CompletedNCT01246830Updated Dec 3, 2014

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

An observational study in Orthodontics, Malocclusion and Impacted Tooth, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 2 sites in Belgium. Open to participants aged 12 Years to 25 Years. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 32
Ages: 12 Years to 25 Years
Sex: All

Study summary

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 studied

Orthodontics
Malocclusion
Impacted Tooth
Cephalometry
Cone-Beam Computed Tomography
Panoramic Radiography

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In context

Malocclusion

455 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 77 observational studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 927 studies on the registry; 260 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 25 Years
Sexes eligible: All
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.

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

Exclusion Criteria:

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

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 32 participants (actual)

Groups and cohorts

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

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

2 sites

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

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01246830
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Collaborators: KU Leuven
Responsible party: Sponsor
First posted: Nov 23, 2010
Start date: Jan 2012
Primary completion: Dec 2013
Completion: Sep 2014
Last update: Dec 3, 2014

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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