Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction

Not Applicable

Completed

• Conditions: Temporomandibular Disorders

• Registration Number: NCT02839967
• Lead Sponsor: University of Nove de Julho

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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Study Start: 2016-09-25
• Primary Completion: 2017-05-10
• Study Completion: 2018-01-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intensity of pain as measured by Visual analogue scale	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	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.

Secondary Outcome Measures

Name	Time	Method
quality of life measured by questionnaire (WHOQOL-BREF)	ten minutes
Functional as measured by Patient specific Functional scale	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.

Trial Locations

Locations (1)

University of Nove de Julho; 🇧🇷 Sao Paulo, São Paulo, Brazil