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3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

Primary Purpose

Craniofacial Abnormalities, Maxillofacial Abnormalities, Cleft Lip

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

3D stereophotogrammetric imaging

3D CT-imaging with cone-beam CT

Case report form

About this trial

This is an interventional diagnostic trial for Craniofacial Abnormalities focused on measuring 3D computer assisted imaging, maxillofacial surgery, cephalometry, normative value

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Dysgnathic deformity Caucasian > 15 years No history of orthognathic surgery Informed Consent Exclusion Criteria: < 15 years History of Orthognathic surgery Not Caucasian

Sites / Locations

Rijnstate HospitalRecruiting
Hospital Gelderse ValleiRecruiting
Radboud University Nijmegen Medical CentreRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

NCT ID

NCT00285714

First Posted

February 1, 2006

Last Updated

July 26, 2007

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00285714

Brief Title

3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

Official Title

An Analysis of the Clinical Applicability of a Three-Dimensional Imaging Platform Used to Register the Influence of Orthognathic Surgery on Facial Hard and Soft Tissue in Patients With Congenital Maxillofacial Deformities.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Unknown status

Study Start Date

February 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Radboud University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Craniofacial Abnormalities, Maxillofacial Abnormalities, Cleft Lip, Cleft Palate

Keywords

3D computer assisted imaging, maxillofacial surgery, cephalometry, normative value

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

3D stereophotogrammetric imaging

Intervention Type

Procedure

Intervention Name(s)

3D CT-imaging with cone-beam CT

Intervention Type

Procedure

Intervention Name(s)

Case report form

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

All postoperative changes in functionality at 1 year

Title

patients' satisfaction of facial proportions at 1 year

Title

surgeons' satisfaction of the 3D planning platform at 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joanneke Plooij, MD

Phone

+31-24-3619464

j.plooij@mka.umcn.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Maal, MsC

Phone

+31-24-3614845

t.maal@mka.umcn.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefaan J Bergé, Prof, MD, DMD, PhD,

Organizational Affiliation

Radboud University Medical Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Filip AC Schutyser, MsC

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rijnstate Hospital

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Th.J.M. Hoppenreijs, Dr.

Phone

+31-26-3787434

First Name & Middle Initial & Last Name & Degree

Th.J.M. Hoppenreijs, MD, DMD, PhD

Facility Name

Hospital Gelderse Vallei

City

Ede

ZIP/Postal Code

6716 RP

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

P.J. Van Strijen, Dr.

Phone

+31-318-435140

First Name & Middle Initial & Last Name & Degree

P.J. Van Strijen, MD, DMD, PhD

Facility Name

Radboud University Nijmegen Medical Centre

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joanneke Plooij, MD

Phone

+31-24-3619464

j.plooij@mka.umcn.nl

First Name & Middle Initial & Last Name & Degree

Joanneke Plooij, MD

First Name & Middle Initial & Last Name & Degree

Filip Schutyser, MsC

12. IPD Sharing Statement

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3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

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