Anti-infective therapy of peri-implantitis with adjunctive local drug delivery or photodynamic therapy: 12-month outcomes of a randomized controlled clinical trial

OBJECTIVE: The objective of the study is to compare the clinical, microbiological and host-derived effects in the non-surgical treatment of initial peri-implantitis with either adjunctive local drug delivery (LDD) or adjunctive photodynamic therapy (PDT) after 12 months. MATERIALS AND METHODS: Forty subjects with initial peri-implantitis, that is, pocket probing depths (PPD) 4-6 mm with bleeding on probing (BoP) and radiographic bone loss ≤2 mm, were randomly assigned to two treatment groups. All implants were mechanically debrided with titanium curettes and with a glycine-based powder airpolishing system. Implants in the test group (N = 20) received adjunctive PDT, whereas minocycline microspheres were locally delivered into the peri-implant pockets of control implants (N = 20). At sites with residual BoP, treatment was repeated after 3, 6, 9 and 12 months. The primary outcome variable was the change in the number of peri-implant sites with BoP. Secondary outcome variables included changes in PPD, clinical attachment level (CAL), mucosal recession (REC) and in bacterial counts and crevicular fluid (CF) levels of host-derived biomarkers. RESULTS: After 12 months, the number of BoP-positive sites decreased statistically significantly (P < 0.05) from baseline in both groups (PDT: 4.03 ± 1.66-1.74 ± 1.37, LDD: 4.41 ± 1.47-1.55 ± 1.26). A statistically significant (P < 0.05) decrease in PPD from baseline was observed at PDT-treated sites up to 9 months (4.19 ± 0.55 mm to 3.89 ± 0.68 mm) and up to 12 months at LDD-treated sites (4.39 ± 0.77 mm to 3.83 ± 0.85 mm). Counts of Porphyromonas gingivalis and Tannerella forsythia decreased statistically significantly (P < 0.05) from baseline to 6 months in the PDT and to 12 months in the LDD group, respectively. CF levels of IL-1β decreased statistically significantly (P < 0.05) from baseline to 12 months in both groups. No statistically significant differences (P > 0.05) were observed between groups after 12 months with respect to clinical, microbiological and host-derived parameters. CONCLUSIONS: Non-surgical mechanical debridement with adjunctive PDT was equally effective in the reduction of mucosal inflammation as with adjunctive delivery of minocycline microspheres up to 12 months. Adjunctive PDT may represent an alternative approach to LDD in the non-surgical treatment of initial peri-implantitis.

Atorvastatin added to interferon beta for relapsing multiple sclerosis: 12-month treatment extension of the randomized multicenter SWABIMS trial

BACKGROUND Statins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects. OBJECTIVES To report the 12-month extension of a phase II trial evaluating the efficacy, safety and tolerability of atorvastatin 40 mg/d added to interferon beta-1b (IFNB-1b) in relapsing-remitting multiple sclerosis (RRMS). METHODS In the randomized, multicenter, parallel-group, rater-blinded core study, 77 RRMS patients started IFNB-1b. At month three they were randomized 1∶1 to receive atorvastatin 40 mg/d or not in addition to IFNB-1b until month 15. In the subsequent extension study, patients continued with unchanged medication for another 12 months. Data at study end were compared to data at month three of the core study. RESULTS 27 of 72 patients that finished the core study entered the extension study. 45 patients were lost mainly due to a safety analysis during the core study including a recruitment stop for the extension study. The primary end point, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.926; 95% CI 0.265-14.0007; p = 0.51). All secondary endpoints including number of new lesions and total lesion volume on T2-weighted images, total number of Gd-enhancing lesions on T1-weighted images, volume of grey and white matter, EDSS, MSFC, relapse rate, number of relapse-free patients and neutralizing antibodies did not show significant differences either. The combination therapy was well tolerated. CONCLUSIONS Atorvastatin 40 mg/day in addition to IFNB-1b did not have any beneficial effects on RRMS compared to IFNB-1b monotherapy over a period of 24 months.

Urgent consultations at the dermatology department of Basel University Hospital, Switzerland: characterisation of patients and setting - a 12-month study with 2,222 patients data and review of the literature.

BACKGROUND Urgent consultations for skin disorders are commonly done in different settings. Scarce data exist about the characteristics of these patients. OBJECTIVE The aim of this study was to analyse specific characteristics of patients receiving an urgent consultation at a dermatology department in a university hospital. METHODS We prospectively recorded the data of all patients having had an urgent consultation during a period of 12 months. RESULTS We registered 2,222 urgent consultations. The most frequent diagnoses were eczemas (24.8%), dermatomycoses (5.1%) and dermatitis not otherwise specified (4.8%). The most frequent treatments were topical steroids, emollients, topical antibiotics, systemic antihistamines, antibiotics and virostatics. 2.2% of patients were hospitalized, 78.8% asked for a consultation for a disease lasting less than 4 weeks, and 6.9% presented the same day as the skin disease appeared. CONCLUSIONS This study shows the characteristics of patients receiving an urgent dermatologic consultation. It underlines the need for collaboration between dermatologists, other physicians, general practitioners and nurses.

Corneal cross-linking in keratoconus using the standard and rapid treatment protocol: differences in demarcation line and 12-month outcomes.

