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/NCT05978856</url>
    </required_header>
    <id_info>
      <org_study_id>VTO</org_study_id>
      <nct_id>NCT05978856</nct_id>
    </id_info>
    <brief_title>The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment</brief_title>
    <official_title>The Accuracy of Computer Software Prediction of Soft Tissue Profile for Patients Undergoing Fixed Orthodontic Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Azhar University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A clinical study to evaluate the accuracy of computer software in predicting soft tissue&#xD;
        profile changes in patients undergoing fixed orthodontic treatment&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The computer software programs exhibit certain soft tissue simulation . The purpose of the&#xD;
        study to assess the accuracy of computer software in predicting profile changes in patients&#xD;
        undergoing fixed orthodontic treatment&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>accuracy of computer software in predicting soft tissue profile changes</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Separate analyses will be performed on the initial and final cephalograms.&#xD;
  All of the cephalometric analyses will be done via computer software; the linear and angular measurements will be done via the software.&#xD;
  Through the use of software, the initial cephalogram and the initial photograph will be linked.&#xD;
  Then, the final values of some angles will be extracted from the post-treatment cephalogram.&#xD;
  These values will be inserted in the &quot;treatment simulation&quot; section of the software.&#xD;
  A post-treatment projected image of the patient will be simulated by the software.&#xD;
  Then the actual post-treatment photograph will be placed on the simulated image in transparent form.&#xD;
  From the pupil , real horizontal and vertical reference lines will be drawn.&#xD;
  Then certain measurements will be taken from reference lines to fixed points on the soft tissue to determine the discrepancies between the real and simulated images.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Dental Malocclusion</condition>
    <arm_group>
      <arm_group_label>A</arm_group_label>
      <description>real photoes (after treatment)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>B</arm_group_label>
      <description>simulated photoes</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Accuracy of computer software in predicting soft tissue profile changes</intervention_name>
      <description>Separate analyses will be performed on the initial and final cephalograms.&#xD;
  All of the cephalometric analyses will be done via computer software,the linear and angular measurements will be done via the software.&#xD;
  Through the use of software, the initial cephalogram and the initial photograph will be linked.&#xD;
  Then, the final values of some angles will be tracted from the post-treatment cephalogram.&#xD;
  These values will be inserted in the &quot;treatment simulation&quot;section of the software.&#xD;
  A post-treatment projected image of the patient will be simulated by the software.&#xD;
  Then the actual post-treatment photograph will be placed on the simulated image in transparent form.&#xD;
  From the pupil , real horizontal and vertical reference lines will be drawn.&#xD;
  Then certain measurements will be taken from referance lines to fixed points on the soft tissue to determine the discrepancies between the real and simulated images.</description>
      <arm_group_label>A</arm_group_label>
      <other_name>visual treatment objective</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will be performed on patients treate in the orthodontics department, faculty of&#xD;
          dentistry, alazhar university,assuit branch.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          The inclusion criteria included:&#xD;
  &#xD;
            -  Patient undergo fixed orthodontic treatment with the edgewise technique.&#xD;
  &#xD;
            -  Skeletal class I.&#xD;
  &#xD;
            -  Dental class I or II or III.&#xD;
  &#xD;
            -  Final class I occlusion without spacing or crowding, with normal overjet and overbite&#xD;
               (2-4 mm)&#xD;
  &#xD;
            -  Availability of full diagnostic and therapeutic records before to and following&#xD;
               orthodontic treatment, including medical and dental history, dental casts, panoramic&#xD;
               and cephalometric x-rays, and photographic photographs.&#xD;
  &#xD;
          The exclusion criteria included:&#xD;
  &#xD;
            -  Missing tooth or significant Bolton discrepancies (more than 3 mm).&#xD;
  &#xD;
            -  Craniofacial syndromes or skeletal abnormalities.&#xD;
  &#xD;
            -  Failed orthodontic treatment in the past.&#xD;
  &#xD;
            -  Cosmetic or reconstructive facial surgery during orthodontic treatment, or up to a&#xD;
               year beforehand.&#xD;
  &#xD;
            -  Using drugs that could reduce the volume of soft tissues.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>salah hasan, gp</last_name>
      <phone>01125237178</phone>
      <email>dr.salah.hassan.1995@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dental medicine al-azhar university</name>
        <address>
          <city>Assiut</city>
