<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/NCT04468464</url>
  </required_header>
  <id_info>
    <org_study_id>ACorekci</org_study_id>
    <nct_id>NCT04468464</nct_id>
  </id_info>
  <brief_title>Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging</brief_title>
  <acronym>TMD</acronym>
  <official_title>Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yeditepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yeditepe University</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 aim of this study is to assess the impact of osteopathic manual treatment in patients&#xD;
      with an anterior disc displacement over sleep and health quality, pain scores and the&#xD;
      movement of the condyle and disc of the temporomandibular joint (TMJ) quantitatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with TMD will involve to this study. After having the diagnose in Yeditepe U. Dental&#xD;
      Hospital patients will be sent to the Radiology Department. MRI images will be gathered in&#xD;
      sagittal, coronal and axial plane for each patient before and after treatment. Volunteers&#xD;
      will be divided into two groups; (1) splint therapy for 6 weeks, (2) splint therapy +&#xD;
      osteopathy 2 times a week for 6 weeks randomly. At the end of the treatment, patients will be&#xD;
      sent to Radiology for the second images. Health Survey and pain scores, Disc condyle angle,&#xD;
      disc and condyle displacements will be measured and compared inter and intra groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 15, 2018</start_date>
  <completion_date type="Anticipated">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 20, 2019</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>
    <intervention_model_description>Both groups receive splint treatment, but study group also receives osteopathic manual treatment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The Radiologist who evaluates the MRI results was blinded about the group of participants and also blinded about the diagnosis of the dentist.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Temporomandibular Joint Pain</measure>
    <time_frame>6 weeks after the first measurement</time_frame>
    <description>10 point scale 0- no pain 10- severe pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in TMJ MR images</measure>
    <time_frame>6 weeks after the first measurement</time_frame>
    <description>Disc-condyle angle, disc and condyle positions were measured over TMJ images</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mandibular Movements</measure>
    <time_frame>6 weeks after the first measurement</time_frame>
    <description>Depression, Left and Right lateralization of the mandibula was measured by the caliper</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cervical Movement</measure>
    <time_frame>6 weeks after the first measurement</time_frame>
    <description>Cervical Region range of motions was measured by a goniometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in bodily pain</measure>
    <time_frame>6 weeks after the first measurement</time_frame>
    <description>10 point scale 0- no pain 10- severe pain</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Life Quality score</measure>
    <time_frame>6 weeks after the first measurement</time_frame>
    <description>A high score corresponds to a good quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in sleep quality score</measure>
    <time_frame>6 weeks after the first measurement</time_frame>
    <description>A high score corresponds to a low quality of the sleep</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">19</enrollment>
  <condition>Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing)</condition>
  <condition>Osteopathy in Temporomandibular Disorders</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Occlusal Splint</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Osteopathic Manuel Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Occlusal Splint Treatment</intervention_name>
    <description>Occlusal splint is used by a dentist during sleep or day time to protect the teeth and temporomandibular joint. Manufactured individually by the technicians according to the dentists measurement procedure.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Osteopathic Manual Treatment</intervention_name>
    <description>Osteopathy treats the body as a whole and applied by hands over the related structures of the body. TMJ, Cervical, Thoracal, Lumbar vertebra mobilization was applied as well as the fascial and visceral mobilization. Patients also used occlusal splint for 6 weeks during the intervention.</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Clinical diagnosis of TMD (anterior disc displacement)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active orthodontic treatment&#xD;
&#xD;
          -  Systemic diseases&#xD;
&#xD;
          -  Oral or dental pathologies&#xD;
&#xD;
          -  Dental implant placement&#xD;
&#xD;
          -  Exodontia within 6 months&#xD;
&#xD;
          -  Cranial and cervical trauma or surgery&#xD;
&#xD;
          -  Taking antidepressant medication&#xD;
&#xD;
          -  Contraindication of MRI scans&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yeditepe University</name>
      <address>
        <city>İstanbul</city>
        <state>Ataşehir</state>
        <zip>34755</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kalamir, A., Pollard, H., Vitiello, A. L., &amp; Bonello, R. (2007). Manual therapy for temporomandibular disorders: A review of the literature. Journal of Bodywork and Movement Therapies, 11(1), 84-90. https://doi.org/10.1016/j.jbmt.2006.07.003</citation>
  </reference>
  <reference>
    <citation>Kurita H, Kurashina K, Ohtsuka A, Kotani A. Change of position of the temporomandibular joint disk with insertion of a disk-repositioning appliance. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Feb;85(2):142-5. doi: 10.1016/s1079-2104(98)90416-4.</citation>
    <PMID>9503446</PMID>
  </reference>
  <reference>
    <citation>Gesslbauer C, Vavti N, Keilani M, Mickel M, Crevenna R. Effectiveness of osteopathic manipulative treatment versus osteopathy in the cranial field in temporomandibular disorders - a pilot study. Disabil Rehabil. 2018 Mar;40(6):631-636. doi: 10.1080/09638288.2016.1269368. Epub 2016 Dec 28.</citation>
    <PMID>28029069</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>temporomandibular disorders, anterior disc displacement with reduction, MRI analyses, Osteopathy</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>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>


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/NCT04468464
org study id: ACorekci
nct id: NCT04468464
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the impact of osteopathic manual treatment in patients
      with an anterior disc displacement over sleep and health quality, pain scores and the
      movement of the condyle and disc of the temporomandibular joint (TMJ) quantitatively.
