<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/NCT02991326</url>
  </required_header>
  <id_info>
    <org_study_id>Simone Oliveira</org_study_id>
    <nct_id>NCT02991326</nct_id>
  </id_info>
  <brief_title>Osteopathic Manipulative Treatment in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints</brief_title>
  <official_title>Osteopathic Manipulative Treatment Effect in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal Fluminense</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal Fluminense</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim to contribute with the investigation of the therapeutic effect of osteopathic&#xD;
      manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with&#xD;
      temporomandibular disorder who make use of occlusal splints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective:&#xD;
&#xD;
      It is known the multifactorial etiology of Temporomandibular Disorders(TMD) which raises the&#xD;
      need of a multidisciplinary approach for its treatment. Studies have presented good results&#xD;
      about the use of occlusal splints along with other therapies. The Osteopathic Manipulative&#xD;
      Treatment(OMT) has as characteristic the philosophy of global approach and precise functional&#xD;
      diagnosis. Based on a lack of randomized blind trials about this subject, This study aim to&#xD;
      contribute with the investigation of the therapeutic effect OMT in pain intensity and Quality&#xD;
      of Life in participants diagnosed with TMD making use of occlusal splints.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      This study is a randomized blind trial, with sample composed by 18 participants referred to&#xD;
      the occlusion clinic of Fluminense Federal University (UFF), diagnosed by the team of&#xD;
      dentists and interns of occlusion clinic through the Research Diagnostic Criteria for&#xD;
      Temporomandibular Disorders (RDC/TMD). The participants will complete the Short Form 36&#xD;
      Health Survey(SF-36) to measure the quality of life, and pain intensity diagram with Numeric&#xD;
      Rating Scale (NRS) to measure the pain intensity. The sample will be randomized into 2 groups&#xD;
      (9 individuals for each): Test Group (TG) - patients subject to Clinical Treatment with&#xD;
      splints (CT) offered at the Occlusion Clinic unit along with Osteopathic Manipulative&#xD;
      Treatment - OMT. Control Group (CG) - patients subject only to CT and will receive a sham&#xD;
      treatment that simulate the OMT to blind these participants. After the treatment, patients&#xD;
      will be re-evaluated in 8 weeks' time.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The SF-36 and the pain intensity and the most intense pain evaluation diagram with Numeric&#xD;
      Rating Scale (NRS) will be performed by the Wilcoxon's non parametric test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month</measure>
    <time_frame>2 months</time_frame>
    <description>The use of Numeric Rating Scale (NRS) to measure the pain intensity in each body area related by the individuals before and 2 months after the first intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months</measure>
    <time_frame>2 months</time_frame>
    <description>The use of Numeric Rating Scale (NRS) to measure de pain intensity in the body area with the most intensity pain related by the individuals before and 2 months after first intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months</measure>
    <time_frame>2 months</time_frame>
    <description>The use of SF36 to measure the score of quality of life before and 2 months after first intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Temporomandibular Disorder</condition>
  <arm_group>
    <arm_group_label>Test Group (TG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to Osteopathic Manipulative Treatment - OMT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (CG)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to sham intervention (Osteopathic Manipulative Treatment simulated).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Osteopathic Manipulative Treatment</intervention_name>
    <description>The Osteopathic manipulative treatment will follow the approach bellow (using latex gloves for intra oral techniques):&#xD;
Compression of the fourth ventricle;&#xD;
inhibitory intra-oral pressure technique (IPT) of the temporal muscle;&#xD;
inhibition of the inferior head of the lateral pterygoid muscle;&#xD;
intra-oral inhibition of the masseter muscle;&#xD;
Balanced ligamentous tension (BLT) of the accessory ligaments - sphenopalatine;&#xD;
BLT of the accessory ligaments - pterygomandibular raphe;&#xD;
sphenopalatine ganglion technique;&#xD;
Craniosacral rebalancing;</description>
    <arm_group_label>Test Group (TG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham intervention</intervention_name>
    <description>The sham intervention will be made in the same examination table and the same position, with the use of the latex gloves, to simulate the Osteopathic Manipulative Treatment, only doing simple touches without therapeutic effect intention.</description>
    <arm_group_label>Control Group (CG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals who has diagnosis of Temporomandibular disorder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals who already has subjected to osteopathic manipulative treatment to&#xD;
             temporomandibular disorder.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Felipe RT Goulart, Graduated</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal Fluminense University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal Fuminense University</name>
      <address>
        <city>Niteroi</city>
        <state>RJ</state>
        <zip>24020-140</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>May 16, 2019</last_update_submitted>
  <last_update_submitted_qc>May 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal Fluminense</investigator_affiliation>
    <investigator_full_name>Simone Saldanha Oliveira</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Osteopathic Manipulative Treatment</keyword>
  <keyword>Temporomandibular Disorder</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>
  </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/NCT02991326
org study id: Simone Oliveira
nct id: NCT02991326
lead sponsor: 
has dmc: No
This study aim to contribute with the investigation of the therapeutic effect of osteopathic
      manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with
      temporomandibular disorder who make use of occlusal splints.
Objective:

