<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/NCT03804437</url>
  </required_header>
  <id_info>
    <org_study_id>ORAD 7-1-1</org_study_id>
    <nct_id>NCT03804437</nct_id>
  </id_info>
  <brief_title>The Prevalence and Anatomical Variations of Bifid Mandibular Canal in the Egyptian Population Using Cone Beam CT (CBCT)</brief_title>
  <official_title>The Prevalence and Anatomical Variations of Bifid Mandibular Canal in a Sample of Egyptian Population Using CBCT.A Hospital-based 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>
      The prevalence of bifid mandibular canal will be detected in a sample of Egyptian&#xD;
      Population.Anatomical variations of the bifid canal will also be detected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Settings:&#xD;
&#xD;
      The data collection will be obtained from the data base available at the department of Oral&#xD;
      and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be&#xD;
      obtained from Egyptian patients who were referred to the CBCT unit in oral and maxillofacial&#xD;
      radiology department for different purposes.&#xD;
&#xD;
      Variables:&#xD;
&#xD;
      •Prevalence of bifid canals - Classification and prevalence of observed types - Distance from&#xD;
      the involved teeth&#xD;
&#xD;
      Data Sources / Measurements:&#xD;
&#xD;
        -  Retrospective Data Analysis will be performed after the CBCT images are pooled from the&#xD;
           computer database.&#xD;
&#xD;
        -  Exposure parameters of the scans will vary depending on patients' sizes (according to&#xD;
           the manufacturer's recommendations).&#xD;
&#xD;
        -  Both images with 0.2 and 0.4 voxel sizes will be reviewed.&#xD;
&#xD;
        -  For proper visualization of the mandibular canal, the reference lines will be rotated,&#xD;
           so that it lies perpendicular to the mandibular foramen on the axial cuts. Then,&#xD;
           scrolling through the corrected sagittal cuts will be performed to review the clearest&#xD;
           cut of the full course of the mandibular canal. Moreover, corrected coronal cuts will be&#xD;
           reviewed, to determine the exits of the accessory branches (buccal or lingual) if&#xD;
           present.&#xD;
&#xD;
        -  CBCT images will be interpreted by two oral and maxillofacial radiologists (with&#xD;
           different experiences) independently; blinded from demographic data of the patients and&#xD;
           from the results of each other.&#xD;
&#xD;
        -  The classification of Naitoh et al 2009 will be followed for the categorization of the&#xD;
           accessory branches:&#xD;
&#xD;
             1. Forward canal: emerging from the superior wall of the main canal.&#xD;
&#xD;
             2. Bucco-lingual canal: emerging from the buccal or the lingual wall of the main&#xD;
                canal.&#xD;
&#xD;
             3. Dental canal: the end of the bifid canal is at the root apex of the molars.&#xD;
&#xD;
             4. Retromolar canal: emerging from the main canal, opening at the retromolar foramen&#xD;
                in the retromolar area.&#xD;
&#xD;
        -  Each radiologist will evaluate the images for presence of bifid canal twice with a time&#xD;
           lag of two weeks between the two reading sessions. If present, its configuration&#xD;
           (classification) will be registered. Any disagreement will be solved by consensus&#xD;
           between the two observers.&#xD;
&#xD;
        -  If adherence or closeness of the canals to the teeth is detected, then the distance&#xD;
           between the canal and the involved tooth will be measured using built in measuring tool&#xD;
           in the software.&#xD;
&#xD;
        -  The measurements will be carried out by one observer (EE) and will be repeated 2 weeks&#xD;
           later for intra-observer reliability assessment.&#xD;
&#xD;
      Bias&#xD;
&#xD;
      No source of bias.&#xD;
&#xD;
      Study Size:&#xD;
&#xD;
      The aim of the study is to assess the prevalence of bifid mandibular canal in Egyptian&#xD;
      population. Based on the previous paper by Afsa and Rahmati 2017, the prevalence of bifid&#xD;
      mandibular canal was 31% Using a precision of 5, a design effect set at 1 with 95% CI&#xD;
      (confidence interval), a total sample size of 329 hemimandibles will be sufficient. The&#xD;
      sample size was calculated by Epi info 7 software.&#xD;
&#xD;
      Quantitative Variables:&#xD;
&#xD;
      Quantitative data: The distance between the canal and involved teeth and will be reported as&#xD;
      mean and standard deviation.&#xD;
&#xD;
      Statistical methods:&#xD;
&#xD;
      Data will be analyzed using SPSS® v. 15 (SPSS Inc., Chicago, IL) software program. Pearson&#xD;
      Chi square and t-tests was performed for statistical analysis among gender, localization and&#xD;
      measurements. Categorical data will be described as numbers and percentages. A p value of&#xD;
      &lt;0.05 will be considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2019</start_date>
  <completion_date type="Actual">October 15, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</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>Bifid mandibular canal detection, measuring device is CBCT software Romexis, measuring unit is percentage ( Dichotomous data - Yes or No )</measure>
    <time_frame>up to 2019</time_frame>
    <description>Detection of bifid mandibular canal in Egyptian population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of types,measuring device is CBCT software Romexis, measuring unit is Categorical nominal data(%)</measure>
    <time_frame>up to 2019</time_frame>
    <description>They are either Forward canal, Bucco-lingual canal , Retromolar canal, Dental canal</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Distance to adjacent teeth, measuring device is Built-in measuring tool (ruler), measuring unit is mm</measure>
    <time_frame>up to 2019</time_frame>
    <description>distance to adjacent teeth will be measured</description>
  </other_outcome>
  <other_outcome>
    <measure>Region of exit of retromolar canal,measuring device is CBCT software Romexis, measuring unit is Categorical nominal data (%)</measure>
    <time_frame>up to 2019</time_frame>
    <description>They are either buccal or lingual or non-visible</description>
  </other_outcome>
  <other_outcome>
    <measure>Prevalence according to gender,measuring unit is categorical nominal data (%)</measure>
    <time_frame>up to 2019</time_frame>
    <description>They are either male or female</description>
  </other_outcome>
  <enrollment type="Actual">329</enrollment>
  <condition>The Prevalence of Bifid Mandibular Canal</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Egyptian population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range from 18 to 70&#xD;
&#xD;
          -  Scans showing the premolar, molar, retromolar areas.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with mandibular lesions.&#xD;
&#xD;
          -  Scans with severe metallic artifacts.&#xD;
&#xD;
          -  Patients with previous fractures or surgeries.&#xD;
&#xD;
          -  Severe bone resorption.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of dentistry, Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Enas El Saket</investigator_full_name>
    <investigator_title>Master degree student</investigator_title>
  </responsible_party>
  <keyword>Mandibular canals</keyword>
  <keyword>bifid canal</keyword>
  <keyword>cbct</keyword>
  <keyword>cbct dental.</keyword>
  <!-- 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/NCT03804437
org study id: ORAD 7-1-1
nct id: NCT03804437
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prevalence of bifid mandibular canal will be detected in a sample of Egyptian
      Population.Anatomical variations of the bifid canal will also be detected.
Settings:

