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OpenTrials
Completed

NCT Number: NCT05654844

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

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.

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Key information

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University, School of Dentistry

Izmir, Bornova, 35040, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LC images

Radiation

Angular and Linear Measurements were compared in mandibular symphysis region using the LC images

CBCT images

Radiation

Angular and Linear Measurements were compared in mandibular symphysis region using the CBCT images

Primary outcomes

  1. Angular measurement-1

    Time frame: 4 weeks

    Vestibular Concavity Angle (VCA) measurements had completed by 3 investigator on both images

  2. Angular measurement-2

    Time frame: 4 weeks

    Tooth Inclination Angle (TIA) measurements had completed by 3 investigator on both images

  3. Angular measurement-3

    Time frame: 4 weeks

    Lingual Inclination Angle (LIA) measurements had completed by 3 investigator on both images

  4. Linear measurement-1

    Time frame: 4 weeks

    Vestibular cortical bone thickness measurements had completed by 3 investigator on both images

  5. Linear measurement-2

    Time frame: 4 weeks

    Lingual cortical bone thickness (LCT) had completed by 3 investigator on both images

  6. Linear measurement-3

    Time frame: 4 weeks

    Total bone thickness (TBT) measurements had completed by 3 investigator on both images

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2022
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.