Compliance of Randomized Clinical Trials in Noncarious Cervical Lesions With the CONSORT Statement: A Systematic Review of Methodology

Reis, A; de Geus, JL; Wambier, L; Schroeder, M; Loguercio, AD

doi:10.2341/17-060-l

Cited by 36Meta-analysis and systematic reviewsDental materials and restorationsClinical practice guidelines implementation

Compliance of Randomized Clinical Trials in Noncarious Cervical Lesions With the CONSORT Statement: A Systematic Review of Methodology

Reis, A, de Geus, JL, Wambier, L, Schroeder, M, Loguercio, AD·2018·Operative Dentistry

DOI 10.2341/17-060-l

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Abstract

SUMMARY: The literature was reviewed to evaluate the compliance of randomized clinical trials (RCTs) with the CONsolidated Standards of Reporting Trials (CONSORT ) and the risk of bias of these studies through the Cochrane Collaboration risk of bias tool (CCRT). RCTs were searched at Cochrane Library, PubMed, and other electronic databases to find studies about adhesive systems for cervical lesions. The compliance of the articles with CONSORT was evaluated using the following scale: 0 = no description, 1 = poor description, and 2 = adequate description. Descriptive analyses about the number of studies by journal, follow-up period, country, and quality assessments were performed with CCRT for assessing risk of bias in RCTs. One hundred thirty-eight RCTs were left for assessment. More than 30% of the studies received scores of 0 or 1. Flow chart, effect size, allocation concealment, and sample size were more critical items, with 80% receiving a score of 0. The overall CONSORT score for the included studies was 15.0 ± 4.8 points, which represents 46.9% of the maximum CONSORT score. A significant difference among countries was observed (p<0.001), as well as range of year (p<0.001). Only 4.3% of the studies were judged as at low risk; 36.2% were classified as having unclear risk and 59.4% as having high risk of bias. The adherence of RCTs evaluating adhesive systems to the CONSORT is low with unclear/high risk of bias.

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The evaluation of compliance with the CONSORT statement was performed using a previously validated tool.
“The evaluation of compliance with the CONSORT statement was performed using a previously validated tool that has been applied in other studies (Loguercio et al. 2017; Reis et al. 2018).”
From Adherence to the CONSORT statement of randomized clinical trials on dentin hypersensitivity treatment using mouthwashes (2025) · cites this paper as Reis et al. 2018

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Adherence to the CONSORT statement of randomized clinical trials on ART restorations in children: current status and reporting characteristics
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Self-citation

Authors: Reis, A., de Geus, J., Wambier, L., Schroeder, M., & Loguercio, A.
Affiliations: Universidade Estadual de Ponta Grossa (BR)
Juliana L de Geus, MS, PhD, professor, School of Dentistry, School Paulo Picanço, Fortaleza, Ceará, Brazil and Department of Restorative Dentistry, Guairacá Faculty, Guarapuava, Paraná, Brazil.
Universidade Federal do Rio de Janeiro (BR)
Alessandro D. Loguercio, DDS, MS, PhD, professor, Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Parana, Brazil
Corresponding author: Reis, A
ORCID: Reis, A
Wambier, L
Schroeder, M
Venue: Operative Dentistry
Publisher: Operative Dentistry
Published: 2018-05-01
Volume: 43
Issue: 3
Pages: E129-E151
ISSN: 0361-7734 (ISSN-L)
1559-2863
DOI: 10.2341/17-060-l
OpenAlex: W2802609962
Cited by: 35
References: 182
Citations by year: 2026: 1 · 2025: 2 · 2024: 8 · 2023: 1 · 2022: 7 · 2021: 8 · 2020: 4 · 2019: 4
FWCI: 0.79
Type: journal article
Language: en
Open access: closed
Locations: Operative Dentistry (publishedVersion)
PubMed (publishedVersion)
Funders: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
U.S. Public Health Service
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Health Sciences › Dentistry › Orthodontics › Dental materials and restorations
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Keywords: CONSORT statement, reporting quality, risk of bias, non-carious cervical lesions, adhesive restorative systems, randomized controlled trials, allocation concealment, flowcharts, sample size, Cochrane risk of bias tool
MeSH terms: Dental Bonding, Dental Cements, Humans, Tooth Diseases, Observer Variation, Randomized Controlled Trials as Topic, Tooth Cervix, Guideline Adherence

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Compliance of Randomized Clinical Trials in Noncarious Cervical Lesions With the CONSORT Statement: A Systematic Review of Methodology

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