- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03257748
Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder
October 10, 2018 updated by: Sandra Kalil Bussadori, University of Nove de Julho
Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder: a Randomized, Controlled, Double-blind, Clinical Trial
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sandra K Bussadori, PhD
- Phone Number: +55 11 26339000
- Email: sandra.skb@gmail.com
Study Contact Backup
- Name: Luciana G Langella, Ms
- Phone Number: +55 11 26339000
- Email: lucianalangella@hotmail.com
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 01504001
- Recruiting
- UniNove
-
Contact:
- Sandra K Bussadori, Ms
- Phone Number: +55 11 26339000
- Email: sandra.skb@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LED group
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.
|
Experimental: Laser group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: Through study completion, an average of 1 year.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: Through study completion, an average of 1 year.
|
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.
|
Maximum vertical mandibular movement
Time Frame: Through study completion, an average of 1 year.
|
Maximum vertical mandibular movement: The volunteer will be instructed to open his/her mouth a wide as possible.
Maximum vertical mandibular movement will be measured as the distance between the maxillary and mandibular central incisors determined with the aid of digital calipers.
The volunteer will then be instructed to exert pressure on the mandibular teeth with the mouth open and move the mandible to the right and left for the determination of excursion (distance between upper and lower mid points).
These procedures will be performed before and immediately after treatment.
|
Through study completion, an average of 1 year.
|
Muscle tension
Time Frame: Through study completion, an average of 1 year.
|
Muscle tension: Palpation will be performed of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscle.
The classification proposed by Jensen et al. will be used, with the following scores: 0 = absence of pain; 1 = mild discomfort; 2 = moderate pain; and 3 = severe pain.
These procedures will be performed before and immediately after treatment.
|
Through study completion, an average of 1 year.
|
Electromyography
Time Frame: Through study completion, an average of 1 year.
|
The electrical signals of the right and left masseter and anterior temporal muscles will be captured.
The EMG signal will be determined using a four-channel acquisition system (EMG System do Brasil Ltda.) with a sampling frequency of 2 KHz.
The signal will be digitized using an analog-to-digital converter with 16 bits of resolution.
The EMGLab (EMG System do Brasil Ltda) will be employed as the acquisition system.
These procedures will be performed before and immediately after treatment.
|
Through study completion, an average of 1 year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandra K Bussadori, PhD, University of Nove de Julho
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Anticipated)
November 20, 2018
Study Completion (Anticipated)
December 20, 2018
Study Registration Dates
First Submitted
August 11, 2017
First Submitted That Met QC Criteria
August 21, 2017
First Posted (Actual)
August 22, 2017
Study Record Updates
Last Update Posted (Actual)
October 11, 2018
Last Update Submitted That Met QC Criteria
October 10, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DTMLU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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