NCT05654844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

3.6 years

First QC Date

December 8, 2022

Last Update Submit

December 8, 2022

Conditions

Measurements in Mandibular Symphysis

Keywords

mandibular symphysislateral cephalometrycone beam CT

Outcome Measures

Primary Outcomes (6)

  • Angular measurement-1

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

    4 weeks

  • Angular measurement-2

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

    4 weeks

  • Angular measurement-3

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

    4 weeks

  • Linear measurement-1

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

    4 weeks

  • Linear measurement-2

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

    4 weeks

  • Linear measurement-3

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

    4 weeks

Study Arms (1)

Digital Lateral Cephalometry

OTHER

Patients justifying the indication for LC and CBCT exposure

Radiation: LC imagesRadiation: CBCT images

Interventions

LC imagesRADIATION

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

Digital Lateral Cephalometry
CBCT imagesRADIATION

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

Digital Lateral Cephalometry

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University, School of Dentistry

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

Related Publications (3)

  • Houston WJ, Maher RE, McElroy D, Sherriff M. Sources of error in measurements from cephalometric radiographs. Eur J Orthod. 1986 Aug;8(3):149-51. doi: 10.1093/ejo/8.3.149. No abstract available.

    PMID: 3464438BACKGROUND

  • Rai S, Misra D, Misra A, Kidwai S, Bisla S, Jain A, Gangwal P. Evaluation of neurovascular anatomical variation in the anterior mandible in North Indian population: A CBCT assessment. J Oral Biol Craniofac Res. 2022 Sep-Oct;12(5):505-511. doi: 10.1016/j.jobcr.2022.06.005. Epub 2022 Jun 17.

    PMID: 35783918BACKGROUND

  • Kumar V, Ludlow JB, Mol A, Cevidanes L. Comparison of conventional and cone beam CT synthesized cephalograms. Dentomaxillofac Radiol. 2007 Jul;36(5):263-9. doi: 10.1259/dmfr/98032356.

    PMID: 17586852BACKGROUND

Study Officials

  • Erinç Onem, Prof

    Academician in Ege University

    STUDY DIRECTOR

  • Oguzhan Baydar, MSD

    Master of Science in Dentistry in Ege University

    PRINCIPAL INVESTIGATOR

  • B. Guniz Baksi, Prof

    Academician in Ege University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, PhD, Professor

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 16, 2022

Study Start

June 1, 2017

Primary Completion

December 29, 2020

Study Completion

December 29, 2020

Last Updated

December 16, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)