Paranasal Sinus Volumes of Maxillary Deficiency Patients Requiring Le Fort Osteotomy

Maxillary Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637568
• Other study ID #: AnkaraU 08/03
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maxillary Deficiency
• Micrognathism

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Dentistry	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Ankara University	Ankara Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.