Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 11, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2018
CompletedOctober 11, 2018
October 1, 2018
1.6 years
August 11, 2017
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale
This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.
Through study completion, an average of 1 year.
Other Outcomes (4)
Visual Analog Scale
Through study completion, an average of 1 year.
Maximum vertical mandibular movement
Through study completion, an average of 1 year.
Muscle tension
Through study completion, an average of 1 year.
- +1 more other outcomes
Study Arms (2)
LED group
EXPERIMENTALThe groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
Laser group
EXPERIMENTALThe groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
Interventions
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of TMD based on the RDC/TMD;
- Age between 40 and 70 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UniNove
São Paulo, São Paulo, 01504001, Brazil
Related Publications (1)
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.
PMID: 29373998DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra K Bussadori, PhD
University of Nove de Julho
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 11, 2017
First Posted
August 22, 2017
Study Start
May 1, 2017
Primary Completion
November 20, 2018
Study Completion
December 20, 2018
Last Updated
October 11, 2018
Record last verified: 2018-10