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OBJECTIVE AND AIM: Challenging defect configurations and dimensions arise from severe, localized vertical alveolar ridge defects caused by trauma or prior surgery. This study aims to analyze three-dimensional bone gain, assess marginal bone stability in such defect configurations, and evaluate the impact of grafting outside the bone contour on the overall outcome, with a focus on iliac crest block grafts as a valid treatment option. MATERIALS AND METHODS: The prospective cohort study evaluated patients who required vertical block grafting due to localized bone defects in the maxilla or mandible and who had received iliac grafts. Three-dimensional bone gain was analyzed using cone beam computed tomography (CBCT) after 3 months of bone healing for each treated site and implant position. A comparison between bone grafts inside and outside the bone contour was conducted. Marginal bone stability was measured using intraoral radiographs during routine annual follow-up visits. RESULTS: Seventy patients with 89 treated sites were evaluated. After 3 months of graft healing, the mean vertical bone gain was 11.03 ± 3.54 mm, the mean horizontal bone gain was 7.18 ± 2.00 mm, and the mean graft length was 28.19 ± 11.01 mm. A total of 217 implants were placed in the augmented regions. On implant level, a mean vertical bone gain of 10.44 ± 3.44 mm and a mean horizontal bone gain of 6.54 ± 1.86 mm were measured. Over a 43-month observation period, mesial and distal marginal bone loss averaged 0.44 ± 0.92 mm and 0.49 ± 1.05 mm, respectively. Eight implants were diagnosed with periimplantitis, resulting in the loss of four implants, while no early implant losses were reported. CONCLUSION: Within the limitations of this study, vertical bone grafts with iliac crest block grafts were found to be a dependable treatment option for dental implant placement, and placing block grafts outside the bone contour did not lead to inferior outcomes.
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BACKGROUND: For time-to-event endpoints, three additional benefit assessment methods have been developed aiming at an unbiased knowledge about the magnitude of clinical benefit of newly approved treatments. The American Society of Clinical Oncology (ASCO) defines a continuous score using the hazard ratio point estimate (HR-PE). The European Society for Medical Oncology (ESMO) and the German Institute for Quality and Efficiency in Health Care (IQWiG) developed methods with an ordinal outcome using lower and upper limits of the 95% HR confidence interval (HR-CI), respectively. We describe all three frameworks for additional benefit assessment aiming at a fair comparison across different stakeholders. Furthermore, we determine which ASCO score is consistent with which ESMO/IQWiG category. METHODS: In a comprehensive simulation study with different failure time distributions and treatment effects, we compare all methods using Spearman's correlation and descriptive measures. For determination of ASCO values consistent with categories of ESMO/IQWiG, maximizing weighted Cohen's Kappa approach was used. RESULTS: Our research depicts a high positive relationship between ASCO/IQWiG and a low positive relationship between ASCO/ESMO. An ASCO score smaller than 17, 17 to 20, 20 to 24, and greater than 24 corresponds to ESMO categories. Using ASCO values of 21 and 38 as cutoffs represents IQWiG categories. LIMITATIONS: We investigated the statistical aspects of the methods and hence implemented slightly reduced versions of all methods. CONCLUSIONS: IQWiG and ASCO are more conservative than ESMO, which often awards the maximal category independent of the true effect and is at risk of overcompensating with various failure time distributions. ASCO has similar characteristics as IQWiG. Delayed treatment effects and underpowered/overpowered studies influence all methods in some degree. Nevertheless, ESMO is the most liberal one. HIGHLIGHTS: For the additional benefit assessment, the American Society of Clinical Oncology (ASCO) uses the hazard ratio point estimate (HR-PE) for their continuous score. In contrast, the European Society for Medical Oncology (ESMO) and the German Institute for Quality and Efficiency in Health Care (IQWiG) use the lower and upper 95% HR confidence interval (HR-CI) to specific thresholds, respectively. ESMO generously assigns maximal scores, while IQWiG is more conservative.This research provides the first comparison between IQWiG and ASCO and describes all three frameworks for additional benefit assessment aiming for a fair comparison across different stakeholders. Furthermore, thresholds for ASCO consistent with ESMO and IQWiG categories are determined, enabling a comparison of the methods in practice in a fair manner.IQWiG and ASCO are the more conservative methods, while ESMO awards high percentages of maximal categories, especially with various failure time distributions. ASCO has similar characteristics as IQWiG. Delayed treatment effects and under/-overpowered studies influence all methods. Nevertheless, ESMO is the most liberal one. An ASCO score smaller than 17, 17 to 20, 20 to 24, and greater than 24 correspond to the categories of ESMO. Using ASCO values of 21 and 38 as cutoffs represents categories of IQWiG.
