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Materials 2016, 9(5), 372; doi:10.3390/ma9050372

Design and Validity of Randomized Controlled Dental Restorative Trials

Department of Operative and Preventive Dentistry, Charité—Universitätsmedizin Berlin, 14197 Berlin, Germany
Author to whom correspondence should be addressed.
Academic Editor: Marco Salerno
Received: 23 March 2016 / Revised: 3 May 2016 / Accepted: 10 May 2016 / Published: 13 May 2016
(This article belongs to the Section Biomaterials)
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Background: The evidence stemming from trials on restorative materials is shaped not only by trial findings, but also trial design and validity. We aimed to evaluate both aspects in randomized controlled dental restorative trials published from 2005–2015. Methods: Using systematic review methodology, we retrieved trials comparing restorative or adhesive dental materials. Two authors independently assessed design, risk of bias, registration status, and findings of trials. Descriptive and regression analyses were performed. Results: 114 studies on 15,321 restorations placed mainly in permanent teeth of 5232 patients were included. Per trial, the median number of patients was 37 (25th/75th percentiles: 30/51). Follow-up was 24 (20/48) months. Seventeen percent of trials reported on sample size calculations, 2% had been registered. Most trials (90%) used US Public Health Service (USPHS) criteria, and had a high risk of bias. More recent trials were more likely to have been registered, to have reported on sample size calculations, to be of low risk of bias, and to use other than USPHS-criteria. Twenty-three percent of trials yielded significant differences between groups. The likelihood of such differences was significantly increased in older studies, studies with potential reporting bias, published in journals with high impact factor (>2), longer follow-up periods, and not using USPHS-criteria. Conclusions: The majority of dental restorative trials published from 2005–2015 had limited validity. Risk of bias decreased in more recent trials. Future trials should aim for high validity, be registered, and use defined and appropriate sample sizes, follow-up periods, and outcome measures. View Full-Text
Keywords: clinical trial; dental restorations; evidence-based dentistry; randomized controlled trial; risk of bias; trial registration clinical trial; dental restorations; evidence-based dentistry; randomized controlled trial; risk of bias; trial registration

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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

Göstemeyer, G.; Blunck, U.; Paris, S.; Schwendicke, F. Design and Validity of Randomized Controlled Dental Restorative Trials. Materials 2016, 9, 372.

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