3D Imaging of Hard and Soft Tissue in Orthognathic Surgery | NCT00285714

Studies
3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

NCT00285714

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Jul 27, 2007Estimated

Enrollment

450Estimated

Phase

Not Applicable

Conditions

Craniofacial Abnormalities
Maxillofacial Abnormalities
Cleft Lip
Cleft Palate

Interventions

3D stereophotogrammetric imaging
3D CT-imaging with cone-beam CT
Case report form

Countries

Netherlands

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Dec 2010Estimated

First Submitted Date

Feb 1, 2006

First Submission Date that Met QC Criteria

Feb 1, 2006

First Posted Date

Feb 2, 2006Estimated

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

Jul 26, 2007

Last Update Posted Date

Jul 27, 2007Estimated

Description Module

Brief Summary

The primary objective of this clinical trial is to assess the influence of orthognathic surgery on facial soft tissue, such as changes (volume, linear, angular) of facial hard and soft tissue, in three dimensions, so enabling the setup of 3D normative value tables.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All changes (volumetric, linear or angular) of facial hard and soft tissue caused by orthognathic surgery at 1 months, 6 months, 12 months and 24 months.

Secondary Outcomes

Measure	Description	Time Frame
All postoperative changes in functionality at 1 year
patients' satisfaction of facial proportions at 1 year
surgeons' satisfaction of the 3D planning platform at 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dysgnathic deformity
Caucasian
> 15 years
No history of orthognathic surgery
Informed Consent

Exclusion Criteria:

< 15 years
History of Orthognathic surgery
Not Caucasian

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joanneke Plooij, MD	Contact	+31-24-3619464		j.plooij@mka.umcn.nl
Thomas Maal, MsC	Contact	+31-24-3614845		t.maal@mka.umcn.nl

Overall Officials

Name	Affiliation	Role
Stefaan J Bergé, Prof, MD, DMD, PhD,	Radboud University Medical Center	Study Director
Filip AC Schutyser, MsC	Radboud University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rijnstate Hospital	Recruiting	Arnhem		6815 AD	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D019465	Craniofacial Abnormalities
D019767	Maxillofacial Abnormalities
D002971	Cleft Lip
D002972	Cleft Palate

Ancestor Terms

ID	Term
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
3D stereophotogrammetric imaging	Procedure
3D CT-imaging with cone-beam CT	Procedure
Case report form	Procedure