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Modelos de Riesgos Proporcionales , Humanos , Simulación por Computador , Intervalos de Confianza , Oncología Médica/métodos , Oncología Médica/normasRESUMEN
BACKGROUND: Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are common forms of analgesia after pancreatic surgery. Current guidelines recommend EDA over PCIA, and evidence suggests that EDA may improve long-term survival after surgery, especially in cancer patients. The aim of this study was to determine whether perioperative EDA is associated with an improved patient prognosis compared to PCIA in pancreatic surgery. METHODS: The PAKMAN trial was an adaptive, pragmatic, international, multicenter, randomized controlled superiority trial conducted from June 2015 to October 2017. Three to five years after index surgery a long-term follow-up was performed from October 2020 to April 2021. RESULTS: For long-term follow-up of survival, 109 patients with EDA were compared to 111 patients with PCIA after partial pancreatoduodenectomy (PD). Long-term follow-up of quality of life (QoL) and pain assessment was available for 40 patients with EDA and 45 patients with PCIA (questionnaire response rate: 94%). Survival analysis revealed that EDA, when compared to PCIA, was not associated with improved overall survival (OS, HR, 1.176, 95% HR-CI, 0.809-1.710, P = .397, n = 220). Likewise, recurrence-free survival did not differ between groups (HR, 1.116, 95% HR-CI, 0.817-1.664, P = .397, n = 220). OS subgroup analysis including only patients with malignancies showed no significant difference between EDA and PCIA (HR, 1.369, 95% HR-CI, 0.932-2.011, P = .109, n = 179). Similar long-term effects on QoL and pain severity were observed in both groups (EDA: n = 40, PCIA: n = 45). CONCLUSIONS: Results from this long-term follow-up of the PAKMAN randomized controlled trial do not support favoring EDA over PCIA in pancreatic surgery. Until further evidence is available, EDA and PCIA should be considered similar regarding long-term survival.
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OBJECTIVES: Shear wave elastography (SWE) is increasingly used in breast cancer diagnostics. However, large, prospective, multicenter data evaluating the reliability of SWE is missing. We evaluated the intra- and interobserver reliability of SWE in patients with breast lesions categorized as BIRADS 3 or 4. METHODS: We used data of 1288 women at 12 institutions in 7 countries with breast lesions categorized as BIRADS 3 to 4 who underwent conventional B-mode ultrasound and SWE. 1243 (96.5%) women had three repetitive conventional B-mode ultrasounds as well as SWE measurements performed by a board-certified senior physician. 375 of 1288 (29.1%) women received an additional ultrasound examination with B-mode and SWE by a second physician. Intraclass correlation coefficients (ICC) were calculated to examine intra- and interobserver reliability. RESULTS: ICC for intraobserver reliability showed an excellent correlation with ICC >0.9, while interobserver reliability was moderate with ICC of 0.7. There were no clinically significant differences in intraobserver reliability when SWE was performed in lesions categorized as BI-RADS 3 or 4 as well as in histopathologically benign or malignant lesions. CONCLUSION: Reliability of additional SWE was evaluated on a study cohort consisting of 1288 breast lesions categorized as BI-RADS 3 and 4. SWE shows an excellent intraobserver reliability and a moderate interobserver reliability in the evaluation of solid breast masses.
