Al-Khateeb Khadega Ali, Aboulfotouh Mai Hamdy, Abdelsayed Fatma, Mohamed Wesam, Abd-El-Ghafour Mohamed
Department of Orthodontics, Faculty of Dentistry, Cairo University, 11 El-Saraya Street, Manial, Giza, Cairo, Egypt.
Department of Orthodontics, Faculty of Dentistry, Ibb University, Ibb, Yemen.
BMC Oral Health. 2025 Aug 19;25(1):1339. doi: 10.1186/s12903-025-06607-w.
This study aimed to compare the 3D changes of maxillary arches in infants with bilateral cleft lip and palate (BCLP) undergoing vacuum formed nasoalveolar molding appliance with active screw (VF-NAM) to those who received conventional Grayson (G-NAM).
A total of 24 BCLP infants were randomly allocated into, group 1 (n = 12) who received V-NAM and Group 2 (n = 12) underwent G-NAM appliances. In the V-NAM group, all infants received 1- 2 vacuum formed maxillary plates incorporated with active retraction screw. In the G-NAM group, Grayson's NAM technique was followed. The nasal stents were added to the maxillary plates in both groups in the same manner to mold the deformed nasal cartilages. Sixteen items in the digital maxillary models were analyzed at T1 (pre-NAM therapy) and T2 (post-NAM therapy) using 3D software. Parametric data were analyzed using a repeated measures ANOVA test to compare between groups and assess changes within each group by time, while non-parametric data were analyzed using the Mann-Whitney U test to compare between groups and the Wilcoxon signed-rank test to assess changes within each group by time.
By the end of this study, both groups showed no statistically significant differences in all variables associated with changes in the transverse and vertical arch dimensions except the mid-arch width in which the VF-NAM group exhibited a significantly greater change compared to the G-NAM group, with an effect size of 0.953 (CI 95%: -0.03 - 2.46). In the sagittal dimensions, A more significant decrease in the right and left alveolar cleft widths was observed in the VF-NAM group relative to the G-NAM group with effect sizes of 0.89 (CI 95%: -3.73-0.11). and 0.85 (CI 95%: -3.82 - 0.14), respectively (P < 0.05). Conversely, the G-NAM group demonstrated a significantly greater increase in the premaxillary rotation angle compared to the VF-NAM group, with an effect size of 0.875(CI 95%: -3.06 - 13.56) (P < 0.05).
Both VF-NAM and G-NAM effectively reduced alveolar cleft gaps, retracted the premaxillary segment, and normalized alveolar contour. However, VF-NAM resulted in greater reductions in cleft width and mid-arch width expansion. Conversely, G-NAM was more effective in improving premaxillary rotation. These findings may contribute to clinical decision-making in the early cleft management by guiding the selection of appliances based on individual anatomical characteristics. The use of a VF-NAM or G-NAM appliance could strategically optimize pre-surgical outcomes and enhance treatment planning in infants with BCLP.
NCT04966572 -July 8th 2021.
本研究旨在比较接受带主动螺杆的真空成型鼻牙槽塑形矫治器（VF-NAM）的双侧唇腭裂（BCLP）婴儿与接受传统格雷森矫治器（G-NAM）的婴儿上颌牙弓的三维变化。
总共24名BCLP婴儿被随机分为两组，第1组（n = 12）接受VF-NAM，第2组（n = 12）接受G-NAM矫治器。在VF-NAM组中，所有婴儿均接受1 - 2个带有主动回缩螺杆的真空成型上颌板。在G-NAM组中，遵循格雷森的NAM技术。两组均以上述相同方式在上颌板上添加鼻支架以塑形变形的鼻软骨。使用三维软件在T1（NAM治疗前）和T2（NAM治疗后）分析数字化上颌模型中的16项指标。参数数据采用重复测量方差分析进行组间比较并评估每组随时间的变化，而非参数数据采用曼-惠特尼U检验进行组间比较，并采用威尔科克森符号秩检验评估每组随时间的变化。
在本研究结束时，除了牙弓中段宽度外，两组在与横向和垂直牙弓尺寸变化相关的所有变量上均无统计学显著差异，其中VF-NAM组的牙弓中段宽度变化显著大于G-NAM组，效应量为0.953（95%CI：-0.03 - 2.46）。在矢状维度上，相对于G-NAM组，VF-NAM组的左右牙槽裂宽度有更显著的减小，效应量分别为0.89（95%CI：-3.73 - 0.11）和0.85（95%CI：-3.82 - 0.14）（P < 0.05）。相反，G-NAM组相对于VF-NAM组在前颌骨旋转角度上有显著更大的增加，效应量为0.875（95%CI：-3.06 - 13.56）（P < 0.05）。
VF-NAM和G-NAM均能有效减小牙槽裂间隙，回缩前颌骨段，并使牙槽轮廓正常化。然而，VF-NAM导致裂宽减小和牙弓中段宽度扩展更大。相反，G-NAM在改善前颌骨旋转方面更有效。这些发现可能有助于在早期腭裂治疗中进行临床决策，通过根据个体解剖特征指导矫治器的选择。使用VF-NAM或G-NAM矫治器可以从策略上优化手术前的结果并加强对BCLP婴儿的治疗规划。
NCT04966572 - 2021年7月8日
