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| Name | Class |
|---|---|
| Anthropology and Human Genetics | UNKNOWN |
| Otorhinolaryngology, 2nd Faculty of Medicine | UNKNOWN |
| Department of Newborns with Intensive Care Unit | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral cleft lip and palate patients | Newborns with complete bilateral cleft lip and palate (cBCLP) and bilateral cleft lip and palate with tissue bridges (BCLP + B) analyzed one year after neonatal cheiloplasty |
| |
| Unilateral cleft lip and palate patients | Newborns with complete unilateral cleft lip and palate (cUCLP) and unilateral cleft lip and palate with tissue bridges (UCLP + B) analyzed one year after neonatal cheiloplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early neonatal cheiloplasty | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth changes during the first year of life | Analysis of palatal growth changes in individuals with orofacial clefts after neonatal cheiloplasty (5 ± 5 days) and before palatoplasty (12 ± 6 months). | T0 before early neonatal cheiloplasty (5 ± 5 days) and T1 before palatoplasty (12 ± 6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the palatal growth in orofacial cleft patients | Comparison of the growth of the palate in complete and incomplete cleft patients | 1 year |
| Differences between cleft types | Morphological differences between complete and incomplete cleft types |
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Inclusion Criteria:
Exclusion Criteria:
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Newborns with orofacial clefts operated in the first week of life at the Motol University Hospital in Prague by the same surgeon following the modified Veau surgery protocol.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lenka Jaklová | Contact | 723899485 | jaklovale@natur.cuni.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jana VelemĂnská | Department of Anthropology and Human Genetics | Study Director |
| Jiřà Borský | Department of Otorhinolaryngology | Study Chair |
| Lenka Jaklová |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenka Jaklová | Recruiting | Prague | Czech Republic | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29728158 | Background | Hoffmannova E, Moslerova V, Dupej J, Borsky J, Bejdova S, Veleminska J. Three-dimensional development of the upper dental arch in unilateral cleft lip and palate patients after early neonatal cheiloplasty. Int J Pediatr Otorhinolaryngol. 2018 Jun;109:1-6. doi: 10.1016/j.ijporl.2018.03.009. Epub 2018 Mar 14. | |
| 27729158 | Background |
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| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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| 1 year |
| Department of Anthropology and Human Genetics |
| Study Chair |
| Hoffmannova E, Bejdova S, Borsky J, Dupej J, Caganova V, Veleminska J. Palatal growth in complete unilateral cleft lip and palate patients following neonatal cheiloplasty: Classic and geometric morphometric assessment. Int J Pediatr Otorhinolaryngol. 2016 Nov;90:71-76. doi: 10.1016/j.ijporl.2016.08.028. Epub 2016 Aug 31. |
| 22906307 | Background | Jiri B, Jana V, Michal J, Jiri K, Dana H, Miroslav T, Milos C, Zdenek K, Jaroslav F, Jan J, Jiri Z, Renata P, Miroslav P. Successful early neonatal repair of cleft lip within first 8 days of life. Int J Pediatr Otorhinolaryngol. 2012 Nov;76(11):1616-26. doi: 10.1016/j.ijporl.2012.07.031. Epub 2012 Aug 18. |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008047 | Lip Diseases |