Discoloration after revascularization using calcium phosphosilicate-based bioceramic versus mineral trioxide aggregate in necrotic immature permanent anterior teeth: A Randomized clinical trial.

Aim: The aim of the current study is to evaluate the effect of calcium phophosilicate-based bioceramic "Totalfill bioceramic putty" and white mineral trioxide aggregate (WMTA) as the coronal plug on discoloration after revascularization of necrotic immature permanent anterior teeth. Materials and Methods: This study was conducted on (48) necrotic young permanent central incisors in children ranging from 8 to 14 years old, that were randomly allocated to either Totalfill bioceramic (Group I = 24) or WMTA (Group II = 24) as the coronal plug. Two visits revascularization protocol was adopted in this study using 1.5% sodium hypochlorite, followed by 17% ethylenediaminetetraacetic acid, and ending with a saline flush as irrigation solution. The double antibiotic paste was used as intracanal medication. The blood clot was used as scaffold followed by the application of collagen membrane followed by coronal plud malterial. Finally, the access was sealed using resin composite restoration and composite restoration. Clinical assessment was conducted at 1, 3, 6, 9, and 12 months, while radiographic assessment was conducted at 6 and 12 months. Data were statistically analyzed using the Chi-squared test for intergroup comparisons and Cochran's Q test for intragroup comparison. Results: Clinically, Group I exhibited a success rate of 100%, whereas Group II exhibited a success rate of 85.7%. Radiographically, both materials showed a 90.5% success rate. There was no statistically significant difference between both materials for all assessed clinical and radiographic parameters at different follow-up periods. Conclusions: Both Totalfill bioceramic putty and WMTA can be used successfully as coronal plug in esthetic areas.

Radioactivity levels, soil-to-grass and grass-to-milk transfer factor of natural radionuclides from grazing area in Erbil governorate, Iraq.

The levels of naturally occurring radionuclides in soil, grass, and milk were measured in this study in order to calculate the transfer factor of radionuclides from soil to grass and grass to milk obtained from Erbil governorate in Iraq. High efficiency gamma spectrometry used for the measurement. It has been determined that the mean activity concentrations of 232Th, 226Ra, and 40K are 3.08, 8.37, and 253 BqKg-1 in soil, 0.5, 0.39, and 203.05 BqKg-1, in grass, and 0.29, 0.084, and 29.69 BqL-1, in milk, respectively. For soil to grass, the transfer factor values for 232Th, 226Ra, and 40K were found to be 0.18, 0.052, and 0.84, respectively, for soil to grass. For grass to milk, the transfer factor values for 232Th, 226Ra, and 40K were found to be 0.45, 0.166, and 0.11 dayL-1, respectively. The average transfer factor for 232Th, 226Ra, and 40K in all samples were lower than the world average value.

Assessment of natural radionuclides in powder milk imported to Erbil Governorate, Kurdistan Region-Iraq.

In this study, the activity concentrations of 40K, 232Th, and 226Ra radionuclides were estimated in imported milk powder samples from 40 brands available in local markets in Erbil Governorate, Iraq. The measurements were performed using High Purity Germanium (HPGe) detector. The results indicated that the average activity concentrations of 40K, 232Th, and 226Ra were 241, 0.476, and 1.23 Bq kg-1, respectively, and comparisons were made based on the typical consumption characteristics of powdered milk by Kurdistan residents. In all investigated age groups (2-17 years), the average annual effective doses were below the ICRP-recommended limit of 1 mSv y-1 for public exposure. Radiological hazard parameters were determined based on the measured radioactivity concentrations. The relation between all the determined activities of natural radionuclides and radiological parameters was examined using multivariate statistical analysis techniques such as histograms, descriptive statistics, and Pearson correlation analyses. The cancer risk in all samples was lower than the allowable value of (2.5 × 10-3), while the ingestion dose in two samples was higher than the worldwide acceptable value of (0.29) mSv y-1.

