<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/NCT02251015</url>
  </required_header>
  <id_info>
    <org_study_id>Postural balance</org_study_id>
    <nct_id>NCT02251015</nct_id>
  </id_info>
  <brief_title>Effects of the Use of Occlusal Splint on the Postural Balance of Individuals With Temporomandibular Disorder</brief_title>
  <official_title>Evaluation of Postural Balance in Individuals With Temporomandibular Disorder by Means of Force Platform After Using Occlusal Stabilizer Splint Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effects of the use of occlusal splint over postural balance in individuals&#xD;
      with signs and symptoms of temporomandibular disorder. The research group consists of 49&#xD;
      patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old,&#xD;
      both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD questionnaire and&#xD;
      magnetic resonance imaging of the temporomandibular joints. The research is a randomized,&#xD;
      controlled, prospective clinical study with intervention. Postural equilibrium will be&#xD;
      evaluated by means of a force plate. In the randomization, the splinted group was under an&#xD;
      occlusal-stability criterion as well as advised under therapeutic exercises while the control&#xD;
      group got only orientation about therapeutic exercises. After 12 weeks, the groups were&#xD;
      re-evaluated. The results will be analyzed by categorical data using absolute and relative&#xD;
      frequencies as well as continuous data using average, median, standard deviation, 25 and 75&#xD;
      percentiles, besides minimum and maximum values; comparison between the times by&#xD;
      non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of significance of&#xD;
      0.05.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      approved 06/29/2011&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>to investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.</measure>
    <time_frame>twelve weeks</time_frame>
    <description>Postural equilibrium was evaluated by means of a force plate. In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation related to therapeutic exercises.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Temporomandibular Disorders</condition>
  <arm_group>
    <arm_group_label>therapeutic exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>13 as control group - The control group got only orientation related to therapeutic exercises.The orientation for therapeutic exercises seek to correctly position the jaw in the resting position. Maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>occlusal plate group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>36 getting occlusal splints - the splinted group was subjects that used occlusal plate under the occlusal stability criteria. The patients also received therapeutic exercises too. The plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>occlusal plate</intervention_name>
    <description>In the plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day.&#xD;
The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day.</description>
    <arm_group_label>occlusal plate group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>therapeutic exercises</intervention_name>
    <description>The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day.</description>
    <arm_group_label>occlusal plate group</arm_group_label>
    <arm_group_label>therapeutic exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic Criteria Temporomandibular Disorders and dentate subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simone de Oliveira, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>São Paulo/SP</state>
        <zip>05508-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>November 6, 2013</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 9, 2015</last_update_submitted>
  <last_update_submitted_qc>September 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Simone Saldanha Ignacio de Oliveira</investigator_full_name>
    <investigator_title>Effects of the use of occlusal splint on the postural balance of individuals with temporomandibular disorder</investigator_title>
  </responsible_party>
  <keyword>Postural balance</keyword>
  <keyword>Temporomandibular disorders</keyword>
  <keyword>splints</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salicylic Acid</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02251015
org study id: Postural balance
nct id: NCT02251015
lead sponsor: 
has dmc: Yes
To investigate the effects of the use of occlusal splint over postural balance in individuals
      with signs and symptoms of temporomandibular disorder. The research group consists of 49
      patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old,
      both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD questionnaire and
      magnetic resonance imaging of the temporomandibular joints. The research is a randomized,
      controlled, prospective clinical study with intervention. Postural equilibrium will be
      evaluated by means of a force plate. In the randomization, the splinted group was under an
      occlusal-stability criterion as well as advised under therapeutic exercises while the control
      group got only orientation about therapeutic exercises. After 12 weeks, the groups were
      re-evaluated. The results will be analyzed by categorical data using absolute and relative
      frequencies as well as continuous data using average, median, standard deviation, 25 and 75
      percentiles, besides minimum and maximum values; comparison between the times by
      non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of significance of
      0.05.
approved 06/29/2011
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: to investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.
time frame: twelve weeks
description: Postural equilibrium was evaluated by means of a force plate. In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation related to therapeutic exercises.
arm group label: therapeutic exercises
arm group type: Active Comparator
description: 13 as control group - The control group got only orientation related to therapeutic exercises.The orientation for therapeutic exercises seek to correctly position the jaw in the resting position. Maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day.
arm group label: occlusal plate group
arm group type: Experimental
description: 36 getting occlusal splints - the splinted group was subjects that used occlusal plate under the occlusal stability criteria. The patients also received therapeutic exercises too. The plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day.
intervention type: Procedure
intervention name: occlusal plate
description: In the plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day.
The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day.
arm group label: occlusal plate group
intervention type: Procedure
intervention name: therapeutic exercises
description: The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day.
arm group label: occlusal plate group
arm group label: therapeutic exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Simone de Oliveira, PHD
role: Principal Investigator
affiliation: University of São Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Simone Saldanha Ignacio de Oliveira
investigator title: Effects of the use of occlusal splint on the postural balance of individuals with temporomandibular disorder
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Salicylic Acid