<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03257748</url>
  </required_header>
  <id_info>
    <org_study_id>DTMLU</org_study_id>
    <nct_id>NCT03257748</nct_id>
  </id_info>
  <brief_title>Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder</brief_title>
  <official_title>Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder: a Randomized, Controlled, Double-blind, Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of&#xD;
      signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and&#xD;
      neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is&#xD;
      affected with at least one sign. The disorder progresses with orofacial pain, muscle pain&#xD;
      involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block,&#xD;
      mandibular dysfunction and headache. The etiology can be abnormal occlusion and/or posture,&#xD;
      trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase&#xD;
      in emotional stress. Studies have demonstrated that phototherapy is an efficient option for&#xD;
      the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the&#xD;
      proposed study is to analyze the effects of low-level laser therapy and light-emitting diode&#xD;
      (LED) therapy on pain and function in patients with TMD. Methods: A randomized, controlled,&#xD;
      double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70&#xD;
      years of age allocated to either a laser group or LED group submitted to twelve sessions of&#xD;
      phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all&#xD;
      participants. Pain will be measured using the visual analog scale. Orofacial function will be&#xD;
      measured based on maximum vertical mandibular movement and muscle tension (determined through&#xD;
      palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius&#xD;
      muscles). Electromyographic analysis of the masseter and anterior temporal muscles will also&#xD;
      be performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">December 20, 2018</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Maximum vertical mandibular movement</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Muscle tension</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Electromyography</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder</condition>
  <arm_group>
    <arm_group_label>LED group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Laser Therapy</intervention_name>
    <description>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.</description>
    <arm_group_label>Laser group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>LED therapy</intervention_name>
    <description>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.</description>
    <arm_group_label>LED group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of TMD based on the RDC/TMD;&#xD;
&#xD;
          -  Age between 40 and 70 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dentofacial anomalies;&#xD;
&#xD;
          -  Currently in orthodontic or orthopedic treatment for the jaw;&#xD;
&#xD;
          -  Currently undergoing physical therapy;&#xD;
&#xD;
          -  Currently undergoing psychological treatment;&#xD;
&#xD;
          -  Use of muscle relaxant or anti-inflammatory agent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra K Bussadori, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nove de Julho</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandra K Bussadori, PhD</last_name>
    <phone>+55 11 26339000</phone>
    <email>sandra.skb@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luciana G Langella, Ms</last_name>
    <phone>+55 11 26339000</phone>
    <email>lucianalangella@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UniNove</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01504001</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra K Bussadori, Ms</last_name>
      <phone>+55 11 26339000</phone>
      <email>sandra.skb@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Sandra Kalil Bussadori</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257748
org study id: DTMLU
nct id: NCT03257748
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Visual Analog Scale
time frame: Through study completion, an average of 1 year.
description: 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.
measure: Visual Analog Scale
time frame: Through study completion, an average of 1 year.
description: 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.
measure: Maximum vertical mandibular movement
time frame: Through study completion, an average of 1 year.
description: 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.
measure: Muscle tension
time frame: Through study completion, an average of 1 year.
description: 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.
measure: Electromyography
time frame: Through study completion, an average of 1 year.
description: 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.
arm group label: LED group
arm group type: Experimental
description: 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.
arm group label: Laser group
arm group type: Experimental
description: 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.
intervention type: Radiation
intervention name: Laser Therapy
description: 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.
arm group label: Laser group
intervention type: Radiation
intervention name: LED therapy
description: 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.
arm group label: LED group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sandra K Bussadori, PhD
role: Principal Investigator
affiliation: University of Nove de Julho
last name: Sandra K Bussadori, PhD
phone: +55 11 26339000
email: sandra.skb@gmail.com
last name: Luciana G Langella, Ms
phone: +55 11 26339000
email: lucianalangella@hotmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Sandra Kalil Bussadori
investigator title: Principal Investigator
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
sharing ipd: Undecided