Paranasal Sinus Volumes of Maxillary Deficiency Patients Requiring Le Fort Osteotomy

NCT04637568 | Completed

• 1 other identifier: AnkaraU 08/03
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Deficiency

Keywords

Maxillary Deficiency; Le Fort Osteotomy; Paranasal Sinus Volume; Computerized Tomography

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

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

Computerized tomography DIAGNOSTIC_TEST

Obtained CT scans involving the head region were analyzed retrospectively.

Control; Maxillary Deficiency

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Ankara University: lead
• Ankara Medipol University: collaborator

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Retrognathia

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Poyzan Bozkurt, Associate Professor

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 19, 2020
• Study Start: October 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)