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. 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. 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. 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. 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.
The objective of this work was to assess the prevalence of human immunodeficiency virus-related oral lesions (HIV-ROL) in HIV-positive/acquired immunodeficiency syndrome (AIDS) patients receiving highly active antiretroviral therapy (HAART) including HIV-protease inhibitors. One hundred fifty-five (154) AIDS patients (69 intravenous drug users [IDU], 53 heterosexuals, 29 males who have sex with males, 1 transfused, and 2 of unknown contagious source) receiving HAART, were examined. We found the following prevalences: HIV-ROL 53.2%; oral candidiasis 34.4%; hairy leucoplakia 26.6%; xerostomia 15.5%; herpes simplex labialis 1.9%; HIV/periodontitis-gingivits 0.6%. No cases of Kaposi's sarcoma were observed. The highest prevalence of HIV-ROL was found in the IDU group, and in patients with viral load more than 10,000 copies and CD4+ cell count less than 200. Using our historical controls, this suggests that the prevalence of all oral lesions, particularly oral candidiasis, herpes simplex labiali, Kaposi's sarcoma, and periodontal disease has decreased more than 30% after the institution of HAART.