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Neoplasias de la Mama , Diagnóstico por Imagen de Elasticidad , Humanos , Femenino , Masculino , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/patología , Ultrasonografía Mamaria , Estudios Prospectivos , Reproducibilidad de los Resultados , Mama/diagnóstico por imagen , Mama/patología , Sensibilidad y Especificidad , Diagnóstico DiferencialRESUMEN
INTRODUCTION: Prosthodontic rehabilitation after reconstruction with microvascular revascularized free flaps following ablative tumor surgery is challenging due to the altered anatomical and functional conditions. The aim of this retrospective study was to determine whether the type of graft and the type of peri-implant tissue have an effect on peri-implant inflammatory parameters and implant survival. MATERIALS AND METHODS: Patients who received a free flap reconstruction with subsequent implant-prosthetic rehabilitation between 2010 and 2022 were retrospectively included. The primary outcome variable was the probing depth (PPD) at a minimum of 1 year after completion of prosthetic restoration. Predictive variables were type of free flap, emergence profile, and history of radiation. RESULTS: Seventy-one patients after free flap reconstruction were included in the analysis. At a minimum of 24 months after implant insertion the primary outcome, PPD showed no clinically relevant differences between the types of free flaps used. The emergence profile through a skin island resulted in an increase in BOP compared to native mucosa in the descriptive analysis (p-value > .05). The analysis showed a 5-year implant survival of 96.2% (95% CI: 0.929-0.996) in cases without irradiation and 87.6% (95% CI: 0.810-0.948) with irradiation of the region evaluated (p-value .034). CONCLUSION: Flap and associated soft tissue type had no significant effect on 5-year implant survival or peri-implant inflammatory parameters. However, the large heterogeneity of the patient population indicates that further prolonged studies are required for a more differentiated assessment of the long-term success.
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Implantes Dentales , Colgajos Tisulares Libres , Procedimientos de Cirugía Plástica , Humanos , Implantación Dental Endoósea/métodos , Implantes Dentales/efectos adversos , Estudios Retrospectivos , Colgajos Tisulares Libres/cirugíaRESUMEN
AIM: To assess the agreement rates of dental records derived from intraoral scan-based digital three-dimensional models (3DM) and 3DM + panoramic radiographs (3DM+PAN-X) compared to clinical findings. MATERIALS AND METHODS: Based on the 3DM/3DM+PAN-X of 50 patients undergoing supportive periodontal therapy (SPT), ten remote raters (inexperienced in using IOS or 3DM) assessed for each site of the dental scheme (32 sites) whether a tooth was missing (M), filled (F), restoration- and caries-free (H), replaced by an implant (I) or decayed (D). Remote records were compared to the clinical reference record of each patient at tooth-level. The clinical records were assessed by an experienced dentist who supplemented the clinical findings with information from available radiographs and the patient records to define the clinical reference record. RESULTS: The agreement-rates for 3DM/3DM+PAN-X at tooth-level are: M: 93%/94%, F: 84%/88%, H: 92%/92%, I: 65%/96%, D: 29%/29%. The overall agreement-rate is 88% for the 3DM-based dental records (14093 of 16000 entries true) and 91% for 3DM+PAN-X (14499 of 16000 entries true). Using 3DM for dental record assessment, posterior teeth had higher odds of correct findings compared to anterior teeth (upper jaw OR=2.34, lower jaw OR=1.27). CONCLUSIONS: The remote detection of healthy, missing and filled teeth and implants by raters inexperienced in using IOS or 3DM shows a high agreement-rate with the clinical findings. The additional evaluation of PAN-X increased the agreement-rate significantly for implants. Thus, the remote assessment of dental records using 3DM+PAN-X has a high accuracy when applied in SPT-patients with low caries activity.
