Adherence to the CONSORT statement of randomized clinical trials on ART restorations in children: current status and reporting characteristics
Open accessAbstract
Appropriate research reports are important to facilitate the evaluation of studies and the decision-making by dentists and policymakers. This meta-research study assessed the conformity of randomized clinical trials (RCTs) on atraumatic restorative treatment (ART) restorations with the CONSORT recommendations and their risk of bias (RoB). Cochrane Library, MEDLINE, BBO, LILACS, Scopus, and Web of Science databases were searched from April 2019 to June 2021 for RCTs that assessed the longevity of ART restorations in children. A specific tool was used to assess adherence to the CONSORT recommendations; RoB was evaluated with the Cochrane risk-of-bias tool. Descriptive analyses included the number of studies by journal, follow-up period, country, and quality assessments. A total of 2,181 papers were retrieved and 36 of them were analyzed qualitatively. The overall CONSORT mean score (CONms) was 22.52 ± 6.17 out of 32 points. The best described items were intervention and outcomes, whereas allocation concealment was described in only 22% of the papers. Significant differences in CONms were detected in the analysis by country and publication dates. High CONms were observed in recently published papers (26.7 ± 3.1) when compared to first ART studies (18.1 ± 4.6; p < 0.001). RoB was low in four studies, unclear in 11, and high in 21. Adherence of the papers to the CONSORT recommendations was not fully achieved and most of the papers had unclear and high RoB (PROSPERO registration #CRD42020201460).
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Studies suggest that articles with a high level of evidence are not consistently associated with the impact factor of the scientific journal in which they are published.
“Additionally, studies suggest that articles with a high level of evidence are not consistently associated with the impact factor of the scientific journal in which they are published 7 , 8 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [8]
The Correlation between variables section (page unavailable) reports no significant association between journal impact factor and either CONSORT reporting scores or risk of bias. This supports the general point that impact factor is not a reliable indicator of these measures, but the paper examines randomized trials of ART restorations in children; it does not directly measure articles’ levels of evidence across fields. (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn dentistry, studies have shown that 40% to 52% of the RCTs included in their analyses presented a high risk of bias, indicating inappropriate conduct.
“In dentistry, studies have shown that 40% to 52% of the RCTs included in their analyses presented a high risk of bias, indicating inappropriate conduct 8 , 15 , 18 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [8]
The Risk of BIAS section reports that 21 of 36 RCTs on ART restorations in children had a high risk of bias—about 58%, not 40%–52%. The Discussion describes shortcomings in randomization and warns that bias can distort results, but the cited paper does not support the stated percentage range. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIssues in the methodology and study design can introduce bias, random error, or limit the generalizability of RCTs.
“Despite their importance, issues in the methodology and study design can introduce bias, random error, or limit the generalizability of RCTs (Spieth et al. 2016; Wambier et al. 2022).”
From Adherence to the CONSORT statement of randomized clinical trials on dentin hypersensitivity treatment using mouthwashes (2025) · cites this paper as Wambier et al. 2022
Several studies in different dental specialties indicate a need for improvement.
“Over time, evidence of the impact of CONSORT has accumulated, and studies have already shown that its endorsement by journals improves the quality of RCT reports in dentistry 6 ; however, several studies in different dental specialties indicate a need for improvement 8 , 15 , 16 , 17 , 18 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [8]
Similar percentages of non-reporting were also observed in areas such as endodontics (40%), pediatric dentistry (64%), and restorative dentistry (60% to 83%).
