Centre for Craniofacial Development & Regeneration, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, Floor 27, Guy's Hospital, London, SE1 9RT, UK.
Maxillofacial Unit, William Harvey Hospital, Kennington Rd., Willesborough, Ashford, TN24 0LZ, UK.
Trials. 2022 Sep 16;23(1):787. doi: 10.1186/s13063-022-06711-0.
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.
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).
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.
ISRCTN Registry ISRCTN12709966 . Registered on 16 June 2022.
上颌恒牙萌出失败通常发生在 7 至 9 岁的混合牙列期。缺失和未萌出的上颌切牙可能不美观，并对面部和牙齿美观产生潜在的负面影响。多生牙（或牙瘤）的存在通常是导致上颌恒切牙萌出失败或阻生的原因。本试验的主要目的是研究由于上颌前部多生牙而萌出失败的上颌切牙的萌出成功率。
本方案描述了一项干预性、多中心、双臂随机临床试验。符合入选标准的参与者将被随机分组（无限制均衡分配[1:1]），分别接受正畸矫治器间隙创造、多生牙去除和直接正畸牵引，或正畸矫治器间隙创造、多生牙去除和监测。本试验的主要结局是确定多生牙去除后 6 个月上颌恒中切牙成功萌出的比例。次要结局指标包括：（1）初始牙齿位置（影像学评估）对牙齿萌出时间的影响；（2）未萌出牙齿排齐至正确咬合位置所需的时间；（3）牙龈美观；（4）治疗前后自我报告的口腔健康相关生活质量（OHRQoL）的变化。
目前缺乏比较干预措施治疗这种疾病效果的高质量、稳健的前瞻性研究。此外，英国国家临床指南强调，对于由于多生牙而导致上颌恒切牙未萌出的儿童，缺乏明确的治疗方案。本试验的结果将为管理这种情况的未来治疗指南提供信息。
ISRCTN 注册处 ISRCTN81056306。于 2022 年 6 月 16 日注册。
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