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OBJECTIVE: To evaluate radiographic bone gain after alveolar ridge augmentation with two different designs of autogenous block graft harvested from the mandible. MATERIALS AND METHODS: Alveolar ridge defects were evaluated by preoperative cone beam computed tomography (CBCT) and grafted in a staged approach using intraoral block grafts. The ridge augmentation was either performed using the full-block technique (group 1) or the split-block technique (cortical plate with autogenous bone chips) (group 2). After 4 months of bone healing, a further CBCT scan was performed before implant placement. Horizontal and vertical bone gain were measured. RESULTS: In this retrospective study, 91 patients were grafted with block grafts (36 patients with full-block grafts; 55 patients with split-block grafts) resulting in 171 block grafts in total. The mean horizontal bone gain was 3.37 ± 0.71 mm in group 1 and 5.79 ± 2.20 mm in group 2. A linear mixed-effect model also showed a statistically significant group difference (p < 0.001, estimate: 3.455, 95% CI: [2.082-4.829]). The mean vertical bone gain was 2.85 ± 0.73 mm in group 1 and 7.60 ± 1.87 mm in group 2. A linear mixed-effect model also showed a statistically significant group difference (p: 0.029, estimate: 3.126, 95% CI: [0.718-5.557]). Mean marginal bone level was 0.33 ± 0.37 mm (group 1) and 0.17 ± 0.29 mm (group 2). CONCLUSION: The split-block technique resulted in a greater bone gain than the full-block technique. This effect was observed in both the vertical and the horizontal dimensions.
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Aumento de la Cresta Alveolar , Implantación Dental Endoósea , Humanos , Implantación Dental Endoósea/métodos , Estudios Retrospectivos , Proceso Alveolar/diagnóstico por imagen , Proceso Alveolar/cirugía , Aumento de la Cresta Alveolar/métodos , Tomografía Computarizada de Haz Cónico , Trasplante Óseo/métodosRESUMEN
BACKGROUND: Successful periodontal therapy can lead to poor esthetic results, especially in the anterior region, for which there are treatment options such as direct composite or indirect veneer restorations. Until now, there are no data describing the long-term results of veneer restorations in periodontally treated patients. The aim of this retrospective study was to evaluate the outcome of anterior porcelain veneer restorations in periodontally compromised and noncompromised patients. METHODS: Periodontally healthy and periodontally compromised patients, who had received anterior veneer restorations at least 5 years ago, were invited to a follow-up examination. Groups were divided according to their periodontal diagnosis (periodontally healthy, stage I/II, stage III/IV). Tooth loss, veneer loss, biologic parameters, and complication rates were examined. Also, veneers were evaluated according to modified United States Public Health Service criteria. RESULTS: A total of 68 patients with 312 veneers were examined with a mean follow-up time of 8 years. Veneered teeth in patients with periodontitis stage III/IV showed no difference regarding tooth-specific, overall, and functional veneer survival when compared to periodontally healthy patients (Kaplan-Meier analyses). In Cox regression analysis, follow-up time had an impact on complications and veneer loss, whereas periodontal diagnosis showed no significant influence on the survival of restorations. Comparative tests showed that patients with severe periodontitis at baseline have slightly lower veneer survival rates after 8 years and slightly higher complication rates after 13 years. CONCLUSION: Long-term results and complication rates of veneer restorations in periodontally compromised patients are comparable to periodontally healthy patients over a mean follow-up of 8 years.
