An in vitro trial on the effect of arch form on connector size requirements in long span anterior zirconia fixed dental prostheses.

PURPOSE: To test the fracture resistance of maxillary canine to canine fixed partial denture with four missing incisors, with increasing anterior-cantilevers of the pontics and varying connector sizes. MATERIALS AND METHODS: Two 3D-printed titanium alloy (Ti6Al4V) models mimicking a maxillary canine to canine fixed partial denture (FPD) with four pontics replacing the incisors were used as master models. Zirconia FPDs were digitally designed and milled with two different connector sizes (9 and 12 mm2 ) each with three different anterior cantilevers (7, 10, and 13 mm) accounting for 6 test groups. Seven samples were milled for each group generating a total of 42 samples. The zirconia FPDs were cemented on the titanium model using resin modified glass ionomer cement and the model fixated to a variable angle vice. A sinusoidal cyclic waveform load from 50 to 280N was applied using a universal testing machine at a frequency of 30 cycles per second and a total of 5 million cycles. RESULTS: The results of Fisher's exact tests showed that the difference in the proportion of fractured versus nonfractured fixed partial dentures was not statistically significant when comparing the 9 with the 12 mm2 connector size (p = 1.00), as well as when comparing the six test groups (p = 0.2338); on the other hand, it proved to be statistically significant when comparing the 7 mm cantilever with the 10 and 13 mm cantilevers combined (p = 0.0407) indicating that a 7 mm anterior spread of the pontics showed a significantly greater proportion of fixed partial dentures that fractured. CONCLUSIONS: Fracture susceptibility was not a function of cantilever length in this testing configuration for anterior FPDs. Retainer crown thickness seems to be a more important parameter than connector size thickness. Based on the results, a smaller connector size (9 mm2 ) can be used to improve the esthetics of pontics in long span anterior FPDs.

Incidence of Serious Infections and Design of Utilization and Safety Studies for Biologic and Biosimilar Surveillance.

BACKGROUND: There is a need for postmarketing evidence generation for novel biologics and biosimilars. OBJECTIVE: To assess the feasibility, strengths, and limitations of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (DRN) to examine the utilization and comparative safety of immune-modulating agents among patients with autoimmune diseases. METHODS: We conducted a retrospective cohort study among patients enrolled in health insurance plans participating in the BBCIC DRN between January 1, 2006, and September 30, 2015. Eligible patients were adult (≥18 years) new users of a disease-modifying nonbiologic and/or biologic agent with a prior diagnosis of rheumatoid arthritis (RA), other inflammatory conditions (psoriasis, psoriatic arthritis, ankylosing spondylitis), or inflammatory bowel disease (IBD). Follow-up started at treatment initiation and ended at the earliest of outcome occurrence (serious infection); treatment discontinuation; or switching, death, disenrollment, or end of study period. The study leveraged the FDA Sentinel System infrastructure for data management and analysis; descriptive statistics of patient characteristics and unadjusted incidence rates of study outcomes during follow-up were calculated. RESULTS: Eligible patient drug episodes included 111,611 with RA (75% female), 61,050 with other inflammatory conditions (51% female), and 30,628 with IBD (52% female). Across all 3 cohorts, approximately half of the patient drug episodes initiated a biologic (50% in RA; 60% in psoriasis, psoriatic arthritis, ankylosing spondylitis; and 55% in IBD). The crude incidence rate of serious infection was 9.8 (9.5-10.0) cases per 100 person-years in RA, 7.1 (6.8-7.5) in other inflammatory conditions, and 14.2 (13.6-14.8) in IBD patients. CONCLUSIONS: This study successfully identified large numbers of new users of biologics and produced results that were consistent with those from earlier published studies. The BBCIC DRN is a potential resource for surveillance of biologics. DISCLOSURES: This study was funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC). HealthCore conducted this study in collaboration with Harvard Pilgrim Health Care. Zhang and Sridhar were employed by HealthCore at the time of this study. Haynes is employed by HealthCore funded by PCORI, the NIH, and the FDA. Barr and Eichelberger were employed by AMCP at the time of this study. Lockhart is employed by the BBCIC. Holmes and Clewell are employed by AbbVie. Accrott is an employee of and shareholder in Amgen. Marshall and Brown are employed by Harvard Pilgrim Health Care. Barr is a shareholder in Roche/Genentech. Curtis has received research grants from and consults with the following: Amgen, AbbVie, BMS, CORRONA, Lilly, Janssen, Myriad, Pfizer, Roche, Regeneron, and UCB. Brown has received research grants from GSK and Pfizer and consulting fees from Bayer, Roche, and Jazz Pharmaceuticals, along with funding from the Reagan-Udall Foundation for the FDA to conduct studies for medical product manufacturers, including Eli Lilly, Novartis, Abbvie, and Merck. Brown is also funded by PCORI, the NIH, and the FDA. McMahill-Walraven subcontracts with Harvard Pilgrim Health Care Institute for public health and safety surveillance distributed data network activtities and with the FDA, GSK, and Pfizer. She also reports fees from Reagan Udall Foundation for the FDA and the Patient Centered Outcomes Research Institute.

Capture of biologic and biosimilar dispensings in a consortium of U.S.-based claims databases: Utilization of national drug codes and Healthcare Common Procedure Coding System modifiers in medical claims.

