LIP PRESSURE AFTER MILLARD AND SPINA CLEFT LIP SURGERY

米勒德和脊柱裂唇手术后的唇压

• 批准号: 2015546
• 负责人: P EDWARDS
• 金额: $ 3.9万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-20 至 1999-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2015546
• 关键词: age difference; cleft lip; cleft palate; clinical research; clinical trials; craniofacial; dental alveolus; dental disorder; human subject; human therapy evaluation; infant human (0-1 year); lip; longitudinal human study; mechanical pressure; oral pharyngeal surgery; postoperative state; preoperative state; preschool child (1-5); tooth

The incidence of cleft lip/palate is 1/750 making it one of the most common congenital malformations. Typically, surgical closure of the lip is performed around 3 months of age and palatal closure by 12-24 months. Following surgical repair of the lip and palate, maxillary retrusion generally becomes a prominent morphologic feature, and it has long been purported that it is tissue scarring and contracturing following closure of the palate that creates aberrations in midfacial growth. However, there is growing evidence that impaired growth may be related more to surgical repair of the lip than to palatal surgery. The University of Florida (UF) in collaboration with the University of Sao Paulo (USP), Brazil is proposing a two-year prospective randomized, controlled study to determine whether lip repair by the Spina and Millard techniques results in different levels of resting lip pressure against the alveolus and teeth. The Spina procedure is generally used throughout Brazil while the Millard technique is commonly used in the US. Subjects will be randomly selected from a cohort of 608 unilateral cleft lip and palate infants currently being entered into a collaborative NIDR R01 study being conducted by these two centers. Lip pressure will be assessed using an electrical pressure transducer with a range of 0 to 10 psi. The transducer will be embedded in silastic and curved to fit between the anterior maxillary alveolus and the upper lip. The transducer will be connected to a signal conditioning and indicator unit which provides a 5 VDC excitation voltage, amplifies and displays the output on a digital display chart. All 200 cleft lip patients will be assessed for resting lip pressure at the time of surgery and at their regularly scheduled postoperative evaluations at USP (6, 12, 18 and 24 months) following surgery. The 200 normal control infants will be assessed in the pediatric clinics at the University of Florida. Lip pressure will be assessed at midline, as well as right and left of midline. This study represents a unique opportunity to further our understanding of whether two different and commonly used surgical techniques for the repair of cleft lip result in quantifiably different levels of resting lip pressure against the alveolus and teeth. Findings of differences in resting lip pressure relative to surgical technique and/or between the cleft infants and normal controls will provide the basis for subsequent long-term assessment of midfacial growth patterns.

唇腭裂的发病率为1/750，是世界上最常见的唇腭裂之一。 常见的先天性畸形 通常，唇的手术闭合 大约在3个月大时进行，12-24岁时进行腭闭合 个月 唇腭裂手术修复后，上颌 一般来说，它是一个突出的形态特征， 长期以来，它被认为是组织疤痕和挛缩 在腭闭合后， 增长 然而，越来越多的证据表明， 与唇的外科修复有关，而不是与腭部手术有关。 佛罗里达大学（UF）与佛罗里达大学合作， 圣保罗（USP），巴西提出了一个为期两年的前瞻性随机， 对照研究，以确定是否唇修复的脊柱和 Millard技术导致不同水平的静息唇压 对着牙槽和牙齿 脊柱手术通常用于 在整个巴西，虽然米勒德技术通常用于 我们 受试者将从608例单侧 唇腭裂婴儿目前正在进入一个合作 NIDR R 01研究由这两个中心进行。 将使用电子压力传感器评估唇压 压力范围为0到10磅/平方英寸 传感器将嵌入到 硅橡胶和弯曲，以适应前上颌牙槽之间， 上唇 传感器将连接到信号 提供5 VDC激励的调节和指示装置 电压，放大并显示在数字显示图表上的输出。 所有200名唇裂患者将在 手术时间和术后定期计划 术后USP评价（6、12、18和24个月）。 的200 正常对照婴儿将在儿科诊所进行评估， 佛罗里达大学。 唇压也将在中线进行评估， 作为中线的左右。 这项研究是一个独特的机会，以进一步我们的 了解两种不同和常用的手术方式 修复唇裂的技术导致量化的不同， 唇对牙槽和牙齿的静息压力水平。 结果 与手术技术相关的静息唇压差异 和/或唇裂婴儿与正常对照之间的差异将提供 为随后的面中部生长模式的长期评估奠定基础。