          <state>Assuit</state>
          <zip>12345</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>abd-AlAziz A baioumy, professor</last_name>
        <phone>0020882181056</phone>
        <email>aadj@azhar.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Kolokitha OE, Chatzistavrou E. Factors influencing the accuracy of cephalometric prediction of soft tissue profile changes following orthognathic surgery. J Maxillofac Oral Surg. 2012 Mar;11(1):82-90. doi: 10.1007/s12663-011-0253-6. Epub 2011 Jul 7.</citation>
      <PMID>23450114</PMID>
    </reference>
    <reference>
      <citation>Kolokitha OE. Validity of a manual soft tissue profile prediction method following mandibular setback osteotomy. Eur J Dent. 2007 Oct;1(4):202-11.</citation>
      <PMID>19212468</PMID>
    </reference>
    <reference>
      <citation>Leonardi R, Annunziata A, Licciardello V, Barbato E. Soft tissue changes following the extraction of premolars in nongrowing patients with bimaxillary protrusion. A systematic review. Angle Orthod. 2010 Jan;80(1):211-6. doi: 10.2319/010709-16.1.</citation>
      <PMID>19852663</PMID>
    </reference>
    <reference>
      <citation>Drobocky OB, Smith RJ. Changes in facial profile during orthodontic treatment with extraction of four first premolars. Am J Orthod Dentofacial Orthop. 1989 Mar;95(3):220-30. doi: 10.1016/0889-5406(89)90052-8.</citation>
      <PMID>2923102</PMID>
    </reference>
    <reference>
      <citation>Al-Omiri MK, Abu Alhaija ES. Factors affecting patient satisfaction after orthodontic treatment. Angle Orthod. 2006 May;76(3):422-31. doi: 10.1043/0003-3219(2006)076[0422:FAPSAO]2.0.CO;2.</citation>
      <PMID>16637722</PMID>
    </reference>
    <reference>
      <citation>Kolokitha OE, Topouzelis N. Cephalometric methods of prediction in orthognathic surgery. J Maxillofac Oral Surg. 2011 Sep;10(3):236-45. doi: 10.1007/s12663-011-0228-7. Epub 2011 May 17.</citation>
      <PMID>22942594</PMID>
    </reference>
    <reference>
      <citation>Smith JD, Thomas PM, Proffit WR. A comparison of current prediction imaging programs. Am J Orthod Dentofacial Orthop. 2004 May;125(5):527-36. doi: 10.1016/S0889540604001210.</citation>
      <PMID>15127020</PMID>
    </reference>
    <reference>
      <citation>Patterson Dental Supply. Imaging. In: Dolphin Imaging. 2012. Retrieved December 17th 2012, from http://www.dolphinimaging.com/imaging.html.</citation>
    </reference>
    <reference>
      <citation>Gossett CB, Preston CB, Dunford R, Lampasso J. Prediction accuracy of computer-assisted surgical visual treatment objectives as compared with conventional visual treatment objectives. J Oral Maxillofac Surg. 2005 May;63(5):609-17. doi: 10.1016/j.joms.2005.01.004.</citation>
      <PMID>15883933</PMID>
    </reference>
    <reference>
      <citation>Ioannidou-Marathiotou I, Papamanou DA, Papadopoulos MA. Orthodontics and esthetics of the face: from the &quot;canons&quot; of ancient times to contemporary pluralism. A critical review. Prog Orthod. 2008;9(2):20-33.</citation>
      <PMID>19350056</PMID>
    </reference>
    <reference>
      <citation>Prabhakar R, Rajakumar P, Karthikeyan MK, Saravanan R, Vikram NR, Reddy A. A hard tissue cephalometric comparative study between hand tracing and computerized tracing. J Pharm Bioallied Sci. 2014 Jul;6(Suppl 1):S101-6. doi: 10.4103/0975-7406.137401.</citation>
      <PMID>25210347</PMID>
    </reference>
    <reference>
      <citation>Nadjmi N, Tehranchi A, Azami N, Saedi B, Mollemans W. Comparison of soft-tissue profiles in Le Fort I osteotomy patients with Dolphin and Maxilim softwares. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):654-62. doi: 10.1016/j.ajodo.2013.06.019.</citation>
      <PMID>24182581</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Salah Hasan Saleh Mohamed</investigator_full_name>
      <investigator_title>General Physician at the Ministry of Health</investigator_title>
    </responsible_party>
    <keyword>VTO</keyword>
    <keyword>orthodontic software</keyword>
    <keyword>prediction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Malocclusion</mesh_term>
    </condition_browse>
    <!-- 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/NCT05978856
  org study id: VTO
  nct id: NCT05978856
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A clinical study to evaluate the accuracy of computer software in predicting soft tissue
        profile changes in patients undergoing fixed orthodontic treatment
  The computer software programs exhibit certain soft tissue simulation . The purpose of the
        study to assess the accuracy of computer software in predicting profile changes in patients
        undergoing fixed orthodontic treatment
  observational model: Other
  time perspective: Retrospective
  measure: accuracy of computer software in predicting soft tissue profile changes
  time frame: through study completion, an average of 1 year
  description: Separate analyses will be performed on the initial and final cephalograms.
  All of the cephalometric analyses will be done via computer software; the linear and angular measurements will be done via the software.
  Through the use of software, the initial cephalogram and the initial photograph will be linked.
  Then, the final values of some angles will be extracted from the post-treatment cephalogram.
  These values will be inserted in the "treatment simulation" section of the software.
