Paranasal Sinus Volumes of Maxillary Deficiency Patients Requiring Le Fort Osteotomy

Comparative Evaluation of Paranasal Sinus Volumes Between Maxillary Deficiency Patients Requiring Le Fort Osteotomy and Control Patients

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.

Study Overview

• Status: Completed
• Conditions: Maxillary Deficiency
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ethmoid sinus volumes	Ethmoid sinus volumes were calculated	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	Sphenoid sinus volumes were calculated	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.
Maxillary sinus volumes	Left and Right maxillary sinus volumes were calculated	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.

Collaborators and Investigators

• Sponsor: Ankara University
• Collaborators: Ankara Medipol University
• Investigators: Principal Investigator: Poyzan Bozkurt, Associate Professor, Ankara University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ACTUAL): November 1, 2020
• Study Completion (ACTUAL): November 1, 2020

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (ACTUAL): November 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Computerized Tomography; Maxillary Deficiency; Le Fort Osteotomy; Paranasal Sinus Volume
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Micrognathism
• Other Study ID Numbers: AnkaraU 08/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No