Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03839290
Study type Observational
Source Charles University, Czech Republic
Contact Lenka Jaklová
Phone 723899485
Email jaklovale@natur.cuni.cz
Status Recruiting
Phase
Start date September 2016
Completion date May 2019

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05876169 - How Does Orthognathic Surgery Affect Jaw and Neck Motor Function? N/A
Recruiting NCT04455035 - DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants N/A
Not yet recruiting NCT05031039 - Skeletal and Dental Maturational Stages in a Sample of Egyptian Subjects With Cleft Lip and Palate Deformity
Recruiting NCT04771156 - Ketorolac in Palatoplasty Phase 4
Completed NCT04725370 - Characterization of Cleft Lip and Palate Conditions in Guatemala
Enrolling by invitation NCT02702869 - Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
Active, not recruiting NCT05971914 - Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft N/A
Completed NCT03708406 - Otologic and Rhinologic Outcomes in Children With Clef Palate
Recruiting NCT06105099 - Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate N/A
Completed NCT06075069 - Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function N/A
Completed NCT04384276 - Weigh Easy: Simplifying Home Weight Monitoring for Infants N/A
Recruiting NCT04619030 - Augmented Reality (AR): The Future of "Patient Information Leaflets N/A
Recruiting NCT03065686 - Identification of Genetic Factors Implicated in Orofacial Cleft Using Whole Exome Sequencing N/A
Completed NCT02845193 - Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial N/A
Completed NCT03308266 - Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders N/A
Completed NCT01932164 - Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients N/A
Not yet recruiting NCT06411444 - Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance N/A
Not yet recruiting NCT06292234 - Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla N/A
Recruiting NCT05081258 - Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate N/A
Not yet recruiting NCT04791813 - Assessment of Maxillary Arch Depth and Width in a Group of Surgically Repaired Unilateral Cleft Lip and Palate Children Versus Normal Children .