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

Abstract

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 536 191 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 100-999. 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 double-blind 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 phaseⅡ study (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 well-known stomatology majors in China, take the lead in conducting high-quality, multi-center clinical research, and realize the transformation of results.

Keywords

• clinicaltrials.gov|chictr|endodontic diseases|caries|pulposis|periapical disease|clinical research|registration