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CompletedNCT04637568Updated Nov 23, 2020

Paranasal Sinus Volumes of Maxillary Deficiency Patients Requiring Le Fort Osteotomy

An observational study in Maxillary Deficiency, sponsored by Ankara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-23.

Sponsored by Ankara University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
120
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The present study aims to compare ethmoid, sphenoid and maxillary sinus volumes of patients with maxillary deficiency requiring Le Fort osteotomy with healthy patients, by employing computed tomography imaging. No accessible information could be found on this subject during literature search. The authors believe anatomical knowledge of these structures in patients with maxillary deficiency will influence all branches performing surgeries in these areas.

Read the detailed description

The anatomy of the paranasal sinuses is important for many surgeon groups. The precise knowledge of such structures with variable anatomy will be important for the preservation of these structures and the management of complications in surgeries such as endoscopic sinus surgery and osteotomies involving the maxilla such as Le Fort osteotomies. The maxillomandibular complex is often affected by developmental problems and growth problems, and unilateral, bilateral, horizontal, vertical and / or transverse deficiencies are observed. Treatment of this complex is often performed by surgical intervention involving one or both jaws. In surgeries involving the maxilla, maxillary sinuses are affected by the surgery and affect the course of surgery. Paranasal sinuses are also very important structures for closely related endoscopic sinus surgeries. Detailed preoperative investigation is crucial for patient selection and hence desired outcome. Study was conducted in Ankara University Faculty of Dentistry with Ethical approval number:08/03. Computed tomography scans of 120 patients (59 maxillary deficiency patients and 61 healthy controls) were included in the study. CT scan indications for the group with maxillary deficiency was surgical preparation for Le Fort I osteotomy. The control group had no maxillary deficiency and CT images were obtained for several reasons such as temporomandibular disease, preparation for orthodontic treatment, obstructive sleep apnea and also paranasal sinus imaging Patients with a history of trauma in the midline skull base were excluded. Statistically significant results were obtained between groups for ethmoid and maxillary sinus volumes (left and right). Ethmoid and maxillary sinus volumes (left and right) were smaller in the Le Fort group. No statistically significant differences were present for sphenoid sinus volume of two groups and for the left and right maxillary sinus volumes in both groups.

02

Conditions studied

  • Maxillary Deficiency

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Keywords

  • Maxillary Deficiency
  • Le Fort Osteotomy
  • Paranasal Sinus Volume
  • Computerized Tomography
03

In context

Retrognathia

62 studies on the registry are indexed under Retrognathia; 15 are open to participants now.

This study's enrollment of 120 is below the median of 154 across 10 observational studies indexed under Retrognathia.

Browse Retrognathia studies →

Lead sponsor

Ankara University is the lead sponsor of 320 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Study population consisted of 58 male and 62 female participants, aged between 18-69.

Eligibility criteria

Inclusion Criteria for the study group:

  • Maxillary deficiency (CT scans involving the head and paranasal sinuses, obtained for Le Fort I osteotomy).

Inclusion Criteria for the control group:

-Healthy patients. (CT scans involving the head and paranasal sinuses, obtained for several reasons such as temporomandibular disease, preparation for orthodontic treatment, obstructive sleep apnea and also paranasal sinus imaging, no maxillary deficiency).

Exclusion Criteria: Patients with a history of trauma in the midline skull base were excluded.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Maxillary Deficiency

    59 CT scans of patients with maxillary deficiency requiring Le Fort osteotomy

    Diagnostic Test: Computerized tomography

  • Control

    61 CT scans of healthy patients

    Diagnostic Test: Computerized tomography

Interventions

  • Diagnostic testComputerized tomography

    Obtained CT scans involving the head region were analyzed retrospectively.

06

What researchers measure

Primary outcomes

  1. Ethmoid sinus volumes

    Ethmoid sinus volumes were calculated

    Time frame: All measurements were taken twice by the same observers. The observers performed the study twice with an interval of 2 weeks to detect intra-observer variability.

  2. Sphenoid sinus volumes

    Sphenoid sinus volumes were calculated

    Time frame: All measurements were taken twice by the same observers. The observers performed the study twice with an interval of 2 weeks to detect intra-observer variability.

  3. Maxillary sinus volumes

    Left and Right maxillary sinus volumes were calculated

    Time frame: All measurements were taken twice by the same observers. The observers performed the study twice with an interval of 2 weeks to detect intra-observer variability.

07

Study locations

1 site
  • Ankara University Faculty of Dentistry
    Ankara, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04637568
Lead sponsor
Ankara University
Collaborators
Ankara Medipol University
Responsible party
Poyzan Bozkurt (Associate Professor, Ankara University) — Principal investigator
First posted
Nov 19, 2020
Start date
Oct 1, 2020
Primary completion
Nov 1, 2020
Completion
Nov 1, 2020
Last update
Nov 23, 2020

Study contacts

Poyzan Bozkurt, Associate Professor
principal investigator · Ankara 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 completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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