CONSORT statement adherence and risk of bias in randomized controlled trials on deep caries management: a meta-research
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BACKGROUND: Recently, trials have supported changes in deep caries management. However, reporting might lack details, affecting interpretation and implementation. Thus, we aimed to evaluate the adherence to the CONSORT statement and the risk of bias of randomized controlled trials (RCTs) on deep caries management published in pediatric dental journals. METHODS: We searched PubMed for RCTs in six pediatric dental journals between 2010 and 2022, focusing on deep caries lesion management. Adherence to the CONSORT guideline and the risk of bias were assessed using a modified tool with 19 items; each scored from 0 to 2 (maximum of 38 points), and the Cochrane risk-of-bias (RoB 2) tool. We performed descriptive and regression analyses (α = 5%). RESULTS: We analyzed 127 RCTs. The mean (standard deviation) CONSORT adherence score was 21.1 (6.7). Notably, 96.1% of the studies received a score of 2 for the "intervention" item, whereas 83.5% scored 0 for the "estimated effect size". The risk of bias assessment revealed that 40.2% of the RCTs were at high risk, 59% were at low risk, and 0.8% were at low risk. RCTs with a high risk of bias had lower CONSORT scores (p<0.001) than those with low or some concerns. RCTs published in journals without the endorsement of the CONSORT statement had lower scores than those in journals with the endorsement of the CONSORT statement. Older RCTs (6-10 years old and more than 10 years old) showed significantly lower CONSORT statement compliance than trials published recently within 5 years. CONCLUSION: Adherence to the CONSORT was relatively low among the investigated RCTs. Moreover, lower adherence to the CONSORT was associated with a higher risk of bias. TRIAL REGISTRATION: This study protocol was prospectively registered on the Open Science Framework - DOI ( 10.17605/OSF.IO/V6SYZ ).
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Reports in other dental specialties have produced similar results to the present study.
“Additionally, reports in other dental specialties, such as restorative dentistry, (Elagami et al. 2024) endodontics, (Cabral et al. 2021) surgery, (Shete-Motgi et al. 2022; Kshirsagar et al. 2021) prosthetics, (Chen et al. 2018; Lempesi et al. 2014) and pediatric dentistry, (Wambier et al. 2022) have produced similar results.”
From Adherence to the CONSORT statement of randomized clinical trials on dentin hypersensitivity treatment using mouthwashes (2025) · cites this paper as Elagami et al. 2024
The Discussion and Conclusions report low CONSORT adherence and risk-of-bias concerns, supporting the claim of similar findings. But the Methods specify that the study examined deep-caries trials in pediatric dentistry journals; it does not establish these results for restorative dentistry generally. The passages in our copy have no page numbers. (LLM, conf=0.82)
Experimental — accuracy not yet measuredSimilar results were reported in the evaluation of dental RCTs (64.2%) and RCTs on deep caries management (49.6%).
“Similar results were reported in the evaluation of dental RCTs (64.2%) and RCTs on deep caries management (49.6%) 6 , 18 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [18]
In a recent study, 85% of studies did not report using CONSORT.
“In a recent study, 85% of studies did not report using CONSORT 18 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [18]
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.
“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 [18]
In dentistry, many authors agree that reporting of RCTs is still suboptimal.
“In dentistry, many authors agree that reporting of RCTs is still suboptimal 15 , 17 , 18 , 30 .”
From Global mapping of randomized controlled trials in dentistry (2024) · cites this paper as [18]
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- Authors
- Elagami, R. A., Reis, T. M., Hassan, M. A., Tedesco, T. K., Braga, M. M., Mendes, F. M., Cenci, M. S., Huysmans, M.-C., & Raggio, D. P.
- Affiliations
- Universidade de São Paulo (BR)
- Radboud University Medical Center (NL)
- Corresponding author
- Raggio, Daniela Prócida
- ORCID
- Venue
- BMC Oral Health
- Published
- 2024-06-13
- Volume
- 24
- Issue
- 1
- Pages
- 687-687
- ISSN
- 1472-6831 (ISSN-L)
- PMC
- PMC11177528
- OpenAlex
- W4399694676
- Cited by
- 14
- References
- 35
- Citations by year
- 2026: 2 · 2025: 11 · 2024: 1
- FWCI
- 3.91
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Oral Health (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (001)
- The Latin American Oral Health Association
- Conselho Nacional de Desenvolvimento Científico e Tecnológico (316974/2021-8, 303230/2019-3, 310972/2021-3)
- 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
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Keywords
- risk of bias, deep caries, pediatric dentistry, randomized controlled trials, trial reporting quality, meta-research
- MeSH terms
- Dental Caries, Humans, Bias, Randomized Controlled Trials as Topic, Guideline Adherence
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