3D Imaging of Hard and Soft Tissue in Orthognathic Surgery

Radboud University Medical Center450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

450

Conditions

Craniofacial Abnormalities Maxillofacial Abnormalities Cleft Lip Cleft Palate

Interventions

3D stereophotogrammetric imagingPROCEDURE

3D CT-imaging with cone-beam CTPROCEDURE

Case report formPROCEDURE

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Locations (3)

Rijnstate Hospital

Arnhem, Netherlands

RECRUITING

Hospital Gelderse Vallei

Ede, Netherlands

RECRUITING

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

Central Contacts

Joanneke Plooij, MD

CONTACT

+31-24-3619464 j.plooij@mka.umcn.nl

Thomas Maal, MsC

CONTACT

+31-24-3614845 t.maal@mka.umcn.nl

Data from ClinicalTrials.gov

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