3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

Not Applicable

• Conditions: Craniofacial Abnormalities; Maxillofacial Abnormalities; Cleft Lip; Cleft Palate

• Registration Number: NCT00285714
• Lead Sponsor: Radboud University Medical Center

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 available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-02
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-26
• Last Update Posted: 2007-07-27
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

Hospital Gelderse Vallei; 🇳🇱 Ede, Netherlands