<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/NCT03300245</url>
  </required_header>
  <id_info>
    <org_study_id>17100286</org_study_id>
    <nct_id>NCT03300245</nct_id>
  </id_info>
  <brief_title>Nasal Septum Deviation May Affect Facial Morphologic Parameters.</brief_title>
  <acronym>Nasalseptum</acronym>
  <official_title>The Relationship Between the Direction and Degree of Nasal Septal Deviation and Nasal Bone Morphology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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 aim of the study is to evaluate the relationship between the direction and degree of&#xD;
      nasal septal deviation with nasal bone morphology , along with factors such as age and&#xD;
      gender.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The nasal septum is located in the middle of the nasal cavity and it forms the major part of&#xD;
      the nose structure. It is divided into a posterior part by the vomer and perpendicular plate&#xD;
      of the ethmoid bone and an anterior part by the quadrangular cartilage .&#xD;
&#xD;
      In the growth period, the nasal septum acts as a growth plate that affects surrounding bones&#xD;
      and facial skeletal tissues .Thus, nasal septum deviation affects facial morphologic&#xD;
      parameters such as interalveolar distance and maxillary rotation distance, causing&#xD;
      compensatory changes in the lateral nasal wall and septal deviation,which are associated with&#xD;
      nasal floor and palatal region asymmetries .&#xD;
&#xD;
      Nasal septum deviation is the most common anatomic variation in up to 80% of healthy adults .&#xD;
&#xD;
      From the initial growth stages, the maxillary bone and nasal structure have significant&#xD;
      anatomic connections because of their close embryologic development.&#xD;
&#xD;
      The severity of septal deviation also affects the ipsilateral lateral lamina of the&#xD;
      cribriform plate width and ipsilateral middle turbinate length . Nasal septal deviation may&#xD;
      affect nasal bone growth and facial morphology .Knowledge of nasal morphologic parameters&#xD;
      plays an important role in planning successful rhinoplasty and septoplasty operations.&#xD;
&#xD;
      Some morphological characteristics of the nose such as bone length and thickness may present&#xD;
      different forms according to factors correlated with age, gender, climate and race.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">August 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The nasal deviation angle</measure>
    <time_frame>10 minutes</time_frame>
    <description>It will be measured on coronal CT images as the angle between the most deviated point of the septum and the midline which is the line from the crista galli to the palatum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The lateral and intermediate nasal bone thickness</measure>
    <time_frame>10 minutes</time_frame>
    <description>The nasal bone thickness will be measured in axial images at the site of the lateral and intermediate osteotomy lines.&#xD;
The lateral osteotomy lines run along nasomaxillary suture and intermediate (or midline) osteotomy lines runs along the internasal suture.&#xD;
The lateral nasal bone thickness will be measured at the nasomaxillary suture. Intermediate nasal bone thickness was measured at the midpoint between the nasomaxillary suture and the rhinion .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nasal bone length</measure>
    <time_frame>10 minutes</time_frame>
    <description>The nasal bone length will be measured from frontonasal suture to the endpoint of the nasal bone on the sagittal plane</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Internasal angle</measure>
    <time_frame>10 minutes</time_frame>
    <description>The internasal angle will be measured on coronal CT images at the site of the nasion point</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Nasal Septal Deviation</condition>
  <arm_group>
    <arm_group_label>patients with nasal septal deviation</arm_group_label>
    <description>Maxillofacial CT scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Maxillofacial CT</intervention_name>
    <description>clinical and maxillofacial CT data will be tabulated and analysed using by computer software e.g. Statistical Package for the Social Sciences (SPSS)</description>
    <arm_group_label>patients with nasal septal deviation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients attending to E N T clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years old who attending to Ear,Nose and throat department out&#xD;
             patients complaining of nasal septum deviation causing nasal symptoms are exposed to&#xD;
             maxillofacial CT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of rhinoplasty,&#xD;
&#xD;
          2. Patients with cranial and facial trauma or bone deformity (e.g. S-shaped septum&#xD;
             deviation).&#xD;
&#xD;
          3. Patients with a mass or polyp in the nasal cavity.&#xD;
&#xD;
          4. Patients with adenoid .&#xD;
&#xD;
          5. Patients with nasopharyngeal lesions.&#xD;
&#xD;
          6. Patients with craniofacial anomalies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martina Shawky</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Hartman C, Holton N, Miller S, Yokley T, Marshall S, Srinivasan S, Southard T. Nasal Septal Deviation and Facial Skeletal Asymmetries. Anat Rec (Hoboken). 2016 Mar;299(3):295-306. doi: 10.1002/ar.23303. Epub 2016 Jan 22.</citation>
    <PMID>26677010</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>June 29, 2018</last_update_submitted>
  <last_update_submitted_qc>June 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Martina Boshra Shawky</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03300245
org study id: 17100286
nct id: NCT03300245
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the relationship between the direction and degree of
      nasal septal deviation with nasal bone morphology , along with factors such as age and
      gender.
The nasal septum is located in the middle of the nasal cavity and it forms the major part of
      the nose structure. It is divided into a posterior part by the vomer and perpendicular plate
      of the ethmoid bone and an anterior part by the quadrangular cartilage .

