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牙髓血管再生治療年輕恒牙牙髓壞死的安全性和有效性:單中心、隨機(jī)、對(duì)照臨床試驗(yàn)方案

發(fā)布時(shí)間:2018-11-22 16:15
【摘要】:背景:目前國(guó)內(nèi)外臨床上治療牙髓壞死而根尖未發(fā)育完全年輕恒牙的傳統(tǒng)手段主要是"根尖誘導(dǎo)成形術(shù)"以及近些年發(fā)展起來(lái)的"MTA根尖屏障術(shù)",但這兩種方法均不能使根管長(zhǎng)度增加和根管壁增厚。那么是否有一種方法能夠讓患者利用自身的潛能,促進(jìn)患牙牙根的進(jìn)一步發(fā)育呢?牙髓血管再生術(shù)的出現(xiàn)帶來(lái)了曙光,但目前臨床上牙髓血管再生術(shù)成功的幾乎都是個(gè)例。目的:印證牙髓血管再生術(shù)用于臨床治療因齲病、牙體發(fā)育異常、外傷導(dǎo)致年輕恒牙牙髓壞死、牙根發(fā)育停滯的療效,為其在臨床上大規(guī)模應(yīng)用提供經(jīng)驗(yàn)和證據(jù)。方法:試驗(yàn)為前瞻性單中心隨機(jī)對(duì)照臨床試驗(yàn),在中國(guó)陜西省,西安交通大學(xué)附屬口腔醫(yī)院牙體牙髓科完成。選擇2013年12月至2016年12月收治,牙髓壞死或根尖周炎根尖未發(fā)育完全的年輕恒牙患者82例82顆患牙,隨機(jī)分為2組,試驗(yàn)組41例采用牙髓血管再生術(shù)治療,對(duì)照組41例采用根尖誘導(dǎo)成形術(shù)治療。治療后3,6,9,12,18個(gè)月復(fù)診,通過(guò)臨床檢查和X射線片評(píng)價(jià)療效,觀察兩組患牙牙髓活力及牙根發(fā)育情況。試驗(yàn)方案經(jīng)西安交通大學(xué)附屬口腔醫(yī)院倫理委員會(huì)批準(zhǔn),批準(zhǔn)號(hào)為JDKY015-02。臨床試驗(yàn)研究的實(shí)施符合《赫爾辛基宣言》和醫(yī)院對(duì)人體研究的相關(guān)倫理要求。參與試驗(yàn)的患病個(gè)體及其監(jiān)護(hù)人為自愿參加,均對(duì)試驗(yàn)過(guò)程完全知情同意,在充分了解治療方案的前提下簽署"知情同意書(shū)"。結(jié)果與結(jié)論:截止2017年3月25日,患者已經(jīng)隨訪6.5-18個(gè)月。試驗(yàn)組治療成功率97.6%,高于對(duì)照組82.9%(P0.05);試驗(yàn)組的牙髓活力陽(yáng)性率24.4%,高于對(duì)照組0(P0.05);試驗(yàn)組的牙根繼續(xù)發(fā)育所占比例為63.4%,對(duì)照組為29.3%,試驗(yàn)組高于對(duì)照組(P0.05)。說(shuō)明與根尖誘導(dǎo)成形術(shù)相比,采用牙髓血管再生術(shù)治療牙髓壞死而根尖未發(fā)育完全的年輕恒牙可以取得較高的成功率,并可促使牙根繼續(xù)發(fā)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.
【作者單位】: 西安交通大學(xué)附屬口腔醫(yī)院第一門(mén)診;
【基金】:陜西省衛(wèi)計(jì)委科研項(xiàng)目(SWJ2016QN013)~~
【分類號(hào)】:R781.05

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