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

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246830
• Other study ID #: S52731
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: December 2, 2014
• Start date: January 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2010
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 25 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven	Leuven
Belgium	University Hospital Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (14)

Broadbent BH. A new x-ray technique and its application to orthodontia. Angle Orthodontist 1931;51: 115-150

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. — View 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. — View 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. — View 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. — View 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. Epub 2006 Oct 27. Review. — View 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. Epub 2006 Sep 29. — View 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. — View 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. — View Citation

Proffit WR, Fields HW Jr., Sarver DM. Contemporary Orthodontics. 4th ed, Mosby Inc., Elsevier Science, Philadelphia, 2006.

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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cephalometric analysis	linear and angular cephalometric measurement	at treatment planning step and after 2 years of treatment	No
Secondary	outcome of orthodontic treatment		after 2 years of treatment	No