Trends in Clinical Trial Registration in Dentistry: An Analysis of Registered Clinical Trials in the Clinical Research Information Service from 2013 to 2021 in South Korea

Authors

  • Hye In Lee Daegu International School
  • Dr. Young-Ran Yoon Kyungpook National University Graduate School and Hospital

DOI:

https://doi.org/10.47611/jsrhs.v10i3.2121

Keywords:

Dental research, Clinical trial, Registry, Clinical Research Information Service

Abstract

The Clinical Research Information Service (CRIS) in South Korea provides a clinical trial registry platform in which all clinical trials should be mandatorily and prospectively registered. However, to date, the registration status of clinical trials in the field of dentistry has not been investigated. Therefore, this study aimed to provide an overview of the methodological design and trends of the registered clinical trials over a period of nine years. Information about registered clinical trials in the field of dentistry from the CRIS was comprehensively collected from 2013 to 2021. The details assessed from the collected trials include: type of sponsors, recruitment status, study design, randomization, allocation concealment, single or multi-centric, retrospective or prospective registration, and publication status. A total of 65 registered clinical trials were identified. The number of clinical trials in dentistry in South Korea was found to be less; however, an increasing trend was observed in the recent three years. A majority of the trials were interventional (81.5%), single-centered (86.2%), and conducted on patients (81.5%) and in private hospitals (55.4%). A considerable number of trials had an unclear phase, were retrospectively registered, and rarely published. Regarding the quality, most trials have inadequately reported the method of randomization and allocation concealment. The number of clinical trials in dentistry is still low in South Korea, and most of them were registered retrospectively. A poor-quality reporting of methods at several specific areas was observed. It is necessary for dental investigators to raise awareness of the need to register clinical trials.

Downloads

Download data is not yet available.

Author Biography

Dr. Young-Ran Yoon, Kyungpook National University Graduate School and Hospital

Dr. Young-Ran Yoon M.D/Ph.D

Department of Biomedical Science and Clinical Trial Center, Kyungpook National University Graduate School and Hospital

References or Bibliography

Cairo, F., Sanz, I., Matesanz, P., Nieri, M., & Pagliaro, U. (2012). Quality of reporting of randomized clinical trials in implant dentistry. A systematic review on critical aspects in design, outcome assessment and clinical relevance. Journal of Clinical Periodontology, 39 Suppl 12, 81-107. http://doi.org/10.1111/j.1600-051X.2011.01839.x

Dickersin, K., & Min, Y. I. (1993). NIH clinical trials and publication bias. Online Journal of Current Clinical Trials, Doc No 50. http://www.ncbi.nlm.nih.gov/pubmed/8306005

Dickersin, K., Min, Y. I., & Meinert, C. L. (1992). Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA, 267(3), 374-378. http://www.ncbi.nlm.nih.gov/pubmed/1727960

Faggion, C. M., Jr., & Giannakopoulos, N. N. (2012). Quality of reporting in abstracts of randomized controlled trials published in leading journals of periodontology and implant dentistry: a survey. Journal of Periodontology, 83(10), 1251-1256. http://doi.org/10.1902/jop.2012.110609

Jeon, J., Lee, G., Kim, Y., Kim, S., Jeong, J., Won, Y., Jeong, G. (2020). 2019 Year Book of the Korean Dentistry. Seoul: KS Sensation.

Kim, S., & Kim, Y. (2020). 2019 National Health Insurance Statistical Yearbook. Wonju: Health Insurance Review & Assessment Service.

McFadden, E., Bashir, S., Canham, S., Darbyshire, J., Davidson, P., Day, S., . . . Brown, J. (2015). The impact of registration of clinical trials units: the UK experience. Clinical Trials, 12(2), 166-173. http://doi.org/10.1177/1740774514561242

Park, H. (2011). Primary registry of the WHO International Clinical Trial Registry Platform: Clinical Research Information Service (CRIS) Journal of Korean Medical Association, 54(1), 92-97. http://doi.org/10.5124/jkma.2011.54.1.92

Saltaji, H., Armijo-Olivo, S., Cummings, G. G., Amin, M., & Flores-Mir, C. (2017). Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013. PLoS One, 12(12), e0190089. http://doi.org/10.1371/journal.pone.0190089

Simes, R. J. (1986). Publication bias: the case for an international registry of clinical trials. Journal of Clinical Oncology, 4(10), 1529-1541. http://doi.org/10.1200/JCO.1986.4.10.1529

Smail-Faugeron, V., Fron-Chabouis, H., & Durieux, P. (2015). Clinical trial registration in oral health journals. Journal of Dental Research, 94(3 Suppl), 8S-13S. http://doi.org/10.1177/0022034514552492

Published

11-08-2021

How to Cite

Lee, H. I., & Yoon, Y.-R. (2021). Trends in Clinical Trial Registration in Dentistry: An Analysis of Registered Clinical Trials in the Clinical Research Information Service from 2013 to 2021 in South Korea. Journal of Student Research, 10(3). https://doi.org/10.47611/jsrhs.v10i3.2121

Issue

Section

HS Research Articles