Are Most of the Published Clinical Trial Results in Restorative Dentistry Invalid? An Empirical Investigation

Abstract

<jats:sec> <jats:title>Background:</jats:title> <jats:p>To establish the number of invalid clinical trial reports in restorative dentistry, due to lack of effective randomisation and/or inadequate sample size and whether this number changed, during the 1990-2019 period.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>Databases were searched up to 14 July 2019 without limitations regarding publication language. A Journal hand search and reference check were conducted for trial reports. Selection criteria were: reporting on a prospective, controlled clinical trial; relevance to placing direct tooth restorations in human vital teeth; direct comparison between restorative materials concerning tooth restoration longevity; trial report published from 1990. Randomisation reported (Yes/No) and treatment group sample size ≥ 200 were applied as criteria, using the deductive falsification approach for trial report appraisal.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>683 trial reports were appraised. 660 lacked effective randomisation. Of the remaining 23 reports, only 2 included a sample size of more than 200 restored teeth (mean number per treatment group 87; Standard deviation = 108.51). 92.5% of all treatment groups had a sample size of &lt;200. Randomisation reporting increased and sample size remained essentially unchanged between 1990 and 2019.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion:</jats:title> <jats:p>Most of the published clinical trial results in restorative dentistry were judged invalid, due to lack of effective randomisation and adequate sample size. These results are in line with previous findings. Evidence-based recommendations on how to improve trial methodology are available in the dental/medical literature.</jats:p> </jats:sec>

The composite quality score for the appraisal of prospective controlled clinical therapy trials in systematic reviews and its limits

“…Based on a systematic literature search, 683 prospective clinical controlled trial reports were identified out of a total of 14,694 citations. Of these, the bias risk of 99.7% of trials could be appraised and identified as high, despite the low stringency of the applied criteria ( 9 ). In 2021, the inter-rater reliability of the CQS approach was investigated for the first time.…”

Extension of the Composite Quality Score (CQS) as an appraisal tool for prospective, controlled clinical therapy trials–A systematic review of meta-epidemiological evidence

“…The current number of three CQS criteria appears to have been sufficient for clinical trial appraisal in the field of restorative dentistry [11], where only two from the total of 683 trial reports were not rated as of low quality of evidence (QoE). However, other fields of clinical therapy may contain a higher number of trials that would pass the three simple and nonrestrictive CQS criteria.…”

The Composite Quality Score for the appraisal of prospective controlled clinical therapy trials in systematic reviews and its limits (Preprint)

“…Based on a systematic literature search, 683 prospective clinical controlled trial reports were identi ed out of a total of 14 694 citations. Of these, the bias risk of 99.7% of trials could be appraised and identi ed as high, despite the low stringency of the applied criteria [9]. In 2021, the interrater reliability of the CQS approach was investigated for the rst time.…”