NCT00285714

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 27, 2007

Status Verified

July 1, 2007

First QC Date

February 1, 2006

Last Update Submit

July 26, 2007

Conditions

Craniofacial AbnormalitiesMaxillofacial AbnormalitiesCleft LipCleft Palate

Keywords

3D computer assisted imagingmaxillofacial surgerycephalometrynormative value

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • 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

Interventions

3D stereophotogrammetric imagingPROCEDURE
3D CT-imaging with cone-beam CTPROCEDURE
Case report formPROCEDURE

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \< 15 years
  • History of Orthognathic surgery
  • Not Caucasian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

RECRUITING

Hospital Gelderse Vallei

Ede, 6716 RP, Netherlands

RECRUITING

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Craniofacial AbnormalitiesMaxillofacial AbnormalitiesCleft LipCleft Palate

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesLip DiseasesMouth DiseasesMouth AbnormalitiesJaw AbnormalitiesJaw Diseases

Study Officials

  • Stefaan J Bergé, Prof, MD, DMD, PhD,

    Radboud University Medical Center

    STUDY DIRECTOR

  • Filip AC Schutyser, MsC

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanneke Plooij, MD

CONTACT

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

Thomas Maal, MsC

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 2, 2006

Study Start

February 1, 2006

Study Completion

December 1, 2010

Last Updated

July 27, 2007

Record last verified: 2007-07

Locations

NL(3)