Clinical trial NCT05654844: Comparison of Lateral Cephalometric and Cone Beam CT Measurements in Mandibular Symphysis
Official title: Comparison of Linear And Angular Measurements in Mandibular Symphyseal Region Using Lateral Cephalometric and Cone Beam CT Images
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Measurements in Mandibular Symphysis
Keywords: mandibular symphysis
lateral cephalometry
cone beam CT
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Angular measurement-1
timeFrame: 4 weeks
measure: Angular measurement-2
timeFrame: 4 weeks
measure: Angular measurement-3
timeFrame: 4 weeks
measure: Linear measurement-1
timeFrame: 4 weeks
measure: Linear measurement-2
timeFrame: 4 weeks
measure: Linear measurement-3
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University, School of Dentistry
state: Bornova
Study officials:
affiliation: Academician in Ege University
name: Erinç Onem, Prof
role: STUDY_DIRECTOR
affiliation: Master of Science in Dentistry in Ege University
name: Oguzhan Baydar, MSD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academician in Ege University
name: B. Guniz Baksi, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.