Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate

University of Erlangen-Nürnberg

Status: Enrolling

Conditions: Cleft Lip and Palate; Unilateral Cleft Lip

Treatments: Procedure: Nasoalveolar Molding; Procedure: passive Alveolar Molding

Study type: Interventional

Funder types: Other

Identifiers

NCT05081258

ER-pAM-NAM-UCLP-RCT

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 1 day to 2 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

NAM treatment

Active Comparator group

Description:

Study Group: newborns with UCLP will be treated with a palate plate with nasal stent (Nasoalveolar Molding = NAM)

Treatment:

Procedure: Nasoalveolar Molding

pAM treatment

Sham Comparator group

Description:

Control Group: newborns with UCLP will be treated with a palate plate without nasal stent (passive Alveolar Molding = pAM)

Treatment:

Procedure: passive Alveolar Molding