Nasal Septal DeviationNasalseptumNCT03300245
Nasal Septum Deviation May Affect Facial Morphologic Parameters.
An observational study of Nasal Septal Deviation, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasal Septal Deviation
- What is being tested?
- Maxillofacial CT
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients attending to E N T clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between the Direction and Degree of Nasal Septal Deviation and Nasal Bone Morphology
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.
- Conditions
- Nasal Septal Deviation
- Being tested
- Maxillofacial CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillofacial CTRadiation
clinical and maxillofacial CT data will be tabulated and analysed using by computer software e.g. Statistical Package for the Social Sciences (SPSS)
| Study group | Role | What they receive |
|---|---|---|
| patients with nasal septal deviation | Maxillofacial CT scan Receives: Radiation: Maxillofacial CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 .
Measured: 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
Measured: 10 minutes
Internasal angle
The internasal angle will be measured on coronal CT images at the site of the nasion point
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Aug 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal Septal DeviationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Boshra Shawky, Assiut University
- Investigators
- Martina Shawky, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300245
- Sponsor's protocol ID
- 17100286
- Acronym
- Nasalseptum
- Status last verified
- Jun 2018
- First submitted
- 27 Sep 2017
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Direction and Degree of Nasal Septal Deviation and Nasal Bone Morphology
- ClinicalTrials.gov ID
- NCT03300245
- Acronym / sponsor ID
- Nasalseptum / 17100286
- Conditions
- Nasal Septal Deviation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with nasal septal deviation | – | Radiation: Maxillofacial CTMaxillofacial CT scan |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients attending to E N T clinic
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxillofacial CTclinical and maxillofacial CT data will be tabulated and analysed using by computer software e.g. Statistical Package for the Social Sciences (SPSS) | Radiation | patients with nasal septal deviation |
Primary outcome
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
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 .
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
Internasal angle
Time frame: 10 minutes
The internasal angle will be measured on coronal CT images at the site of the nasion point
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Background: PubMed 26677010Hartman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Shawky principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Septal Deviation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The nasal deviation angle (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.