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

Not Applicable

Completed

• Conditions: Measurements in Mandibular Symphysis
• Interventions: Radiation: LC images; Radiation: CBCT images

• Registration Number: NCT05654844
• Lead Sponsor: Ege University

Brief Summary

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.

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 Timeline

• Study Start: 2017-06-01
• Primary Completion: 2020-12-29
• Study Completion: 2020-12-29
• Status Verified: 2022-12
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Study First Posted: 2022-12-16
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital Lateral Cephalometry	LC images	Patients justifying the indication for LC and CBCT exposure
Digital Lateral Cephalometry	CBCT images	Patients justifying the indication for LC and CBCT exposure

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ege University, School of Dentistry; 🇹🇷 Izmir, Bornova, Turkey