Comparison of Lateral Cephalometric and Cone Beam CT Measurements in Mandibular Symphysis

December 8, 2022 updated by: Erinc Onem, Ege University

Comparison of Linear And Angular Measurements in Mandibular Symphyseal Region Using Lateral Cephalometric and Cone Beam CT Images

The goal of this clinical trial is to compare the linear and angular measurements of the mandibular symphyseal region using lateral cephalometric (LC) and cone beam computed tomography (CBCT) images. The main question it aims to answer are:

Is there a significant difference in measurements on lateral cephalometric and cone beam CT? Measurements were made by 3 radiologists, and the intra-class correlation coefficient (ICC) was used to measure interobserver reliability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to compare the linear and angular measurements of the mandibular symphyseal region using lateral cephalometric (LC) and cone beam computed tomography (CBCT) images. One hundred patients justifying both LC and CBCT exposures were included. Both lateral cephalometric and CBCT images of the patients were used for angular and linear measurements. Angular measurements included vestibular-concavity, lingual- and tooth-inclination angles. Vestibular and lingual cortical bone and total bone thickness measurements were obtained for the comparison of linear measurements. Three radiologists performed the measurements on 200 images. Comparison of the measurements and the imaging methods were done using paired- and Wilcoxon t-tests. Inter-observer reliability was evaluated with the intra-class correlation coefficient (ICC).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bornova
      • Izmir, Bornova, Turkey, 35040
        • Ege University, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 25 to 40 years with lateral cephalometric and CBCT exposure indication for various reasons and/or dental procedures.

Exclusion Criteria:

  • Patients under 25 and above 40 years of age, with more than single missing mandibular anterior teeth, with implants and/or metal restorations in the mandibular anterior region that may disrupt image quality and thus measurements, prominent asymmetry of the mandibular anterior region, having orthodontic appliances, temporomandibular joint and/or muscle disorders and history of trauma were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Digital Lateral Cephalometry
Patients justifying the indication for LC and CBCT exposure
Radiation: LC images
Angular and Linear Measurements were compared in mandibular symphysis region using the LC images
Radiation: CBCT images
Angular and Linear Measurements were compared in mandibular symphysis region using the CBCT images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angular measurement-1
Time Frame: 4 weeks
Vestibular Concavity Angle (VCA) measurements had completed by 3 investigator on both images
4 weeks
Angular measurement-2
Time Frame: 4 weeks
Tooth Inclination Angle (TIA) measurements had completed by 3 investigator on both images
4 weeks
Angular measurement-3
Time Frame: 4 weeks
Lingual Inclination Angle (LIA) measurements had completed by 3 investigator on both images
4 weeks
Linear measurement-1
Time Frame: 4 weeks
Vestibular cortical bone thickness measurements had completed by 3 investigator on both images
4 weeks
Linear measurement-2
Time Frame: 4 weeks
Lingual cortical bone thickness (LCT) had completed by 3 investigator on both images
4 weeks
Linear measurement-3
Time Frame: 4 weeks
Total bone thickness (TBT) measurements had completed by 3 investigator on both images
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Study Director: Erinç Onem, Prof, Academician in Ege University
  • Principal Investigator: Oguzhan Baydar, MSD, Master of Science in Dentistry in Ege University
  • Study Chair: B. Guniz Baksi, Prof, Academician in Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

December 29, 2020

Study Completion (Actual)

December 29, 2020

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • comparison of LC and CBCT

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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