Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: occlusion in 8-year-olds according to the Modified Huddart and Bodenham index.
Scandicle单侧唇腭裂初次手术的随机试验: 根据改良Huddart和Bodenham指数对 8 岁儿童进行咬合。
- 作者列表："Karsten A","Marcusson A","Rizell S","Chalien MN","Heliövaara A","Küseler A","Skaare P","Brinck E","Shaw W","Bellardie H","Mooney J","Mølsted K","Sæle P","Eyres P","Semb G
BACKGROUND:The Scandcleft international multicenter study is a prospective clinical trial of the long-term outcome after four different surgical protocols for palatal closure in patients born with unilateral cleft lip and palate (UCLP). This paper is one of a series of follow-up studies in 8-year olds. OBJECTIVES:To evaluate the dental occlusion of 8-year-old patients after four different protocols of primary surgery for UCLP. TRIAL DESIGN:Ten cleft centres in five countries tested three different surgical procedures for primary palatal repair in three parallel trials (Arms B, C, and D) against a common procedure (Arm A). METHODS:Initially 448 children born with non-syndromic UCLP were included in the project. At 8 years of age, 428 children remained in the study. Dental casts of 411 patients (270 boys, 141 girls), mean age 8.1 years (range 7.0-10.0) were taken. The casts were blindly assessed with the Modified Huddart and Bodenham (MHB) index by four orthodontists. The main outcome measures were anterior (+2 to -6) and posterior (0 to -8) mean scores. Comparisons were made with previous data in 5-year-olds. RESULTS:The inter- and intra-examiner reliability was good to excellent (0.75-0.90; 0.73-0.97), respectively. The mean total scores varied from -7.09 (Trial 2C) to -10.13 (Trial 3D). The mean anterior scores varied from -1.75 (Trial 2C) to -3.18 (Trial 1A). The mean posterior cleft-side scores varied from -4.32 (Trial 1B) to -5.21 (Trial 3D) and the mean non-cleft-side scores varied from -0.88 (Trial 2C) to -2.40 (Trial 3A). No significant differences were found within the trials. A significant difference was found between Trials 2 and 3 (Arm C/D) for the total score (P = 0.004). CONCLUSIONS:There was no evidence of clinically significant differences in occlusion between the two surgical methods in each trial or between the trials. All mean scores showed more negative values in 8-year-olds compared with previously reported values in 5-year-olds. TRIAL REGISTRATION:ISRCTN29932826.
背景: scandlice international多中心研究是一项前瞻性临床试验，研究了单侧唇腭裂 (UCLP) 患者在 4 种不同手术方案下腭闭合后的长期预后。本文是 8 岁儿童系列随访研究之一。 目的: 评估 8 岁儿童UCLP初次手术四种不同方案后的牙合情况。 试验设计: 5 个国家的 10 个腭裂中心在 3 个平行试验 (Arms B、C和D) 中测试了 3 种不同的原发性腭修复手术，而不是普通手术 (Arm a)。 方法: 最初 448 例非综合征型UCLP出生的儿童被纳入该项目。8 岁时，428 名儿童仍在研究中。取 411 例患者 (270 例男孩，141 例女孩) 的牙科铸型，平均年龄 8.1 岁 (范围 7.0-10.0)。由 4 名正畸医生用改良的Huddart和Bodenham (MHB) 指数盲目评估管型。主要结局指标为前 (+ 2 至-6) 和后 (0 至-8) 平均评分。在 5 岁儿童中与以前的数据进行比较。 结果: 检查间和检查内信度从好到优 (分别为 0.75-0.90; 0.73-0.97)。平均总分从-7.09 (试验 2C) 到-10.13 (试验 3D) 不等。平均前评分从-1.75 (试验 2C) 到-3.18 (试验 1A) 不等。平均后裂侧评分从-4.32 (试验 1B) 到-5.21 (试验 3D) 不等，平均非裂侧评分从-0.88 (试验 2C) 不等to -2.40 (试验 3A)。试验内未发现显著差异。发现试验 2 和 3 (Arm C/D) 之间的总分存在显著差异 (P = 0.004)。 结论: 在每个试验中或试验之间，没有证据表明两种手术方法在咬合方面存在临床显著差异。与以前报告的 5 岁儿童值相比，所有平均得分在 8 岁儿童中显示出更多的负值。 试用注册: isrctn29932826。
METHODS:BACKGROUND:The anterior oronasal fistulae neighboring the alveolar cleft could persist or reappear after the alveolar reconstruction with cancellous bone grafting. The persistent symptomatic anterior oronasal fistulae need to be repaired, but surgery remains a challenge in cleft care. Surprisingly, this issue has rarely been reported in the literature. The purpose of this long-term study was to report a single surgeon experience with a therapeutic protocol for persistent symptomatic anterior oronasal fistula repair. METHODS:This is a retrospective study of consecutive patients with Veau type III and IV clefts and persistent symptomatic anterior oronasal fistulae managed according to a therapeutic protocol from 1997 to 2018. Depending on fistula size, patients were treated with local flaps associated with an interpositional graft or two-stage tongue flaps (small/medium or large fistulae, respectively). The surgical outcomes were classified as "good" (complete fistula closure