3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

Cleft Palate Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00285714
• Other study ID #: 3D_MKC590_JP01
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2006
• Last updated: July 26, 2007
• Start date: February 2006
• Est. completion date: December 2010

Study information

• Verified date: July 2007
• Source: Radboud University
• Contact: Joanneke Plooij, MD
• Phone: +31-24-3619464
• Email: j.plooij[@]mka.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Dysgnathic deformity

• Caucasian

• > 15 years

• No history of orthognathic surgery

• Informed Consent

Exclusion Criteria:

• < 15 years

• History of Orthognathic surgery

• Not Caucasian

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Palate
• Congenital Abnormalities
• Craniofacial Abnormalities
• Maxillofacial Abnormalities

Intervention

Procedure:
• 3D stereophotogrammetric imaging

• 3D CT-imaging with cone-beam CT

• Case report form

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Hospital Gelderse Vallei	Ede
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All postoperative changes in functionality at 1 year
Secondary	patients' satisfaction of facial proportions at 1 year
Secondary	surgeons' satisfaction of the 3D planning platform at 1 month