xml: <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/NCT05989217</url>
    </required_header>
    <id_info>
      <org_study_id>TMJ Disorders</org_study_id>
      <nct_id>NCT05989217</nct_id>
    </id_info>
    <brief_title>Conservative Therapies in the Treatment of Temporomandibular Disorders</brief_title>
    <official_title>Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidade Federal de Alfenas</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidade Federal de Alfenas</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The present study was designed to compare the effects of the mixed occlusal device using the&#xD;
        simplified technique and the low-intensity laser alone or in combination in patients with&#xD;
        temporomandibular disorders. A total of 96 patients will be selected after the diagnosis of&#xD;
        TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD), axis I.&#xD;
        Patients will be randomly divided into three groups: Occlusal Device (N=32), Laser (N=32)&#xD;
        =32) and Occlusal Device and Laser (N=32). Patients undergoing therapy with a stabilizing&#xD;
        plate made using the simplified technique will be instructed to use the device every night&#xD;
        while sleeping for four weeks. Photobiomodulation will be applied with low-intensity laser at&#xD;
        predetermined points and at specific trigger points identified during the clinical&#xD;
        examination (3 J/cm2) once a week for four weeks. The intensity of pain will be classified&#xD;
        using the Visual Analog Scale (VAS). Mandible function will be assessed by maximum unassisted&#xD;
        mouth opening. The impact of therapies on oral health will also be evaluated through the Oral&#xD;
        Health Impact Profile (OHIP-14) instrument in a simplified form. The ANOVA test will be used&#xD;
        to compare the results obtained between the study groups, while the Repeated Measurements&#xD;
        Anova test complemented by the Tukey test will be used for longitudinal evaluation of the&#xD;
        data within each group.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <phase>N/A</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain in the Temporomandibular Joint and/or masticatory muscles</measure>
      <time_frame>Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.</time_frame>
      <description>The visual analog scale (VAS) will be used to quantify spontaneous pain in the Temporomandibular Joint and/or masticatory muscles at rest or during palpation. The VAS is a line (ruler) 10 cm long, with a left end point indicating a pain-free state and a right end point indicating the greatest imaginable pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mouth opening</measure>
      <time_frame>Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks.</time_frame>
      <description>Pain-free opening is defined as the maximum amount a patient can achieve when opening their mouth without experiencing pain and will be measured as the distance between the incisal edges of the upper and lower central incisors.&#xD;
  Maximum unassisted mouth opening will be measured as the distance between the upper and lower central incisors and defined as the greatest amount of opening a patient can achieve regardless of pain and discomfort.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral Health Impact Profile</measure>
      <time_frame>Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.</time_frame>
      <description>The impact of oral health-related quality of life will be analyzed using the Oral Health Impact Profile - Short form (OHIP-14) questionnaire.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Temporomandibular Joint Disorders</condition>
    <condition>Temporomandibular Joint Pain</condition>
    <condition>Splints</condition>
    <condition>Photobiomodulation</condition>
    <arm_group>
      <arm_group_label>Occlusal Splint</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants allocated will receive therapy with a stabilizing plate made by the simplified technique. This plate is made of an acetate plate, plasticized in a plaster model, and individualized by acrylic resin. This technique allows the professional to make and install the plate in a short time, without the laboratory step, and is also more economical.&#xD;
  After the plate installation and adjustments, the participant will be instructed to use the device every night during sleep. Weekly adjustments will be performed for 4 weeks, and in these sessions information regarding the research parameters will be collected.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Laser Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will be examined and pain trigger points will be identified, if any. The laser will be applied at predetermined points and at specific trigger points identified during the clinical examination. The application of the laser will be symmetrical, i.e. on both sides of the face, with the same number of points, regardless of whether it is a &quot;trigger point&quot; or not.&#xD;
