The Use of 2D and 3D Imaging Modalities and Its Influence... | NCT01246830

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

NCT01246830

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Dec 3, 2014Estimated

Enrollment

32Actual

Phase

Not provided

Conditions

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

Interventions

Panoramic radiograph, Cephalometric radiograph
Cone-beam computed tomography (CBCT)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Sep 2014Actual

First Submitted Date

Nov 22, 2010

First Submission Date that Met QC Criteria

Nov 22, 2010

First Posted Date

Nov 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2014

Last Update Posted Date

Dec 3, 2014Estimated

Name	Class
KU Leuven	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Research questions:

Will the panoramic images derived from cone beam CT data give better diagnostic ability than conventional panoramic radiographs?
Will 3D cephalometric analysis offer the orthodontists and surgeons better information for treatment planning?
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:

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3D cephalometric analysis			Radiation: Cone-beam computed tomography (CBCT)
2D cephalometric analysis			Radiation: Panoramic radiograph, Cephalometric radiograph

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Panoramic radiograph, Cephalometric radiograph	Radiation	2D images that are used for orthodontic treatment planning	2D cephalometric analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cephalometric analysis	linear and angular cephalometric measurement	at treatment planning step and after 2 years of treatment

Secondary Outcomes

Measure	Description	Time Frame
outcome of orthodontic treatment		after 2 years of treatment

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Katholieke Universiteit Leuven		Leuven		3000	Belgium
University Hospital Leuven

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Broadbent BH. A new x-ray technique and its application to orthodontia. Angle Orthodontist 1931;51: 115-150
16633181	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.
16979502

ID	Term
D008310	Malocclusion
D014095	Tooth, Impacted

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

ID	Term
D011861	Radiography, Dental
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D003945	Diagnosis, Oral
D003813	Dentistry