The aim of this longitudinal prospective study is to investigate facial morphology in children with and without orofacial clefts three-dimensionally using noninvasive stereophotogrammetry in order:- to establish reference values for normal facial…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
schisis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in soft tissue facial growth between case and control group will be
evaluated by measurement of three-dimensional facial volume changes and changes
in landmark position over time during the first 6 years of life.
Secondary outcome
Not applicable
Background summary
Medical imaging has moved from two-dimensional representations to more
sophisticated 3D techniques. Nowadays it is possible to study facial morphology
in patients with orofacial clefts three-dimensionally. This longitudinal study
will describe the three-dimensional facial growth of cleft patients compared to
controls using the stereophotogrammetry method. Stereophotogrammetry is a
non-invasive method without any form of radiation.
Study objective
The aim of this longitudinal prospective study is to investigate facial
morphology in children with and without orofacial clefts three-dimensionally
using noninvasive stereophotogrammetry in order:
- to establish reference values for normal facial growth and development
- to evaluate facial growth and treatment outcome in children with orofacial
clefts
Study design
Observational study; longitudinal cohort study
No intervention
Study burden and risks
Children with OFC are photographed 13 times in the first 6 years of life as
much as possible during the regular visits at the Cleft Palate Craniofacial
Unit. These photographs are taken by means of the non-invasive 3D
stereophotogrammetry method without exposure to ionizing radiation. During each
visit a short questionnaire about the history of the child's health will be
taken from the parents and the child's weight, length, head circumference,
relative sitting height and arm span are measured.
The control group of healthy newborns and their parents have to come to the
Radboud University, Medical Centre 13 times during the first 6 years of their
child's life. A 3D picture will be taken and a short questionnaire. The child's
weight, length, head circumference, relative sitting height and arm span are
measured as well. The study can only be done using this control group, because
three-dimensional reference values for normal facial growth are not yet
available in this age group (0-6 years). Neither longitudinal three-dimensional
facial growth data of cleft patients (age 0-6 years) are available.
Philips van Leydenlaan 25
6500 HB Nijmegen
NL
Philips van Leydenlaan 25
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
The patient inclusion criteria are non-syndromic UCLP or BCLP. Infants should be born at term (38+ wk) and both parents should be Caucasisch for both the case and control group.
Exclusion criteria
Other congenital malformations and soft tissue bands. In addition no oral clefts have occured in the first, second or third degree relatives of the control child.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17934.091.07 |