      In the growth period, the nasal septum acts as a growth plate that affects surrounding bones
      and facial skeletal tissues .Thus, nasal septum deviation affects facial morphologic
      parameters such as interalveolar distance and maxillary rotation distance, causing
      compensatory changes in the lateral nasal wall and septal deviation,which are associated with
      nasal floor and palatal region asymmetries .

      Nasal septum deviation is the most common anatomic variation in up to 80% of healthy adults .

      From the initial growth stages, the maxillary bone and nasal structure have significant
      anatomic connections because of their close embryologic development.

      The severity of septal deviation also affects the ipsilateral lateral lamina of the
      cribriform plate width and ipsilateral middle turbinate length . Nasal septal deviation may
      affect nasal bone growth and facial morphology .Knowledge of nasal morphologic parameters
      plays an important role in planning successful rhinoplasty and septoplasty operations.

      Some morphological characteristics of the nose such as bone length and thickness may present
      different forms according to factors correlated with age, gender, climate and race.
observational model: Cohort
time perspective: Cross-Sectional
measure: The nasal deviation angle
time frame: 10 minutes
description: It will be measured on coronal CT images as the angle between the most deviated point of the septum and the midline which is the line from the crista galli to the palatum
measure: The lateral and intermediate nasal bone thickness
time frame: 10 minutes
description: The nasal bone thickness will be measured in axial images at the site of the lateral and intermediate osteotomy lines.
The lateral osteotomy lines run along nasomaxillary suture and intermediate (or midline) osteotomy lines runs along the internasal suture.
The lateral nasal bone thickness will be measured at the nasomaxillary suture. Intermediate nasal bone thickness was measured at the midpoint between the nasomaxillary suture and the rhinion .
measure: Nasal bone length
time frame: 10 minutes
description: The nasal bone length will be measured from frontonasal suture to the endpoint of the nasal bone on the sagittal plane
measure: Internasal angle
time frame: 10 minutes
description: The internasal angle will be measured on coronal CT images at the site of the nasion point
arm group label: patients with nasal septal deviation
description: Maxillofacial CT scan
intervention type: Radiation
intervention name: Maxillofacial CT
description: clinical and maxillofacial CT data will be tabulated and analysed using by computer software e.g. Statistical Package for the Social Sciences (SPSS)
arm group label: patients with nasal septal deviation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Martina Shawky
role: Principal Investigator
affiliation: Assiut University
facility: 
country: Egypt
citation: Hartman C, Holton N, Miller S, Yokley T, Marshall S, Srinivasan S, Southard T. Nasal Septal Deviation and Facial Skeletal Asymmetries. Anat Rec (Hoboken). 2016 Mar;299(3):295-306. doi: 10.1002/ar.23303. Epub 2016 Jan 22.
PMID: 26677010
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Martina Boshra Shawky
investigator title: principal investigator
sharing ipd: No