Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03300245
Other study ID # 17100286
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date March 1, 2019

Study information

Verified date June 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date March 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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:

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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Internasal angle The internasal angle will be measured on coronal CT images at the site of the nasion point 10 minutes
See also
  Status Clinical Trial Phase
Completed NCT04579042 - Cartilaginous Batten Graft Septoplasty in Caudal Septal Deviation N/A
Completed NCT01592123 - Effects of Nasal Septal Surgery on Sleep Quality, Daytime and Dream Anxiety N/A
Recruiting NCT06163404 - Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant N/A