NCT03300245

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

September 27, 2017

Last Update Submit

June 29, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • The nasal deviation angle

    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

    10 minutes

  • The lateral and intermediate nasal bone thickness

    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 .

    10 minutes

  • Nasal bone length

    The nasal bone length will be measured from frontonasal suture to the endpoint of the nasal bone on the sagittal plane

    10 minutes

  • Internasal angle

    The internasal angle will be measured on coronal CT images at the site of the nasion point

    10 minutes

Study Arms (1)

patients with nasal septal deviation

Maxillofacial CT scan

Radiation: Maxillofacial CT

Interventions

clinical and maxillofacial CT data will be tabulated and analysed using by computer software e.g. Statistical Package for the Social Sciences (SPSS)

patients with nasal septal deviation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients attending to E N T clinic

You may qualify if:

  • Patients over 18 years old who attending to Ear,Nose and throat department out patients complaining of nasal septum deviation causing nasal symptoms are exposed to maxillofacial CT.

You may not qualify if:

  • Patients with a history of rhinoplasty,
  • Patients with cranial and facial trauma or bone deformity (e.g. S-shaped septum deviation).
  • Patients with a mass or polyp in the nasal cavity.
  • Patients with adenoid .
  • Patients with nasopharyngeal lesions.
  • Patients with craniofacial anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

Related Publications (1)

  • 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: 26677010BACKGROUND

Study Officials

  • Martina Shawky

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 3, 2017

Study Start

August 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

July 3, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations