NCT01246830

Brief Summary

Research questions:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

September 1, 2010

Enrollment Period

1.9 years

First QC Date

November 22, 2010

Last Update Submit

December 2, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cephalometric analysis

    linear and angular cephalometric measurement

    at treatment planning step and after 2 years of treatment

Secondary Outcomes (1)

  • outcome of orthodontic treatment

    after 2 years of treatment

Study Arms (2)

3D cephalometric analysis

Radiation: Cone-beam computed tomography (CBCT)

2D cephalometric analysis

Radiation: Panoramic radiograph, Cephalometric radiograph

Interventions

2D images that are used for orthodontic treatment planning

2D cephalometric analysis

CBCT data will be used in 3D cephalometric analysis softwares

3D cephalometric analysis

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (14)

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

    BACKGROUND
  • 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.

    PMID: 16633181BACKGROUND
  • 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.

    PMID: 16979502BACKGROUND
  • 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.

    PMID: 17009024BACKGROUND
  • 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.

    PMID: 18805225BACKGROUND
  • 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.

    PMID: 18928899BACKGROUND
  • 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.

    PMID: 19106265BACKGROUND
  • 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.

    PMID: 17709072BACKGROUND
  • 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.

    PMID: 18718796BACKGROUND
  • 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.

    PMID: 18416632BACKGROUND
  • 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.

    PMID: 19123719BACKGROUND
  • 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.

    PMID: 19574058BACKGROUND
  • Proffit WR, Fields HW Jr., Sarver DM. Contemporary Orthodontics. 4th ed, Mosby Inc., Elsevier Science, Philadelphia, 2006.

    BACKGROUND
  • 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.

    PMID: 18805224BACKGROUND

MeSH Terms

Conditions

MalocclusionTooth, Impacted

Interventions

Radiography, Panoramic

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Radiography, DentalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnosis, OralDentistry

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 23, 2010

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

September 1, 2014

Last Updated

December 3, 2014

Record last verified: 2010-09

Locations