The reporting adequacy of noninferiority trials in dentistry: a methodological study

This study aimed to assess the reporting adequacy of noninferiority (NI) trials in dentistry using the CONSORT 2010 Statement extension for reporting noninferiority and equivalence randomized trials. A systematic search of PubMed, Embase, and Web of Science identified dental NI trials published between 2015 and 2024. Studies were assessed using a checklist based on the CONSORT 2010 Statement extension, with each item scored from 0 (not reported) to 2 (adequately reported). Temporal trends, reporting quality, and journal metrics associations were analyzed using a linear mixed-effects model with repeated measures. Eighty-seven trials were included. Although 17% stated an explicit NI hypothesis, an NI margin was stated in 74% of trials, but only 46% included it in sample size determination. Confidence intervals were reported in 83% of trials, although their sidedness was often unspecified. The annual number of NI trials increased by 12% (IRR = 1.12, p = 0.005). Reporting quality varied significantly across checklist items (p < 0.001). Publication year was not associated with reporting quality (p = 0.306). Journal CiteScore and IF were positively associated with reporting scores (βCiteScore = 0.014, pCiteScore < 0.001; βIF = 0.016, pIF = 0.008). No significant difference was observed between general and specialty journals (p = 0.151). Despite growing publication of NI trials in dentistry, adherence to the CONSORT reporting standards remains inconsistent, particularly in justification for NI margins, hypotheses clarity, and sample size determination. Improved reporting practices are needed to enhance transparency, interpretability, and evidence-based decision-making. Transparent reporting of NI trials is essential to enable clinicians and researchers to assess whether new dental interventions perform acceptably relative to standard treatments. This study reveals frequent reporting deficiencies and underscores the need for stronger adherence to reporting guidance in dental NI research. The number of published NI trials in dentistry has increased over time, but reporting quality remains inconsistent. Key methodological components, including clearly reporting the rationale for using the NI design, hypothesis clarity, and justification of the margin, are often overlooked. Journal metrics such as Impact Factor or CiteScores do not reliably predict the quality of reporting. Stronger adherence to the CONSORT 2010 Statement extension is needed to improve transparency, interpretation, and clinical applicability of dental NI trials.