- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07579091
Correlation Between Nasal Septal Deviation and Transverse Maxillary Deficiency on CT Scans
Correlation Between Nasal Septal Deviation and Transverse Maxillary Deficiency : a Retrospective Study on CT Scan
The maxillary bones and the nasal septum are interconnected structures. The nasal septum acts as a growth center that facilitates normal maxillofacial growth and development. The objective of this study is to evaluate the presence or absence of septal deviation, as well as its degree of severity, within two adult population groups with or without maxillary transverse deficiency. This is a retrospective CT scan study. While several studies have been conducted in this field, our study is original in its approach to: maxillary transverse deficiency as a measure of the transverse dimension of the maxilla, the use of CT scans as the radiological medium for evaluating the primary endpoint, and finally, the specific method used to measure septal deviation.
If a correlation exists between the two, it would be interesting to investigate whether maxillary transverse deficiency leads to septal deviation, or if septal deviation contributes to maxillary deficiency through nasal obstruction. This could highlight the importance of early management of both maxillary transverse deficiency and nasal obstruction.
In adult patients, it could support the idea of performing a single combined procedure involving maxillary expansion and septoplasty, which would reduce comorbidities and risks; ultimately representing a true benefit for the patient.
Study Overview
Status
Conditions
Detailed Description
The study is a non-interventional (observational) research involving the human person, research on existing data (retrospective study).
This study analyzes the maxillary transverse deficiency and the septal deviation This is a comparative retrospective study of radiographs in three dimensions before any orthodontic treatment to study a potential correlation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Nancy, France, 54000
- Delcampe
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult with completed growth (> 18 years old)
- Deceased from natural causes and underwent a whole-body CT scan between 2010 and 2017, in the State of New Mexico (USA)
- Presence of maxillar and mandibular teeth from first molar to first molar (from 6 to 6)
- No body decomposition at the time of the CT scan
Exclusion Criteria:
- History of maxillofacial surgery or trauma
- Congenital craniofacial pathologies or anomalies
- Presence of maxillary or mandibular orthodontic appliances (or retainers)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patient with maxillary transverse deficiency
Patient with maxillary constriction
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Patient without maxillary transverse deficiency
Patient without maxillary constriction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Nasal septal deviation measured by coronal CT scan
Time Frame: one day
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Width of the piriform apertures measured by coronal CT scan
Time Frame: one day
|
one day
|
|
Depth of the palatal vault measured by sagittal CT scan
Time Frame: one day
|
one day
|
|
location of the septal deviation measured by coronal CT scan
Time Frame: one day
|
one day
|
|
degree of septal deviation and depth of the palatal vault
Time Frame: one day
|
one day
|
|
width of the piriform apertures and depth of the palatal vault
Time Frame: one day
|
one day
|
|
height of the septal deviation and depth of the palatal vault
Time Frame: one day
|
one day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bart Vande Vannet, Central Hospital, Nancy, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- 2025PI134
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
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