<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/NCT04465617</url>
  </required_header>
  <id_info>
    <org_study_id>ORAD 7.1.1</org_study_id>
    <nct_id>NCT04465617</nct_id>
  </id_info>
  <brief_title>Assessment of the Anterior Loop of the IAN in a Sample of Egyptian Population Using CBCT</brief_title>
  <official_title>Assessment of the Anterior Loop of the Inferior Alveolar Nerve in a Sample of Egyptian Population Using CBCT: An Observational 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>
      in this study the prevalence &amp; length of the anterior loop of the inferior alveolar nerve&#xD;
      will be calculated and measured on retrospective CBCT patient's scans&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proper knowledge of anatomical structures and their precise position is of a paramount&#xD;
      importance for different dental specialties. The inferior alveolar nerve (IAN) canal is one&#xD;
      of the most important anatomical landmarks in the mandible Shaban et al., 2017. By definition&#xD;
      the inferior alveolar nerve (IAN) is a terminal division of the mandibular branch of the&#xD;
      trigeminal nerve, it is confined within the mandibular canal and innervates all the&#xD;
      mandibular teeth. The IAN initiates from the mandibular foramen and goes obliquely downward&#xD;
      and forward in the ramus, and then horizontally within the body of the mandible. The IAN&#xD;
      gives off the mental nerve, which exits the mandible through the mental foramen, supplying&#xD;
      sensory branches to the chin, lower lip, mucous membranes and the gingiva; from the midline&#xD;
      to about the second premolar region. It then continues its path anteriorly and turn into the&#xD;
      mandibular incisive nerve, which innervates the mandibular canines and incisors Siddiqui et&#xD;
      al. 2018. Before leaving the mental foramen and branching into the incisive nerve, the IAN&#xD;
      may continue anteriorly and form an anterior loop (Al). This anterior loop is the part where&#xD;
      the IAN directs mesially and occlusally before reversing direction and coursing distally&#xD;
      towards the mental foramen Ragu et al., 2019. During implant planning and other surgical&#xD;
      procedures knowing the presence of the anterior loop and its length is very crucial to avoid&#xD;
      its injury. Specially concerning implantology where the location of the mental foramen and&#xD;
      anterior loop determines the most distal point for implant placement in the interforaminal&#xD;
      area; in order to avoid any injury resulting in sensory disturbances in this area Panjnoush&#xD;
      et al., 2016 Recently, several studies have been published discussing the prevalence and&#xD;
      length measurement of the anterior loop in many populations. However, no published researches&#xD;
      were done on the Egyptian population. Therefore, this study is designed to assess the&#xD;
      presence of the anterior loop and its length in a sample of Egyptian population using CBCT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2022</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>Prevalence of the anterior loop</measure>
    <time_frame>1 month</time_frame>
    <description>it will be measured using CBCT axial cuts (Ondemand 3D software)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of the anterior loop</measure>
    <time_frame>1 month</time_frame>
    <description>Built in measuring tools (axial cuts) in Ondemand 3D software &quot;MPR* module&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mesial extension of the anterior loop</measure>
    <time_frame>1 month</time_frame>
    <description>Cross-sectional cuts on Ondemand 3D software &quot;DVR** module&quot;</description>
  </secondary_outcome>
  <enrollment type="Anticipated">192</enrollment>
  <condition>Mandibular Nerve</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Egyptian population including males &amp; females&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CBCT scans of adult Egyptian patients, males and females.&#xD;
&#xD;
          -  CBCT scans with unilateral or bilateral anterior mandibles; with minimum 2 mm length&#xD;
             distal to the mental foramen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CBCT images of poor quality or artifacts interfering with the assessment of the&#xD;
             anterior loop of IAN.&#xD;
&#xD;
          -  Scans showing any pathosis in the interforaminal area (tumor or impaction).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>ORASCAN Oral &amp; Maxillofacial Imaging Centre</last_name>
    <phone>+2 0223780756</phone>
    <email>Info@orascan.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Abdelrahman Zohny</last_name>
    <phone>01222376888</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Orascan</name>
      <address>
        <city>Cairo</city>
        <state>Maadi</state>
        <zip>11728</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Orascan Oral &amp; Maxillofacial Imaging Centre</last_name>
      <phone>+20223780756</phone>
      <email>Info@orascan.org</email>
    </contact>
    <contact_backup>
      <last_name>Abdelrahman Zohny</last_name>
      <phone>01222376888</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>November 4, 2021</last_update_submitted>
  <last_update_submitted_qc>November 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Professor Hossam Kandil</investigator_full_name>
    <investigator_title>Professor of Oral &amp; Maxillofacial Radiology, Faculty of Dentistry</investigator_title>
  </responsible_party>
  <keyword>Presence of the anterior loop of the mental nerve (branching from the inferior alveolar nerve) will be recorded &amp; its length will be measured</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT04465617/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04465617
org study id: ORAD 7.1.1
nct id: NCT04465617
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
in this study the prevalence & length of the anterior loop of the inferior alveolar nerve
      will be calculated and measured on retrospective CBCT patient's scans
The proper knowledge of anatomical structures and their precise position is of a paramount
      importance for different dental specialties. The inferior alveolar nerve (IAN) canal is one
      of the most important anatomical landmarks in the mandible Shaban et al., 2017. By definition
      the inferior alveolar nerve (IAN) is a terminal division of the mandibular branch of the
      trigeminal nerve, it is confined within the mandibular canal and innervates all the
      mandibular teeth. The IAN initiates from the mandibular foramen and goes obliquely downward
      and forward in the ramus, and then horizontally within the body of the mandible. The IAN
      gives off the mental nerve, which exits the mandible through the mental foramen, supplying
      sensory branches to the chin, lower lip, mucous membranes and the gingiva; from the midline
      to about the second premolar region. It then continues its path anteriorly and turn into the
      mandibular incisive nerve, which innervates the mandibular canines and incisors Siddiqui et
      al. 2018. Before leaving the mental foramen and branching into the incisive nerve, the IAN
      may continue anteriorly and form an anterior loop (Al). This anterior loop is the part where
      the IAN directs mesially and occlusally before reversing direction and coursing distally
      towards the mental foramen Ragu et al., 2019. During implant planning and other surgical
      procedures knowing the presence of the anterior loop and its length is very crucial to avoid
      its injury. Specially concerning implantology where the location of the mental foramen and
      anterior loop determines the most distal point for implant placement in the interforaminal
      area; in order to avoid any injury resulting in sensory disturbances in this area Panjnoush
      et al., 2016 Recently, several studies have been published discussing the prevalence and
      length measurement of the anterior loop in many populations. However, no published researches
      were done on the Egyptian population. Therefore, this study is designed to assess the
      presence of the anterior loop and its length in a sample of Egyptian population using CBCT.
observational model: Other
time perspective: Retrospective
measure: Prevalence of the anterior loop
time frame: 1 month
description: it will be measured using CBCT axial cuts (Ondemand 3D software)
measure: length of the anterior loop
time frame: 1 month
description: Built in measuring tools (axial cuts) in Ondemand 3D software "MPR* module"
measure: Mesial extension of the anterior loop
time frame: 1 month
description: Cross-sectional cuts on Ondemand 3D software "DVR** module"
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: ORASCAN Oral & Maxillofacial Imaging Centre
phone: +2 0223780756
email: Info@orascan.org
last name: Abdelrahman Zohny
phone: 01222376888
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Professor Hossam Kandil
investigator title: Professor of Oral & Maxillofacial Radiology, Faculty of Dentistry
sharing ipd: No
provided document: 