Radiological health assessment of infant milk in Erbil Governorate, Iraq.

In this research, the radioactivity caused by natural radionuclides (40 K, 232Th, and 226Ra) was evaluated in infant milk consumed in Erbil, Iraq. The measurements were performed using an HPGe gamma-ray spectrometer. The variation of activity concentrations in milk samples was (99.56-256.9 Bq kg-1) for 40 K, (BDL-0.53 Bq kg-1) for 232Th, and (0.27-5.59 Bq kg-1) for 226Ra, as determined by the results. The radiological parameters of Eing, Dorg, and ELCR were calculated and compared to international standards. The correlation between computed radiological hazard parameters and natural radionuclides was analyzed statistically using Pearson's correlation. Overall, the results indicate that infant milk consumption in Erbil is radiologically safe and that consumers of these brands of milk are unlikely to be directly exposed to radiological health risks.

Assessment of mandibular osseous changes using radiomorphometric indices by cone beam computed tomography in patients with End-stage renal failure versus normal population (Observational Study).

Our study aimed to assess mandibular osseous changes using radiomorphometric indices by Cone-Beam Computed Tomography (CBCT) in patients with end-stage renal failure (ESRF) to evaluate their jaw bone quality versus a healthy sex- and age-matching population. Twenty-six patients were included in this study. They were divided equally into two groups. The first group (study group) included 13 ESRF patients and the second group (control group) included 13 patients free from any condition that could affect bone metabolism. All of the 26 participants were scanned using CBCT scanner then five indices were obtained from the reformatted panoramic images and the cross-sectional images of each mandible bilaterally mandibular cortical index (MCI), panoramic mandibular index (PMI), mental index (MI), gonial index (GI), and antegonial index (AI). There was no significant difference between MCI, MI, AI, GI and PMI of patients with ESRF and that of the control group. The assessment of intra-observer and inter-observer reliability regarding all measurements (GI, AGI, MI, and PMI) showed very strong agreement except MCI showed substantial agreement. Bone quality assessment of patients, investigated in the current study, with ESRF was not different from those of healthy sex- and age-matching dental patients using radiomorphometric indices. Quantitative radiomorphometric indices (MI, AI, GI, and PMI) are more reliable than qualitative radiomorphometric index (MCI) in the assessment of jawbones.

Measurement properties of the minimal disease activity criteria for psoriatic arthritis.

Objective: To comprehensively assess evidence on the measurement properties of the minimal disease activity (MDA) criteria, a composite measure of the state of disease activity in psoriatic arthritis (PsA). Methods: A targeted literature review was conducted to identify studies that informed the validity and/or ability of the MDA to detect change among patients known to have experienced a change in clinical status. The search was conducted using MEDLINE and Embase databases (published as of October 2017). Pertinent articles provided by investigators and identified from select conference proceedings were also evaluated. Results: A total of 20 publications met the inclusion criteria. The MDA criteria were consistently associated with other indicators of disease activity/severity. The ability of the MDA criteria to detect change was supported in randomised controlled trials (n=10), with a greater percentage of patients randomised to active treatments achieving MDA relative to patients in comparator arms. Long-term observational studies (n=2) provided additional support for the ability of the MDA to detect within-subject change in the real-world settings. Conclusion: Evidence supports the MDA as a valid measure of disease activity in PsA that can detect between-group and within-subject change. The MDA is a comprehensive measure and clinically meaningful endpoint to assess the impact of interventions on PsA disease activity.

Decreased Injection Site Pain Associated with Phosphate-Free Etanercept Formulation in Rheumatoid Arthritis or Psoriatic Arthritis Patients: A Randomized Controlled Trial.

INTRODUCTION: Etanercept, a tumor necrosis factor inhibitor, is used to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA), and is administered via subcutaneous injection. Injection site pain (ISP) associated with subcutaneous administration may affect compliance or hinder initiation of prescribed medications. To improve the patient experience, a new phosphate-free formulation of etanercept was evaluated for reduced ISP associated with administration. METHODS: This phase 3b, multicenter, randomized, double-blind, cross-over study compared the prior formulation of etanercept to a phosphate-free formulation. Etanercept-naïve adults with RA or PsA indicated for treatment with etanercept were eligible. Patients were randomized (1:1) to receive both etanercept formulations (50 mg) in one of two crossover sequences: prior formulation followed by phosphate-free formulation (sequence AB) or phosphate-free formulation followed by prior formulation (sequence BA) at visits 1 week apart. Patients self-reported ISP using a fit-for-purpose 100-mm visual analog scale within 30 s after injection. Safety outcomes included incidence of treatment-emergent adverse events. Mixed-effects analysis of variance model was used to assess ISP, with treatment, study period, sequence, and disease indication as fixed-effect covariates and patient-within-sequence as random effect. RESULTS: A total of 111 patients enrolled (56 sequence AB; 55 sequence BA). Mean ISP score for prior formulation was 23.1 mm and for phosphate-free formulation was 19.1 mm (mean difference - 4 mm; 95% confidence interval: - 8.0, 0.0; P = 0.048). Patients with the highest ISP scores from the prior formulation (by quartile cut points) had the largest reduction in pain with phosphate-free formulation. Injection site reactions were few in number and similar between formulations; no new safety signals were observed. CONCLUSIONS: The new phosphate-free formulation of etanercept had statistically significantly lower mean pain scores than the prior formulation, with largest pain reductions observed among patients who reported highest pain with the prior formulation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02986139. FUNDING: Amgen Inc, Thousand Oaks, CA USA.

Open-Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast.

INTRODUCTION: Response to etanercept therapy in patients who have failed apremilast therapy has not been well characterized. METHODS: In this multicenter, open-label, single-arm, phase 4, estimation study, subjects with moderate to severe plaque psoriasis received etanercept 50 mg SC twice weekly for 12 weeks, followed by etanercept 50 mg SC once weekly for an additional 12 weeks. Subjects had BSA greater than equal to 10%, PASI greater than equal to 10, and sPGA greater than equal to 3 at screening and baseline; and had failed apremilast-because of either failure to achieve or loss of adequate clinical response, or intolerability to apremilast in the opinion of the investigator. Primary endpoint was PASI 75 at week 12. Secondary endpoints included PASI 75 at week 24, PASI 90 at weeks 12 and 24, and patient-reported outcomes: Psoriasis Symptom Inventory (PSI) score (total and individual items) at baseline and weeks 12 and 24, and over time; DLQI responder analysis (5-point improvement in DLQI from baseline or score of 0) at weeks 12 and 24; and patient assessment of treatment satisfaction at baseline and weeks 12 and 24. RESULTS: Among 80 patients, PASI 75 at weeks 12 and 24 was 41.6% (95% CI, 30.4%-53.4%) and 45.5% (34.1%-57.1%), respectively; PASI 90 was 13.0% (6.4%-22.6%) and 22.1% (13.4%-33.0%), respectively. Mean total PSI score (LOCF) improved from 16.6 (95% CI, 15.1-18.0) at baseline to 8.8 (7.3-10.2) and 9.6 (7.9-11.4) at weeks 12 and 24, respectively; improvements in item PSI scores were similar. The percentage of DLQI responders was 66.2% (95% CI, 54.3%-76.8%) and 57.3% (45.4%-68.7%) at weeks 12 and 24, respectively. The percentage of subjects who were satisfied/very satisfied with their psoriasis treatment improved from 5.0% at baseline to 60.8% and 53.3% at weeks 12 and 24, respectively. During the 24-week study, 23.8% and 2.5% of subjects reported an adverse event and serious adverse event, respectively; there were no new safety signals in this study. DISCUSSION: In patients who have failed apremilast, etanercept may represent an effective therapeutic option. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02749370 J Drugs Dermatol. 2018;17(10):1078-1082.

Design and rationale of the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA).

OBJECTIVE: To evaluate the efficacy of etanercept and methotrexate as monotherapies and as combination therapy in subjects with active psoriatic arthritis (PsA). METHODS: The Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA) is an ongoing, global, double-blind, 48-week, randomised, controlled study. Subjects are randomised (1:1:1) to etanercept monotherapy, methotrexate monotherapy or etanercept-methotrexate combination therapy. Endpoints include rates of ACR20 response and Minimal Disease Activity, measures to characterise extra-articular manifestations (dactylitis, enthesitis, nail disease) and safety. CONCLUSION: SEAM-PsA will characterise the effects of etanercept with and without background methotrexate and methotrexate alone on PsA manifestations, and provide information of practical importance to clinicians on the optimal treatment of PsA.

A Randomized Trial Comparing Disease Activity Measures for the Assessment and Prediction of Response in Rheumatoid Arthritis Patients Initiating Certolizumab Pegol.

OBJECTIVE: The aim of the Patient/Physician Reported Efficacy Determination In Clinical Practice Trial (PREDICT; ClinicalTrials identifier NCT01255761) was to compare the patient-reported Routine Assessment of Patient Index Data 3 (RAPID-3) instrument with the investigator-based Clinical Disease Activity Index (CDAI) for assessing certolizumab pegol (CZP) treatment response in rheumatoid arthritis patients at 12 weeks and to predict the treatment response at week 52 using the data from week 12 (coprimary end points). METHODS: Patients received 400 mg of CZP at weeks 0, 2, and 4 (loading dose), followed by 200 mg every 2 weeks thereafter. Patients were randomized 1:1 to assessment with the RAPID-3 or the CDAI. Responder classification was performed at week 12; treatment response was defined as a score of ≤6 or a 20% improvement over baseline on the RAPID-3 or a score of ≤10 or a 20% improvement over baseline on the CDAI. Long-term treatment success was defined as a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) of ≤3.2 at week 52. Comparisons were made for the coprimary end points using noninferiority methods. Patients with improvement of <1 on the CDAI score or with no improvement on the RAPID-3 score at week 12 or patients with high levels of disease activity (CDAI score >22 or RAPID-3 score >12) at 2 consecutive visits were withdrawn from the study. RESULTS: Patients had longstanding disease (mean 8.9 years) and high levels of disease activity (mean scores of 6.3 on the DAS28-ESR, 16.1 on the RAPID-3, and 40.2 on the CDAI). Previous anti-tumor necrosis factor therapy had failed in 55.5% of them. At week 12, a total of 64.7% (by RAPID-3) and 76.4% (by CDAI) of the patients were classified as responders (difference of -11.9% [95% confidence interval -18.4%, -5.3%]). At week 52, a total of 31.5% (by RAPID-3) and 32.3% (by CDAI) of the responders achieved a low level of disease activity on the DAS28-ESR (difference of -1.3% [95% confidence interval -9.3%, 6.6%]). CONCLUSION: The CDAI classified more patients as CZP responders at week 12 than did the RAPID-3. Although these outcome measures were not statistically comparable, the positive predictive value for low disease activity at week 52 was similar. As these tools cover differing domains of therapy response, further evaluation for clinical disease activity assessments and treatment decisions is needed.

Treatment of pulmonary hemorrhage in childhood systemic lupus erythematosus with mycophenolate mofetil.

Systemic lupus erythematosus is a chronic autoimmune disease of unknown etiology with multisystem involvement. Pulmonary hemorrhage is a major life-threatening manifestation in children and adolescents with systemic lupus erythematosus, as well as in adults. Treatment has traditionally been with high-dose corticosteroids, with or without the addition of cytotoxic agents. We report the response of a patient with childhood systemic lupus erythematosus with recurrent pulmonary hemorrhage to treatment with mycophenolate mofetil.