NCT01413373

Brief Summary

Development of three-dimensional craniofacial cephalometric analysis for virtual planning in orthognathic surgery.

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
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

12.3 years

First QC Date

July 20, 2011

Last Update Submit

July 12, 2019

Conditions

Keywords

cephalometrythree-dimensionalCT scanlateral radiographyfacial symmetrymaxillomandibular dysmorphoses

Outcome Measures

Primary Outcomes (1)

  • topological description of maxillomandibular dysmorphosis (angles, distances)

    Anterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Posterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Ratio between distance from nasion to anterior nasal spine/anterior nasal spine to chin landmark (without unit of maesurment) Measurements between various anatomic landmarks for orbits and maxillary sinus structures on the three-dimensional CT reconstruction of the patient's skull (in mm).

    2014

Interventions

A preoperative CBCT is performed for all patients in this study for medical reason

Also known as: medical imaging, CBCT

One cone beam computer tomography examination before surgery

Also known as: medical imaging

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patient more than 18 yeras old, no pregnant women, no child

You may qualify if:

  • maxillomandibular dysmorphoses,
  • facial asymmetry,
  • craniofacial syndromes

You may not qualify if:

  • patients with orthodontic treatment only
  • growing patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of oral and maxillofacial surgery, Cliniques universitaires saint Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Malocclusion

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Raphael Olszewski, DDS,MD,PhD

    Department of Oral and maxillofacial surgery, Cliniques Universitaires saint Luc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rapahel Olszewski, DDS,MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2011

First Posted

August 10, 2011

Study Start

August 1, 2008

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations