A new modification of the chiron ACS assay for total prostate-specific antigen achieves equimolar response characteristics and improves the detection of prostate cancer

Nonequimolar-response assays for prostate-specific antigen (PSA) are criticized for overestimating total PSA in some men without prostate cancer (PCA), and underestimating total PSA in some men with PCA. We recently studied three nonequimolar-response PSA assays that had undergone modifications. While two of the studied assays achieved equimolar-response characteristics with improved areas under receiver operating characteristic (ROC) curves (AUC), the modification of the Chiron ACS PSA assay (ACS PSA2, Chiron) failed to achieve this. Recently, the ACS assay underwent another modification (ACS PSA, Bayer), which we investigated. Sera from 305 men (155 without and 150 with PCA, PSA greater than or equal to2 and less than or equal to30 mug/l, TandemE) were measured using both modifications of the ACS assay and equimolar-response reference methods (TandemR free and Tandem E, Hybritech). Molar response relative to the reference method and clinical performance (comparison of AUCs) between the previous and new ACS assay modifications were studied. The new modification of the ACS assay (ACS PSA, Bayer) achieved equimolar-response characteristics but reported lower values (average 10%) than the Tandem E assay. Compared to the previous modification (ACS PSA2, Chiron), a 3% improvement in AUC (p=0.01) was found. Using results of the redesigned equimolar-response assay (ACS PSA, Bayer), we calculated that 6 of 155 men without PCA in this sample set could be spared unnecessary biopsy compared with the previous nonequimolar-response assay (ACS PSA2, Chiron) without missing additional PCA (90% sensitivity). These data provide additional evidence for clinical advantages of equimolar-response over nonequimolar-response PSA assay formats

The randomized shortened dental arch study (RaSDA): design and protocol

<p>Abstract</p> <p>Background</p> <p>Various treatment options for the prosthetic treatment of jaws where all molars are lost are under discussion. Besides the placement of implants, two main treatment types can be distinguished: replacement of the missing molars with removable dental prostheses and non-replacement of the molars, i.e. preservation of the shortened dental arch. Evidence is lacking regarding the long-term outcome and the clinical performance of these approaches. High treatment costs and the long time required for the treatment impede respective clinical trials.</p> <p>Methods/design</p> <p>This 14-center randomized controlled investigator-initiated trial is ongoing. Last patient out will be in 2010. Patients over 35 years of age with all molars missing in one jaw and with at least both canines and one premolar left on each side were eligible. One group received a treatment with removable dental prostheses for molar replacement (treatment A). The other group received a treatment limited to the replacement of all missing anterior and premolar teeth using fixed bridges (treatment B). A pilot trial with 32 patients was carried out. Two hundred and fifteen patients were enrolled in the main trial where 109 patients were randomized for treatment A and 106 for treatment B. The primary outcome measure is further tooth loss during the 5-year follow-up. The secondary outcome measures encompassed clinical, technical and subjective variables. The study is funded by the Deutsche Forschungsgemeinschaft (German Research Foundation, DFG WA 831/2-1, 2-2, 2-3, 2-4, 2-5).</p> <p>Discussion</p> <p>The particular value of this trial is the adaptation of common design components to the very specific features of complex dental prosthetic treatments. The pilot trial proved to be indispensable because it led to a number of adjustments in the study protocol that considerably improved the practicability. The expected results are of high clinical relevance and will show the efficacy of two common treatment approaches in terms of oral health. An array of secondary outcome measures will deliver valuable supplementary information. If the results can be implemented in the clinical practice, the daily dental care should strongly profit thereof.</p> <p>Trial registration</p> <p>The trial is registered at ClinicalTrials.gov under ISRCTN68590603 (pilot trial) and ISRCTN97265367 (main trial).</p

Subgingival plaque removal in buccal and lingual sites using a novel low abrasive air-polishing powder

Aim of the Study: This study was aimed at assessing the efficacy of subgingival plaque removal in buccal and lingual sites during supportive periodontal therapy (SPT) using a novel low abrasive air-polishing powder. Material and Methods: In 27 SPT patients, subgingival debridement was performed using the novel air-polishing powder (test) and hand instruments (positive control) in a randomized split mouth design. Before and immediately after treatment, subgingival plaque samples were taken from two teeth with pockets of 3-5 mm depth in both groups. To assess the influence of plaque sampling on the microflora, samples were also taken twice from two untreated teeth (negative control). The mean reduction in total colony forming units (CFU) was assessed by anaerobic culture. The patients' perception of treatment was assessed by a visual analog score (VAS). Therapy and plaque sampling were repeated after a 3-month interval. Results: Test treatment resulted in a significantly greater reduction in mean CFU than positive control treatment (log 1.7±0.98 and log 0.61±0.79 respectively; p<0.05). Following both treatments, the CFU reduction was significantly greater compared to negative control treatment (log 0.06±0.49; p<0.05). In addition, test treatment was perceived as significantly more pleasant than hand instrumentation (p<0.05). Conclusion: The novel low abrasive air-polishing powder is superior to curettes in removing subgingival plaque from pockets of 3-5 mm depth in supportive periodontal therapy and offers greater patient comfort.link_to_subscribed_fulltex

Assessment of root curvature and distance using computed tomography.

The safety and efficacy of subgingival root surface instrumentation may be enhanced by optimized adaptation between instrument and treated surface. Thus, detailed knowledge of root geometry may allow advances in instrument design. The aim of this study was therefore to measure root radii of various tooth types as well as distances between tooth roots using computed tomography. Two hundred sixteen teeth in eight patients were studied, with cross sections of teeth at the level of the cemento-enamel junction (CEJ) being regarded as ellipses. The maximum radii of ellipses were calculated and averaged for each tooth surface within various tooth groups. In addition, the spacing between roots at CEJ level and 5 mm below the CEJ was measured. Mean radii varied from 1.09+/-0.50 mm (lower incisor, lingual) to 13.7+/-0.96 mm (upper molar, mesial). Radii of 1 mm to 6 mm were most frequently found at buccal, palatal, and lingual surfaces, whereas the majority of radii were between 2 mm and 11 mm at mesial and distal sites. Root distance varied between 1.04+/-0.49 mm (lower incisors, CEJ level) and 2.81+/-1.70 mm (lower molars, 5 mm below CEJ). The curvature of an instrument for root surface instrumentation should correspond to a radius of at least 11 mm to achieve maximum adaptation to the treated surface, and the width of the working end should be less than 1 mm to allow sufficient interdental instrumentation.link_to_subscribed_fulltex

Microbiological shifts in intra- and extraoral habitats following mechanical periodontal therapy

Objectives: The aim of the present study was to analyze the intra- and extraoral colonization dynamics of periodontal pathogens following supra- and subgingival debridement. Material and Methods: Thirty five patients with chronic periodontitis were enrolled in the study. Supra- and subgingival plaque samples, saliva, and swab samples from mucosa and extraoral sites were taken at baseline and 6 weeks, 3 months and 6 months after mechanical periodontal therapy. Actinobacillus actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Eikenella corrodens (Ec), Tannerella forsythensis (Tf), Prevotella intermedia (Pi), Prevotella nigrescens (Pn), and Treponema denticola (Td) were identified by PCR. Results: Supra- and subgingival debridement decreased the number of subgingival sites infected with the analyzed pathogens only transiently, if at all. However, the detection frequencies of Tf, Td, Ec, Pi, and Pn in the supragingival region, of Pg, Td, and Pn at the oral mucosa sites (mostly the tongue), and of all pathogens except Aa in saliva increased over the 6-month observation period. Td was the only pathogen recorded in notable quantities in the extraoral habitat (external ear canal). Conclusion: The results indicate that supra- and subgingival debridement results in a dissemination of periodontal pathogens within the oral cavity. © Blackwell Munksgaard, 2004.link_to_subscribed_fulltex

Transjugular intrahepatic portosystemic shunt in the treatment of portal hypertension using memotherm stents: a prospective multicenter study.