  The equipment to be used and the parameters for the applications have the following characteristics: 808 nm wavelength, 100 mW of useful emitter power, 105 J/cm2 of energy density, spot area 0.028 cm2, Energy/point 3 J, 1 application per week for 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Occlusal Splint + Laser Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Occlusal Splint</intervention_name>
      <description>Occlusion Splint</description>
      <arm_group_label>Occlusal Splint</arm_group_label>
      <arm_group_label>Occlusal Splint + Laser Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Laser Therapy</intervention_name>
      <description>Laser Therapy</description>
      <arm_group_label>Laser Therapy</arm_group_label>
      <arm_group_label>Occlusal Splint + Laser Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults of legal age&#xD;
  &#xD;
            -  Both sexes&#xD;
  &#xD;
            -  Regardless of race or social class&#xD;
  &#xD;
            -  With the main complaint of pain in the temporomandibular joint or orofacial region&#xD;
  &#xD;
            -  With or without limitation of mouth opening, diagnosed through the DC/TMD axis1, with&#xD;
               pain in the masticatory mm and muscular TMD&#xD;
  &#xD;
            -  Participants must have complete permanent dentition and normal occlusion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Congenital problems affecting the TMJ and/or orofacial and cervical region of the&#xD;
               skull;&#xD;
  &#xD;
            -  Neoplastic conditions;&#xD;
  &#xD;
            -  History of recent trauma to the orofacial/cervical region of the skull;&#xD;
  &#xD;
            -  Previous use of any type of TMD treatment plate;&#xD;
  &#xD;
            -  Current use of functional orthopedic appliances or fixed and/or removable orthodontic&#xD;
               appliances;&#xD;
  &#xD;
            -  Cleft lip and/or palate syndromes;&#xD;
  &#xD;
            -  Psychiatric disorders;&#xD;
  &#xD;
            -  Severe cardiac problems;&#xD;
  &#xD;
            -  A severely poor dental condition such as periodontitis and/or indication for&#xD;
               endodontic treatment;&#xD;
  &#xD;
            -  Those using topical or systemic photosensitizing drugs;&#xD;
  &#xD;
            -  Pregnant women;&#xD;
  &#xD;
            -  Dermatological diseases in the region where irradiation will be performed;&#xD;
  &#xD;
            -  Patients with impaired cognitive ability;&#xD;
  &#xD;
            -  History of head trauma related to the etiology of orofacial pain;&#xD;
  &#xD;
            -  Migraine or intracranial disorders;&#xD;
  &#xD;
            -  Who used medications in the last 3 months that may interfere with the effect of&#xD;
               therapies, such as relaxants, anticonvulsants and who used medications to treat TMD or&#xD;
               muscular pain;&#xD;
  &#xD;
            -  Who had other causes of orofacial pain, such as caries, neuropathies and fibromyalgia;&#xD;
  &#xD;
            -  Who had phobia about needles or bleeding disorders;&#xD;
  &#xD;
            -  Patients who are unable to attend the clinic during the prescribed treatment period;&#xD;
  &#xD;
            -  Patient who insists on a specific treatment (e.g. occlusal adjustments, medication);&#xD;
  &#xD;
            -  Presence of removable full or partial dentures with distal extension.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel Almeida, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universidade Federal de Alfenas</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daniel Almeida</last_name>
      <phone>+553537019400</phone>
      <email>daniel.faria@unifal-mg.edu.br</email>
    </overall_contact>
    <location>
      <facility>
        <name>Universidade Federal de Alfenas</name>
        <address>
          <city>Alfenas</city>
          <state>Minas Gerais</state>
          <zip>37130001</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniel Almeida, PhD</last_name>
        <phone>+5535999593069</phone>
      </contact>
      <investigator>
        <last_name>Daniel F Almeida, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Letícia C Siqueira</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidade Federal de Alfenas</investigator_affiliation>
      <investigator_full_name>Daniel Augusto de Faria Almeida</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Temporomandibular Joint Disorders</keyword>
    <keyword>Splints</keyword>
    <keyword>Laser therapy</keyword>
    <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>
      <mesh_term>Arthralgia</mesh_term>
      <mesh_term>Joint Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Salicylic Acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989217
  org study id: TMJ Disorders
  nct id: NCT05989217
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The present study was designed to compare the effects of the mixed occlusal device using the
        simplified technique and the low-intensity laser alone or in combination in patients with
        temporomandibular disorders. A total of 96 patients will be selected after the diagnosis of
        TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD), axis I.
