NCT03839290

Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty

Three-dimensional Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty: Classic and Geometric Morphometric Evaluation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 137 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cleft Palate
• Cleft Lip
• Cleft Lip and Palate
• Cleft Lip, Bilateral

Interventions

Type	Name	Description
PROCEDURE	Early neonatal cheiloplasty

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2019-02-15
• Last updated: 2019-02-26

Locations

1 site across 1 country: Czechia