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Evidence Mapping and Quality Assessment of Randomized Controlled Trials in Dental Traumatology
Nitesh Tewari1,2, Garima Jhunjhunwala1, Amritha Rajeswary1
1Division of Pediatric and Preventive Dentistry, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.
Background/Aims:
This evidence mapping (EM) and quality assessment of randomized controlled trials (RCTs) in Dental Traumatology (DT) aimed to identify the RCTs, distribute them in different domains and subdomains, analyze their methodological characteristics, and assess their quality.
Methods:
A protocol was developed as per the principles of Global-Evidence-Mapping (EM) and registered in open-sciences-framework. A systematic electronic search was performed in the PubMed, SCOPUS, EMBASE, Web of Science, LILACS, and COCHRANE on September 30, 2025. Grey literature and reference searches were also performed. RCTs with intervention arms with/without a control group, having details of randomization related to any domain of DT, were included after screening of titles, abstracts, and full-text articles. Studies were distributed in domains and subdomains, and data related to demographic and methodological characteristics were extracted and analyzed. Risk of bias (ROB) was assessed using the Cochrane risk-of-bias tool for randomized trials (RoB-2) and details were presented in the form of an abacus EM plot.
Results:
The study identified 30 RCTs in four domains of DT, with the highest in the therapeutic domain and subdomain of treatment protocols in permanent dentition. Seven studies were published before 2010, nine between 2010 and 2019, and 14 others from 2020 to date. They represented 13 countries, with the highest from China, the United Kingdom, and India. A protocol was registered in 10 studies, and the majority of the studies had not followed Consolidated Standards of Reporting Trials (CONSORT) guidelines. Only three RCTs were found to have a low ROB.
Conclusion:
The majority of studies exhibited a lack of methodological robustness in defining their hypothesis, sample size estimation, randomization, and statistical evaluation of outcomes. This was the reason for 27 of them being graded as having high ROB or some concerns. The results of this EM may help researchers in identifying the areas for future research and guide them to follow the best practices in the planning and conduct of RCTs.