      The data collection will be obtained from the data base available at the department of Oral
      and Maxillofacial Radiology, Faculty of Dentistry, Cairo University. CBCT images will be
      obtained from Egyptian patients who were referred to the CBCT unit in oral and maxillofacial
      radiology department for different purposes.

      Variables:

      •Prevalence of bifid canals - Classification and prevalence of observed types - Distance from
      the involved teeth

      Data Sources / Measurements:

        -  Retrospective Data Analysis will be performed after the CBCT images are pooled from the
           computer database.

        -  Exposure parameters of the scans will vary depending on patients' sizes (according to
           the manufacturer's recommendations).

        -  Both images with 0.2 and 0.4 voxel sizes will be reviewed.

        -  For proper visualization of the mandibular canal, the reference lines will be rotated,
           so that it lies perpendicular to the mandibular foramen on the axial cuts. Then,
           scrolling through the corrected sagittal cuts will be performed to review the clearest
           cut of the full course of the mandibular canal. Moreover, corrected coronal cuts will be
           reviewed, to determine the exits of the accessory branches (buccal or lingual) if
           present.

        -  CBCT images will be interpreted by two oral and maxillofacial radiologists (with
           different experiences) independently; blinded from demographic data of the patients and
           from the results of each other.

        -  The classification of Naitoh et al 2009 will be followed for the categorization of the
           accessory branches:

             1. Forward canal: emerging from the superior wall of the main canal.

             2. Bucco-lingual canal: emerging from the buccal or the lingual wall of the main
                canal.

             3. Dental canal: the end of the bifid canal is at the root apex of the molars.

             4. Retromolar canal: emerging from the main canal, opening at the retromolar foramen
                in the retromolar area.

        -  Each radiologist will evaluate the images for presence of bifid canal twice with a time
           lag of two weeks between the two reading sessions. If present, its configuration
           (classification) will be registered. Any disagreement will be solved by consensus
           between the two observers.

        -  If adherence or closeness of the canals to the teeth is detected, then the distance
           between the canal and the involved tooth will be measured using built in measuring tool
           in the software.

        -  The measurements will be carried out by one observer (EE) and will be repeated 2 weeks
           later for intra-observer reliability assessment.

      Bias

      No source of bias.

      Study Size:

      The aim of the study is to assess the prevalence of bifid mandibular canal in Egyptian
      population. Based on the previous paper by Afsa and Rahmati 2017, the prevalence of bifid
      mandibular canal was 31% Using a precision of 5, a design effect set at 1 with 95% CI
      (confidence interval), a total sample size of 329 hemimandibles will be sufficient. The
      sample size was calculated by Epi info 7 software.

      Quantitative Variables:

      Quantitative data: The distance between the canal and involved teeth and will be reported as
      mean and standard deviation.

      Statistical methods:

      Data will be analyzed using SPSS® v. 15 (SPSS Inc., Chicago, IL) software program. Pearson
      Chi square and t-tests was performed for statistical analysis among gender, localization and
      measurements. Categorical data will be described as numbers and percentages. A p value of
      <0.05 will be considered statistically significant.
observational model: Other
time perspective: Cross-Sectional
measure: Bifid mandibular canal detection, measuring device is CBCT software Romexis, measuring unit is percentage ( Dichotomous data - Yes or No )
time frame: up to 2019
description: Detection of bifid mandibular canal in Egyptian population
measure: Prevalence of types,measuring device is CBCT software Romexis, measuring unit is Categorical nominal data(%)
time frame: up to 2019
description: They are either Forward canal, Bucco-lingual canal , Retromolar canal, Dental canal
measure: Distance to adjacent teeth, measuring device is Built-in measuring tool (ruler), measuring unit is mm
time frame: up to 2019
description: distance to adjacent teeth will be measured
measure: Region of exit of retromolar canal,measuring device is CBCT software Romexis, measuring unit is Categorical nominal data (%)
time frame: up to 2019
description: They are either buccal or lingual or non-visible
measure: Prevalence according to gender,measuring unit is categorical nominal data (%)
time frame: up to 2019
description: They are either male or female
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Enas El Saket
investigator title: Master degree student