【摘要】：背景:乳牙活髓保存治療的成功與否除了要準確判斷牙髓的健康狀況,還要針對性地選擇最適合的蓋髓劑。目前臨床常用的經(jīng)典蓋髓劑材料有氫氧化鈣制劑、礦物三氧化物聚合體(MTA)等,近年來,新型生物相容性較好且能提供較好的邊緣封閉性的生物材料(如Bioaggregate,Biodentine,TheraC al等)相繼問世,并得以發(fā)揚光大。目的:比較兒童口腔科常用材料MTA、氫氧化鈣制劑、Biodentine及TheraC al LC在乳牙牙髓保存術(shù)中的臨床療效。方法:試驗為單中心、前瞻性、隨機對照臨床試驗,在中國四川省,成都市婦幼兒童中心完成。選擇乳牙深齲需行間接蓋髓術(shù)、直接蓋髓術(shù)及活髓切斷術(shù)的患兒,根據(jù)所使用的蓋髓材料將患牙隨機分成4組,MTA組、氫氧化鈣組、Biodentine組和Thera Cal組,術(shù)后3,6,12個月隨訪復診,進行X射線片拍攝,觀察比較在幾種生物材料的作用下,牙本質(zhì)橋形成的速度、質(zhì)量,并評估治療失敗的原因。試驗于2017年7月14日在北美臨床試驗注冊中心注冊(NCT03220360);試驗方案經(jīng)成都市婦幼兒童中心倫理委員會批準,批準號為20170506。臨床試驗研究的實施符合《赫爾辛基宣言》和醫(yī)院對人體研究的相關(guān)倫理要求。參與試驗的患病個體及其監(jiān)護人為自愿參加,均對試驗過程完全知情同意,在充分了解治療方案的前提下簽署"知情同意書"。結(jié)果與結(jié)論:研究比較不同生物材料在乳牙牙髓保存術(shù)中的療效,材料的選擇上,選取新型材料Biodentine、TheraC al作為經(jīng)典技術(shù)新材料的嘗試,驗證其有效性、探索其是否有優(yōu)越性;經(jīng)典材料選擇氫氧化鈣、MTA作為新型材料的對照,分別應用于3種乳牙活髓保存術(shù)的治療,以期為臨床醫(yī)生提供可靠的選擇。
[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.
【作者單位】： 成都市婦女兒童中心醫(yī)院;徐州醫(yī)科大學口腔醫(yī)學院口腔內(nèi)科教研室;
【基金】：四川省衛(wèi)計委普及應用課題(PJYY16-067)~~
【分類號】：R783.1

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