背景:上颌恒切牙的萌出失败通常出现在7至9岁的混合牙列中。缺失和未萌出的上颌切牙可以被认为是没有吸引力的,并且对面部和牙齿美学有潜在的负面影响。多余牙齿(或牙瘤)的存在通常是导致永久性上颌切牙萌出或嵌塞失败的原因。这项试验的主要目的是调查与上颌切牙相关的萌出的成功,这些切牙由于上颌前牙的多余牙齿而未能萌出。
方法:本方案描述了一项介入多中心双臂随机临床试验。符合资格标准的参与者将被随机分配(不受限制的平等参与者分配[1:1]),以使用正畸矫治器创建空间,去除多余的牙齿,并使用正畸矫治器进行直接正畸牵引或空间创造,去除多余的牙齿和监测。该试验的主要结果是确定移除多余牙齿后6个月成功爆发的上颌中央永久切牙的患病率。次要结果指标包括(1)初始牙齿位置(影像学评估)对牙齿萌出时间的影响,(2)将未萌出的牙齿对准正确的咬合位置所需的时间,(3)牙龈美学和(4)自我报告的口腔健康相关生活质量(OHRQoL)(治疗前后)的变化。
结论:缺乏对干预措施的有效性进行比较的高质量、稳健的前瞻性研究。此外,英国国家临床指南强调,缺乏明确的治疗方案来治疗因多生牙齿而出现上颌切牙未萌出的儿童.该试验的结果将为未来的治疗指南提供指导,以管理幼儿的这种情况。
背景:ISRCTN注册表ISRCTN12709966。2022年6月16日注册。
BACKGROUND: Failure of eruption of the maxillary permanent incisor teeth usually presents in the mixed dentition between the ages of 7 and 9 years. Missing and unerupted maxillary incisors can be regarded as unattractive and have a potentially negative impact on facial and dental aesthetics. The presence of a supernumerary tooth (or odontoma) is commonly responsible for failed eruption or impaction of the permanent maxillary incisors. The primary objective of this
trial is to investigate the success of eruption associated with maxillary incisor teeth that have failed to erupt because of a supernumerary tooth in the anterior maxilla.
METHODS: This protocol describes an interventional multicentre two-arm randomised clinical
trial. Participants meeting the eligibility criteria will be randomised (unrestricted equal participant allocation [1:1]) to either space creation with an orthodontic appliance, removal of the supernumerary tooth and application of direct orthodontic traction or space creation with an orthodontic appliance, removal of the supernumerary tooth and monitoring. The primary outcome of this
trial is to determine the prevalence of successfully erupted maxillary central permanent incisors at 6 months following removal of the supernumerary tooth. Secondary outcome measures include (1) the effect of initial tooth position (assessed radiographically) on time taken for the tooth to erupt, (2) time taken to align the unerupted tooth to the correct occlusal position, (3) gingival aesthetics and (4) changes in the self-reported Oral Health Related-Quality of Life (OHRQoL) (pre-and post-treatment).
CONCLUSIONS: There is a lack of high-quality robust prospective studies comparing the effectiveness of interventions to manage this condition. Furthermore, the UK national clinical guidelines have highlighted a lack of definitive treatment protocols for the management of children who present with an unerupted maxillary incisor due to the presence of a supernumerary tooth. The results of this
trial will inform future treatment guidelines for the management of this condition in young children.
BACKGROUND: ISRCTN Registry ISRCTN12709966 . Registered on 16 June 2022.