Paranasal Sinus Volumes of Maxillary Deficiency Patients Requiring Le Fort Osteotomy

Sponsor
Ankara University (Other)
Overall Status
Completed
CT.gov ID
NCT04637568
Collaborator
Ankara Medipol University (Other)
120
1
1
117.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Computerized tomography

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.

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Comparative Evaluation of Paranasal Sinus Volumes Between Maxillary Deficiency Patients Requiring Le Fort Osteotomy and Control Patients
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Maxillary Deficiency

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

Diagnostic Test: Computerized tomography
Obtained CT scans involving the head region were analyzed retrospectively.

Control

61 CT scans of healthy patients

Diagnostic Test: Computerized tomography
Obtained CT scans involving the head region were analyzed retrospectively.

Outcome Measures

Primary Outcome Measures

  1. Ethmoid sinus volumes [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.]

    Ethmoid sinus volumes were calculated

  2. Sphenoid sinus volumes [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.]

    Sphenoid sinus volumes were calculated

  3. Maxillary sinus volumes [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.]

    Left and Right maxillary sinus volumes were calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara University Faculty of Dentistry Ankara Turkey

Sponsors and Collaborators

  • Ankara University
  • Ankara Medipol University

Investigators

  • Principal Investigator: Poyzan Bozkurt, Associate Professor, Ankara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poyzan Bozkurt, Associate Professor, Ankara University
ClinicalTrials.gov Identifier:
NCT04637568
Other Study ID Numbers:
  • AnkaraU 08/03
First Posted:
Nov 19, 2020
Last Update Posted:
Nov 23, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Poyzan Bozkurt, Associate Professor, Ankara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2020