Clinical trial NCT03257748: Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder
Official title: Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder: a Randomized, Controlled, Double-blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction and headache. The etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase in emotional stress. Studies have demonstrated that phototherapy is an efficient option for the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the proposed study is to analyze the effects of low-level laser therapy and light-emitting diode (LED) therapy on pain and function in patients with TMD. Methods: A randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70 years of age allocated to either a laser group or LED group submitted to twelve sessions of phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all participants. Pain will be measured using the visual analog scale. Orofacial function will be measured based on maximum vertical mandibular movement and muscle tension (determined through palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscles). Electromyographic analysis of the masseter and anterior temporal muscles will also be performed.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of TMD based on the RDC/TMD;
* Age between 40 and 70 years.

Exclusion Criteria:

* Dentofacial anomalies;
* Currently in orthodontic or orthopedic treatment for the jaw;
* Currently undergoing physical therapy;
* Currently undergoing psychological treatment;
* Use of muscle relaxant or anti-inflammatory agent.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
measure: Visual Analog Scale
timeFrame: Through study completion, an average of 1 year.
measure: Maximum vertical mandibular movement
timeFrame: Through study completion, an average of 1 year.
measure: Muscle tension
timeFrame: Through study completion, an average of 1 year.
measure: Electromyography
timeFrame: Through study completion, an average of 1 year.
Locations:
city: São Paulo
country: Brazil
facility: UniNove
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Sandra K Bussadori, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langella LG, Silva PFC, Costa-Santos L, Goncalves MLL, Motta LJ, Deana AM, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial. Trials. 2018 Jan 26;19(1):71. doi: 10.1186/s13063-018-2444-7.