Clinical trial NCT01246830: The Use of 2D and 3D Imaging Modalities and Its Influence on Diagnosis and Treatment Planning in Orthodontics
Official title: The Use of 2D and 3D Imaging Modalities and Its Influence on Diagnosis and Treatment Planning in Orthodontics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthodontics
Malocclusion
Impacted Tooth
Cephalometry
Cone-Beam Computed Tomography
Panoramic Radiography
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2010-11-23
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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. 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:

1. The availability of the 3D cephalometric analysis influences the orthodontic and maxillofacial treatment plan and decision, and might change the treatment outcome.
2. Panoramic images derived from cone beam CT data may provide equal information for diagnosis as conventional panoramic images.
3. 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.


Eligibility 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.

Primary outcomes:
measure: Cephalometric analysis
timeFrame: at treatment planning step and after 2 years of treatment
Secondary outcomes:
measure: outcome of orthodontic treatment
timeFrame: after 2 years of treatment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
References:
citation: Broadbent BH. A new x-ray technique and its application to orthodontia. Angle Orthodontist 1931;51: 115-150
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Proffit WR, Fields HW Jr., Sarver DM. Contemporary Orthodontics. 4th ed, Mosby Inc., Elsevier Science, Philadelphia, 2006.
citation: 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.