<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/NCT03008681</url>
  </required_header>
  <id_info>
    <org_study_id>2010-918</org_study_id>
    <nct_id>NCT03008681</nct_id>
  </id_info>
  <brief_title>OHRQoL Evaluation After Functional Therapy in JIA Patients</brief_title>
  <official_title>Oral Health-Related Quality of Life in Patients With Juvenile Idiopathic Arthritis and Temporomandibular Joint Disorders Evaluation After Treatment With a Functional Appliance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Messina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Messina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to determine the changes in Oral Health-Related Quality of Life&#xD;
      (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint&#xD;
      (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex&#xD;
      group in which the functional therapy was most effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective interventional study included 93 patients with JIA and TMJ disorders at the&#xD;
      start of functional orthodontic therapy. Children were prospectively followed in the 24&#xD;
      months of treatment and completed the Oral Health Impact Profile (OHIP-14) before treatment&#xD;
      (T0), and at 6 months (T1), 12 months (T2), and 24 months (T3) after the start of therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2004</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TMJ disorder cessation</measure>
    <time_frame>24 months</time_frame>
    <description>TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>Andresen functional removable orthodontic appliance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the enrolled patients was applied the Andresen Activator (a removable orthodontic appliance) 12-14 hours in a day in total.&#xD;
Functional appliances helped the movement of the teeth, with the achievement of good facial muscle function. All patients in the cohort were treated with the andresen actovator appliancev for deep bite and class II malocclusion correction.&#xD;
The appliances were individually manufactured of acrylic resin, with a central screw and a vestibular arch, fabricated through a wax bite registration; the patient was guided to close the mouth in mandibular protrusion with coincidence of the upper and lower midlines. The registration bite was very thin in order to obtain a minimum vertical dimension. The activator was modified every three months increasing its posterior vertical dimension in order to stimulate the mandibular ramus growth thanks to the dislocation of the mandibular condyle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Andresen functional removable orthodontic appliance</intervention_name>
    <description>Included patients were treated for 24 months with a Functional removable orthodontic appliance, the Andresen activator. The initial checks were performed after 6 weeks with subsequent checks being carried out every 8th week, with the final follow-up at 24 months. The patient underwent functional treatment using the activator described in the protocol with midlines coincidence.</description>
    <arm_group_label>Andresen functional removable orthodontic appliance</arm_group_label>
    <other_name>Andresen Activator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The inclusion criteria were:&#xD;
&#xD;
          -  JIA with unilateral or bilateral TMJ arthritis treated with a functional appliance;&#xD;
&#xD;
          -  Clear signs or symptoms of TMJ arthritis based on clinical and radiological&#xD;
             examination.&#xD;
&#xD;
          -  No administration of intra-articular TMJ steroid injections throughout the course of&#xD;
             the orthopaedic functional treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous orthodontic treatment;&#xD;
&#xD;
          -  history of maxillofacial surgery;&#xD;
&#xD;
          -  genetic diseases, syndromes, other congenital deformities or any concurrent medical&#xD;
             condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giovanni Matarese, DDS</last_name>
    <role>Study Director</role>
    <affiliation>University of Messina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Messina</name>
      <address>
        <city>Messina</city>
        <zip>98125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Messina</investigator_affiliation>
    <investigator_full_name>Gaetano Isola, DDS, PhD</investigator_full_name>
    <investigator_title>DDS. PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_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/NCT03008681
org study id: 2010-918
nct id: NCT03008681
lead sponsor: 
has dmc: Yes
The aim of the study was to determine the changes in Oral Health-Related Quality of Life
      (OHRQoL) in patients with juvenile idiopathic arthritis (JIA) and temporomandibular joint
      (TMJ) disorders who underwent functional therapy for 24 months to assess the age and sex
      group in which the functional therapy was most effective.
This prospective interventional study included 93 patients with JIA and TMJ disorders at the
      start of functional orthodontic therapy. Children were prospectively followed in the 24
      months of treatment and completed the Oral Health Impact Profile (OHIP-14) before treatment
      (T0), and at 6 months (T1), 12 months (T2), and 24 months (T3) after the start of therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: TMJ disorder cessation
time frame: 24 months
description: TMJ disorder and clinical mandibular symmetry was achieved or if mandibular growth was estimated as ceased.
arm group label: Andresen functional removable orthodontic appliance
arm group type: Experimental
description: All the enrolled patients was applied the Andresen Activator (a removable orthodontic appliance) 12-14 hours in a day in total.
Functional appliances helped the movement of the teeth, with the achievement of good facial muscle function. All patients in the cohort were treated with the andresen actovator appliancev for deep bite and class II malocclusion correction.
The appliances were individually manufactured of acrylic resin, with a central screw and a vestibular arch, fabricated through a wax bite registration; the patient was guided to close the mouth in mandibular protrusion with coincidence of the upper and lower midlines. The registration bite was very thin in order to obtain a minimum vertical dimension. The activator was modified every three months increasing its posterior vertical dimension in order to stimulate the mandibular ramus growth thanks to the dislocation of the mandibular condyle.
intervention type: Device
intervention name: Andresen functional removable orthodontic appliance
description: Included patients were treated for 24 months with a Functional removable orthodontic appliance, the Andresen activator. The initial checks were performed after 6 weeks with subsequent checks being carried out every 8th week, with the final follow-up at 24 months. The patient underwent functional treatment using the activator described in the protocol with midlines coincidence.
arm group label: Andresen functional removable orthodontic appliance
other name: Andresen Activator
criteria: 
gender: All
minimum age: 8 Years
maximum age: 20 Years
healthy volunteers: No
last name: Giovanni Matarese, DDS
role: Study Director
affiliation: University of Messina
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Messina
investigator full name: Gaetano Isola, DDS, PhD
investigator title: DDS. PhD
mesh term: Arthritis
mesh term: Arthritis, Juvenile
sharing ipd: No