Background: Quality of reporting randomized controlled trials (RCTs) in periodontology has been poor. Consolidated Standards of Reporting Trials guidelines and an extension for non-pharmacologic trials (CONSORT-NPE), were introduced to aid in improving this.
Aims: The aim of this study was to assess the quality of reporting in periodontology, changes over the last 14 years, and adherence to CONSORT-NPE.
Methods: Randomized controlled trials in humans, published in three periodontal journals, from 2013 to 2015 were included. Search was conducted through Medline, Embase and hand searching.
Results: One hundred and seventy-three full-text articles included. Two reviewers screened for reporting quality (κ = 0.69, 95% CI 0.60-0.76). 84% of studies (n = 145) described randomization methods, 74% (n = 128) highlighted examiner blinding and 87% (n = 151) accounted for patients at study conclusion. Patient and caregiver blinding was addressed in 50% (n = 70) and 50% (n = 27) of studies respectively. 64% (n = 110) described adequate allocation concealment. Compared with Montenegro et al. (2002, Journal of Dental Research, 81, 866), improvements seen in describing randomization (2002, 16.5%; 2016, 84%), allocation concealment (2002, 6.5%; 2016, 64%), caregiver masking (2002, 17%; 2016, 50%). CONSORT-NPE; 62% (n = 107) had detailed explanations of all treatments, 88% (n = 152) lacked protocols for adherence of caregivers' to an intervention. Only 17% (n = 29) described caregivers' expertise and case volume.
Conclusions: Substantial improvements have occurred. Attention is required for statistical analysis of patient losses and masking. CONSORT-NPE aspects were poorly reported.
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