PURPOSE To compare the occurrence rate and depth of the demarcation line and topographical outcome after corneal cross-linking (CXL) for keratoconus using two different treatment protocols. METHODS A retrospective analysis of 131 eyes with progressive keratoconus treated with CXL using riboflavin and UV-A was performed. Eyes were treated either with the standard Dresden protocol (30 minutes irradiation, 3 mW/cm(2), UV-XTM 1000) or a rapid protocol (10 minutes irradiation, 9 mW/cm(2), UV-XTM 2000). The presence and depth of the corneal demarcation line was assessed with an anterior segment optical coherence tomography device 1 month after CXL by a masked observer. Corneal topography and tomography was performed at baseline and at 12-month follow-up with Pentacam and the TMS (Topographic Modeling System) device. RESULTS In the standard protocol group, 76.5% (62/81) of treated corneas revealed a demarcation line 1 month after CXL, whereas such a demarcation line was observed in only 22% (11/50) of eyes treated with the rapid protocol (P < 0.0001). The demarcation line was significantly more superficial in the rapid protocol group (P = 0.004). Corneal topography values between baseline and 12 months after CXL showed a mean change of -0.76 diopters (D) in Kmax (SD ± 2.7) in the standard protocol group versus a mean change of +0.72 D in Kmax (SD ± 1.5) in the rapid protocol (P = 0.007). CONCLUSIONS The rapid CXL protocol negatively influences the occurrence and depth of the demarcation line 1 month after CXL. Our results show a negative effect on the topographical outcome 1 year after CXL.

Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial.

BACKGROUND Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation. OBJECTIVES The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI). METHODS Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR. RESULTS Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080). CONCLUSIONS In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).

Renovascular hypertension in a 12 month old boy: what can the radiologist do?

We report a clinical case of renovascular disease, probably linked to fibromuscular dysplasia, in a 12 months old boy with severe arterial hypertension with target-organ damage, highlighting the radiological approach. Initial investigation included renal ultrasound that showed normal sized kidneys, with normal cortical echogenicity on the right and focally increased echogenicity of the posterior aspect of the left kidney, forming a mass-like lesion. Magnetic resonance imaging excluded renal tumor, which was confirmed by ultrasound guided biopsy. A doppler ultrasonography was also performed suggesting a right renal artery stenosis and decreased flow to the posterior aspect of the left kidney. Angiography with diagnostic and therapeutic intention was performed: right renal artery stenosis was detected and transluminal ballon dilation was performed; the left renal artery bifurcated precociously and the branch that irrigated the posterior part of the kidney had a stenosis which was also successfully dilated. After the intervention good blood pressure control with antihypertensive drugs was achieved, which was not possible before the angiographic procedure. The authors underline various methods of imaging used to accurately diagnose renovascular disease and the usefulness of interventional radiology treatment for this disease in very young children.

Short term rehabilitation (STR) study. Interim analysis of STR performance and effectiveness. 12-month analyses. Interim report.

National Highway Traffic Safety Administration, Office of Driver and Pedestrian Programs, Washington, D.C.

National high blood pressure 12-month kit.

"May 1988."

Lifetime prevalence estimates of major depression: An indirect estimation method and a quantification of recall bias

The measurement of lifetime prevalence of depression in cross-sectional surveys is biased by recall problems. We estimated it indirectly for two countries using modelling, and quantified the underestimation in the empirical estimate for one. A microsimulation model was used to generate population-based epidemiological measures of depression. We fitted the model to 1-and 12-month prevalence data from the Netherlands Mental Health Survey and Incidence Study (NEMESIS) and the Australian Adult Mental Health and Wellbeing Survey. The lowest proportion of cases ever having an episode in their life is 30% of men and 40% of women, for both countries. This corresponds to a lifetime prevalence of 20 and 30%, respectively, in a cross-sectional setting (aged 15-65). The NEMESIS data were 38% lower than these estimates. We conclude that modelling enabled us to estimate lifetime prevalence of depression indirectly. This method is useful in the absence of direct measurement, but also showed that direct estimates are underestimated by recall bias and by the cross-sectional setting.

Mother-Infant Reciprocity and the Development of Joint Attention in 12 Month Old Infants

Social contingency is the ability to connect social stimuli, such as those behaviors performed by oneself and those performed by others. Detecting social contingencies occurs by means of reciprocity through shared experiences with others. Reciprocity denotes a circumstance in which two individuals participate in a collaborative exchange, and is distinguished from an event in which two individuals engage in separate, unrelated activities. Specifically, reciprocity incorporates joint attention (JA), which occurs when two individuals simultaneously and visually attend to the same item. JA is facilitated by gazing and pointing, whereby one individual initiates the action and the second individual follows suit by, for example, gaze-following. However, little is known about the role the mother may play in the development of JA. The purpose of our study was to investigate social contingency between mothers and infants engaging in dyadic interactions. Thirty-three 12-month-old typically developing infants (M = 12.2, SD = .19; N = 19 males) were filmed for 10 minutes during free play with their mothers and toys provided by an experimenter. Reciprocity was measured by coding mother-infant interactions when a precise chain of events occurred: (1) mother initiated a bid by introducing a toy/activity or request to the infant, (2) infant accepted the bid/request by engaging in play with the given toy/activity, and (3) mother persisted by continuing to engage in play with said toy/activity. We computed a Pearson Correlation to assess the relation between the mothers’ initiations of JA and their infants’ responses to JA. We found a moderately positive correlation between the two variables (r= 0.37, p<.05). Our findings suggest that reciprocity, an important component of social relationships, during parent-infant dyads may serve as a scaffold for joint attention abilities, which have been linked to social and language development.