Measurements in Mandibular SymphysisNCT05654844
Comparison of Lateral Cephalometric and Cone Beam CT Measurements in Mandibular Symphysis
A study testing LC images and CBCT images in people with Measurements in Mandibular Symphysis, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Measurements in Mandibular Symphysis
- What is being tested?
- LC images and CBCT images
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 29 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 25 to 40 years with lateral cephalometric and CBCT exposure indication for various reasons and/or dental procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, School of Dentistry
Izmir, Bornova, 35040
About this study
Official title: 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.
Read the 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).
- Conditions
- Measurements in Mandibular Symphysis
- Being tested
- LC images, CBCT images
- Keywords
- mandibular symphysis, lateral cephalometry, cone beam CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC imagesRadiation
Angular and Linear Measurements were compared in mandibular symphysis region using the LC images
CBCT imagesRadiation
Angular and Linear Measurements were compared in mandibular symphysis region using the CBCT images
| Study group | Role | What they receive |
|---|---|---|
| Digital Lateral Cephalometry | Other | Patients justifying the indication for LC and CBCT exposure Receives: Radiation: LC images; Radiation: CBCT images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular measurement-1
Vestibular Concavity Angle (VCA) measurements had completed by 3 investigator on both images
Measured: 4 weeks
Angular measurement-2
Tooth Inclination Angle (TIA) measurements had completed by 3 investigator on both images
Measured: 4 weeks
Angular measurement-3
Lingual Inclination Angle (LIA) measurements had completed by 3 investigator on both images
Measured: 4 weeks
Linear measurement-1
Vestibular cortical bone thickness measurements had completed by 3 investigator on both images
Measured: 4 weeks
Linear measurement-2
Lingual cortical bone thickness (LCT) had completed by 3 investigator on both images
Measured: 4 weeks
Linear measurement-3
Total bone thickness (TBT) measurements had completed by 3 investigator on both images
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Jun 2017
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Measurements in Mandibular SymphysisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erinc Onem, Ege University
- Investigators
- Erinç Onem, Prof, Study director, Academician in Ege UniversityOguzhan Baydar, MSD, Principal investigator, Master of Science in Dentistry in Ege UniversityB. Guniz Baksi, Prof, Study chair, Academician in Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654844
- Sponsor's protocol ID
- comparison of LC and CBCT
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3464438Rai 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.
PubMed 35783918Kumar 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.
PubMed 17586852
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Linear And Angular Measurements in Mandibular Symphyseal Region Using Lateral Cephalometric and Cone Beam CT Images
- ClinicalTrials.gov ID
- NCT05654844
- Acronym / sponsor ID
- comparison of LC and CBCT
- Conditions
- Measurements in Mandibular Symphysis
- Keywords
- mandibular symphysis, lateral cephalometry, cone beam CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Lateral Cephalometry | Other | Radiation: LC images, Radiation: CBCT imagesPatients justifying the indication for LC and CBCT exposure |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 25 to 40 years with lateral cephalometric and CBCT exposure indication for various reasons and/or dental procedures.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC imagesAngular and Linear Measurements were compared in mandibular symphysis region using the LC images | Radiation | Digital Lateral Cephalometry |
| CBCT imagesAngular and Linear Measurements were compared in mandibular symphysis region using the CBCT images | Radiation | Digital Lateral Cephalometry |
Primary outcome
Angular measurement-1
Time frame: 4 weeks
Vestibular Concavity Angle (VCA) measurements had completed by 3 investigator on both images
Angular measurement-2
Time frame: 4 weeks
Tooth Inclination Angle (TIA) measurements had completed by 3 investigator on both images
Angular measurement-3
Time frame: 4 weeks
Lingual Inclination Angle (LIA) measurements had completed by 3 investigator on both images
Linear measurement-1
Time frame: 4 weeks
Vestibular cortical bone thickness measurements had completed by 3 investigator on both images
Linear measurement-2
Time frame: 4 weeks
Lingual cortical bone thickness (LCT) had completed by 3 investigator on both images
Linear measurement-3
Time frame: 4 weeks
Total bone thickness (TBT) measurements had completed by 3 investigator on both images
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Background: PubMed 3464438Houston 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.
- Background: PubMed 35783918Rai 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.
- Background: PubMed 17586852Kumar 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erinç Onem, Prof study director
Academician in Ege University
Oguzhan Baydar, MSD principal investigator
Master of Science in Dentistry in Ege University
B. Guniz Baksi, Prof study chair
Academician in Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LC images and CBCT images in people with Measurements in Mandibular Symphysis, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular measurement-1 (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654844, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.