Clinical Trial: Influence of Intraoral Phototherapy in Individuals With Temporomandibular Joint Dysfunction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Influence of Intraoral Phototherapy on Pain, Joint Mobility, Functionality and Quality of Life in Individuals With Temporomandibular Joint Dysfunction

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 phototherapy 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%.

Detailed Summary:
Sponsor: University of Nove de Julho

Current Primary Outcome:

• Intensity of pain as measured by Visual analogue scale [ Time Frame: five minutes ]
  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 [ Time Frame: ten minutes ]
  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.

Original Primary Outcome:

• Intensity of pain as measured by Visual analogue scale (EVA) [ Time Frame: five minutes ]
  EVA 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 [ Time Frame: ten minutes ]
  Will be used a digital paquimetro Starrett ® 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.

Current Secondary Outcome:

• Functional as measured by Patient specific Functional scale [ Time Frame: ten minutes ]
  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) [ Time Frame: ten minutes ]

Original Secondary Outcome:

• Functional as measured by Patient specific Functional scale [ Time Frame: ten minutes ]
  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 WHOQOL-BREF questionnaire [ Time Frame: ten minutes ]

Dates:
Date Received: September 29, 2015
Date Started: July 2016
Date Completion: June 2017
Last Updated: December 26, 2016
Last Verified: December 2016