In 2007, new clinical criteria were approved by the FDI World Dental Federation and simultaneously published in three dental journals. The criteria were categorized into three groups: esthetic parameters (four criteria), functional parameters (six criteria) and biological parameters (six criteria). Each criterion can be expressed with five scores, three for acceptable and two for non-acceptable (one for reparable and one for replacement). The criteria have been used in several clinical studies since 2007, and the resulting experience in their application has led to a requirement to modify some of the criteria and scores. The two major alterations involve staining and approximal contacts. As staining of the margins and the surface has different causes, both phenomena do not appear simultaneously. Thus, staining has been differentiated into marginal staining and surface staining. The approximal contact now appears under the name "approximal anatomic form" as the approximal contour is a specific, often non-esthetic issue that cannot be integrated into the criterion "esthetic anatomical form". In 2008, a web-based training and calibration tool called e-calib ( www.e-calib.info ) was made available. Clinical investigators and other research workers can train and calibrate themselves interactively by assessing clinical cases of posterior restorations which are presented as high-quality pictures. Currently, about 300 clinical cases are included in the database which is regularly updated. Training for eight of the 16 clinical criteria is available in the program: "Surface lustre"; "Staining (surface, margins)"; "Color match and translucency"; Esthetic anatomical form"; "Fracture of material and retention"; "Marginal adaptation"; "Recurrence of caries, erosion, abfraction"; and "Tooth integrity (enamel cracks, tooth fractures)". Typical clinical cases are presented for each of these eight criteria and their corresponding five scores.

No abstract

No abstract

No abstract

No abstract

No abstract

No abstract

About 35 years ago, Ryge provided a practical approach to evaluation of clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and non-standard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to meaningfully interpret. In many cases, the insensitivity of the original Ryge methods is misinterpreted as good clinical performance. While there are many good features of the original system, it is now time to move to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for clinical trial designs, guidelines for design, randomization, number of subjects, characteristics of participants, clinical assessment, standards and calibration, categories for assessment, criteria for evaluation, and supplemental documentation. Part 2 of the review considers categories of assessment for esthetic evaluation, functional assessment, biological responses to restorative materials, and statistical analysis of results. The overall review represents a considerable effort to include a range of clinical research interests over the past years. As part of the recognition of the importance of these suggestions, the review is being published simultaneously in identical form in both the "Journal of Adhesive Dentistry" and the "Clinical Oral Investigations." Additionally an extended abstract will be published in the "International Dental Journal" giving a link to the web full version. This should help to introduce these considerations more quickly to the scientific community.