Patients with TMD will involve to this study. After having the diagnose in Yeditepe U. Dental
      Hospital patients will be sent to the Radiology Department. MRI images will be gathered in
      sagittal, coronal and axial plane for each patient before and after treatment. Volunteers
      will be divided into two groups; (1) splint therapy for 6 weeks, (2) splint therapy +
      osteopathy 2 times a week for 6 weeks randomly. At the end of the treatment, patients will be
      sent to Radiology for the second images. Health Survey and pain scores, Disc condyle angle,
      disc and condyle displacements will be measured and compared inter and intra groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Both groups receive splint treatment, but study group also receives osteopathic manual treatment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: The Radiologist who evaluates the MRI results was blinded about the group of participants and also blinded about the diagnosis of the dentist.
measure: Change in Temporomandibular Joint Pain
time frame: 6 weeks after the first measurement
description: 10 point scale 0- no pain 10- severe pain
measure: Change in TMJ MR images
time frame: 6 weeks after the first measurement
description: Disc-condyle angle, disc and condyle positions were measured over TMJ images
measure: Change in Mandibular Movements
time frame: 6 weeks after the first measurement
description: Depression, Left and Right lateralization of the mandibula was measured by the caliper
measure: Change in Cervical Movement
time frame: 6 weeks after the first measurement
description: Cervical Region range of motions was measured by a goniometer
measure: Changes in bodily pain
time frame: 6 weeks after the first measurement
description: 10 point scale 0- no pain 10- severe pain
measure: Change in Life Quality score
time frame: 6 weeks after the first measurement
description: A high score corresponds to a good quality of life
measure: Change in sleep quality score
time frame: 6 weeks after the first measurement
description: A high score corresponds to a low quality of the sleep
arm group label: Control Group
arm group type: Active Comparator
description: Occlusal Splint
arm group label: Study Group
arm group type: Experimental
description: Osteopathic Manuel Therapy
intervention type: Other
intervention name: Occlusal Splint Treatment
description: Occlusal splint is used by a dentist during sleep or day time to protect the teeth and temporomandibular joint. Manufactured individually by the technicians according to the dentists measurement procedure.
arm group label: Control Group
arm group label: Study Group
intervention type: Other
intervention name: Osteopathic Manual Treatment
description: Osteopathy treats the body as a whole and applied by hands over the related structures of the body. TMJ, Cervical, Thoracal, Lumbar vertebra mobilization was applied as well as the fascial and visceral mobilization. Patients also used occlusal splint for 6 weeks during the intervention.
arm group label: Study Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Kalamir, A., Pollard, H., Vitiello, A. L., & Bonello, R. (2007). Manual therapy for temporomandibular disorders: A review of the literature. Journal of Bodywork and Movement Therapies, 11(1), 84-90. https://doi.org/10.1016/j.jbmt.2006.07.003
citation: Kurita H, Kurashina K, Ohtsuka A, Kotani A. Change of position of the temporomandibular joint disk with insertion of a disk-repositioning appliance. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Feb;85(2):142-5. doi: 10.1016/s1079-2104(98)90416-4.
PMID: 9503446
citation: Gesslbauer C, Vavti N, Keilani M, Mickel M, Crevenna R. Effectiveness of osteopathic manipulative treatment versus osteopathy in the cranial field in temporomandibular disorders - a pilot study. Disabil Rehabil. 2018 Mar;40(6):631-636. doi: 10.1080/09638288.2016.1269368. Epub 2016 Dec 28.
PMID: 28029069
responsible party type: Sponsor
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Joint Diseases
mesh term: Salicylic Acid
sharing ipd: No