- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300245
Nasal Septum Deviation May Affect Facial Morphologic Parameters. (Nasalseptum)
The Relationship Between the Direction and Degree of Nasal Septal Deviation and Nasal Bone Morphology
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Assiut, Egypt, 71515
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients with nasal septal deviation
Maxillofacial CT scan
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clinical and maxillofacial CT data will be tabulated and analysed using by computer software e.g.
Statistical Package for the Social Sciences (SPSS)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The nasal deviation angle
Time Frame: 10 minutes
|
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
Time Frame: 10 minutes
|
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
Time Frame: 10 minutes
|
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
Time Frame: 10 minutes
|
The internasal angle will be measured on coronal CT images at the site of the nasion point
|
10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martina Shawky, Assiut University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17100286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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