A Randomized Prospective Clinical Trial of the Effect of Infant Orthopedics in Unilateral Cleft Lip and Palate: Prevention of Collapse of the Alveolar Segments (Dutchcleft)

A Randomized Prospective Clinical Trial of the Effect of Infant Orthopedics in Unilateral Cleft Lip and Palate: Prevention of Collapse of the Alveolar Segments (Dutchcleft)
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婴儿骨科治疗单侧唇裂和腭裂效果的随机前瞻性临床试验:预防牙槽段塌陷(荷兰裂)

DOI:
10.1597/1545-1569_2003_040_0337_arpcto_2.0.co_2
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发表时间:
2003
期刊:
The Cleft Palate-Craniofacial Journal
影响因子:
--
通讯作者:
B. Prahl
B. Prahl
中科院分区:
--
文献类型:
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作者:
C. Prahl;A. Kuijpers;M. V. van’t Hof;B. Prahl

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目的研究婴幼儿矫形术(IO)对上颌牙弓形态和牙槽骨段位置的影响。设计前瞻性双臂随机对照试验,与三个参与的学术腭裂中心平行进行。治疗通过计算机化的平衡分配方法进行分配。设在荷兰阿姆斯特丹、奈梅亨和鹿特丹的腭裂中心。受试者为单侧完全性唇腭裂患儿,无其他畸形。干预措施一组(IO+)在出生第一年时佩戴被动式上颌骨钢板,另一组(IO−)则不戴。所有其他干预措施都是相同的。主要观察指标(S)出生后不久、15周、24周、48周、58周和78周时,上颌管型上颌骨之间是否存在接触和/或重叠(塌陷)。评估了接触和坍塌的生存经验,以及不同拱形和坍塌严重程度的出现频率。结果两组出生时牙弓形态相似,上颌骨段无接触或重叠。随着时间的推移,崩溃的频率增加,组间没有显著差异。在观察期结束时,在接触和坍塌的生存经历或坍塌的严重程度方面,没有发现显著的组间差异。结论婴幼儿矫形器不能防止牙弓塌陷,可作为改善上颌牙弓形态的一种工具。
Objective To study the effect of infant orthopedics (IO) on maxillary arch form and position of the alveolar segments. Design Prospective two-arm randomized, controlled trial in parallel with three participating academic cleft palate centers. Treatment was assigned by means of a computerized balanced allocation method. Setting Cleft palate centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. Patients, Participants Infants with complete unilateral cleft lip and palate and no other malformations. Interventions One group (IO+) wore passive maxillary plates during the first year of life; the other group (IO−) did not. All other interventions were the same. Main Outcome Measure(s) The presence of contact and/or overlap (collapse) between the maxillary segments at maxillary casts made shortly after birth, at 15, 24, 48, 58, and 78 weeks. Survival experience of contact and collapse with time as well as the frequencies of different arch forms and severity of collapse were evaluated. Results Comparable arch forms with no contact or overlap of the maxillary segments were seen at birth in both groups. With time the frequency of collapse increased, with no significant differences between groups. No significant group differences were found with respect to the survival experience of contact and collapse or for the severity of collapse at the end of the observational period. Conclusions Infant orthopedics does not prevent collapse and can be abandoned as a tool to improve maxillary arch form.