Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013
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OBJECTIVES: To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. METHODS: We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. RESULTS: Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955-2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. CONCLUSIONS: The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed.
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Many research projects in the USA are funded by private initiatives, unlike most other countries.
“Also, many research projects in the USA are funded by private initiatives, unlike most other countries 29 , 30 , 31 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [30]
The Results (Trial publication and characteristics; page unavailable) report that 171 of 540 dental trials received industry funding, supporting the narrower point that some research has private funding. Funding is not broken down by country, so the paper does not establish that many US projects are privately funded or that the USA differs from most other countries. The Discussion instead speculates that government and public-sector interest may facilitate trials in the USA and UK. (LLM, conf=0.78)
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- Authors
- Saltaji, H., Armijo-Olivo, S., Cummings, G. G., Amin, M., & Flores-Mir, C.
- Affiliations
- University of Alberta (CA)
- Corresponding author
- Saltaji, Humam
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2017-12-22
- Volume
- 12
- Issue
- 12
- Pages
- e0190089
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC5741237
- OpenAlex
- W2781460076
- Cited by
- 43
- References
- 77
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 4 · 2023: 2 · 2022: 3 · 2021: 12 · 2020: 13 · 2019: 2 · 2018: 3
- FWCI
- 4.40
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- Funders
- Alberta Innovates - Health Solutions (AIHS)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Dentistry › Orthodontics › Dental materials and restorations
- Keywords
- randomized controlled trials, oral health interventions, risk of bias, reporting quality, methodological quality, sequence generation, allocation concealment, blinding, sample size determination, Cochrane risk of bias tool
- MeSH terms
- Dentistry, Humans, Research Design, Observer Variation, Chi-Square Distribution, Logistic Models, Randomized Controlled Trials as Topic, History, 20th Century, History, 21st Century
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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