CClinicalTrials.gg
Status unknownNCT03300245NasalseptumUpdated Jul 3, 2018

Nasal Septum Deviation May Affect Facial Morphologic Parameters.

An observational study in Nasal Septal Deviation, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-07-03.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Nasal Septal Deviation
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients attending to E N T clinic

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  1. Patients with a history of rhinoplasty,
  2. Patients with cranial and facial trauma or bone deformity (e.g. S-shaped septum deviation).
  3. Patients with a mass or polyp in the nasal cavity.
  4. Patients with adenoid .
  5. Patients with nasopharyngeal lesions.
  6. Patients with craniofacial anomalies.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients with nasal septal deviation

    Maxillofacial CT scan

    Radiation: Maxillofacial CT

Interventions

  • RadiationMaxillofacial CT

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 minutes

  2. 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 .

    Time frame: 10 minutes

  3. Nasal bone length

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

    Time frame: 10 minutes

  4. Internasal angle

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

    Time frame: 10 minutes

06

Study locations

1 site
  • Assiut university
    Assiut, 71515, Egypt
07

References and documents

Publications

  • 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. PubMed 26677010 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03300245
Lead sponsor
Assiut University
Responsible party
Martina Boshra Shawky (principal investigator, Assiut University) — Principal investigator
First posted
Oct 3, 2017
Start date
Aug 1, 2018 (estimated)
Primary completion
Jan 1, 2019 (estimated)
Completion
Mar 1, 2019 (estimated)
Last update
Jul 3, 2018

Study contacts

Martina Shawky
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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