty and may incorporate issues that were not addressed in a generic scale but it's important for the patient's problem. The measurement is made by Likert-type scales of 11 points for each activity, and the higher the average score (0-10) the better the patient's ability to perform the activities.
Time Frame
ten minutes
Title
quality of life measured by questionnaire (WHOQOL-BREF)
Time Frame
ten minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with disfunction temporomandibular. Limitation of mandibular opening below 40 mm. score of masticatory muscle pain greater than 3 cm in accordance with EVA. Exclusion Criteria: women who have dental failures, total or partial prosthesis. systemic diseases . history of trauma to the face and or ATMor the ATM dislocation history. orthodontic treatment and/or medicated that affects the musculoskeletal system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela ap Biasotto-Gonzalez, Phd
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nove de Julho
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01415000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31325122
Citation
Herpich CM, Leal-Junior ECP, Politti F, de Paula Gomes CAF, Dos Santos Gloria IP, de Souza Amaral MFR, Herpich G, de Azevedo LMA, de Oliveira Gonzalez T, Biasotto-Gonzalez DA. Intraoral photobiomodulation diminishes pain and improves functioning in women with temporomandibular disorder: a randomized, sham-controlled, double-blind clinical trial : Intraoral photobiomodulation diminishes pain in women with temporomandibular disorder. Lasers Med Sci. 2020 Mar;35(2):439-445. doi: 10.1007/s10103-019-02841-1. Epub 2019 Jul 19.
Results Reference
derived

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Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction

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