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3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

NCT ID: NCT00285714

Last Updated: 2007-07-27

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Craniofacial Abnormalities Maxillofacial Abnormalities Cleft Lip Cleft Palate

Keywords

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3D computer assisted imaging maxillofacial surgery cephalometry normative value

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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3D stereophotogrammetric imaging

Intervention Type PROCEDURE

3D CT-imaging with cone-beam CT

Intervention Type PROCEDURE

Case report form

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \< 15 years
* History of Orthognathic surgery
* Not Caucasian
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Stefaan J Bergé, Prof, MD, DMD, PhD,

Role: STUDY_DIRECTOR

Radboud University Medical Center

Filip AC Schutyser, MsC

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Rijnstate Hospital

Arnhem, , Netherlands

Site Status RECRUITING

Hospital Gelderse Vallei

Ede, , Netherlands

Site Status RECRUITING

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Joanneke Plooij, MD

Role: CONTACT

Phone: +31-24-3619464

Email: [email protected]

Thomas Maal, MsC

Role: CONTACT

Phone: +31-24-3614845

Email: [email protected]

Facility Contacts

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Th.J.M. Hoppenreijs, Dr.

Role: primary

P.J. Van Strijen, Dr.

Role: primary

Joanneke Plooij, MD

Role: primary

Other Identifiers

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3D_MKC590_JP01

Identifier Type: -

Identifier Source: org_study_id