Unilateral Cleft Lip

The objective of this clinical trial is to evaluate the supportive effectiveness of a customized nostril retainer in unilateral cleft lip repair at several hospitals in Hanoi. The main question that this trial aims to answer is: Does a customized nostril retainer help improve the aesthetic reconstruction of the nose in children following unilateral cleft lip repair? The researchers will compare the use and non-use of a customized nostril retainer to determine whether the retainer is effective in supporting the aesthetic reconstruction of the nose. Participants will be divided into two groups (the intervention group and the control group): Study population: Patients younger than 18 months with unilateral cleft lip who undergo primary lip and nasal repair. Intervention group: Participants who use a customized nostril retainer after unilateral cleft lip repair. Control group: Participants who do not use a customized nostril retainer after unilateral cleft lip repair. Follow-up: Participants will return for follow-up visits at 1 week, 3 months, and 6 months after surgery. Outcome assessment: Nasal aesthetics will be evaluated at each follow-up visit, along with the convenience and ease of use of the retainer, assessed through interviews with caregivers.

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.