Clinical trial NCT05081258: Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate
Official title: Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate: a Prospective, Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cleft Lip and Palate
Unilateral Cleft Lip
Keywords: passie Alveolar Molding
Nasoalveolar Molding
Maxillary Growth
Facial Asymmetry
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, longitudinal, randomized, clinical trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* newborns/infants with non-syndromal (ns) unilateral cleft lip palate (UCLP)
* signed informed consent by the parents or legal guardian

Exclusion Criteria:

* newborns/infants with syndromal (s) unilateral cleft lip palate (UCLP)
* insufficient adherence and compliance by the parents or legal guardian
* withdrawal of informed consent by the parents or legal guardian

Primary outcomes:
measure: Columella Deviation Angle
timeFrame: From baseline (after birth) until surgical lip closure (6 - 7 months of life)
measure: Nostril Width on the cleft side
timeFrame: From baseline (after birth) until surgical lip closure (6 - 7 months of life)
Secondary outcomes:
measure: Nasal shape
timeFrame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
measure: Nasal symmetry
timeFrame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
measure: Alveolar cleft width and transversal/sagittal maxillary growth
timeFrame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
measure: Alveolar symmetry and rotation of alveolar segments
timeFrame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
measure: Statistical and dynamical facial asymmetries
timeFrame: From baseline (after birth) until one year after surgical palate closure (24 months of life)
measure: Facial perception
timeFrame: From Baseline (after birth) until surgical lip closure (6-7 months of life)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
state: Bavaria
Study officials:
affiliation: Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
name: Corinna Seidel, Dr.
role: STUDY_DIRECTOR
affiliation: Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
name: Lina Gölz, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
name: Karin Strobel, Dr.
role: STUDY_DIRECTOR
References: