scholarly journals Evidence and Risk Indicators of Non‐Random Sampling in Clinical Trials in Implant Dentistry: A Systematic Appraisal

2021 ◽  
Author(s):  
Jun‐Yu Shi ◽  
Xiao Zhang ◽  
Shu‐Jiao Qian ◽  
Shi‐min Wei ◽  
Kai‐Xiao Yan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Random Sampling ◽  
Risk Indicators ◽  
Implant Dentistry ◽  
Systematic Appraisal

Industry sponsorship bias in clinical trials in implant dentistry: Systematic review and meta‐regression

2019 ◽  
Vol 46 (4) ◽  
pp. 510-519 ◽  
Author(s):  
Mateus Bertolini Fernandes dos Santos ◽  
Bernardo Antônio Agostini ◽  
Rafael Ratto Moraes ◽  
Falk Schwendicke ◽  
Rafael Sarkis‐Onofre
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Industry Sponsorship ◽  
Meta Regression ◽  
Implant Dentistry

scholarly journals The Application of Beta-Tricalcium Phosphate in Implant Dentistry: A Systematic Evaluation of Clinical Studies

Materials ◽  
2022 ◽  
Vol 15 (2) ◽  
pp. 655
Author(s):  
Elisabet Roca-Millan ◽  
Enric Jané-Salas ◽  
Antonio Marí-Roig ◽  
Álvaro Jiménez-Guerra ◽  
Iván Ortiz-García ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Survival Rate ◽  
Tricalcium Phosphate ◽  
Randomized Clinical Trials ◽  
Systematic Evaluation ◽  
Control Group ◽  
Cochrane Central Register ◽  
Graft Material ◽  
Synthetic Graft ◽  
Implant Dentistry

The demand for synthetic graft materials in implant dentistry is rising. This systematic review aims to evaluate the survival rate of dental implants placed simultaneously with bone regeneration procedures using the material β-tricalcium phosphate, one of the most promising synthetic graft materials. The electronic search was conducted in PubMed, Scielo, and the Cochrane Central Register of Controlled Trials. There were five randomized clinical trials, one of which was a non-randomized controlled clinical trial and four of which were observational studies without a control group included. Implant survival rate and other clinical, radiographic, and histological parameters did not differ from those of implants placed simultaneously with another type of graft material, or placed in blood clots or natural alveolar ridges. Based on the available literature, β-tricalcium phosphate seems to be a promising graft material in implant dentistry. Nevertheless, more randomized clinical trials, with long follow-up periods, preoperative and postoperative CBCT, and histological analysis, are necessary to assess its long-term behavior.

scholarly journals Risk-Based Monitoring in Clinical Trials: Past, Present, and Future

2021 ◽  
Author(s):  
Brian Barnes ◽  
Nicole Stansbury ◽  
Debby Brown ◽  
Lauren Garson ◽  
Geoff Gerard ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Risk Indicators ◽  
Remote Site ◽  
Trial Quality ◽  
Site Monitoring ◽  
Source Data Verification ◽  
Landscape Survey ◽  
Trial Monitoring ◽  
The Individual

AbstractRisk-based monitoring (RBM) is a powerful tool for efficiently ensuring patient safety and data integrity in a clinical trial, enhancing overall trial quality. To better understand the state of RBM implementation across the clinical trial industry, the Association of Clinical Research Organizations (ACRO) conducted a landscape survey among its member companies across 6,513 clinical trials ongoing at the end of 2019. Of these trials, 22% included at least 1 of the 5 RBM components: key risk indicators (KRIs), centralized monitoring, off-site/remote-site monitoring, reduced source data verification (SDV), and reduced source document review (SDR). The implementation rates for the individual RBM components ranged 8%–19%, with the most frequently implemented component being centralized monitoring and the least frequently implemented being reduced SDR. When the COVID-19 pandemic emerged in early 2020, additional data were collected to assess its impact on trial monitoring, focusing specifically on trials switching from on-site monitoring to off-site/remote-site monitoring. These mid-pandemic data show that the vast majority of monitoring visits were on-site in February 2020, but an even higher percentage were off-site in April, corresponding with the first peak of the pandemic. Despite this shift, similar numbers of non-COVID-related protocol deviations were detected from February through June, suggesting little or no reduction in monitoring effectiveness. The pre- and mid-pandemic data provide two very different snapshots of RBM implementation, but both support the need to promote adoption of this approach while also highlighting an opportunity to capitalize on the recent shift toward greater RBM uptake in a post-pandemic environment.

