Analysis of Surface Characteristics of ProTaper Universal and ProTaper Next Instruments by Scanning Electron Microscopy.

BACKGROUND: Many new rotary files systems have been introduced, however, limited research has been conducted related to the surface irregularities of these files and if these have any effects on the files themselves. Hence, the aim of the present study was to analyze surface irregularities of the ProTaper® Universal rotary files (PTU) and the ProTaper Next™ rotary files (PTN) before and after instrumentation in curved canals. The main objective was to investigate the nature of these irregularities and how they might influence the use and fracture of rotary files during root-canal treatments. MATERIAL AND METHODS: The files were examined pre-operatively using a stereomicroscope and scanning electron microscopy(SEM) to analyze surface imperfections and the presence of particles. Mesial roots of forty extracted mandibular molars were selected. Each instrument was used to prepare one of the mesial canals. The files were then rinsed with alcohol, and autoclaved and analyzed again. RESULTS: Of the 80 files used in this study, five files fractured, five files unwound and seven files were curved or bent and they all belonged to the PTU group. Irregularities and debris could be visualized with the SEM on both unused PTU and PTN files. Most of the debris was found associated with deeper milling grooves and defects on the surface of the metal. Surface analysis of the files that were used and sterilized were performed and the SEM images demonstrated organic debris, metal flash, and crack formation and initiation of fractures for both file types. All files showed machining grooves, metal flash, debris, and defects on cutting edges. CONCLUSIONS: These irregularities appear to be critical in the accumulation of debris and initiation of fatigue and crack propagation within the NiTi alloy. The accumulation of debris could be a concern due to the potential exchange of organic debris between patients. Key words:ProTaper® Universal, ProTaper Next™, surface characteristics, SEM.

Palliative treatment of patients with inoperable locally advanced, recurrent or metastatic head and neck squamous cell cancer, using a low-dose and personalized chemotherapeutic regimen.

Inoperable or metastatic head and neck squamous cell cancer (HNSCC) is known to be associated with a poor patient prognosis. First line therapies include a Taxol, platinum-based antineoplastic and fluorouracil (FU) treatment regimen (TPF) or a platinum-based antineoplastic, FU and EGFR inhibitor treatment regimen (PFE). The toxicity of these regimens is one of the major limiting factors, particularly for palliative treatment. The present study is a retrospective study of 15 patients with HNSCC, where the treatment goal was palliative. Of the 15 patients, 8 received a TPF, while 7 received a PFE. A total of 129 treatment cycles were administered with a median of 9 cycles (range, 3-14). Chemotherapy began with low doses and was subsequently titrated up based on tolerance and response. Positive responses were noted with the lower doses compared with the conventional doses, and maximal doses were not required. The median dose of cisplatin, paclitaxel and 5-FU administered was 40 mg/m2, 80 mg/m2 and 360 mg/m2/day for 5 days, respectively. Cetuximab was used at a standard dose. At the initial follow-up (mean, 64 days; 3 cycles), a 100% disease control rate (DCR) and 80% overall response rate (ORR) was achieved. A positive response, 60% DCR and 60% ORR, was maintained until the late stages of the study (mean, 217 days; 9 cycles). Following termination of chemotherapy after >9 cycles, 4 patients remained disease free for ~1 year. A total of 3 patients exhibited a pathologic complete response despite radiologically exhibiting residual disease. The median progression-free survival time was 10.03 months and the overall survival time was 15.77 months. The only grade 3 hematologic toxicity noted was neutropenia in 3 (20%) patients. Grade 3 vomiting was noted in 1 (6.67%) patient and grade 3 stomatitis was noted in 1 (6.67%) patient. Due to low toxicity patients exhibited improved tolerance to this approach, particularly in terms of palliative care. Furthermore, these results are in contrast to the axiom that increased doses are more effective.

An alternative approach with a low dose and prolonged chemotherapy for palliative treatment of locally advanced, metastatic or recurrent squamous cell head and neck cancer

