BACKGROUND:The success of the preservation of vital pulp in carious deciduous teeth depends not only on determining the health status of the pulp,but also on selecting the most suitable pulp capping agent.At present,the commonly used pulp capping agent materials contain calcium hydroxide preparation and mineral trioxide aggregate (MTA).Recently,new biomaterials,such as Bioaggregate,Biodentine,and TheraCal,with good biocompatibility and good edge sealing,have been developed and extensively used.OBJECTIVE:To compare the efficacies of MTA,calcium hydroxide preparation,Biodentine and TheraCal LC that are commonly used in pediatric dentistry in the preservation of vital pulp in carious deciduous teeth.METHODS:This prospective,single-center,randomized controlled clinical trial will be conducted in Chengdu Maternal and Child Center,China.Children with deep caries of deciduous teeth,who will be scheduled to undergo indirect pulp capping,direct pulp capping,and vital pulpotomy,will be selected and randomized into four groups according to pulp capping agents:MTA group,calcium hydroxide group,Biodentine group and TheraCal group.Patients will receive return visit at postoperative 3,6 and 12 months during follow-up.By using X-ray,we will observe and compare the speed and quality of the formation of the dentin bridge with different biomaterials,and assess the reason for the failure of treatment.This trial was registered in ClinicalTrials.gov identifier:NCT03220360,on July 14,2017.The study protocol has been approved by the Ethics Committee of Chengdu Maternal and Child Center,China (approval number:20170506).All protocols will be performed in accordance with the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki.Written informed consent will be provided by each patient and their family members after they indicated that they fully understood the treatment plan.RESULTS AND CONCLUSION:This study will compare the efficacies of various biomaterials in the preservation of vital pulp in carious deciduous teeth.New materials Biodentine and TheraCal will be selected in classical technique to verify their efficacies and explore their superiorities.Classical materials calcium hydroxide and MTA will be selected as controls,which will be separately used in indirect pulp capping,direct pulp capping,and vital pulpotomy to provide reliable choices for clinicians.%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,TheraCal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TheraCal 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TheraCal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、TheraCal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.
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