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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01246830
First received: November 22, 2010
Last updated: September 28, 2011
Last verified: September 2010
  Purpose

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.

Condition Intervention
Orthodontics
Malocclusion
Impacted Tooth
Cephalometry
Cone-Beam Computed Tomography
Panoramic Radiography
Radiation: Panoramic radiograph, Cephalometric radiograph
Radiation: Cone-beam computed tomography (CBCT)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Use of 2D and 3D Imaging Modalities and Its Influence on Diagnosis and Treatment Planning in Orthodontics

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Cephalometric analysis [ Time Frame: at treatment planning step and after 2 years of treatment ] [ Designated as safety issue: No ]
    linear and angular cephalometric measurement


Secondary Outcome Measures:
  • outcome of orthodontic treatment [ Time Frame: after 2 years of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2012
Groups/Cohorts Assigned Interventions
3D cephalometric analysis Radiation: Cone-beam computed tomography (CBCT)
CBCT data will be used in 3D cephalometric analysis softwares
2D cephalometric analysis Radiation: Panoramic radiograph, Cephalometric radiograph
2D images that are used for orthodontic treatment planning

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246830

Contacts
Contact: Pisha Pittayapat, D.D.S., M.Sc. +3216332951 p.pittayapat@gmail.com
Contact: Reinhilde Jacobs, D.D.S., M.Sc., PhD +3216332410 Reinhilde.Jacobs@med.kuleuven.be

Locations
Belgium
University Hospital Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Reinhilde Jacobs, D.D.S., MSc., PhD    +3216332410    Reinhilde.Jacobs@med.kuleuven.be   
Principal Investigator: Pisha Pittayapat, D.D.S., MSc.         
Katholieke Universiteit Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Reinhilde Jacobs, D.D.S., MSc., PhD    +3216332410    Reinhilde.Jacobs@med.kuleuven.be   
Principal Investigator: Pisha Pittayapat, D.D.S., MSc.         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
  More Information

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

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01246830     History of Changes
Other Study ID Numbers: S52731
Study First Received: November 22, 2010
Last Updated: September 28, 2011
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Malocclusion
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 17, 2014