scholarly journals Keratinized Tissue Assessment for Dental Implant Therapy

2021 ◽  
Vol 1 (2) ◽  
Author(s):  
Amit S Gharpure
Keyword(s):  
Inflammatory Responses ◽  
Meta Analysis ◽  
Risk Indicators ◽  
Disease Etiology ◽  
Inflammatory Conditions ◽  
Keratinized Tissue ◽  
Natural Teeth ◽  
Implant Therapy ◽  
Implant Dentistry ◽  
Bacterial Plaque

Although overall failure rates in implant dentistry are low,1 peri-implant diseases have been recognized as a common biologic complication that can reduce the long-term success of dental implants.2 A recent systematic review and meta-analysis reported prevalence of peri-implant mucositis and peri-implantitis to be at 65% and 47%, respectively.3 Peri-implant mucositis and peri-implantitis are biofilm-associated, inflammatory conditions of peri-implant tissues.4 There has been significant evidence implying the role of bacterial plaque in the initiation of inflammatory responses in the gingiva of natural teeth as well as peri-implant mucosa.5,6 Peri-implant disease etiology is multi factorial in nature,7 and numerous factors may contribute to plaque accumulation and subsequent inflammation, playing a role as risk indicators for the development of peri-implant disease.

Implementation of ICH E6 (R2) through identification of data risks using analytics in oncology clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18319-e18319
Author(s):  
Colin Hayward ◽  
Emile Youssef ◽  
Melissa Nezos ◽  
Debra Jendrasek
Keyword(s):  
Clinical Trials ◽  
Visual Analytics ◽  
Quality Management System ◽  
Risk Indicators ◽  
Survey Analysis ◽  
Monitoring Methods ◽  
Quality Of Data ◽  
Central Monitoring ◽  
Oncology Clinical Trials ◽  
Data Tables

e18319 Background: ICH E6 (R2) has increased the level of scrutiny that we have for the data we collect in clinical trials. The emphasis is on quality-by-design with a quality management system to be incorporated and a focus on using a risk-based approach. This can be time-consuming and expensive - though the goal of this addendum is to improve quality AND efficiency, whilst ensuring patient safety and integrity of trial results. We therefore, piloted a proactive, concise and consistent method for utilizing a risk-based approach with central monitoring. Methods: Our method included 1) identifying risks within our data with 8 standard Key Risk Indicators (KRIs) across different study phases and different therapeutic areas together with 2) an off-the-shelf web-based tool for uniform and efficient review by a team of central monitors to assess which data may need more examination. These 8 KRIs are indicated in the list below, in order of the categories within the TransCelerate Risk Assessment and Categorization Tool: (S)AE rates, Enrollment Rates, Screen Failure Rates, Discontinuation Rate, Protocol Deviation Rates, Overdue Query Rate, Data Latency, and Identification of Potential Fraudulent data. Results: 15 studies were configured with the same KRIs and Visual Analytics; histograms, line- and pie-charts and data tables allowing for interactive data visualization and drill down. This represents research across different Phases 1-3 and observational studies. Based upon qualitative survey analysis from the central monitoring team 5/8 KRIs were found to be extremely valuable to focus on study quality, identifying earlier issues in study conduct for the project teams and Sponsors, while the remaining 3 were less valuable. Conclusions: We Our Risk Management team aims to increase the quality of data and ease of implementation of ICHE6 (R2) by focusing on the areas that matter the most, however identifying those areas and managing those data can sometimes be challenging. Through this innovation we have proven some core KRIs of trials that should be most closely monitored to aid decision making and will continue to evaluate to develop core oncology specific KRIs that will allow a more consistent review of data.

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