PURPOSE: In a prospective multicenter study, efficacy and safety of transjugular intrahepatic portosystemic shunts (TIPS) were evaluated in the treatment of the complications of portal hypertension using a new self-expanding mesh-wire stent (Memotherm). METHODS: One hundred and eighty-one patients suffering from variceal bleeding (either acute or recurrent) or refractory ascites were enrolled. Postinterventional follow-up lasted for 8.4 months on average. Differences were analyzed by the log-rank test (chi-square) or Wilcoxon test. RESULTS: Shunt insertion was completed successfully in all patients (n = 181 patients, 100%). During follow-up, shunt occlusion was evident in 23 patients, and shunt stenosis was found in 33 patients (12.7% and 18.2%, respectively). Variceal rebleeding occurred in 20 of 139 patients (14.4%), with at least one episode of bleeding before TIPS treatment. The overall mortality rate of the patients treated by TIPS was 39.8%. In 51.4% of these cases (37 of 72 patients), however, the patients died within 30 days after TIPS placement. Analysis of subgroups showed that patients who underwent emergency TIPS for acute variceal bleeding had a significantly higher early mortality compared with other patient groups (p = 0.0014). CONCLUSION: In the present prospective multicenter study, we were able to show that insertion of Memotherm stents is an effective tool for TIPS. The occlusion rates seem to be comparable to those reported for the Palmaz stent. It could be shown that in particular, those patients who were treated for acute bleeding were at high risk of early mortality. Consequently, in such a critical condition, the indication for TIPS has to be set carefully

Patients with de novo acute myeloid leukaemia and complex karyotype aberrations show a poor prognosis despite intensive treatment: a study of 90 patients

The clinical significance of complex chromosome aberrations for adults with acute myeloid leukaemia (AML) was assessed in 920 patients with de novo AML who were karyotyped and treated within the German AML Cooperative Group (AMLCG) trials. Complex chromosome aberrations were defined as three or more numerical and/or structural chromosome aberrations excluding translocations t(8;21)(q22;q22), t(15;17)(q22;q11-q12) and inv(16)(p13q22). Complex chromosome anomalies were detected in 10% of all cases with a significantly higher incidence in patients greater than or equal to 60 years of age (17.8% vs. 7.8%, P < 0.0001). Clinical follow-up data were available for 90 patients. Forty-five patients were < 60 years of age and were randomly assigned to double induction therapy with either TAD-TAD [thioguanine, daunorubicin, cytosine arabinoside (AraC)] or TAD-HAM (high-dose AraC, mitoxantrone). Twenty-one patients achieved complete remission (CR) (47%), 20 patients (44%) were non-responders and 9% of patients died during aplasia (early death). The median overall survival (OS) was 7 months and the OS rate at 3 years was 12%. Patients receiving TAD-HAM showed a significantly higher CR rate than patients receiving TAD-TAD (56% vs. 23%, P = 0.04). Median event-free survival was less than 1 month in the TAD-TAD group and 2 months in the TAD-HAM group, respectively (P = 0.04), with a median OS of 4.5 months vs. 7.6 months (P = 0.13) and an OS after 3 years of 7.6% vs. 19.6%. Forty-five patients were greater than or equal to 60 years of age: 28 of these patient were treated for induction using one or two TAD courses and 17 cases received TAD-HAM with an age-adjusted reduction of the AraC dose. The CR rate was 44%, 38% were non-responders and 18% experienced early death. The median OS was 8 months and the OS rate at 3 years was 6%. In conclusion, complex chromosome aberrations in de novo AML predicted a dismal outcome, even when patients were treated with intensive chemotherapy. Patients under the age of 60 years with complex aberrant karyotypes may benefit from HAM treatment during induction. However, long-term survival rates are low and alternative treatment strategies for remission induction and consolidation are urgently needed