  A post-treatment projected image of the patient will be simulated by the software.
  Then the actual post-treatment photograph will be placed on the simulated image in transparent form.
  From the pupil , real horizontal and vertical reference lines will be drawn.
  Then certain measurements will be taken from reference lines to fixed points on the soft tissue to determine the discrepancies between the real and simulated images.
  arm group label: A
  description: real photoes (after treatment)
  arm group label: B
  description: simulated photoes
  intervention type: Other
  intervention name: Accuracy of computer software in predicting soft tissue profile changes
  description: Separate analyses will be performed on the initial and final cephalograms.
  All of the cephalometric analyses will be done via computer software,the linear and angular measurements will be done via the software.
  Through the use of software, the initial cephalogram and the initial photograph will be linked.
  Then, the final values of some angles will be tracted from the post-treatment cephalogram.
  These values will be inserted in the "treatment simulation"section of the software.
  A post-treatment projected image of the patient will be simulated by the software.
  Then the actual post-treatment photograph will be placed on the simulated image in transparent form.
  From the pupil , real horizontal and vertical reference lines will be drawn.
  Then certain measurements will be taken from referance lines to fixed points on the soft tissue to determine the discrepancies between the real and simulated images.
  arm group label: A
  other name: visual treatment objective
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: salah hasan, gp
  phone: 01125237178
  email: dr.salah.hassan.1995@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Kolokitha OE, Chatzistavrou E. Factors influencing the accuracy of cephalometric prediction of soft tissue profile changes following orthognathic surgery. J Maxillofac Oral Surg. 2012 Mar;11(1):82-90. doi: 10.1007/s12663-011-0253-6. Epub 2011 Jul 7.
  PMID: 23450114
  citation: Kolokitha OE. Validity of a manual soft tissue profile prediction method following mandibular setback osteotomy. Eur J Dent. 2007 Oct;1(4):202-11.
  PMID: 19212468
  citation: Leonardi R, Annunziata A, Licciardello V, Barbato E. Soft tissue changes following the extraction of premolars in nongrowing patients with bimaxillary protrusion. A systematic review. Angle Orthod. 2010 Jan;80(1):211-6. doi: 10.2319/010709-16.1.
  PMID: 19852663
  citation: Drobocky OB, Smith RJ. Changes in facial profile during orthodontic treatment with extraction of four first premolars. Am J Orthod Dentofacial Orthop. 1989 Mar;95(3):220-30. doi: 10.1016/0889-5406(89)90052-8.
  PMID: 2923102
  citation: Al-Omiri MK, Abu Alhaija ES. Factors affecting patient satisfaction after orthodontic treatment. Angle Orthod. 2006 May;76(3):422-31. doi: 10.1043/0003-3219(2006)076[0422:FAPSAO]2.0.CO;2.
  PMID: 16637722
  citation: Kolokitha OE, Topouzelis N. Cephalometric methods of prediction in orthognathic surgery. J Maxillofac Oral Surg. 2011 Sep;10(3):236-45. doi: 10.1007/s12663-011-0228-7. Epub 2011 May 17.
  PMID: 22942594
  citation: Smith JD, Thomas PM, Proffit WR. A comparison of current prediction imaging programs. Am J Orthod Dentofacial Orthop. 2004 May;125(5):527-36. doi: 10.1016/S0889540604001210.
  PMID: 15127020
  citation: Patterson Dental Supply. Imaging. In: Dolphin Imaging. 2012. Retrieved December 17th 2012, from http://www.dolphinimaging.com/imaging.html.
  citation: Gossett CB, Preston CB, Dunford R, Lampasso J. Prediction accuracy of computer-assisted surgical visual treatment objectives as compared with conventional visual treatment objectives. J Oral Maxillofac Surg. 2005 May;63(5):609-17. doi: 10.1016/j.joms.2005.01.004.
  PMID: 15883933
  citation: Ioannidou-Marathiotou I, Papamanou DA, Papadopoulos MA. Orthodontics and esthetics of the face: from the "canons" of ancient times to contemporary pluralism. A critical review. Prog Orthod. 2008;9(2):20-33.
  PMID: 19350056
  citation: Prabhakar R, Rajakumar P, Karthikeyan MK, Saravanan R, Vikram NR, Reddy A. A hard tissue cephalometric comparative study between hand tracing and computerized tracing. J Pharm Bioallied Sci. 2014 Jul;6(Suppl 1):S101-6. doi: 10.4103/0975-7406.137401.
  PMID: 25210347
  citation: Nadjmi N, Tehranchi A, Azami N, Saedi B, Mollemans W. Comparison of soft-tissue profiles in Le Fort I osteotomy patients with Dolphin and Maxilim softwares. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):654-62. doi: 10.1016/j.ajodo.2013.06.019.
  PMID: 24182581
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Salah Hasan Saleh Mohamed
  investigator title: General Physician at the Ministry of Health
  mesh term: Malocclusion