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

António H. S. DelgadoCentro 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: [email protected]Salvatore SauroDental Biomaterials and Minimally Invasive Dentistry, Department of Dentistry, Cardenal Herrera-CEU University, CEU Universities, Valencia, SpainAdriano Fonseca LimaDental Research Division, Paulista University, Sao Paulo, BrazilAlessandro Dourado LoguércioDepartment of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, PR, BrazilÁlvaro Della BonaPostgraduate Program in Dentistry, School of Dentistry, University of Passo Fundo, Passo Fundo, RS, BrazilAnnalisa MazzoniDepartment of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna-Alma Mater Studiorum, Bologna, ItalyFabrício Mezzomo CollaresDepartment of Dental Materials, Universidade Federal do Rio Grande do Sul, Porto Alegre, BrazilFrode StaxrudNordic Institute for Dental Materials (NIOM), Oslo, NorwayJack L. FerracaneDepartment of Restorative Dentistry, Oregon Health & Science University, 2730 S. Moody Avenue Portland, OR 97201, Oregon, USAJames Kit Hon TsoiDental Materials Science, Applied Oral Sciences and Community Dental Care, Faculty of Dentistry, The University of Hong Kong, Hong Kong SARJulia AmatoDepartment of Periodontology, Endodontology and Cariology, University Center for Dental Medicine Basel UZB, University of Basel, Basel, SwitzerlandKlaus W. NeuhausUniversity Hospital of BaselLaura CeballosNursing and Stomatology Department, Health Sciences Faculty, Rey Juan Carlos University, Alcorcón, Madrid, SpainLorenzo BreschiDepartment of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna-Alma Mater Studiorum, Bologna, ItalyMatthias HannigClinic of Operative Dentistry, Periodontology and Preventive Dentistry, Saarland University, 66421 Homburg, GermanyMary Anne S. MeloDivision of Operative Dentistry, Department of General Dentistry, University of Maryland School of Dentistry, 650 West Baltimore St, Baltimore, MD 21201, USAMutlu ÖzcanUniversity of Zürich, Division of Dental Biomaterials, Center for Oral Medicine, Clinic for Reconstructive Dentistry, Zürich, SwitzerlandNicola ScottiDepartment of Surgical Sciences, Dental School Lingotto, University of Turin, Turin, ItalyNiek OpdamRadboud University Medical Centre, Department of Dentistry, Radboud Institute for Health Sciences, Nijmegen, The NetherlandsSatoshi YamaguchiDepartment of Biomaterials Science, Osaka University Graduate School of Dentistry, Suita, Osaka 565-0871, JapanSebastian ParisDepartment of Operative, Preventive and Paediatric Dentistry, Center of Oral Health Sciences, Charité - Universitätsmedizin Berlin, GermanyMurat TürkünDepartment of Restorative Dentistry, Ege University School of Dentistry, 35100 Bornova/Izmir TurkeySophie DoméjeanCROC - Centre de Recherche en Odontologie Clinique (Faculté de Chirurgie Dentaire, 2 rue de Braga, 63100 Clermont-Ferrand - France)Vinícius RosaFaculty of Dentistry, National University of Singapore, Singapore; ORCHIDS: Oral Care Health Innovations and Designs Singapore, National University of Singapore, SingaporeWilliam M. PalinDental and Biomaterials Sciences, School of Dentistry, College of Medical and Dental Sciences, University of Birmingham, UKFalk SchwendickeDepartment of Operative and Preventive Dentistry, Charité - Universitätsmedizin Berlin, Germany, Aßmannshauser Str. 4-6, 14199 Berlin, German

2022en

ABI

Annotatsiya

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.

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DOI: 10.1016/j.jdent.2022.104350

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