Characteristics analysis of oral mucosal diseases trials registered in Chinese Clinical Trial Registry
10.3969/j.issn.1001-3733.2025.03.012
- VernacularTitle:中国临床试验注册中心口腔黏膜疾病研究注册项目的特征分析
- Author:
Shijie ZHOU
1
;
Jincai GUO
1
Author Information
1. 410006,长沙市口腔医院药剂科
- Publication Type:Journal Article
- Keywords:
Oral mucosal disease;
Clinical trials;
Chinese Clinical Trial Registry;
Char-acteristics analysis
- From:
Journal of Practical Stomatology
2025;41(3):380-385
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyse the characteristics and development of oral mucosal diseases trials registered in the Chinese Clini-cal Trial Registry(ChiCTR).Methods:The ChiCTR database was searched to collect all studies related to oral mucosal diseases from July 25,2007 to September 30,2022.Statistical analysis was conducted on the names of oral mucosal diseases,registration dates,ge-ographical distribution,registration status,ethics committee approval,funding source,sample size,study type and design and blind-ing method.Results:312 registered studies related to oral mucosal diseases were collected.The diseases were mainly herpes zoster,hand-foot-and-mouth disease,radiotherapy-induced oral mucositis,pemphigus and oral lichen planus.The number of registered pro-jects basically showed an increasing trend.The institutions involved in the implementation of the study were mainly located in Beijing,Sichuan,Shanghai,Guangdong and Jiangsu,accounting for 55.02％of the total(340/618).The top 5 provinces and cities in terms of number of registered projects were Beijing,Sichuan,Jiangsu,Shanghai and Guangdong,accounting for 62.5％of the total included trials(195/312).Single-centre studies accounted for 77.56％(242/312),259 studies(83.01％)were pre-registered and 53(16.99％)were supplementary registrations,262(83.97％)studies were approved by the ethics committee.284 studies(91.03％)had their funding status marked,and a total of 301 grants were received,of which the top 3 were 31.89％(96/301)and were self-funded,23.26％(70/301)were funded by hospitals and 19.93％(60/301)were funded by local governments.The types of studies were mainly interventional studies 67.31％(210/312),followed by observational studies 17.31％(54/312).The research designs were mainly randomized parallel controlled trials,accounting for 63.14％(197/312),of which only 52(26.4％)studies explicitly stated the use of blinding,and 137(69.54％)studies were unspecified or blank in the blinding section.Conclusion:The studies on oral mucosal diseases registered in ChiCTR shows a trend of increasing year by year,the regional distribution is uneven,the number of multi-centre clinical trials is relatively small,and there is still room for improvement in study design and the application of blind ness method.
