<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/NCT03757468</url>
  </required_header>
  <id_info>
    <org_study_id>RCT_Milano-Genova</org_study_id>
    <nct_id>NCT03757468</nct_id>
  </id_info>
  <brief_title>Pain and Discomfort During Maxillary Expansion</brief_title>
  <official_title>Pain and Discomfort During Maxillary Expansion: A Randomized Multicentric Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Genova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Genova</source>
  <oversight_info>
    <has_dmc>No</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 the present study is to investigate and analyze the perception of pain and&#xD;
      function impairment during the first week of activation with two different palatal expansion&#xD;
      screw to identify an effective pain prevention protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maxillary expansion with fixed appliance is a well-known and consolidated practice in&#xD;
      clinical orthodontics but current findings of &quot;evidence based dentistry&quot; have not yet&#xD;
      identified a better clinical expansion protocol. This issue is due both to the several&#xD;
      expansion screws available on the market and to the different screw activation protocols,&#xD;
      which could be grouped into rapid and slow, with several customizations. A recent systematic&#xD;
      review has shown that both rapid and slow expansion protocols are clinically effective on the&#xD;
      primary outcome, i.e. the resolution of the crossbite with a significant increase of skeletal&#xD;
      transversal dimension in the maxillary transverse deficiency subjects. If the type of&#xD;
      appliance based on its ability to solve the maxillary constriction is not any more the main&#xD;
      selection criteria, the choice of the orthodontist should, therefore, be based on the timing&#xD;
      and on a &quot;patient-oriented&quot; device, that minimizes the side effects, such as e.g. appliance&#xD;
      breakages, functional impairments and pain.&#xD;
&#xD;
      In the orthodontic daily practice, the pain of the little patient is the most frequent&#xD;
      symptom during treatment and is the one that most frightens/worries the child and the family.&#xD;
      Literature shows that rapid maxillary expansion is, among the early orthodontic therapies,&#xD;
      the one with the highest frequency of pain (up to 98%) as an adverse symptom reported by&#xD;
      patients. The pain is statistically linked to the rapid expansion protocol (2/turn/day),&#xD;
      during which, for each activation of the screw (0.2 or 0.25 mm) the force expressed can reach&#xD;
      up to 10 pounds which acts in an orthopaedic manner on the palatine suture and the&#xD;
      circummascellar sutures. Following this orthopedic action, a disorganized and highly&#xD;
      vascularized connective tissue (inflammatory) is formed in palatine suture area, which&#xD;
      becomes the main receptor of the pain perceived by the patient during the active maxillary&#xD;
      expansion. In the literature the prevention and management of pain during palate expansion is&#xD;
      a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice and&#xD;
      so the aim of the present study is to investigate and analyze the perception of pain and&#xD;
      function impairment during the first week of activation with two different palatal expansion&#xD;
      screw to identify an effective pain prevention protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Crossbite correction</measure>
    <time_frame>10 months</time_frame>
    <description>Clinical evaluation in vivo (binary outcome yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Traversal maxillary deficiency correction</measure>
    <time_frame>10 months</time_frame>
    <description>Measured on digital dental casts (increase in mm of the intermolar and intercanine width)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain during active expansion phase</measure>
    <time_frame>1 week</time_frame>
    <description>Pain reported on Wong-Baker Faces Pain Scale analysis. Pain intensity was assessed using the Wong-Baker scale (Wong and Baker, 1988) from the first to the seventh day of the screw activation, reporting a daily registration in the evening. The Wong-Baker scale is a tool for self-assessment of pain intensity and is used in children from three years of age. The smiles range from the most smiling, corresponding to &quot;no pain&quot;, to the one that cries, corresponding to &quot;worst pain imaginable&quot;. Each face is also paired with a number, from 0 to 10, which coincides with the intensity of the pain. Higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discomfort during active expansion phase</measure>
    <time_frame>1 week</time_frame>
    <description>Discomfort reported on a questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Crossbite</condition>
  <condition>Maxillary Hypoplasia</condition>
  <arm_group>
    <arm_group_label>RME (rapid maxillary expander)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with the standard hyrax expansion screw anchored on second deciduous molars</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Leaf (leaf maxillary expander)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with Leaf Expander appliance anchored on second deciduous molars.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>orthodontic - maxillary expansion</intervention_name>
    <description>After appliance placement, the screw (hyrax or leaf type) will be activated until overcorrection. Expansion will be considered adequate when the occlusal surface of the first maxillary palatal cusp contact the occlusal surface of the mandibular first molar facial cusp. When will be achieved, the expander will stay in place for 10 months.</description>
    <arm_group_label>Leaf (leaf maxillary expander)</arm_group_label>
    <arm_group_label>RME (rapid maxillary expander)</arm_group_label>
    <other_name>orthodontic - palatal expansion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with transversal maxillary deficiency (with or without crossbite).&#xD;
&#xD;
          -  Class I or Class II dental malocclusion with uni- or bilateral crossbite and/or&#xD;
             constricted maxilla&#xD;
&#xD;
          -  Before the pubertal peak (CVM 1-3).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous orthodontic treatment&#xD;
&#xD;
          -  Hypodontia in any quadrant excluding third molars&#xD;
&#xD;
          -  Inadequate oral hygiene&#xD;
&#xD;
          -  Craniofacial syndromes, or cleft lip or palate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Università di Genova</name>
      <address>
        <city>Genova</city>
        <state>GE</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandro Ugolini</last_name>
      <phone>3475971340</phone>
      <email>alexugolini@yahoo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Università di Milano</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianguido Cossellu</last_name>
      <phone>39 02 503 111</phone>
      <email>gianguido.cossellu@unimi.it</email>
    </contact>
    <investigator>
      <last_name>Valentina Lanteri</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>June 6, 2019</last_update_submitted>
  <last_update_submitted_qc>June 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Genova</investigator_affiliation>
    <investigator_full_name>ALESSANDRO UGOLINI</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</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/NCT03757468
org study id: RCT_Milano-Genova
nct id: NCT03757468
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to investigate and analyze the perception of pain and
      function impairment during the first week of activation with two different palatal expansion
      screw to identify an effective pain prevention protocol.
