基于ClinicalTrials.gov和ChiCTR数据库对牙体牙髓病的临床试验注册特点分析

Characteristics analysis of clinical trial registration for endodontic diseases based on the ClinicalTrials.gov and ChiCTR databases

目的汇总注册于美国ClinicalTrials.gov和中国临床研究注册中心(Chinese Clinical Trial Registry,ChiCTR)的牙体牙髓病临床注册资料,分析牙体牙髓病临床试验的注册特征。方法通过检索2000年1月1日至2023年8月20日期间在两个数据库中注册的牙体牙髓病临床研究,提取并分析牙体牙髓病相关临床研究的信息,提取的内容包括注册地区、注册年度、试验题目、研究方向、样本量、试验进展、研究类型、试验设计、盲法、临床试验分期和参与机构名称等信息。结果两个数据库中临床研究的总注册数为536191项,其中牙体牙髓病的临床研究共634项;涉及到43个国家,排名前三的分别是埃及(188项)、中国(130项)和美国(46项);2015年开始牙体牙髓病临床研究注册数量显著增加;研究方向以牙髓病(434项)、龋病(106项),根尖周病(77项)为主,内容主要涉及到病因学、药物干预、外科干预、新技术、新材料等方面;临床试验样本量<100例的临床研究有430项(67.82%),样本量为100~999例的有185项(29.18%);注册时的研究进展状态为已完成试验的项目数最多,有286项(45.11%),其次是未知项(125项)、招募中(110项)、尚未招募(81项);研究类型主要是干预性研究546项,占86.12%,以随机平行对照设计方式为主要设计模式(473项,74.61%);研究设计类型中使用盲法的有423项(66.72%),其中以双盲为主(195项),其次是其他/未注明情况(123项,19.40%),开放性研究(88项,13.88%);临床分期中标记为其他/未标记的项目数量最多(388项),其次是Ⅱ期研究(69项)和初步研究(62项)。临床研究参与机构数量<3的有611项(96.37%),参与机构数量≥3的有23项(3.63%)。结论牙体牙髓病的临床试验注册数量总体呈上升趋势,但仍旧偏少,研究设计的质量有待加强,临床分期的注册信息的完整性有待提高,且多中心临床研究数量较少。今后应充分开展高质量、多中心的临床研究,实现成果的转化。

Objective To summarize the clinical registration data of endodontic diseases registered in ClinicalTrials.gov in the United States and Chinese Clinical Trial Registry(ChiCTR),and analyze the registration characteristics at home and abroad.Methods We searched the clinical studies related to endodontic disease registered in the two databases from January 1,2000,to August 20,2023.We extracted and analyzed the information from clinical studies related to endodontic diseases.The extracted content included information on the registration region,registration year,trial title,research direction,sample size,trial progress,study type,trial design,blinding method,clinical trial phase,and participating institutions.Results The two databases contained a total of 536191 registered items,of which 634 were endodontic diseases.Clinical trials in the registry of endodontic diseases involved 43 countries,of which the top three were Egypt(188 items),China(130 items),and the America(46 items).In addition,the number of registrations of clinical trials on endodontic diseases has significantly increased since 2015.The research directions were mainly pulposis(434 items),caries(106 items),and periapical diseases(77 items),which mostly involved etiology,drug intervention,surgical intervention,new technology,and new materials.Moreover,there were 430 clinical trials(67.82%)with a sample size<100 and 185(29.18%)with a sample size of 100999.The progress status at the time of registration showed the largest number of completed trials,accounting for 286 items(45.11%),followed by unknown(125 items),recruiting(110 items),and not yet recruiting(81 items).The main research types were intervention studies(546 items,86.12%),and the main design model was randomized parallel controlled trials(473 items,74.61%).Additionally,423 items(66.72%)were marked using the blind method,mainly doubleblind trials(195 items),followed by other/unmarked(123 items,19.40%)and open study(88 items,13.88%).Furthermore,the largest number of items in the study phase were marked other/unlabeled(388 items),followed by phaseⅡstudy(69 items)and preliminary study(62 items).Additionally,611 items(96.37%)were clinical trials with a number of participating institutions<3,and 23 items(3.63%)had a number of participating institutions≥3.Conclusion The number of clinical trials registered for endodontic diseases is generally on the rise,but it is still relatively small.The quality of the study design needs to be enhanced,and the registration information in the study phase needs to be improved.Moreover,the number of multicenter trials is small.In the future,we should fully mobilize the talent advantages of wellknown stomatology majors in China,take the lead in conducting highquality,multicenter clinical research,and realize the transformation of results.