Background: It is expected that about 65,000 new patients will be diagnosed with head and neck cancer in 2017 in the United States. Patients with recurrent or advanced or metastatic head and neck do not have good survival due to aggressive and recurrent nature of this cancer. Moreover, cumulative and residual toxicities from previous and ongoing treatments significantly impede quality of remaining part of their life. Currently available chemotherapeutic regimens for this group are derived from the treatments used for the potentially curable disease. These regimens and associated toxicity are obviously not the best matches for the treatment with palliative intent. We here present a retrospective study where we used dose-adjusted chemotherapy specifically for palliative treatment this sub-group of head and neck cancer patients. Methods: Study population was identified from the University of Florida, and IRB approval was obtained. We used currently available and approved chemotherapeutic agents (including Taxols, Platins, 5-Fluorouracil and Epidermal Growth Factor Receptor inhibitors) for treatment of head and neck cancer but dose-adjusted at approximate 50% dose of currently recommended doses. We then gave personalized doses for a prolonged period by titrating doses based on response and tolerability of each patient. Data was collected for treatment, response, side effects, and outcomes. KM analysis was performed for survival data. Results: Total of 32 patients were included in this study with a median age of 65.2 years and a median follow-up of 10.1 months. 62.5% (n = 20) had locally advanced disease and rest had metastatic disease. 37.5% (n = 12) had new disease while rest had recurrent cancer. Of 32 patients, 14 patients received TPF based while 18 patients received PFE based chemotherapy. Total of 270 chemotherapy cycles were delivered among these 32 patients. They received a median of 9 cycles (range 3­14) over a median of 6.2 months (range 1.8­21.1). With this treatment approach, we noted median progression-free survival of 14.0 months and median overall survival of 15.7 months. Notable grade 3 toxicities were generalized fatigue in 12.5% (n = 4), nausea/vomiting in 6.3% (n = 2), diarrhea in in 6.3% (n = 2), mouth soreness in 6.3% (n = 2), rash in 3.1% (n = 1), neutropenia in 18% (n = 6) and anemia in 15.6% (n = 5) while notable grade 4 toxicities were neutropenia and anaphylaxis in 3.1% (n = 1) patient each (AU)

Challenges and opportunities in designing clinical trials for neuromyelitis optica.

Current management of neuromyelitis optica (NMO) is noncurative and only partially effective. Immunosuppressive or immunomodulatory agents are the mainstays of maintenance treatment. Safer, better-tolerated, and proven effective treatments are needed. The perceived rarity of NMO has impeded clinical trials for this disease. However, a diagnostic biomarker and recognition of a wider spectrum of NMO presentations has expanded the patient population from which study candidates might be recruited. Emerging insights into the pathogenesis of NMO have provided rationale for exploring new therapeutic targets. Academic, pharmaceutical, and regulatory communities are increasingly interested in meeting the unmet needs of patients with NMO. Clinical trials powered to yield unambiguous outcomes and designed to facilitate rapid evaluation of an expanding pipeline of experimental agents are needed. NMO-related disability occurs incrementally as a result of attacks; thus, limiting attack frequency and severity are critical treatment goals. Yet, the severity of NMO and perception that currently available agents are effective pose challenges to study design. We propose strategies for NMO clinical trials to evaluate agents targeting recovery from acute attacks and prevention of relapses, the 2 primary goals of NMO treatment. Aligning the interests of all stakeholders is an essential step to this end.

Occurrence of angiographic femoral artery complications after vascular closure with Mynx and AngioSeal.

INTRODUCTION: There have been recent reports of high vascular complication rates after the use of the Mynx vascular closure device (VCD). At our institution, vascular complications due to these devices have rarely been encountered. A study was undertaken to retrospectively compare angiographic abnormalities seen after femoral artery closure by both the Mynx and AngioSeal VCDs to provide further insight into the risks associated with VCDs. METHODS: All adult patients who underwent deployment of either a Mynx or AngioSeal VCD and subsequently underwent repeat angiography within the next 30 days between 1 July 2010 and 1 April 2011 were reviewed. Two independent blinded radiologists compared blinded pre-procedure and follow-up femoral angiograms for the presence of pseudoaneurysm or other vascular abnormality. Hospital records were reviewed for major or minor complications of the groin site or femoral artery. RESULTS: Thirty patients (31 angiograms) underwent vascular closure with a Mynx and 57 patients (69 angiograms) received an AngioSeal. The average time elapse until repeat femoral angiography was 6.2 days (range 1-21, median 5.5 days) in the Mynx group and 6.3 days (range 0-30, median 5 days) in the AngioSeal group. Two pseudoaneurysms and one minor stenosis were identified in the AngioSeal group. No angiographic abnormalities were seen in the Mynx group. No intraluminal filling defects were demonstrated on any of the follow-up femoral angiograms. One patient who received an AngioSeal developed a delayed minor groin site hematoma that did not require surgical intervention. CONCLUSIONS: Angiographic complications were seen in only 3% of patients after closure with Mynx or AngioSeal VCDs. There were no clinically significant groin site or vascular complications. These data suggest that both VCDs are safe for use after angiography with a low rate of femoral artery complications.

Epistaxis due to Wegener's granulomatosis in a pediatric patient.

Epistaxis is a common problem in children that typically is not severe and seldom requires hospitalization. The nose is a highly vascular structure with a large surface area; subsequently, it is highly predisposed to bleeding. Childhood vasculitides are very rare and are commonly diagnosed by characteristic lesions on imaging studies along with syndrome recognition by clinicians. We present a case of recurrent epistaxis that persisted over 3 months due to Wegener's granulomatosis in an adolescent that was misdiagnosed as a benign hemorrhage from Kiesselbach's plexus.