Outcome reporting discrepancies between trial entries and published final reports of orthodontic randomized controlled trials
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BACKGROUND/OBJECTIVES: The aim of this study was to identify outcome-related discrepancies between registry trial entries and final published reports in orthodontic randomized controlled trials (RCTs). The percentage of registered orthodontic RCTs was also recorded. MATERIALS/METHOD: Five trial registries, ClinicalTrials.gov (https://clinicaltrials.gov/), International Standard Randomised Controlled Trial Number registry (http://www.isrctn.com/), European Union Clinical Trials Register (https://www.clinicaltrialsregister.eu/), Australia New Zealand Clinical Trials Registry (http://www.anzctr.org.au/) and Clinical Trials Registry of India (www.ctri.nic.in/) were searched up to April 2018 in order to identify completed orthodontic RCTs. The unique trial identifier, the title and authors name were used to search for publications based on entries within Google (https://www.google.com), Google Scholar (https://scholar.google.gr/) and MEDLINE via PubMed (https://www.ncbi.nlm.nih.gov/pubmed/). Outcome reporting discrepancies and a number of other entry/publication characteristics were recorded including timing of registration, type of journal/publication, significance of the primary outcome in the final report. The number of trials registered among the total number of published RCTs in orthodontics was recorded within the time span assessed. RESULTS: One hundred and twenty-four entries were identified for completed orthodontic RCTs, whereas 53 of those were related to published final reports. Outcome reporting discrepancies were ascertained for 47 per cent of publications (n = 2 5); discrepancies were more prevalent for non-primary outcomes (n = 21, 40 per cent). Only 16 per cent of the published orthodontic RCTs had been registered. LIMITATIONS: Only a subset of trial entries were assessed as these were related to publication records. CONCLUSIONS/IMPLICATIONS: Registration of clinical trials in orthodontics remains far from universal. A significant level of outcome reporting discrepancy was observed within this subset of registered trials.
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Studies in specific dental areas such as endodontics, orthodontics, and implantology found high rates of SOR.
“studies in specific dental areas such as endodontics, orthodontics, and implantology found high rates of SOR (Koufatzidou et al. 2019; Sendyk et al. 2019; Tzanetakis and Koletsi 2021)”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Koufatzidou et al. 2019
This rate is consistent with SOR rates in endodontics (36.4%), implantology (55%), and orthodontics (47%).
“This rate is consistent with SOR rates in endodontics (36.4%) (Tzanetakis and Koletsi 2021), implantology (55%) (Sendyk et al. 2019), and orthodontics (47%) (Koufatzidou et al. 2019).”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Koufatzidou et al. 2019
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Self-citation
- Authors
- Koufatzidou, M., Koletsi, D., Fleming, P. S., Polychronopoulou, A., & Pandis, N.
- Affiliations
- National and Kapodistrian University of Athens (GR)
- Queen Mary University of London (GB)
- University of Bern (CH)
- Corresponding author
- Koletsi, Despina
- Venue
- European Journal of Orthodontics
- Publisher
- Oxford University Press (OUP)
- Published
- 2018-07-09
- Volume
- 41
- Issue
- 3
- Pages
- 225-230
- ISSN
- 0141-5387 (ISSN-L)
- 1460-2210
- OpenAlex
- W2849286502
- Cited by
- 44
- References
- 21
- Citations by year
- 2025: 3 · 2024: 9 · 2023: 6 · 2022: 9 · 2021: 11 · 2020: 5 · 2019: 1
- FWCI
- 3.24
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- European Journal of Orthodontics (publishedVersion)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- BORIS (University Library Bern) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- clinical trial registration, clinical trial registries, publication characteristics, primary outcomes
- MeSH terms
- Humans, Orthodontics, Registries, Bibliometrics, Randomized Controlled Trials as Topic
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