        Patients will be randomly divided into three groups: Occlusal Device (N=32), Laser (N=32)
        =32) and Occlusal Device and Laser (N=32). Patients undergoing therapy with a stabilizing
        plate made using the simplified technique will be instructed to use the device every night
        while sleeping for four weeks. Photobiomodulation will be applied with low-intensity laser at
        predetermined points and at specific trigger points identified during the clinical
        examination (3 J/cm2) once a week for four weeks. The intensity of pain will be classified
        using the Visual Analog Scale (VAS). Mandible function will be assessed by maximum unassisted
        mouth opening. The impact of therapies on oral health will also be evaluated through the Oral
        Health Impact Profile (OHIP-14) instrument in a simplified form. The ANOVA test will be used
        to compare the results obtained between the study groups, while the Repeated Measurements
        Anova test complemented by the Tukey test will be used for longitudinal evaluation of the
        data within each group.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Pain in the Temporomandibular Joint and/or masticatory muscles
  time frame: Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.
  description: The visual analog scale (VAS) will be used to quantify spontaneous pain in the Temporomandibular Joint and/or masticatory muscles at rest or during palpation. The VAS is a line (ruler) 10 cm long, with a left end point indicating a pain-free state and a right end point indicating the greatest imaginable pain.
  measure: Mouth opening
  time frame: Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks.
  description: Pain-free opening is defined as the maximum amount a patient can achieve when opening their mouth without experiencing pain and will be measured as the distance between the incisal edges of the upper and lower central incisors.
  Maximum unassisted mouth opening will be measured as the distance between the upper and lower central incisors and defined as the greatest amount of opening a patient can achieve regardless of pain and discomfort.
  measure: Oral Health Impact Profile
  time frame: Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.
  description: The impact of oral health-related quality of life will be analyzed using the Oral Health Impact Profile - Short form (OHIP-14) questionnaire.
  arm group label: Occlusal Splint
  arm group type: Experimental
  description: Participants allocated will receive therapy with a stabilizing plate made by the simplified technique. This plate is made of an acetate plate, plasticized in a plaster model, and individualized by acrylic resin. This technique allows the professional to make and install the plate in a short time, without the laboratory step, and is also more economical.
  After the plate installation and adjustments, the participant will be instructed to use the device every night during sleep. Weekly adjustments will be performed for 4 weeks, and in these sessions information regarding the research parameters will be collected.
  arm group label: Laser Therapy
  arm group type: Experimental
  description: All participants will be examined and pain trigger points will be identified, if any. The laser will be applied at predetermined points and at specific trigger points identified during the clinical examination. The application of the laser will be symmetrical, i.e. on both sides of the face, with the same number of points, regardless of whether it is a "trigger point" or not.
  The equipment to be used and the parameters for the applications have the following characteristics: 808 nm wavelength, 100 mW of useful emitter power, 105 J/cm2 of energy density, spot area 0.028 cm2, Energy/point 3 J, 1 application per week for 4 weeks.
  arm group label: Occlusal Splint + Laser Therapy
  arm group type: Experimental
  description: The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.
  intervention type: Device
  intervention name: Occlusal Splint
  description: Occlusion Splint
  arm group label: Occlusal Splint
  arm group label: Occlusal Splint + Laser Therapy
  intervention type: Radiation
  intervention name: Laser Therapy
  description: Laser Therapy
  arm group label: Laser Therapy
  arm group label: Occlusal Splint + Laser Therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daniel Almeida, PhD
  role: Principal Investigator
  affiliation: Universidade Federal de Alfenas
  last name: Daniel Almeida
  phone: +553537019400
  email: daniel.faria@unifal-mg.edu.br
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: Universidade Federal de Alfenas
  investigator full name: Daniel Augusto de Faria Almeida
  investigator title: Principal Investigator
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  mesh term: Arthralgia
  mesh term: Joint Diseases
  mesh term: Salicylic Acid
  sharing ipd: No