Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate: a Prospective, Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Columella Deviation Angle
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •newborns/infants with non-syndromal (ns) unilateral cleft lip palate (UCLP)
- •signed informed consent by the parents or legal guardian
排除标准
- •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
结局指标
主要结局
Columella Deviation Angle
时间窗: From baseline (after birth) until surgical lip closure (6 - 7 months of life)
The change of the Collumella Deviation Angle from Baseline until surgical lip closure. The change of the Columella Deviation Angle will be measured digitally using 3D-scanned models from the nose (scans and impressions from the nose) and defined anatomical points placed by four raters. Sbalc (lNc) = Subalar point on the cleft side Sbalnc (lNnc) = Subalar point on the non-cleft side SN = Subnasal point sn'c (mNc) = Subnasale' point Prn = Pronasal point CDA = Columella Deviation Angle = Angle (°) between the columella axis (connecting line between SN and Prn) and Subalar base line (connecting line between Sbalc and Sbalnc) on the cleft side
Nostril Width on the cleft side
时间窗: From baseline (after birth) until surgical lip closure (6 - 7 months of life)
The change of the Nostril Width on the cleft side from Baseline until surgical lip closure considering different time points. The change of the Nostril Width on the cleft side will be measured digitally using 3D-scanned models from the nose (scans and impressions from the nose) and defined anatomical points placed by four raters: Sbalc (lNc) = Subalar point on the cleft side Sbalnc (lNnc) = Subalar point on the non-cleft side SN = Subnasal point sn'c (mNc) = Subnasale' point Prn = Pronasal point NWc = Nostril Width on the cleft side = Distance (mm) of the connecting line between Sbalc and sn'c
次要结局
- Nasal shape(From baseline (after birth) until one year after surgical palate closure (24 months of life))
- Facial perception(From Baseline (after birth) until surgical lip closure (6-7 months of life))
- Nasal symmetry(From baseline (after birth) until one year after surgical palate closure (24 months of life))
- Alveolar symmetry and rotation of alveolar segments(From baseline (after birth) until one year after surgical palate closure (24 months of life))
- Alveolar cleft width and transversal/sagittal maxillary growth(From baseline (after birth) until one year after surgical palate closure (24 months of life))
- Statistical and dynamical facial asymmetries(From baseline (after birth) until one year after surgical palate closure (24 months of life))
研究者
Dr. Corinna Lesley Seidel
Orthodontist, Senior Physician
University of Erlangen-Nürnberg