OrthodonticsNCT01246830

The Use of 2D and 3D Imaging Modalities and Its Influence on Diagnosis and Treatment Planning in Orthodontics

An observational study of Orthodontics and Malocclusion, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Research questions: 1. Will the panoramic images derived from cone beam CT data give better diagnostic ability than conventional panoramic radiographs? 2. Will 3D cephalometric analysis offer the orthodontists and surgeons better information for treatment planning? 3. Read more about this study

Who is it for?: Ages 12 to 25 years
Conditions the study is for: Orthodontics, Malocclusion, Impacted Tooth
What is being tested?: Panoramic radiograph, Cephalometric radiograph and Cone-beam computed tomography (CBCT)
Type of treatment: Surgery or procedure
How many people: 32 participants
Where: 2 sitesBelgium
Study dates: Jan 2012to Sep 2014
Phase: Observational
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 12 to 25 years
All sexes
No healthy volunteers
Child, Adult

Study population: Patients who are seeking orthodontic and maxillofacial surgery treatments at the University Hospital Leuven with the need of conventional panoramic radiographs, cephalometric radiographs and cone beam CT images.

Who may be able to join

age 12-25 years old
Patients with malocclusions
Patients with jaw relation defect both with or without the need of orthognathic surgery
Patients with maxillofacial defects: tumors and trauma
Patients with eruption problems: embedded or impacted teeth which have to be removed

Who cannot join

Patients with congenital deformities
Patients with systemic diseases that may effect the growth formation: growth factor defect and thyroid hormone defect.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

Katholieke Universiteit Leuven
Leuven, 3000
University Hospital Leuven
Leuven, 3000

Other trials in Belgium

About this study

Research questions:

Will the panoramic images derived from cone beam CT data give better diagnostic ability than conventional panoramic radiographs?
Will 3D cephalometric analysis offer the orthodontists and surgeons better information for treatment planning?
Will the 3D cephalometric analysis give more accurate treatment plan and better treatment outcome?

General hypothesis and special aims

Overall aims:

To compare 2D versus 3D cephalometric analysis: treatment planning and therapeutic outcome.
To determine the accuracy and diagnostic ability and usability of the 3D cephalometric analysis.
To evaluate the diagnostic ability and usability of the panoramic image derived from cone beam CT data as compared to 2D panoramic images.
To evaluate the value of the cone beam CT data in cephalometric analysing process for orthodontic and maxillofacial surgery treatment.

Hypotheses:

The availability of the 3D cephalometric analysis influences the orthodontic and maxillofacial treatment plan and decision, and might change the treatment outcome.
Panoramic images derived from cone beam CT data may provide equal information for diagnosis as conventional panoramic images.
Cone beam CT will be able to replace "classic orthodontic imaging" being more time and dose efficient and having a beneficial effect on treatment outcome.

Conditions: Orthodontics, Malocclusion, Impacted Tooth, Cephalometry, Cone-Beam Computed Tomography, Panoramic Radiography
Being tested: Panoramic radiograph, Cephalometric radiograph, Cone-beam computed tomography (CBCT)
Medical subject headings: Malocclusion, Tooth, Impacted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Panoramic radiograph, Cephalometric radiographRadiation
2D images that are used for orthodontic treatment planning
Cone-beam computed tomography (CBCT)Radiation
CBCT data will be used in 3D cephalometric analysis softwares

Study groups in NCT01246830
Study group	Role	What they receive
3D cephalometric analysis		Not described Receives: Radiation: Cone-beam computed tomography (CBCT)
2D cephalometric analysis		Not described Receives: Radiation: Panoramic radiograph, Cephalometric radiograph

What is being measured

The primary outcome is the main question the study is designed to answer.

