Heliövaara Arja, Küseler Annelise, Skaare Pål, Shaw William, Mølsted Kirsten, Karsten Agneta, Brinck Eli, Rizell Sara, Marcusson Agneta, Sæle Paul, Hurmerinta Kirsti, Rønning Elisabeth, Najar Chalien Midia, Bellardie Haydn, Mooney Jeanette, Eyres Phil, Semb Gunvor
a Department of Plastic Surgery, Cleft Palate and Craniofacial Center , Helsinki University Hospital , Helsinki , Finland.
b Cleft Palate Center , Aarhus , Denmark.
J Plast Surg Hand Surg. 2017 Feb;51(1):52-57. doi: 10.1080/2000656X.2016.1221352. Epub 2016 Oct 25.
Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP.
Three parallel randomised clinical trials were undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK.
Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born with non-syndromic UCLP. Study models of 418 patients (273 boys) at the mean age of 5.1 years (range = 4.8-7.0) were available. Dental arch relationships were assessed using the 5-year index by a blinded panel of 16 orthodontists. Kappa statistics were calculated to assess reliability. The trials were tested statistically with t- and Chi-square tests.
Good-to-very good levels of intra- and interrater reliability were obtained (0.71-0.94 and 0.70-0.87). Comparisons within each trial showed no statistically significant differences in the mean 5-year index scores or their distributions between the common method and the local team protocol. The mean index scores varied from 2.52 (Trial 2, Arm C) to 2.94 (Trial 3, Arm D).
The results of the three trials do not provide statistical evidence that one technique is better than the others. Further analysis of the possible influence of individual surgical skill and learning curve are being pursued in this dataset.
ISRCTN29932826.
良好的牙颌面生长是单侧唇腭裂（UCLP）治疗的主要目标。本研究旨在评估采用四种不同一期手术方案治疗UCLP后5岁时的牙弓关系。
由丹麦、芬兰、瑞典、挪威和英国五个国家的10个腭裂治疗团队开展了三项平行随机临床试验，作为一项国际多中心研究。
在448例非综合征性UCLP患儿的总队列中，将三种不同的腭裂一期修复手术方法（B组、C组、D组）与一种常用方法（A组）进行对比。获取了418例患者（273名男孩）的研究模型，平均年龄为5.1岁（范围 = 4.8 - 7.0岁）。由16名正畸医生组成的盲法小组使用5年指数评估牙弓关系。计算kappa统计量以评估可靠性。采用t检验和卡方检验对试验进行统计学分析。
评估者内和评估者间的可靠性达到了良好至极优水平（0.71 - 0.94和0.70 - 0.87）。每项试验中的比较显示，常用方法与当地团队方案之间在平均5年指数评分或其分布上无统计学显著差异。平均指数评分从2.52（试验2，C组）到2.94（试验3，D组）不等。
三项试验的结果未提供统计学证据表明一种技术优于其他技术。正在对该数据集中个体手术技能和学习曲线的可能影响进行进一步分析。
ISRCTN29932826
