Cleft Lip and Palate Clinical Trial
Official title:
Three-dimensional Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty: Classic and Geometric Morphometric Evaluation
Early neonatal cheiloplasty is modified surgery protocol applied in the first week of newborn's life used for treating orofacial cleft patients. This prospective study analyzes the effects of early neonatal cheiloplasty on the growth and development of maxilla and palate during the observed period of one year.
Multidisciplinary treatment of patients with orofacial clefts begins immediately after birth.
The first surgical procedure is early neonatal cheiloplasty applied in the first week of the
newborn's life, which has been practiced in the Czech Republic for many years. It is a
popular parental choice and has a lot of benefits compared to classic cheiloplasty performed
between 3-6 months. Unrestricted growth of jaws is essential for the successful therapy of
aesthetics and functions. Although there are known a lot of benefits to this surgery, its
influence on facial growth is still being studied.
The methodology of this study is based on modern three-dimensional imaging methods and will
be evaluated by classic and geometric morphometric analysis of virtual dental models. The
existing database includes 137 virtual dental casts (complete and incomplete bilateral or
unilateral cleft lip and palate).
The main aim is to verify that the effects of early neonatal cheiloplasty on the facial or
palatal growth are minimal in affected individuals and therefore the subsequent development
of these structures can be predicted at a later age. Other goals are to evaluate palatal
morphology before and one year after early neonatal cheiloplasty, to assess growth of maxilla
and palate using classic and geometric morphometry, to assess morphological differences
between cleft types and to compare the results with previously published data of neonates
operated by later operation protocol and noncleft control groups.
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