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

NCT ID: NCT01246830

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3D cephalometric analysis

Cone-beam computed tomography (CBCT)

Intervention Type RADIATION

CBCT data will be used in 3D cephalometric analysis softwares

2D cephalometric analysis

Panoramic radiograph, Cephalometric radiograph

Intervention Type RADIATION

2D images that are used for orthodontic treatment planning

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Panoramic radiograph, Cephalometric radiograph

2D images that are used for orthodontic treatment planning

Intervention Type RADIATION

Cone-beam computed tomography (CBCT)

CBCT data will be used in 3D cephalometric analysis softwares

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KU Leuven

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Katholieke Universiteit Leuven

Leuven, , Belgium

Site Status

University Hospital Leuven

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 16633181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16979502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17009024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18805225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18928899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19106265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17709072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18718796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18416632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19123719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19574058 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 18805224 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S52731

Identifier Type: -

Identifier Source: org_study_id