RoBDEMAT: A risk of bias tool and guideline to support reporting of pre-clinical dental materials research and assessment of systematic reviews

António Hs Delgado; Salvatore Sauro; Adriano F Lima; Alessandro D Loguercio; Alvaro Della Bona; Annalisa Mazzoni; Fabricio Mezzomo Collares; Frode Staxrud; Jack Ferracane; James Tsoi; Julia Amato; Klaus W Neuhaus; Laura Ceballos; Lorenzo Breschi; Matthias Hannig; Mary Anne Melo; Mutlu Özcan; Nicola Scotti; Niek Opdam; Satoshi Yamaguchi; Sebastian Paris; Lezize Sebnem Turkun; Sophie Doméjean; Vinicius Rosa; William Palin; Falk Schwendicke

doi:10.1016/j.jdent.2022.104350

RoBDEMAT: A risk of bias tool and guideline to support reporting of pre-clinical dental materials research and assessment of systematic reviews

J Dent. 2022 Dec:127:104350. doi: 10.1016/j.jdent.2022.104350. Epub 2022 Oct 28.

Authors

António Hs Delgado¹, Salvatore Sauro², Adriano F Lima³, Alessandro D Loguercio⁴, Alvaro Della Bona⁵, Annalisa Mazzoni⁶, Fabricio Mezzomo Collares⁷, Frode Staxrud⁸, Jack Ferracane⁹, James Tsoi¹⁰, Julia Amato¹¹, Klaus W Neuhaus¹², Laura Ceballos¹³, Lorenzo Breschi⁶, Matthias Hannig¹⁴, Mary Anne Melo¹⁵, Mutlu Özcan¹⁶, Nicola Scotti¹⁷, Niek Opdam¹⁸, Satoshi Yamaguchi¹⁹, Sebastian Paris²⁰, Lezize Sebnem Turkun²¹, Sophie Doméjean²², Vinicius Rosa²³, William Palin²⁴, Falk Schwendicke²⁵

Affiliations

¹ Centro de Investigação Interdisciplinar Egas Moniz (CiiEM), Monte de Caparica, Almada 2829-511 Portugal; Department of Biomaterials and Tissue Engineering, UCL Eastman Dental Institute, London, UK. Electronic address: antonio.delgado.17@ucl.ac.uk.
² Dental Biomaterials and Minimally Invasive Dentistry, Department of Dentistry, Cardenal Herrera-CEU University, CEU Universities, Valencia, Spain.
³ Dental Research Division, Paulista University, Sao Paulo, Brazil.
⁴ Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, PR, Brazil.
⁵ Postgraduate Program in Dentistry, School of Dentistry, University of Passo Fundo, Passo Fundo, RS, Brazil.
⁶ Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna-Alma Mater Studiorum, Bologna, Italy.
⁷ Department of Dental Materials, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
⁸ Nordic Institute for Dental Materials (NIOM), Oslo, Norway.
⁹ Department of Restorative Dentistry, Oregon Health & Science University, 2730 S. Moody Avenue Portland, OR 97201, Oregon, USA.
¹⁰ Dental Materials Science, Applied Oral Sciences and Community Dental Care, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR.
¹¹ Department of Periodontology, Endodontology and Cariology, University Center for Dental Medicine Basel UZB, University of Basel, Basel, Switzerland.
¹² Department of Periodontology, Endodontology and Cariology, University Center for Dental Medicine Basel UZB, University of Basel, Basel, Switzerland; Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
¹³ Nursing and Stomatology Department, Health Sciences Faculty, Rey Juan Carlos University, Alcorcón, Madrid, Spain.
¹⁴ Clinic of Operative Dentistry, Periodontology and Preventive Dentistry, Saarland University, 66421 Homburg, Germany.
¹⁵ Division of Operative Dentistry, Department of General Dentistry, University of Maryland School of Dentistry, 650 West Baltimore St, Baltimore, MD 21201, USA.
¹⁶ University of Zürich, Division of Dental Biomaterials, Center for Oral Medicine, Clinic for Reconstructive Dentistry, Zürich, Switzerland.
¹⁷ Department of Surgical Sciences, Dental School Lingotto, University of Turin, Turin, Italy.
¹⁸ Radboud University Medical Centre, Department of Dentistry, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.
¹⁹ Department of Biomaterials Science, Osaka University Graduate School of Dentistry, Suita, Osaka 565-0871, Japan.
²⁰ Department of Operative, Preventive and Paediatric Dentistry, Center of Oral Health Sciences, Charité - Universitätsmedizin Berlin, Germany.
²¹ Department of Restorative Dentistry, Ege University School of Dentistry, 35100 Bornova/Izmir Turkey.
²² CHU Estaing, Service d'Odontologie, Clermont-Ferrand, France; Université Clermont Auvergne, UFR d'Odontologie, Clermont-Ferrand, France; Centre de Recherche en Odontologie Clinique EA 4847, Clermont-Ferrand, France.
²³ Faculty of Dentistry, National University of Singapore, Singapore; ORCHIDS: Oral Care Health Innovations and Designs Singapore, National University of Singapore, Singapore.
²⁴ Dental and Biomaterials Sciences, School of Dentistry, College of Medical and Dental Sciences, University of Birmingham, UK.
²⁵ Department of Operative and Preventive Dentistry, Charité - Universitätsmedizin Berlin, Germany, Aßmannshauser Str. 4-6, 14199 Berlin, German.

PMID: 36341980
DOI: 10.1016/j.jdent.2022.104350

Abstract

Objectives: To develop a risk of bias tool for pre-clinical dental materials research studies that aims to support reporting of future investigations and improve assessment in systematic reviews.

Methods: A four-stage process following EQUATOR network recommendations was followed, which included project launch, literature review, Delphi process and the tool finalization. With the support of the European Federation of Conservative Dentistry (EFCD) and the Dental Materials Group of the International Association for Dental Research (DMG-IADR), a total of 26 expert stakeholders were included in the development and Delphi vote of the initial proposal. The proposal was built using data gathered from the literature review stage. During this stage, recent systematic reviews featuring dental materials research, and risk of bias tools found in the literature were comprehensively scanned for bias sources. The experts thus reached a consensus for the items, domains and judgement related to the tool, allowing a detailed guide for each item and corresponding signalling questions.

Results: The tool features nine items in total, spread between 4 domains, pertaining to the following types of bias: bias related to planning and allocation (D1), specimen preparation (D2), outcome assessment (D3) and data treatment and outcome reporting (D4). RoBDEMAT, as presented, features signalling questions and a guide that can be used for RoB judgement. Its use as a checklist is preferred over a final summary score.

Conclusion: RoBDEMAT is the first risk of bias tool for pre-clinical dental materials research, supported and developed by a broad group of expert stakeholders in the field, validating its future use.

Clinical significance: This new tool will contribute the study field by improving the scientific quality and rigour of dental materials research studies and their systematic reviews. Such studies are the foundation and support of future clinical research and evidence-based decisions.

Keywords: Bias; Biomedical and dental materials; Dental materials; In vitro techniques; Laboratory studies; Risk assessment; Systematic review.

MeSH terms

Bias
Checklist*
Dental Materials
Publications*
Systematic Reviews as Topic

Substances

Dental Materials