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

发布时间：2018-11-22 16:15

【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%(P0.05);试验组的牙髓活力阳性率24.4%,高于对照组0(P0.05);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(P0.05)。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。
[Abstract]:Background: at present, the traditional treatment of endodontic necrosis and immature young permanent teeth at home and abroad is mainly "apical induction plasty" and "MTA apical barrier surgery" developed in recent years. But neither of these two methods can increase the length of root canal and the thickness of root canal wall. So is there a way for patients to use their potential to promote the further development of the root of the affected teeth? The appearance of dental pulp angiogenesis has brought dawn, but the clinical success of dental pulp angiogenesis is almost unique. Objective: to confirm the efficacy of dental pulp angiogenesis in the treatment of young permanent teeth with pulp necrosis and root development stagnation due to dental caries, abnormal tooth development and trauma, and to provide experience and evidence for its large-scale clinical application. Methods: a prospective single center randomized controlled clinical trial was carried out in the dental pulp department of Xi'an Jiaotong University Stomatology Hospital, Shaanxi Province, China. From December 2013 to December 2016, 82 young permanent teeth with necrotic pulp or incomplete apical periodontitis were selected and randomly divided into two groups. The experimental group (n = 41) was treated with pulp vascular regeneration. 41 cases in the control group were treated with apical-induced angioplasty. The pulp vigor and root development of the two groups were observed by clinical examination and X-ray radiography. The pilot scheme was approved by the Ethics Committee of Stomatology Hospital affiliated to Xi'an Jiaotong University under the name JDKY015-02. The implementation of clinical trial research is in line with the Helsinki Declaration and the ethical requirements of human research in hospitals. The patients and their guardians took part in the trial voluntarily and signed the "informed consent" on the premise of full understanding of the treatment plan. Results and conclusions: as of March 25, 2017, the patient had been followed up for 6. 5-18 months. The successful rate of treatment in the test group was 97.6, which was higher than that in the control group (82.9%, P0.05), and the positive rate of pulp activity in the experimental group was 24.4%, which was higher than that in the control group (0%, P0.05). The proportion of root development was 63.4 in the experimental group and 29.3in the control group, which was higher in the experimental group than in the control group (P0.05). Compared with apical induced angioplasty, the treatment of pulp necrosis with incomplete apical development of young permanent teeth can achieve a higher success rate and promote the development of root.
【作者单位】：西安交通大学附属口腔医院第一门诊;
【基金】：陕西省卫计委科研项目(SWJ2016QN013)~~
【分类号】：R781.05

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