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Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder

This study is currently recruiting participants.
Verified August 2017 by Sandra Kalil Bussadori, University of Nove de Julho
Sponsor:
ClinicalTrials.gov Identifier:
NCT03257748
First Posted: August 22, 2017
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho
  Purpose
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.

Condition Intervention Phase
Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder Radiation: Laser Therapy Radiation: LED therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder: a Randomized, Controlled, Double-blind, Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sandra Kalil Bussadori, University of Nove de Julho:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 80
Actual Study Start Date: May 1, 2017
Estimated Study Completion Date: December 20, 2017
Estimated Primary Completion Date: December 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Radiation: LED therapy
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.
Radiation: Laser Therapy
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257748


Contacts
Contact: Sandra K Bussadori, PhD +55 11 26339000 sandra.skb@gmail.com
Contact: Luciana G Langella, Ms +55 11 26339000 lucianalangella@hotmail.com

Locations
Brazil
UniNove Recruiting
São Paulo, SP, Brazil, 01504001
Contact: Sandra K Bussadori, Ms    +55 11 26339000    sandra.skb@gmail.com   
Sponsors and Collaborators
University of Nove de Julho
Investigators
Principal Investigator: Sandra K Bussadori, PhD University of Nove de Julho
  More Information

Responsible Party: Sandra Kalil Bussadori, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03257748     History of Changes
Other Study ID Numbers: DTMLU
First Submitted: August 11, 2017
First Posted: August 22, 2017
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes