Assessment of Maxillary Sinus Septum and Its Prevalence in a Sample of Egyptian Population (CBCT)

Assessment of Maxillary Sinus Septum and Its Prevalence in a Sample of Egyptian Population Using 3D CBCT : A Cross-Sectional Study

a cross-sectional study to estimate the prevalence of maxillary sinus septum and assessment of it in a sample of Egyptian Population using cone beam computed tomography through retrospective data analysis

Study Overview

• Status: Unknown
• Conditions: Maxillary Sinus

Detailed Description

Setting and location:

1. The data collection will be obtained from the data base available at the department of Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University, Cairo, Egypt.
2. CBCT images will be obtained from Egyptian patients who had CBCT examination as part of their dental examination, diagnosis or treatment planning.

Participants:

A total sample of 111examined sinus belonging to Egyptian individuals will be included.

Variables:

1. Prevalence of maxillary sinus septa.
2. Location of maxillary sinus septa.
3. Orientation of maxillary sinus septa in dentulous & edentulous individual.

Data Sources / Measurements:

• Retrospective Data collection will be performed after the CBCT images are pooled from the computer database.
• All the CBCT examinations will be scanned using CBCT machine (Planmeca promax 3D Mid).
• CBCT scans using different fields of view, and different voxel resolutions .
• CBCT images will be interpreted by two oral radiologists independently; blinded from demographic data of the patients and from the results of each other.
• Each one will evaluate the images separately twice with a period of two weeks between the two reading sessions.
• Then inter-observational and intra-observational variability between the observers will be evaluated.

Bias:

No source of bias.

Study Size:

The results showed that a total sample size of 111examined sinus will be adequate to detect sinus septum prevalence of 24.6% with an 8% margin of error, a significance level of 5% and a 95% confidence interval.

Quantitative Variables:

The number of CBCT scans of Egyptian individuals with maxillary sinus septa will be counted to estimate the variations in the Egyptian population.

Statistical methods:

Data will be analysed using IBM SPSS advanced statistics (Statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and standard deviation or median and range. Categorical data will be described as numbers and percentages.

• Study Type: Observational
• Enrollment (Anticipated): 111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Egyptian Population

Description

Inclusion Criteria:

• • CBCT scans of partially, fully edentulous and dentulous population.

Exclusion Criteria:

• • CBCT scans that not displaying all the extension of the lower one third of the maxillary sinus.

  • Presence of large pathological lesions involving the maxillary sinus or affecting the confines of the sinus floor.
  • Images exhibiting changes in the morphology of sinus walls due to trauma.
  • Presence of technical artifacts that make difficult the maxillary sinus evaluation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of maxillary sinus septa	Measuring device is CBCT Software on Planmeca Promax 3D Mid,Measuring unit is Percentage	in the years 2017-2018-2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location of maxillary sinus septa	Measuring device is CBCT Software on Planmeca Promax 3D Mid,Measuring unit is Percentage	in the years 2017-2018-2019

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orientation of maxillary sinus septa	Measuring device is CBCT Software on Planmeca Promax 3D Mid,Measuring unit is Categorical data: Transverse; Oblique; sagittal	in the years 2017-2018-2019

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2018
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: July 22, 2018
• First Submitted That Met QC Criteria: July 22, 2018
• First Posted (ACTUAL): July 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: CBCT; Maxillary sinus; sinus septa; sinus septum
• Other Study ID Numbers: RAD1:6:2

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