      It is known the multifactorial etiology of Temporomandibular Disorders(TMD) which raises the
      need of a multidisciplinary approach for its treatment. Studies have presented good results
      about the use of occlusal splints along with other therapies. The Osteopathic Manipulative
      Treatment(OMT) has as characteristic the philosophy of global approach and precise functional
      diagnosis. Based on a lack of randomized blind trials about this subject, This study aim to
      contribute with the investigation of the therapeutic effect OMT in pain intensity and Quality
      of Life in participants diagnosed with TMD making use of occlusal splints.

      Methodology:

      This study is a randomized blind trial, with sample composed by 18 participants referred to
      the occlusion clinic of Fluminense Federal University (UFF), diagnosed by the team of
      dentists and interns of occlusion clinic through the Research Diagnostic Criteria for
      Temporomandibular Disorders (RDC/TMD). The participants will complete the Short Form 36
      Health Survey(SF-36) to measure the quality of life, and pain intensity diagram with Numeric
      Rating Scale (NRS) to measure the pain intensity. The sample will be randomized into 2 groups
      (9 individuals for each): Test Group (TG) - patients subject to Clinical Treatment with
      splints (CT) offered at the Occlusion Clinic unit along with Osteopathic Manipulative
      Treatment - OMT. Control Group (CG) - patients subject only to CT and will receive a sham
      treatment that simulate the OMT to blind these participants. After the treatment, patients
      will be re-evaluated in 8 weeks' time.

      Statistical analysis:

      The SF-36 and the pain intensity and the most intense pain evaluation diagram with Numeric
      Rating Scale (NRS) will be performed by the Wilcoxon's non parametric test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month
time frame: 2 months
description: The use of Numeric Rating Scale (NRS) to measure the pain intensity in each body area related by the individuals before and 2 months after the first intervention.
measure: Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months
time frame: 2 months
description: The use of Numeric Rating Scale (NRS) to measure de pain intensity in the body area with the most intensity pain related by the individuals before and 2 months after first intervention.
measure: Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months
time frame: 2 months
description: The use of SF36 to measure the score of quality of life before and 2 months after first intervention.
arm group label: Test Group (TG)
arm group type: Experimental
description: The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to Osteopathic Manipulative Treatment - OMT.
arm group label: Control Group (CG)
arm group type: Sham Comparator
description: The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to sham intervention (Osteopathic Manipulative Treatment simulated).
intervention type: Other
intervention name: Osteopathic Manipulative Treatment
description: The Osteopathic manipulative treatment will follow the approach bellow (using latex gloves for intra oral techniques):
Compression of the fourth ventricle;
inhibitory intra-oral pressure technique (IPT) of the temporal muscle;
inhibition of the inferior head of the lateral pterygoid muscle;
intra-oral inhibition of the masseter muscle;
Balanced ligamentous tension (BLT) of the accessory ligaments - sphenopalatine;
BLT of the accessory ligaments - pterygomandibular raphe;
sphenopalatine ganglion technique;
Craniosacral rebalancing;
arm group label: Test Group (TG)
intervention type: Other
intervention name: Sham intervention
description: The sham intervention will be made in the same examination table and the same position, with the use of the latex gloves, to simulate the Osteopathic Manipulative Treatment, only doing simple touches without therapeutic effect intention.
arm group label: Control Group (CG)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Felipe RT Goulart, Graduated
role: Principal Investigator
affiliation: Federal Fluminense University
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal Fluminense
investigator full name: Simone Saldanha Oliveira
investigator title: Professor
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
sharing ipd: Undecided