Service d'Odontologie Hôpital Bretonneau, 2 rue Carpeaux 75018 Paris, France.
Trials. 2011 Jul 13;12:174. doi: 10.1186/1745-6215-12-174.
Pulp necrosis is one of the main complications of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling. The aim of this prospective randomized clinical trial is to compare Mineral Trioxide Aggregate(MTA)with Calcium Hydroxide(CH)as materials used to induce root-end closure in necrotic permanent immature incisors.
METHODS/DESIGN: This study, promoted by AP-HP, was approved by the ethics committee(CPP Paris Ile de France IV). 34 children aged from 6 to 18 years and presenting a non-vital permanent incisor are selected. Prior to treatment, an appropriate written consent has to be obtained from both parents and from children. Patients are then randomly assigned to either the MTA(experimental)or CH(control)groups. Recalls are performed after 3, 6 and 12 months to determine the presence or absence of a calcified apical barrier through the use of clinical and radiographic exams. Additional criteria such as clinical symptoms, apical radiolucencies, periapical index(PAI)are also noted.
ClinicalTrials.gov no. NCT00472173 (First inclusion: May 10, 2007; Last inclusion: April 23, 2009; study completed: April 15, 2010).
牙髓坏死是牙外伤的主要并发症之一。当发生在未成熟牙时，牙髓坏死意味着根尖未成熟和根尖闭合。需要进行一种称为根尖诱导成形术的治疗，以诱导形成钙化的根尖屏障，从而实现永久性和密封的根管充填。本前瞻性随机临床试验的目的是比较三氧化矿物凝聚体（MTA）和氢氧化钙（CH）作为诱导坏死性恒前牙根尖闭合的材料。
方法/设计：这项由 AP-HP 发起的研究得到了巴黎大区卫生伦理委员会（CPP Paris Ile de France IV）的批准。选择了 34 名年龄在 6 至 18 岁之间、患有非活力性恒前牙的儿童。在治疗前，必须征得父母和儿童的书面同意。然后，患者被随机分配到 MTA（实验组）或 CH（对照组）组。在 3、6 和 12 个月时进行随访，通过临床和影像学检查确定是否存在钙化的根尖屏障。还记录了其他标准，如临床症状、根尖透影、根尖指数（PAI）等。
ClinicalTrials.gov 编号：NCT00472173（首次纳入：2007 年 5 月 10 日；最后纳入：2009 年 4 月 23 日；研究完成：2010 年 4 月 15 日）。