PURPOSE: To assess the capture of biologics (originator and biosimilar) in the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (DRN), with a focus on medical claim National Drug Code (NDC), a new data field, and Healthcare Common Procedure Coding System (HCPCS) modifier. METHODS: We conducted a repeated cross-sectional study among patients with medical and pharmacy benefits enrolled in insurance plans participating in the BBCIC DRN between 1 January 2013 and 30 September 2017. We calculated the proportion of medical claims with ≥1 NDC and identified select biologics using four different approaches: (a) specific HCPCS alone, (b) specific HCPCS and NDC, (c) non-specific HCPCS with NDC, and (d) HCPCS with modifiers (applicable to biosimilars). Numbers of dispensings were calculated for each biologic by approach and select patient and claim characteristics. RESULTS: More than 1.5 million eligible participants contributed approximately 4 million person-years of data, including 1.2 billion medical claims. The proportion of medical claims with ≥1 NDC increased from 1.2% in 2013 to 3.0% in 2017. Medical claim NDCs identified 39% and 28% of vedolizumab dispensed in 2014 and 2015 and 30% of Epogen/Procrit dispensed overall. Out of 26,381 filgrastim biosimilar dispensings identified, 51% had a HCPCS modifier and 12% had a medical claim NDC for Zarxio. HCPCS modifiers and medical claim NDCs were present for 38% and 3% of all infliximab biosimilars dispensed (total n = 1,244). CONCLUSIONS: Medical claim NDC and HCPCS modifier improves identification of select biologics without product-specific HCPCS code, thereby facilitating product-specific biologic research.

Human Gingival Epithelial Growth In Vitro on a Polymer-Infiltrated Ceramic Network Restorative Material.

PURPOSE: To investigate the growth of primary human gingival epithelial (HGE) cells on polymer-infiltrated ceramic network (PICN) material (Vita Enamic) with different surface roughnesses. MATERIALS AND METHODS: PICN material specimens were polished with either silica carbide paper (grit-polished) or the manufacturer's polishing wheels (wheel-polished), and the surface roughness (Ra ) measured. HGE cells were seeded and grown for 1, 3, or 6 days. Growth on tissue culture plastic was used as a control. Non-linear regression analysis was used to examine the effect of surface roughness on cell growth. RESULTS: HGE cell growth on tissue culture plastic fitted an exponential growth model over the 6-day experimental period (R2 = 0.966). Through day 6, cell density on PICN decreased with increasing surface roughness, with a fit to an exponential decay model (R2 = 0.666). A threshold Ra value of 0.254 µm (95% CI 0.177-0.332) was determined as an upper limit for exponential growth. Cell growth was greatest on the group of specimens with Ra value below 0.127µm. Specimens polished by the manufacturer's method produced surface roughness of 0.118 µm and below. CONCLUSIONS: PICN material polished to a smooth surface (Ra < 0.254 µm) resulted in exponential growth of HGE cell growth compared to rough surfaces. Polishing PICN material as smooth as possible (below a Ra of 0.127 µm) was found to maximize epithelial cell growth on the PICN material surface. The manufacturer's polishing method achieved a sufficiently smooth surface. These results are contrary to previous research regarding surface roughness of transgingival implant restoration components. The study results suggest that smoother restorative material surfaces could improve peri-implant soft tissue health.

Prophylactic Total Gastrectomy for Hereditary Diffuse Gastric Cancer.

Germline mutations in the CDH1 gene that produces E-cadherin have been implicated in the development of early-onset diffuse gastric cancer, termed hereditary diffuse gastric cancer. The mean age of gastric cancer diagnosis in affected individuals is 37 years. By age 80, CDH1 mutation carriers who fulfill the clinical criteria for hereditary diffuse gastric cancer have an estimated lifetime risk of gastric cancer development of 67% for men and 83% for women. Data suggest that endoscopic surveillance for mutation carriers is largely ineffective. Prophylactic total gastrectomy between the ages of 18 and 40 years is recommended in carriers of germline-truncating E-cadherin mutations.

Digital capture, design, and manufacturing of an extraoral device for a clarinet player with Bell's palsy.

An extraoral device was fabricated to assist a clarinet player with Bell's palsy. The device was fabricated by using stereophotogrammetry, digital design, and additive manufacturing technologies.

Digital capture, design, and manufacturing of a facial prosthesis: Clinical report on a pediatric patient.

A digitally captured, designed, and fabricated facial prosthesis is presented as an alternative to customary maxillofacial prosthodontics fabrication techniques, where a facial moulage and patient cooperation may be difficult.

Testicular metastasis in a case of squamous cell carcinoma of the lung.

Testicular metastases are a rare finding. Typically, a testicular metastasis will present as a complication of progressive disease or as a primary sign of malignancy. Excluding lymphoma and leukemia, prostate cancer is the most common primary site that metastasizes to the testes. Testicular metastases resulting from squamous cell carcinoma of the lung have rarely been reported in previous literature. Here, we report a case of stage IV squamous cell carcinoma of the lung with metastases to the brain and multiple bilateral lung lesions. Following palliative systemic chemotherapy, this patient was found to have a right testicular mass. Pathology reports confirmed that this was a testicular metastasis of squamous cell lung carcinoma origin.

Rhabdomyolysis associated with parainfluenza virus.

Influenza virus is the most frequently reported viral cause of rhabdomyolysis. A 7-year-old child is presented with rhabdomyolysis associated with parainfluenza type 2 virus. Nine cases of rhabdomyolysis associated with parainfluenza virus have been reported. Complications may include electrolyte disturbances, acute renal failure, and compartment syndrome.

Advancing the scope of nursing practice: hepatic arterial catheter removal.

A delay in hepatic artery infusion catheter removal may prolong patient discomfort and lead to additional complications. As a result, this article evaluated the effectiveness of shifting the responsibility of catheter removal from advanced practice or medical staff to nurses. Overall, patients were satisfied, felt comfortable, and experienced minimal pain irrespective of whether their catheter was removed by a nurse, physician, or advanced practice staff. Nurses also were satisfied and felt they had enhanced their ability to provide quality patient care.