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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Universitaire Ziekenhuizen Leuven.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Katholieke Universiteit Leuven

Information provided by (Responsible Party):

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01246830

First received: November 22, 2010

Last updated: September 28, 2011

Last verified: September 2010

History of Changes

Purpose

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.

Condition	Intervention
Orthodontics Malocclusion Impacted Tooth Cephalometry Cone-Beam Computed Tomography Panoramic Radiography	Radiation: Panoramic radiograph, Cephalometric radiograph Radiation: Cone-beam computed tomography (CBCT)

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	The Use of 2D and 3D Imaging Modalities and Its Influence on Diagnosis and Treatment Planning in Orthodontics

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Orthodontia X-Rays

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:

Cephalometric analysis [ Time Frame: at treatment planning step and after 2 years of treatment ] [ Designated as safety issue: No ]
linear and angular cephalometric measurement

Secondary Outcome Measures:

outcome of orthodontic treatment [ Time Frame: after 2 years of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2012

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

Eligibility

Ages Eligible for Study:	12 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246830

Contacts

Contact: Pisha Pittayapat, D.D.S., M.Sc.	+3216332951	p.pittayapat@gmail.com
Contact: Reinhilde Jacobs, D.D.S., M.Sc., PhD	+3216332410	Reinhilde.Jacobs@med.kuleuven.be

Locations

Belgium
University Hospital Leuven	Not yet recruiting
Leuven, Belgium, 3000
Contact: Reinhilde Jacobs, D.D.S., MSc., PhD +3216332410 Reinhilde.Jacobs@med.kuleuven.be
Principal Investigator: Pisha Pittayapat, D.D.S., MSc.
Katholieke Universiteit Leuven	Not yet recruiting
Leuven, Belgium, 3000
Contact: Reinhilde Jacobs, D.D.S., MSc., PhD +3216332410 Reinhilde.Jacobs@med.kuleuven.be
Principal Investigator: Pisha Pittayapat, D.D.S., MSc.

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Katholieke Universiteit Leuven

More Information

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.

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.

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. Epub 2006 Sep 29.

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.

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. No abstract available.

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. Epub 2008 Dec 23.

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. Epub 2006 Oct 27. Review.

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. Epub 2008 Aug 20.

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.

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.

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. Epub 2009 Jul 1.

White SC, Pharoah MJ. The evolution and application of dental maxillofacial imaging modalities. Dent Clin North Am. 2008 Oct;52(4):689-705, v.

Responsible Party:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT01246830 History of Changes
Other Study ID Numbers:	S52731
Study First Received:	November 22, 2010
Last Updated:	September 28, 2011
Health Authority:	Belgium: Ethics Committee

Additional relevant MeSH terms:

Malocclusion
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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