Actively Recruiting
Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate: a Prospective, Randomized Clinical Trial
Led by University of Erlangen-Nürnberg · Updated on 2022-05-18
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Orofacial clefts are common birth deformities that include isolated cleft palate, cleft lip, or cleft lip palate. Newborns with unilateral complete cleft lip and palate (UCLP) often have significant facial asymmetries, such as a wide and flat nose wing and deviation of the nose's columella and philtrum to the non-cleft side. Since these asymmetries may persist after surgical lip closure, presurgical orthodontic treatments are important to improve nose symmetry and create better conditions for surgery. This study compares two presurgical orthodontic approaches for newborns with UCLP to better understand their effects on facial growth and symmetry during the first year of life. The study evaluates two treatments: Nasoalveolar Molding (NAM) and passive Alveolar Molding (pAM). Both begin within the first week after birth with a palate plate inserted. NAM includes an added nasal stent after one week to encourage nasal growth and shape adjustment, while pAM uses the palate plate without the stent. Treatments continue until surgical lip closure at 6 to 7 months, followed by use of a nostril retainer and further treatment until palate closure at 10 to 12 months. Newborns are randomly assigned to either the NAM group or the pAM group. Participants will be assessed at specific points from birth through the first two years of life. Measurements include nostril width, nasal shape and symmetry, cleft width, maxillary growth, facial asymmetries, and facial perception. Primary outcomes focus on changes in columella deviation angle and nostril width from birth to surgical lip closure. Secondary outcomes track nasal and alveolar development, symmetry, and facial dynamics up to one year after palate closure. The study aims to provide detailed insight into how these treatments influence facial growth and symmetry in infants with UCLP.
CONDITIONS
Brief Title
Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborns or infants diagnosed with non-syndromal unilateral cleft lip and palate (UCLP)
- Signed informed consent provided by parent or legal guardian
You will not qualify if you...
- Newborns or infants with syndromal unilateral cleft lip and palate (UCLP)
- Insufficient adherence and compliance by parent or legal guardian
- Withdrawal of informed consent by parent or legal guardian
AI-Screening
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Your Study Journey
Duration - Up to 1 week after birth
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - From within the first week after birth until palate closure (10 to 12 months of life)
Participants receive presurgical orthodontic molding with either a palate plate with nasal stent (Nasoalveolar Molding) or a palate plate without nasal stent (passive Alveolar Molding). The appliance is modified regularly and used until surgical lip closure, followed by treatment with a nostril retainer and palate plate until palate closure.
Regular visits for appliance modification until surgical lip closure (6 to 7 months), followed by continued treatment visits until palate closure
Duration - From palate closure (10 to 12 months) until 24 months of life
Participants are followed for assessment of nasal shape, nasal symmetry, alveolar cleft width, facial asymmetries, and other outcomes for up to one year after surgical palate closure.
Follow-up visits for outcomes assessment up to one year after palate closure
Trial Site Locations
Total: 1 location
1
Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurnberg
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
C
Corinna Seidel, Dr.
K
Karin Strobel, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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