Cephalometric analysis
linear and angular cephalometric measurement
Measured: at treatment planning step and after 2 years of treatment

Secondary outcomes (1)

outcome of orthodontic treatment
Measured: after 2 years of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Sep 2014

First posted23 Nov 2010 (estimated)
Study startJan 2012
Primary completionDec 2013
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for OrthodonticsStudies of the same condition, open and under way.
More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01246830
Sponsor's protocol ID: S52731
Status last verified: Sep 2010
First submitted: 22 Nov 2010
Last updated: 3 Dec 2014
Results posted: No
Data monitoring committee: No

Publications

Broadbent BH. A new x-ray technique and its application to orthodontia. Angle Orthodontist 1931;51: 115-150
Swennen GR, Schutyser F, Barth EL, De Groeve P, De Mey A. A new method of 3-D cephalometry Part I: the anatomic Cartesian 3-D reference system. J Craniofac Surg. 2006 Mar;17(2):314-25. doi: 10.1097/00001665-200603000-00019.
PubMed 16633181
Swennen GR, Schutyser F. Three-dimensional cephalometry: spiral multi-slice vs cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2006 Sep;130(3):410-6. doi: 10.1016/j.ajodo.2005.11.035.
PubMed 16979502
Olszewski R, Cosnard G, Macq B, Mahy P, Reychler H. 3D CT-based cephalometric analysis: 3D cephalometric theoretical concept and software. Neuroradiology. 2006 Nov;48(11):853-62. doi: 10.1007/s00234-006-0140-x. Epub 2006 Sep 29.
PubMed 17009024
Scarfe WC, Farman AG. What is cone-beam CT and how does it work? Dent Clin North Am. 2008 Oct;52(4):707-30, v. doi: 10.1016/j.cden.2008.05.005.
PubMed 18805225
Carter L, Farman AG, Geist J, Scarfe WC, Angelopoulos C, Nair MK, Hildebolt CF, Tyndall D, Shrout M; American Academy of Oral and Maxillofacial Radiology. American Academy of Oral and Maxillofacial Radiology executive opinion statement on performing and interpreting diagnostic cone beam computed tomography. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Oct;106(4):561-2. doi: 10.1016/j.tripleo.2008.07.007. No abstract available.
PubMed 18928899
Hassan B, van der Stelt P, Sanderink G. Accuracy of three-dimensional measurements obtained from cone beam computed tomography surface-rendered images for cephalometric analysis: influence of patient scanning position. Eur J Orthod. 2009 Apr;31(2):129-34. doi: 10.1093/ejo/cjn088. Epub 2008 Dec 23.
PubMed 19106265
Lou L, Lagravere MO, Compton S, Major PW, Flores-Mir C. Accuracy of measurements and reliability of landmark identification with computed tomography (CT) techniques in the maxillofacial area: a systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Sep;104(3):402-11. doi: 10.1016/j.tripleo.2006.07.015. Epub 2006 Oct 27.
PubMed 17709072
de Oliveira AE, Cevidanes LH, Phillips C, Motta A, Burke B, Tyndall D. Observer reliability of three-dimensional cephalometric landmark identification on cone-beam computerized tomography. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Feb;107(2):256-65. doi: 10.1016/j.tripleo.2008.05.039. Epub 2008 Aug 20.
PubMed 18718796
Periago DR, Scarfe WC, Moshiri M, Scheetz JP, Silveira AM, Farman AG. Linear accuracy and reliability of cone beam CT derived 3-dimensional images constructed using an orthodontic volumetric rendering program. Angle Orthod. 2008 May;78(3):387-95. doi: 10.2319/122106-52.1.
PubMed 18416632
Brown AA, Scarfe WC, Scheetz JP, Silveira AM, Farman AG. Linear accuracy of cone beam CT derived 3D images. Angle Orthod. 2009 Jan;79(1):150-7. doi: 10.2319/122407-599.1.
PubMed 19123719
Olszewski R, Tanesy O, Cosnard G, Zech F, Reychler H. Reproducibility of osseous landmarks used for computed tomography based three-dimensional cephalometric analyses. J Craniomaxillofac Surg. 2010 Apr;38(3):214-21. doi: 10.1016/j.jcms.2009.05.005. Epub 2009 Jul 1.
PubMed 19574058
Proffit WR, Fields HW Jr., Sarver DM. Contemporary Orthodontics. 4th ed, Mosby Inc., Elsevier Science, Philadelphia, 2006.
White SC, Pharoah MJ. The evolution and application of dental maxillofacial imaging modalities. Dent Clin North Am. 2008 Oct;52(4):689-705, v. doi: 10.1016/j.cden.2008.05.006.
PubMed 18805224

