不同生物材料在乳牙牙髓保存术中的应用:前瞻性、单中心、随机对照临床试验

发布时间：2018-10-30 19:55

【摘要】：背景:乳牙活髓保存治疗的成功与否除了要准确判断牙髓的健康状况,还要针对性地选择最适合的盖髓剂。目前临床常用的经典盖髓剂材料有氢氧化钙制剂、矿物三氧化物聚合体(MTA)等,近年来,新型生物相容性较好且能提供较好的边缘封闭性的生物材料(如Bioaggregate,Biodentine,TheraC al等)相继问世,并得以发扬光大。目的:比较儿童口腔科常用材料MTA、氢氧化钙制剂、Biodentine及TheraC al LC在乳牙牙髓保存术中的临床疗效。方法:试验为单中心、前瞻性、随机对照临床试验,在中国四川省,成都市妇幼儿童中心完成。选择乳牙深龋需行间接盖髓术、直接盖髓术及活髓切断术的患儿,根据所使用的盖髓材料将患牙随机分成4组,MTA组、氢氧化钙组、Biodentine组和Thera Cal组,术后3,6,12个月随访复诊,进行X射线片拍摄,观察比较在几种生物材料的作用下,牙本质桥形成的速度、质量,并评估治疗失败的原因。试验于2017年7月14日在北美临床试验注册中心注册(NCT03220360);试验方案经成都市妇幼儿童中心伦理委员会批准,批准号为20170506。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:研究比较不同生物材料在乳牙牙髓保存术中的疗效,材料的选择上,选取新型材料Biodentine、TheraC al作为经典技术新材料的尝试,验证其有效性、探索其是否有优越性;经典材料选择氢氧化钙、MTA作为新型材料的对照,分别应用于3种乳牙活髓保存术的治疗,以期为临床医生提供可靠的选择。
[Abstract]:Background: the success of pulp preservation in primary teeth should not only judge the dental pulp health accurately, but also select the most suitable pulp capping agent. In recent years, calcium hydroxide preparation, mineral trioxide polymer (MTA) and so on are commonly used in clinic. In recent years, new biomaterials with good biocompatibility and good edge sealing properties (such as Bioaggregate,Biodentine,) have been developed. TheraC al, etc.) came out one after another, and was able to carry forward. Objective: to compare the clinical effect of MTA, calcium hydroxide preparation, Biodentine and TheraC al LC in pulp preservation of primary teeth. Methods: a single center prospective randomized controlled clinical trial was conducted in Chengdu Maternal and Child Center in Sichuan Province China. Children with deep caries were randomly divided into 4 groups: MTA group, calcium hydroxide group, Biodentine group and Thera Cal group. X-ray films were taken to observe and compare the speed and quality of dentin bridge formation under the action of several biomaterials, and to evaluate the causes of failure in treatment. The trial was registered with the North American Clinical trial Registry (NCT03220360) on July 14, 2017; the trial scheme was approved by the Ethics Committee of Chengdu Maternal and Child Center under the number 20170506. 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 conclusion: to compare the efficacy of different biomaterials in pulp preservation of deciduous teeth and the selection of materials, select the new material Biodentine,TheraC al as a new classic technology and try to verify its effectiveness and explore its superiority. Calcium hydroxide and MTA were used as control materials for the treatment of three kinds of vital pulp preservation of deciduous teeth in order to provide a reliable choice for clinicians.
【作者单位】：成都市妇女儿童中心医院;徐州医科大学口腔医学院口腔内科教研室;
【基金】：四川省卫计委普及应用课题(PJYY16-067)~~
【分类号】：R783.1

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