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

Официальное название

Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate: a Prospective, Randomized, Clinical Trial

Обзор

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.

Вмешательства

• Процедура passive Alveolar Molding
  A passive palate plate (passive Alveolar Molding) will be inserted within the first week after birth. The pAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and the treatment with the pAM appliance will continue until palate closure (10-12 months of life).
• Процедура Nasoalveolar Molding
  A passive palate plate will be inserted within the first week after birth. A nasal stent will be added to the palate plate after one week (NAM appliance). The NAM appliance will be modified on regular appointments and remain until surgical lip closure (6-7 months of life). After surgical lip closure, infants will receive a nostril retainer and will be treated with a passive palate plate without nasal stent until palate closure (10-12 months of life).

Первичные конечные точки

• Columella Deviation Angle [Срок оценки: From baseline (after birth) until surgical lip closure (6 - 7 months of life)]
• Nostril Width on the cleft side [Срок оценки: From baseline (after birth) until surgical lip closure (6 - 7 months of life)]

Вторичные конечные точки (6)

• Nasal shape [Срок оценки: From baseline (after birth) until one year after surgical palate closure (24 months of life)]
• Nasal symmetry [Срок оценки: From baseline (after birth) until one year after surgical palate closure (24 months of life)]
• Alveolar cleft width and transversal/sagittal maxillary growth [Срок оценки: From baseline (after birth) until one year after surgical palate closure (24 months of life)]
• Alveolar symmetry and rotation of alveolar segments [Срок оценки: From baseline (after birth) until one year after surgical palate closure (24 months of life)]
• Statistical and dynamical facial asymmetries [Срок оценки: From baseline (after birth) until one year after surgical palate closure (24 months of life)]
• Facial perception [Срок оценки: From Baseline (after birth) until surgical lip closure (6-7 months of life)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Department of Orthodontics and Orofacial Orthopedics, University Hospital of Erlangen-Nurn — Erlangen

Идентификаторы

NCT: NCT05081258 · ER-pAM-NAM-UCLP-RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