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Orthodontics trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of 2D and 3D Imaging Modalities and Its Influence on Diagnosis and Treatment Planning in Orthodontics
ClinicalTrials.gov ID: NCT01246830
Acronym / sponsor ID: S52731
Conditions: Orthodontics, Malocclusion, Impacted Tooth, Cephalometry, Cone-Beam Computed Tomography, Panoramic Radiography
Study type: Observational
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Collaborators: KU Leuven
Study start: Jan 2012
Primary completion: Dec 2013 (actual)
Study completion: Sep 2014 (actual)
First posted: 23 Nov 2010 (estimated)
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.

Research questions:

Will the panoramic images derived from cone beam CT data give better diagnostic ability than conventional panoramic radiographs?
Will 3D cephalometric analysis offer the orthodontists and surgeons better information for treatment planning?
Will the 3D cephalometric analysis give more accurate treatment plan and better treatment outcome?

General hypothesis and special aims

Overall aims:

To compare 2D versus 3D cephalometric analysis: treatment planning and therapeutic outcome.
To determine the accuracy and diagnostic ability and usability of the 3D cephalometric analysis.
To evaluate the diagnostic ability and usability of the panoramic image derived from cone beam CT data as compared to 2D panoramic images.
To evaluate the value of the cone beam CT data in cephalometric analysing process for orthodontic and maxillofacial surgery treatment.

Hypotheses:

The availability of the 3D cephalometric analysis influences the orthodontic and maxillofacial treatment plan and decision, and might change the treatment outcome.
Panoramic images derived from cone beam CT data may provide equal information for diagnosis as conventional panoramic images.
Cone beam CT will be able to replace "classic orthodontic imaging" being more time and dose efficient and having a beneficial effect on treatment outcome.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
3D cephalometric analysis	–	Radiation: Cone-beam computed tomography (CBCT)
2D cephalometric analysis	–	Radiation: Panoramic radiograph, Cephalometric radiograph

Who may qualify

Ages: 12 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Patients who are seeking orthodontic and maxillofacial surgery treatments at the University Hospital Leuven with the need of conventional panoramic radiographs, cephalometric radiographs and cone beam CT images.

Key inclusion criteria (5 listed)

age 12-25 years old
Patients with malocclusions
Patients with jaw relation defect both with or without the need of orthognathic surgery
Patients with maxillofacial defects: tumors and trauma
Patients with eruption problems: embedded or impacted teeth which have to be removed

Key exclusion criteria (2 listed)

Patients with congenital deformities
Patients with systemic diseases that may effect the growth formation: growth factor defect and thyroid hormone defect.

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
Panoramic radiograph, Cephalometric radiograph2D images that are used for orthodontic treatment planning	Radiation	2D cephalometric analysis
Cone-beam computed tomography (CBCT)CBCT data will be used in 3D cephalometric analysis softwares	Radiation	3D cephalometric analysis

Primary outcome

Cephalometric analysis
Time frame: at treatment planning step and after 2 years of treatment
linear and angular cephalometric measurement