“Similar percentages of non-reporting were also observed in areas such as endodontics (40%) 15 , pediatric dentistry (64%) 8 , and restorative dentistry (60% to 83%) 16 , 17 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [8]
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- Clinical Oral Investigations 27.5 ± 3.4 27.5 (23-28) Caries Research 22.5 ± 3.9 22.5 (19-25.5) Int. Journal of Paediatric Dentistry 21.5 ± 3.9 21.5 (18.5-24.5) p = 0.218 Community Dent. Oral Epidemiol. 18 ± 5 18 (13.5-21) Other* 24 ± 5.9 24 (17.3-26) Country Brazil 26.8 ± 3.2 a 27 (24.3-30) China 16.4 ± 4.5 b 16 (12-20.5) Netherlands 21.6 ± 4.5 a , b 22 (18.3-25) p < 0.001 Turkey 19.3 ± 2.08 b 20 (17.8-20.8) Other ** 20.8 ± 4.5 c,b 20.5 (18-25) Publication date 1999 -2004 18.1 ± 4.6 b 17.5 (14.5-22) 2005 -2009 22.7 ± 1.5 a,b 23 (21.5-24) p < 0.001 2010 -2014 23.0 ± 4.6 a,b 21.5 (20-27.0) 2015-2020 26.7 ± 3.1 a 26 (25-30) Follow-up period (year) 0 to 12 months 24.3 ± 4.8 24 (23.5 -27) 13 to 24 months 20.0 ± 6.4 18 (16.3 -24.8) 25 to 36 months 21.1 ± 4.7 20 (18.0 -22.5) p = 0.274 37 to 48 months 25.3 ± 2.1 26 (23.7 -26.7) more than 48 months 23.5 ± 2.1 23.5 (22 -25.0) *Other: 16 journals (BMC Oral Health; Brazilian Dental Science, Pediatric Dentistry, Journal of the Indian Society of Pedodontics and Preventive Dentistry, Journal of Applied Oral Science, Journal of Public Health Dentistry, Contemporary Clinical Dentistry, Journal of Dentistry for Children, Journal of the South African Dental Association, Brazilian Oral Research, Journal the American Dental Association, International Dental Journal, Medical Principles and Practice, Nigerian Journal of Clinical Practice, Journal of Clinical Paediatric Dentistry, Quintessence International, and Journal of Dentistry); **Other: 7 countries (Kenya, Tanzania, South Africa,Australia, Kuwait, India, and Syria).
Cited by
Sorted by citations
Global mapping of randomized controlled trials in dentistry
Prado, M. C., Dotto, L., Agostini, B., & Sarkis-Onofre, R. (2024) · Brazilian Dental Journal · doi:10.1590/0103-644020246233 · Cited by 1 · see citing works
Neto, L. T., Wambier, L. M., & Chibinski, A. C. R. (2025) · The Saudi Dental Journal · doi:10.1007/s44445-025-00017-y
“Despite their importance, issues in the methodology and study design can introduce bias, random error, or limit the generalizability of RCTs (Spieth et al. 2016; Wambier et al. 2022).”
Self-citation
- Authors
- Wambier, L. M., Gonçalves, A. D. R., Wambier, D. S., Reis, A., & Chibinski, A. C. R.
- Affiliations
- Universidade Positivo, Brazil
- Universidade Estadual de Ponta Grossa (BR)
- ORCID
- Venue
- Brazilian Oral Research
- Publisher
- FapUNIFESP (SciELO)
- Published
- 2022
- Volume
- 36
- Pages
- e017-e017
- ISSN
- 1517-7491 (ISSN-L)
- 1807-3107
- 1806-8324
- OpenAlex
- W4210885985
- Cited by
- 8
- References
- 88
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 3 · 2023: 1
- FWCI
- 0.57
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- Locations
- Brazilian Oral Research (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Dentistry › Orthodontics › Dental materials and restorations
- Health Sciences › Dentistry › Oral Surgery › Endodontics and Root Canal Treatments
- Keywords
- CONSORT statement, reporting quality, randomized controlled trials, atraumatic restorative treatment, pediatric dentistry, restoration, risk of bias, allocation concealment, meta-research
- MeSH terms
- Child, Humans, Bibliometrics, Bias, Randomized Controlled Trials as Topic, Guideline Adherence
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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