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/NCT06019351</url>
    </required_header>
    <id_info>
      <org_study_id>711</org_study_id>
      <nct_id>NCT06019351</nct_id>
    </id_info>
    <brief_title>Assessment of Mesiodistal Root Angulation Without Radiographic Guidance Versus CBCT Guidance: A Cross Sectional Study.</brief_title>
    <official_title>Assessment of Mesiodistal Root Angulation Without Radiographic Guidance Versus CBCT Guidance: A Cross Sectional Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</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>
        Digital transformation in the orthodontic field profoundly alters the way in which&#xD;
        orthodontic treatment is perceived and delivered, moreover it aids in creating individualized&#xD;
        orthodontic appliances.A crucial step in digital orthodontic planning in either indirect&#xD;
        bonding or aligner treatment is localization of mesiodistal tip. Earlier, Panoramic&#xD;
        radiographs were formerly recommended to assist clinicians in properly identifying&#xD;
        mesiodistal root angulation. recommended to help clinician to identify mesiodistal root&#xD;
        angulation accurately. Owens et al. recorded clinically significant variation between the&#xD;
        radiographic and the true root angulation. Alternatively CBCT (Cone Beam Computed Tomography)&#xD;
        guided mesiodistal root angulation assessment has superior clinical significance compared to&#xD;
        the routinely taken panoramic radiograph . despite its accuracy ,CBCT is not justified as a&#xD;
        part of diagnostic records for orthodontic treatment planning following the ALARA rule . To&#xD;
        eliminate additional x ray dose Computer aided mesiodistal root angulation identification is&#xD;
        provided by several softwares such as OrthoAnalyzer™ ,OrthoCAD® ,and SureSmile® , however,&#xD;
        the accuracy remains questionable. These finding may point out the importance of studying the&#xD;
        accuracy mesiodistal identification to carry on digital workflow without the radiographic&#xD;
        guidance.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 21, 2022</start_date>
    <completion_date type="Anticipated">September 21, 2023</completion_date>
    <primary_completion_date type="Actual">April 21, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Outcome mesiodistal Angulation: angle between dental axis created by the software according to model clinical crown and the dental long axis guided by the CBCT. (In degrees)</measure>
      <time_frame>through study completion, an average of 1 year&quot;.</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">141</enrollment>
    <condition>Mesiodistal Root Angulation - Radiographic Guidance - CBCT Guidance - Assessment</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>OrthoAnalyzer™ software</intervention_name>
      <description>OrthoAnalyzer™ software module from 3Shape Software</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with digital models and panoramic radiograph as a routine diagnostic orthodontic&#xD;
          record before treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with digital models and panoramic radiograph as a routine diagnostic&#xD;
               orthodontic record before treatment.&#xD;
  &#xD;
            -  Justified CBCT record taken for impacted and ectopic teeth, planning for MARPE&#xD;
               (mini-screw assisted rapid palatal expansion)/MSE (maxillary skeletal expansion),&#xD;
               critical tooth movements in periodontally compromised patients, surgery first cases,&#xD;
               taken for previous studies and other reasons.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe crowding.&#xD;
  &#xD;
            -  Teeth with bizarre anatomy or severely decayed.&#xD;
  &#xD;
            -  Patients in mixed dentition stage.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Cairo University</name>
        <address>
          <city>Cairo</city>
          <state>El Manial</state>
          <zip>35855</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>kholoud khaled</last_name>
        <phone>01001128434</phone>
      </contact>
      <contact_backup>
        <email>dentmail@dentistry.cu.edu.eg</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Kholoud Khaled Abd ElAziz</investigator_full_name>
      <investigator_title>teaching assistant</investigator_title>
    </responsible_party>
    <!-- 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/NCT06019351
  org study id: 711
  nct id: NCT06019351
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Digital transformation in the orthodontic field profoundly alters the way in which
        orthodontic treatment is perceived and delivered, moreover it aids in creating individualized
        orthodontic appliances.A crucial step in digital orthodontic planning in either indirect
        bonding or aligner treatment is localization of mesiodistal tip. Earlier, Panoramic
        radiographs were formerly recommended to assist clinicians in properly identifying
        mesiodistal root angulation. recommended to help clinician to identify mesiodistal root
        angulation accurately. Owens et al. recorded clinically significant variation between the
        radiographic and the true root angulation. Alternatively CBCT (Cone Beam Computed Tomography)
        guided mesiodistal root angulation assessment has superior clinical significance compared to
        the routinely taken panoramic radiograph . despite its accuracy ,CBCT is not justified as a
        part of diagnostic records for orthodontic treatment planning following the ALARA rule . To
        eliminate additional x ray dose Computer aided mesiodistal root angulation identification is
        provided by several softwares such as OrthoAnalyzer™ ,OrthoCAD® ,and SureSmile® , however,
        the accuracy remains questionable. These finding may point out the importance of studying the
        accuracy mesiodistal identification to carry on digital workflow without the radiographic
        guidance.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Outcome mesiodistal Angulation: angle between dental axis created by the software according to model clinical crown and the dental long axis guided by the CBCT. (In degrees)
  time frame: through study completion, an average of 1 year".
  intervention type: Device
  intervention name: OrthoAnalyzer™ software
  description: OrthoAnalyzer™ software module from 3Shape Software
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Kholoud Khaled Abd ElAziz
  investigator title: teaching assistant