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/NCT06023433</url>
    </required_header>
    <id_info>
      <org_study_id>121-26</org_study_id>
      <nct_id>NCT06023433</nct_id>
    </id_info>
    <brief_title>Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement</brief_title>
    <official_title>Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement: a Split Mouth Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Catania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Catania</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>
        A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on&#xD;
        the expression of gingival crevicular fluid miRNAs related to inflammation and&#xD;
        osteoclastogenesis during canine distalization following asymmetrical extraction treatment of&#xD;
        upper first premolars.&#xD;
  &#xD;
        Samples of gingival crevicular fluid on the mesial and distal side of the canines to be&#xD;
        examined will be performed during the baseline and during various follow-ups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on&#xD;
        the expression of gingival crevicular fluid miRNAs related to inflammation and&#xD;
        osteoclastogenesis during canine distalization following asymmetrical extraction treatment of&#xD;
        upper first premolars.&#xD;
  &#xD;
        Orthodontic tooth movement induces bone remodeling by various signaling pathways. The&#xD;
        variations in miRNAs expression and their impact in inflammation and osteoclastogenesis&#xD;
        during the various stages of orthodontic tooth movements is not fully understood.&#xD;
  &#xD;
        58 patients requiring asymmetrical upper first premolar extraction for orthodontic purposes&#xD;
        have been enrolled for this split-mouth study: the canines to be distalized on the extractive&#xD;
        site are considered as the test group, the controlateral canines (on the side without first&#xD;
        premolar extraction) areconsidered as normal controls.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2020</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Actual">July 28, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The main objective of the study is to evaluate the impact of orthodontic tooth movement on gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>Sealed envelopes</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>miRNAs expression</measure>
      <time_frame>6 weeks</time_frame>
      <description>miRNAs expression in the gingival crevicular fluid by PCR</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">27</enrollment>
    <condition>Orthodontic Tooth Movement</condition>
    <arm_group>
      <arm_group_label>Canines to be distalized</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The canines need distalization after orthodontic upper first premolar asymmetrical extractions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Controlateral canines</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The controlateral canines don't need distalization since the adjacent first premolars are not extracted.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Elastomeric powerchain</intervention_name>
      <description>Canine distalization by engaging the elastomeric power chains onto the canine brackets.</description>
      <arm_group_label>Canines to be distalized</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with excellent oral hygiene throughout the study period,&#xD;
  &#xD;
            -  patients requiring asymmetrical maxillary first premolar extraction so monolateral&#xD;
               canine retraction will be performed as a part of the treatment,&#xD;
  &#xD;
            -  patients available to come back at the clinic at the times of sample collection.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  poor oral hygiene and/or bleeding on probing,&#xD;
  &#xD;
            -  use medications, steroids or other anti-inflammatory medications,&#xD;
  &#xD;
            -  systemic health problems or smoking.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gaetano Isola</last_name>
      <role>Principal Investigator</role>
      <affiliation>Università degli Studi di Catania</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gaetano Isola</last_name>
      <phone>0953785652</phone>
      <email>gaetano.isola@unict.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rosalia Leonardi</last_name>
      <email>rleonardi@unict.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>AOU Policlinico G. Rodolico</name>
        <address>
          <city>Catania</city>
          <zip>95124</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gaetano Isola, DDS</last_name>
        <phone>+3909537800</phone>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Catania</investigator_affiliation>
      <investigator_full_name>Gaetano Isola</investigator_full_name>
      <investigator_title>Researcher</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>1 year</ipd_time_frame>
      <ipd_access_criteria>Pubmed</ipd_access_criteria>
    </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/NCT06023433
  org study id: 121-26
  nct id: NCT06023433
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on
        the expression of gingival crevicular fluid miRNAs related to inflammation and
        osteoclastogenesis during canine distalization following asymmetrical extraction treatment of
        upper first premolars.
  
        Samples of gingival crevicular fluid on the mesial and distal side of the canines to be
        examined will be performed during the baseline and during various follow-ups.
  A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on
        the expression of gingival crevicular fluid miRNAs related to inflammation and
        osteoclastogenesis during canine distalization following asymmetrical extraction treatment of
        upper first premolars.
  
        Orthodontic tooth movement induces bone remodeling by various signaling pathways. The
        variations in miRNAs expression and their impact in inflammation and osteoclastogenesis
        during the various stages of orthodontic tooth movements is not fully understood.
  
        58 patients requiring asymmetrical upper first premolar extraction for orthodontic purposes
        have been enrolled for this split-mouth study: the canines to be distalized on the extractive
        site are considered as the test group, the controlateral canines (on the side without first
        premolar extraction) areconsidered as normal controls.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: The main objective of the study is to evaluate the impact of orthodontic tooth movement on gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis.
  primary purpose: Basic Science
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Sealed envelopes
  measure: miRNAs expression
  time frame: 6 weeks
  description: miRNAs expression in the gingival crevicular fluid by PCR
  arm group label: Canines to be distalized
  arm group type: Active Comparator
  description: The canines need distalization after orthodontic upper first premolar asymmetrical extractions.
  arm group label: Controlateral canines
  arm group type: No Intervention
  description: The controlateral canines don't need distalization since the adjacent first premolars are not extracted.
  intervention type: Device
  intervention name: Elastomeric powerchain
  description: Canine distalization by engaging the elastomeric power chains onto the canine brackets.
  arm group label: Canines to be distalized
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gaetano Isola
  role: Principal Investigator
  affiliation: Università degli Studi di Catania
  last name: Gaetano Isola
  phone: 0953785652
  email: gaetano.isola@unict.it
  last name: Rosalia Leonardi
  email: rleonardi@unict.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Catania
  investigator full name: Gaetano Isola
  investigator title: Researcher
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd time frame: 1 year
  ipd access criteria: Pubmed