Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation.

OBJECTIVES: Clinical trial documents are complex and may have inconsistencies, leading to potential site implementation errors and may compromise participant safety. This study characterizes the frequency and type of administrative and potential patient safety interventions (PPSIs) made during the review of oncology trial documents for clinical trial implementation by centralized clinical content specialists. METHODS: A dedicated group of centralized clinical content specialists reviewed trial documents, including the protocol, laboratory manual, and pharmacy/cellular therapy manual, and collected intervention data over a 1-year period. Each trial was categorized by study phase and sponsor type, and multiple interventions could be identified per trial. Interventions were deemed administrative or PPSIs, with PPSIs further subcategorized as medication, laboratory, procedure related, or other. RESULTS: Of 585 clinical trials reviewed, 269 (46%) required intervention(s). Among 1001 interventions, 171 (17.1%) were PPSIs. Most PPSIs were medication related (45.6%), with drug dosing interventions most frequently identified (53.8%). Phase 1 trials had the highest proportion of PPSIs (0.35:1) and administrative interventions (2:1) per trial compared with all other phases. Investigator-initiated trials saw the highest proportion of PPSIs per trial (0.44:1) of all sponsor types. CONCLUSIONS: This study demonstrates a gap in patient safety when assessing trial documents for clinical trial implementation. One solution to address this gap is the utilization of a centralized team of clinical specialists to preemptively review trial documents, thereby enhancing patient safety during clinical trial conduct.

Clinical performance of scientifically designed, hot isostatic-pressed (HIP'd) zirconia cores in a bilayered all-ceramic system.

PURPOSE: The success of bilayered all-ceramic restorations is dependent upon the combination and contributions of the three principal components of these restorations: core material, core design, and core-veneer interface. The purpose of this paper is to describe the fabrication and clinical survival of optimized ceramic restorations having an explicit, scientifically designed core, machined from HIP'd isotropic zirconia and veneered using a specific protocol with thermally compatible porcelain. MATERIALS AND METHODS: Using a consistent clinical and laboratory protocol in a multicenter setting, 3,192 bilayered single and 797 bilayered splinted units were fabricated and placed on teeth and implant abutments in 1,007 patients. Approximately 61.7% (n = 2,462) were posterior restorations and 38.3% (n = 1,527) were anterior. Of the total, approximately 5.7% (n = 227) were placed on implant abutments. Survival of the restorations was determined with the Kaplan-Meier (KM) method by tooth number. RESULTS: For the 3,989 units placed, 9 failures were recorded. The KM survival of most zirconia restorations, when segregated by tooth number, was 100%. Exceptions were the 9 failed units, with a KM survival between 88% and 99% for those restorations. Six restorations failed within the first year of service, including three failed cores. Examination of those restorations revealed failure was related to initial design, quality assessment, or fabrication inconsistencies. CONCLUSION: The incorporation of a reinforcing ring beam onto an anatomically shaped core made from end-state HIP'd zirconia, in partnership with a thermally compatible veneering porcelain and a specific application protocol, resulted in extremely high survival rates for both anterior and posterior all-ceramic restorations after medium-term clinical use. These results equal or surpass the equivalent-term success rates of porcelain-fused-to-metal restorations.

A ten-unit all-ceramic anterior fixed partial denture using Y-TZP zirconia.

High-strength, all-ceramic systems are being recommended with increasing frequency for both anterior and posterior restorations. There are some significant differences in the physical and mechanical properties of these materials that ultimately affect their clinical performances. Consequently, these differences should be clearly understood before the restorative team selects the use of a particular system. This article reviews these differences and demonstrates the use of Y-TZP zirconia for the fabrication of a 10-unit anterior fixed partial denture.

Classification of altered dental esthetics.

Clinical procedures designed to reestablish the idealized framework for the achievement of optimal esthetic restorative results have been frequently reported. Yet complex cases, where remarkable improvements of esthetic appearance are achievable in spite of preoperative conditions, are infrequently presented because the presentation standards appear to be set for idealized situations. If a classification system that reflects dental esthetic compromises and ideals existed, cases could be categorized accordingly, and realistic expectations could be applied to assess the effectiveness and results of a course of therapy. Considering that there is not currently a published classification system to this end, it is the purpose of this article to tender a classification of altered dental esthetics.