with no symptoms), "fair" (asymptomatic narrow fistula remained), or "poor" (failure with persistent symptoms). RESULTS:Forty-four patients with persistent symptomatic anterior oronasal fistulae were reconstructed with local flaps associated with interpositional fascia or dermal fat grafting (52.3%) or two-stage tongue flaps (47.7%). Most of patients (93.2%) presented "good" outcomes, ranging from 87% to 100% (local and tongue flaps, respectively). Three (6.8%) patients presented symptomatic residual fistula ("poor" outcomes). CONCLUSIONS:For the repair of persistent symptomatic anterior oronasal fistulae, this therapeutic protocol provided satisfactory outcome with low fistula recurrence rate.
METHODS:OBJECTIVE:Methadone is a vital treatment for women with opioid use disorder in pregnancy. Previous reports suggested an association between methadone exposure and Pierre Robin sequence (PRS), a rare craniofacial anomaly. We assessed the association between gestational methadone exposure and PRS. DESIGN/SETTING:This case-malformed control study used European Surveillance of Congenital Anomalies population-based registries in Ireland, the Netherlands, Italy, Switzerland, Croatia, Malta, Portugal, Germany, Wales, Norway and Spain, 1995-2011. PATIENTS:Cases included PRS based on International Classification of Disease (ICD), Ninth Edition-British Paediatric Association (BPA) code 75 603 or ICD, Tenth Edition-BPA code Q8708. Malformed controls were all non-PRS anomalies, excluding genetic conditions, among live births, fetal deaths from 20 weeks' gestation and terminations of pregnancy for fetal anomalies. An exploratory analysis assessed the association between methadone exposure and other congenital anomalies (CAs) excluding PRS. Methadone exposure was ascertained from medical records and maternal interview. RESULTS:Among 87 979 CA registrations, there were 127 methadone-exposed pregnancies and 336 PRS cases. There was an association between methadone exposure and PRS (OR adjusted for registry 12.3, 95% CI 5.7 to 26.8). In absolute terms, this association reflects a risk increase from approximately 1-12 cases per 10 000 births. A raised OR was found for cleft palate (adjusted OR 5.0, 95% CI 2.7 to 9.2). CONCLUSIONS:These findings suggest that gestational methadone exposure is associated with PRS. The association may be explained by unmeasured confounding factors. The small increased risk of PRS in itself does not alter the risk-benefit balance for gestational methadone use. The association with cleft palate, a more common CA, should be assessed with independent data.
METHODS::Orthopedic treatment to improve deficient maxillary growth of cleft lip and palate patients is an important part of treatment. The success of this treatment is strongly dependent on the time of initiation of therapy. There has been a large controversy in the available literature regarding the skeletal age of these patients. The aim of the present study was to compare the skeletal age of cleft lip and palate patients with normal individuals.37 unilateral and 14 bilateral cleft lip and palate patients and 47 healthy individuals participated in this cross-sectional study. The patients were classified into 8 to 10 and 11 to 14-year-old individuals. Cervical vertebral maturational stage of participants was evaluated in the lateral cephalometry. The skeletal age of cleft lip and palate patients was compared with normal controls. Chi-square was used for statistical analysis. There was not a significant difference in the skeletal developmental stage of unilateral and bilateral cleft compared to their normal peers according to their age and sex. Also, significant difference in skeletal maturational stage of cleft lip and palate patients was not found between boys and girls (P = 0.8). Similarly, no significant difference was found in the skeletal age of the 3 studied groups without considering the age and sex of participants (P = 0.5). Regarding the similar skeletal maturational stage of cleft lip and palate patients with normal controls in our study, their maxillofacial orthopedic treatment can be initiated at similar time to normal peers.