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/NCT06011382</url>
    </required_header>
    <id_info>
      <org_study_id>NKarvelas</org_study_id>
      <nct_id>NCT06011382</nct_id>
    </id_info>
    <brief_title>Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®)</brief_title>
    <official_title>Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Grigore T. Popa University of Medicine and Pharmacy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aristotle University Of Thessaloniki</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Grigore T. Popa University of Medicine and Pharmacy</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and&#xD;
        skeletal treatment effects of the AMDA when used for distalization of the maxillary first&#xD;
        molars in patients with Class II malocclusion in the permanent dentition.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary aim is to evaluate two different treatment groups from initiation of treatment up&#xD;
        until completion of maxillary molar distalization of:&#xD;
  &#xD;
          -  Group I: patients treated with amda®&#xD;
  &#xD;
          -  Group II: patients treated with buccal mini-implants&#xD;
  &#xD;
        More specifically to evaluate the efficiency of the AMDA using lateral cephalograms and&#xD;
        digital 3D model casts of the patients under investigation at the following time points:&#xD;
  &#xD;
          -  point T0: baseline data - before initiation of the treatment&#xD;
  &#xD;
          -  point T1: immediately after distalization (8-12 months)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 20, 2022</start_date>
    <completion_date type="Anticipated">June 20, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 20, 2024</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>Two arm parallel randomized controlled trial with 1:1 allocation ratio</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Anteroposterior position changes of upper first molars.</measure>
      <time_frame>8-12 months</time_frame>
      <description>Anteroposterior position movement in mm of the upper first molars</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Measurements on the lateral cephalograms and digital 3D model casts.</measure>
      <time_frame>8-12 months</time_frame>
      <description>Angular measurements of the lateral cephalograms and digital models</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Measurements on the lateral cephalograms and digital 3D model casts.</measure>
      <time_frame>8-12 months</time_frame>
      <description>Linear measurements of the lateral cephalograms and digital models</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Angle Class II</condition>
    <arm_group>
      <arm_group_label>patients treated with amda®</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>patients treated with buccal mini-implants</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>from initiation of treatment until completion of maxillary molar distalization.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Advanced Molar Distalization Appliance (amda®)</intervention_name>
      <description>AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization</description>
      <arm_group_label>patients treated with amda®</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Buccal mini-implants</intervention_name>
      <description>Buccal mini-implants for maxillary molar distalization</description>
      <arm_group_label>patients treated with buccal mini-implants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients to have permanent dentition&#xD;
  &#xD;
            -  with or without the 2nd molar erupted&#xD;
  &#xD;
            -  bilateral Class II molar relationships (a quarter to 1 molar cusp).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Past orthodontic treatment&#xD;
  &#xD;
            -  crossbites,&#xD;
  &#xD;
            -  severe carious lesions,&#xD;
  &#xD;
            -  poor oral hygiene,&#xD;
  &#xD;
            -  mobility of the maxillary first molars,&#xD;
  &#xD;
            -  anterior open bites,&#xD;
  &#xD;
            -  vertical growth pattern,&#xD;
  &#xD;
            -  tongue habits.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>20 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nikolaos Karvelas, PhD student</last_name>
      <role>Principal Investigator</role>
      <affiliation>Grigore T Popa University, Department of Orthodontics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nikolaos Karvelas, PhD student</last_name>
      <phone>+40 759481645</phone>
      <email>karvelas93@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Medicine and Pharmacy &quot;Grigore T. Popa&quot;</name>
        <address>
          <city>Iasi</city>
          <zip>70015</zip>
          <country>Romania</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>UMF Grigore T. Popa</last_name>
        <phone>+40759481645</phone>
        <email>karvelas93@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Nikolaos Karvelas, PhD student</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Romania</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Grigore T. Popa University of Medicine and Pharmacy</investigator_affiliation>
      <investigator_full_name>Nikolaos Karvelas</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>amda®</keyword>
    <keyword>maxillary molar distalization</keyword>
    <keyword>randomized controlled trial</keyword>
    <keyword>orthodontics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Malocclusion, Angle Class II</mesh_term>
      <mesh_term>Overbite</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data will be availaible upon request</ipd_description>
    </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/NCT06011382
  org study id: NKarvelas
  nct id: NCT06011382
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and
        skeletal treatment effects of the AMDA when used for distalization of the maxillary first
        molars in patients with Class II malocclusion in the permanent dentition.
  The primary aim is to evaluate two different treatment groups from initiation of treatment up
        until completion of maxillary molar distalization of:
  
          -  Group I: patients treated with amda®
  
          -  Group II: patients treated with buccal mini-implants
  
        More specifically to evaluate the efficiency of the AMDA using lateral cephalograms and
        digital 3D model casts of the patients under investigation at the following time points:
  
          -  point T0: baseline data - before initiation of the treatment
  
          -  point T1: immediately after distalization (8-12 months)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two arm parallel randomized controlled trial with 1:1 allocation ratio
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Anteroposterior position changes of upper first molars.
  time frame: 8-12 months
  description: Anteroposterior position movement in mm of the upper first molars
  measure: Measurements on the lateral cephalograms and digital 3D model casts.
  time frame: 8-12 months
  description: Angular measurements of the lateral cephalograms and digital models
  measure: Measurements on the lateral cephalograms and digital 3D model casts.
  time frame: 8-12 months
  description: Linear measurements of the lateral cephalograms and digital models
  arm group label: patients treated with amda®
  arm group type: Active Comparator
  description: two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization.
  arm group label: patients treated with buccal mini-implants
  arm group type: Active Comparator
  description: from initiation of treatment until completion of maxillary molar distalization.
  intervention type: Device
  intervention name: Advanced Molar Distalization Appliance (amda®)
  description: AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization
  arm group label: patients treated with amda®
  intervention type: Device
  intervention name: Buccal mini-implants
  description: Buccal mini-implants for maxillary molar distalization
  arm group label: patients treated with buccal mini-implants
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 20 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nikolaos Karvelas, PhD student
  role: Principal Investigator
  affiliation: Grigore T Popa University, Department of Orthodontics
  last name: Nikolaos Karvelas, PhD student
  phone: +40 759481645
  email: karvelas93@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Romania
  responsible party type: Principal Investigator
  investigator affiliation: Grigore T. Popa University of Medicine and Pharmacy
  investigator full name: Nikolaos Karvelas
  investigator title: Principal Investigator
  mesh term: Malocclusion, Angle Class II
  mesh term: Overbite
  sharing ipd: No
  ipd description: The data will be availaible upon request