Maxillary expansion with fixed appliance is a well-known and consolidated practice in
      clinical orthodontics but current findings of "evidence based dentistry" have not yet
      identified a better clinical expansion protocol. This issue is due both to the several
      expansion screws available on the market and to the different screw activation protocols,
      which could be grouped into rapid and slow, with several customizations. A recent systematic
      review has shown that both rapid and slow expansion protocols are clinically effective on the
      primary outcome, i.e. the resolution of the crossbite with a significant increase of skeletal
      transversal dimension in the maxillary transverse deficiency subjects. If the type of
      appliance based on its ability to solve the maxillary constriction is not any more the main
      selection criteria, the choice of the orthodontist should, therefore, be based on the timing
      and on a "patient-oriented" device, that minimizes the side effects, such as e.g. appliance
      breakages, functional impairments and pain.

      In the orthodontic daily practice, the pain of the little patient is the most frequent
      symptom during treatment and is the one that most frightens/worries the child and the family.
      Literature shows that rapid maxillary expansion is, among the early orthodontic therapies,
      the one with the highest frequency of pain (up to 98%) as an adverse symptom reported by
      patients. The pain is statistically linked to the rapid expansion protocol (2/turn/day),
      during which, for each activation of the screw (0.2 or 0.25 mm) the force expressed can reach
      up to 10 pounds which acts in an orthopaedic manner on the palatine suture and the
      circummascellar sutures. Following this orthopedic action, a disorganized and highly
      vascularized connective tissue (inflammatory) is formed in palatine suture area, which
      becomes the main receptor of the pain perceived by the patient during the active maxillary
      expansion. In the literature the prevention and management of pain during palate expansion is
      a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice and
      so the aim of the present study is to investigate and analyze the perception of pain and
      function impairment during the first week of activation with two different palatal expansion
      screw to identify an effective pain prevention protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Crossbite correction
time frame: 10 months
description: Clinical evaluation in vivo (binary outcome yes/no)
measure: Traversal maxillary deficiency correction
time frame: 10 months
description: Measured on digital dental casts (increase in mm of the intermolar and intercanine width)
measure: Pain during active expansion phase
time frame: 1 week
description: Pain reported on Wong-Baker Faces Pain Scale analysis. Pain intensity was assessed using the Wong-Baker scale (Wong and Baker, 1988) from the first to the seventh day of the screw activation, reporting a daily registration in the evening. The Wong-Baker scale is a tool for self-assessment of pain intensity and is used in children from three years of age. The smiles range from the most smiling, corresponding to "no pain", to the one that cries, corresponding to "worst pain imaginable". Each face is also paired with a number, from 0 to 10, which coincides with the intensity of the pain. Higher values represent a worse outcome.
measure: Discomfort during active expansion phase
time frame: 1 week
description: Discomfort reported on a questionnaire
arm group label: RME (rapid maxillary expander)
arm group type: Active Comparator
description: Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with the standard hyrax expansion screw anchored on second deciduous molars
arm group label: Leaf (leaf maxillary expander)
arm group type: Experimental
description: Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with Leaf Expander appliance anchored on second deciduous molars.
intervention type: Device
intervention name: orthodontic - maxillary expansion
description: After appliance placement, the screw (hyrax or leaf type) will be activated until overcorrection. Expansion will be considered adequate when the occlusal surface of the first maxillary palatal cusp contact the occlusal surface of the mandibular first molar facial cusp. When will be achieved, the expander will stay in place for 10 months.
arm group label: Leaf (leaf maxillary expander)
arm group label: RME (rapid maxillary expander)
other name: orthodontic - palatal expansion
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Genova
investigator full name: ALESSANDRO UGOLINI
investigator title: Assistant Professor
mesh term: Malocclusion
sharing ipd: No