牙髓血管再生治疗年轻恒牙牙髓坏死的安全性和有效性:单中心、随机、对照临床试验方案  

Effectiveness and safety of pulp regeneration and revascularization therapy for pulpal necrosis of the immature permanent tooth:study protocol for a single-center,randomized,controlled,clinical trial

作　　者：李静[1] 王尔慧[1] 王宇[1] 

机构地区：[1]西安交通大学附属口腔医院第一门诊,陕西省西安市710048

出　　处：《中国组织工程研究》2017年第24期3809-3814,共6页Chinese Journal of Tissue Engineering Research

基　　金：陕西省卫计委科研项目(SWJ2016QN013)~~

摘　　要：背景:目前国内外临床上治疗牙髓坏死而根尖未发育完全年轻恒牙的传统手段主要是"根尖诱导成形术"以及近些年发展起来的"MTA根尖屏障术",但这两种方法均不能使根管长度增加和根管壁增厚。那么是否有一种方法能够让患者利用自身的潜能,促进患牙牙根的进一步发育呢?牙髓血管再生术的出现带来了曙光,但目前临床上牙髓血管再生术成功的几乎都是个例。目的:印证牙髓血管再生术用于临床治疗因龋病、牙体发育异常、外伤导致年轻恒牙牙髓坏死、牙根发育停滞的疗效,为其在临床上大规模应用提供经验和证据。方法:试验为前瞻性单中心随机对照临床试验,在中国陕西省,西安交通大学附属口腔医院牙体牙髓科完成。选择2013年12月至2016年12月收治,牙髓坏死或根尖周炎根尖未发育完全的年轻恒牙患者82例82颗患牙,随机分为2组,试验组41例采用牙髓血管再生术治疗,对照组41例采用根尖诱导成形术治疗。治疗后3,6,9,12,18个月复诊,通过临床检查和X射线片评价疗效,观察两组患牙牙髓活力及牙根发育情况。试验方案经西安交通大学附属口腔医院伦理委员会批准,批准号为JDKY015-02。临床试验研究的实施符合《赫尔辛基宣言》和医院对人体研究的相关伦理要求。参与试验的患病个体及其监护人为自愿参加,均对试验过程完全知情同意,在充分了解治疗方案的前提下签署"知情同意书"。结果与结论:截止2017年3月25日,患者已经随访6.5-18个月。试验组治疗成功率97.6%,高于对照组82.9%(P<0.05);试验组的牙髓活力阳性率24.4%,高于对照组0(P<0.05);试验组的牙根继续发育所占比例为63.4%,对照组为29.3%,试验组高于对照组(P<0.05)。说明与根尖诱导成形术相比,采用牙髓血管再生术治疗牙髓坏死而根尖未发育完全的年轻恒牙可以取得较高的成功率,并可促使牙根继续发育。BACKGROUND： Apexification and mineral trioxide aggregate apexification are mainly used to treat pulpal necrosis in the immature permanent tooth, but neither methods can increase the root canal length and thickness. How to promote the root development of the affected teeth based on patients＇ potential？ Pulp regeneration and revascularization has provided a new direction for clinical treatment, but successful cases are rarely reported. OBJECTIVE： To testify the clinical effectiveness of pulp regeneration and revascularization in the treatment of pulpal necrosis, root development stagnation in the permanent teeth caused by caries, odontodysplasia and injury, thus providing reference for clinical application. METHODS： We propose to conduct a prospective, single-center, randomized, controlled, clinical trial at Stomatological Hospital Affiliated to Xi＇an Jiaotong University, Shaanxi Province, China. Eighty-two patients （82 affected teeth） with pulpal necrosis or periapical periodontitis in the immature permanent tooth from December 2013 to December 2016 were selected, and equally randomized into trial and control groups, followed by treated with pulp regeneration and revascularization, and apexification, respectively. The clinical examinations and X-ray radiology were used to evaluate the clinical effectiveness at 3, 6, 9, 12 and 18 months, and the pulp vitality and rot development were observed. The study protocol has been approved by the Ethics Committee of Stomatological Hospital Affiliated to Xi＇an Jiaotong University of China （approval number： JDKY015-02）. All protocols were performed in accordance with the Ethical Principles for Medical Research involving Human Subjects in the Declaration of Helsinki. Written informed consent was provided by each patient and their family members after they indicated that they fully understood the treatment plan. RESULTS AND CONCLUSION： Up to March 25, 2017, all patients have been followed up for 6.5-18 months. The treatment success rate in the trial and

关 键 词：牙髓坏死 根尖诱导形成术 牙列 恒 组织工程 组织构建 牙髓血管再生术 根尖诱导成形术 年轻恒牙 

分 类 号：R318[医药卫生—生物医学工程]