Cleft Lip and Palate Clinical Trial
Official title:
Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate: a Prospective, Randomized, Clinical Trial
Orofacial clefts are the second most common birth deformity and vary in etiology and phenotype, e.g. isolated cleft palate, cleft lip or cleft lip palate. Especially newborns with unilateral complete cleft lip and palate (UCLP) present severe facial asymmetries auch as a broad and flat ala of the nose, a deviation of the columella and the philtrum to the non cleft side. Since postnatal asymmetries can even remain after surgical lip closure in a alleviated shape, therapeutic presurgical orthodontic approaches to improve symmetrie of the nose and to achieve ideal conditions for lip surgery are essential. Presurgical orthodontic treatment for newborns with UCLP start within the first days after birth to separate oral and nasal cavitiy, to improve breathing and feeding and to regulate growth of the maxillary segments using passive appliances (passive Alveolar Molding (pAM)). An advanced and widely spread concept is the Nasoalveolar Molding (NAM) by Grayson, which was first introduced in 1993 as a palate plate combined with a nasal stent as a non-invasive presurgical appliance to stimulate growth of the nose and use the postnatal potential to modulate the nasal cartilage. The aim of the NAM therapy is to reduce nasal width, to reduce deviation of the columella to the non cleft side and to increase nostril height. However, due to inhomogeneous study designs and results, so far only a slightly positive effect using NAM therapy could be detected and prospective, randomized clinical trials are necessary. The aim of the study is to analyse and to compare the effects of pAM versus NAM treatment in newborns with UCLP in the first year of life. The following parameters will be analysed on defined study time points: nostril width, nasal morphology, cleft width, maxillary growth, statical and dynamical facial asymmetries and facial perception.
n/a
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 |
NCT03839290 -
Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty
|
||
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 | |
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 .
|