3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

Radboud University Medical Center

Status: Unknown

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

Treatments: Procedure: 3D CT-imaging with cone-beam CT; Procedure: Case report form; Procedure: 3D stereophotogrammetric imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT00285714

3D_MKC590_JP01

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)