1 secondary outcome

outcome of orthodontic treatment
Time frame: after 2 years of treatment

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 3 Dec 2014.
BackgroundBroadbent BH. A new x-ray technique and its application to orthodontia. Angle Orthodontist 1931;51: 115-150
Background: PubMed 16633181Swennen GR, Schutyser F, Barth EL, De Groeve P, De Mey A. A new method of 3-D cephalometry Part I: the anatomic Cartesian 3-D reference system. J Craniofac Surg. 2006 Mar;17(2):314-25. doi: 10.1097/00001665-200603000-00019.
Background: PubMed 16979502Swennen GR, Schutyser F. Three-dimensional cephalometry: spiral multi-slice vs cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2006 Sep;130(3):410-6. doi: 10.1016/j.ajodo.2005.11.035.
Background: PubMed 17009024Olszewski R, Cosnard G, Macq B, Mahy P, Reychler H. 3D CT-based cephalometric analysis: 3D cephalometric theoretical concept and software. Neuroradiology. 2006 Nov;48(11):853-62. doi: 10.1007/s00234-006-0140-x. Epub 2006 Sep 29.
Background: PubMed 18805225Scarfe WC, Farman AG. What is cone-beam CT and how does it work? Dent Clin North Am. 2008 Oct;52(4):707-30, v. doi: 10.1016/j.cden.2008.05.005.
Background: PubMed 18928899Carter L, Farman AG, Geist J, Scarfe WC, Angelopoulos C, Nair MK, Hildebolt CF, Tyndall D, Shrout M; American Academy of Oral and Maxillofacial Radiology. American Academy of Oral and Maxillofacial Radiology executive opinion statement on performing and interpreting diagnostic cone beam computed tomography. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Oct;106(4):561-2. doi: 10.1016/j.tripleo.2008.07.007. No abstract available.
Background: PubMed 19106265Hassan B, van der Stelt P, Sanderink G. Accuracy of three-dimensional measurements obtained from cone beam computed tomography surface-rendered images for cephalometric analysis: influence of patient scanning position. Eur J Orthod. 2009 Apr;31(2):129-34. doi: 10.1093/ejo/cjn088. Epub 2008 Dec 23.
Background: PubMed 17709072Lou L, Lagravere MO, Compton S, Major PW, Flores-Mir C. Accuracy of measurements and reliability of landmark identification with computed tomography (CT) techniques in the maxillofacial area: a systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Sep;104(3):402-11. doi: 10.1016/j.tripleo.2006.07.015. Epub 2006 Oct 27.
Background: PubMed 18718796de Oliveira AE, Cevidanes LH, Phillips C, Motta A, Burke B, Tyndall D. Observer reliability of three-dimensional cephalometric landmark identification on cone-beam computerized tomography. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Feb;107(2):256-65. doi: 10.1016/j.tripleo.2008.05.039. Epub 2008 Aug 20.
Background: PubMed 18416632Periago DR, Scarfe WC, Moshiri M, Scheetz JP, Silveira AM, Farman AG. Linear accuracy and reliability of cone beam CT derived 3-dimensional images constructed using an orthodontic volumetric rendering program. Angle Orthod. 2008 May;78(3):387-95. doi: 10.2319/122106-52.1.
Background: PubMed 19123719Brown AA, Scarfe WC, Scheetz JP, Silveira AM, Farman AG. Linear accuracy of cone beam CT derived 3D images. Angle Orthod. 2009 Jan;79(1):150-7. doi: 10.2319/122407-599.1.
Background: PubMed 19574058Olszewski R, Tanesy O, Cosnard G, Zech F, Reychler H. Reproducibility of osseous landmarks used for computed tomography based three-dimensional cephalometric analyses. J Craniomaxillofac Surg. 2010 Apr;38(3):214-21. doi: 10.1016/j.jcms.2009.05.005. Epub 2009 Jul 1.

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Active, not recruitingObservational study
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Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Orthodontics and Malocclusion, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.

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 5 inclusion and 2 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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?

Cephalometric analysis (time frame: at treatment planning step and after 2 years of treatment). 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 NCT01246830, which also lists 14 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 3 Dec 2014.