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Porcelana Dental , Periodontitis , Estados Unidos , Humanos , Estudios Retrospectivos , Estética Dental , Cerámica , Periodontitis/complicaciones , Periodontitis/terapiaRESUMEN
OBJECTIVES: We evaluated whether lesion-to-fat ratio measured by shear wave elastography in patients with Breast Imaging Reporting and Data System (BI-RADS) 3 or 4 lesions has the potential to further refine the assessment of B-mode ultrasound alone in breast cancer diagnostics. METHODS: This was a secondary analysis of an international diagnostic multicenter trial (NCT02638935). Data from 1288 women with breast lesions categorized as BI-RADS 3 and 4a-c by conventional B-mode ultrasound were analyzed, whereby the focus was placed on differentiating lesions categorized as BI-RADS 3 and BI-RADS 4a. All women underwent shear wave elastography and histopathologic evaluation functioning as reference standard. Reduction of benign biopsies as well as the number of missed malignancies after reclassification using lesion-to-fat ratio measured by shear wave elastography were evaluated. RESULTS: Breast cancer was diagnosed in 368 (28.6%) of 1288 lesions. The assessment with conventional B-mode ultrasound resulted in 53.8% (495 of 1288) pathologically benign lesions categorized as BI-RADS 4 and therefore false positives as well as in 1.39% (6 of 431) undetected malignancies categorized as BI-RADS 3. Additional lesion-to-fat ratio in BI-RADS 4a lesions with a cutoff value of 1.85 resulted in 30.11% biopsies of benign lesions which correspond to a reduction of 44.04% of false positives. CONCLUSIONS: Adding lesion-to-fat ratio measured by shear wave elastography to conventional B-mode ultrasound in BI-RADS 4a breast lesions could help reduce the number of benign biopsies by 44.04%. At the same time, however, 1.98% of malignancies were missed, which would still be in line with American College of Radiology BI-RADS 3 definition of <2% of undetected malignancies.
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Neoplasias de la Mama , Diagnóstico por Imagen de Elasticidad , Humanos , Femenino , Sensibilidad y Especificidad , Diagnóstico por Imagen de Elasticidad/métodos , Ultrasonografía Mamaria/métodos , Reproducibilidad de los Resultados , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/patología , Biopsia , Elasticidad , Diagnóstico DiferencialRESUMEN
AIMS: To develop a German version of the Dental Environment Stress (DES) questionnaire, and to evaluate its reliability and validity. METHODS: The original English DES questionnaire was translated into German using a forward-backward translation process. To evaluate construct stability, a subgroup of dental students (n = 43) completed the DES twice (interval: 1 week). To evaluate how the DES responds to anticipated changes in stress, all dental students' (n = 64) DES scores and saliva cortisol levels administered from a clinical study were compared between holiday and term time. Furthermore, the Depression, Anxiety and Stress Scale (DASS) and a stress self-assessment were used to determine the validity of the DES. Reliability analyses were calculated using Kendall's tau correlations. To estimate reliability strength, correlation coefficients and intraclass correlations (ICCs) were used. RESULTS: Regarding construct stability, 24 of 25 DES items had at least moderate correlations, and most items showed strong correlations. Correlations for the seven subdomains were good (range: 0.778-1.000). The same was true for the total DES score (ICC: 0.944). Correlations for response to term-time stress were weaker and more varied. Validity analyses revealed fair correlations between the DES and students' self-assessment (Pearson's r = .592) and DASS score (Pearson's r = .392), suggesting satisfactory validity. Stress levels were quite similar between baseline and follow-up. CONCLUSION: The German DES is a reliable tool for evaluating stress in dental students. Because it can be used to identify individual stressors in various categories, it might enable the detection of specific stress situations in educational situations and facilitate solutions (adjustment of curricula, tailored consulting services).
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Educación en Odontología , Traducción , Humanos , Reproducibilidad de los Resultados , Curriculum , Encuestas y Cuestionarios , PsicometríaRESUMEN
PURPOSE: In this prospective, multicenter trial we evaluated whether additional shear wave elastography (SWE) for patients with BI-RADS 3 or 4 lesions on breast ultrasound could further refine the assessment with B-mode breast ultrasound for breast cancer diagnosis. MATERIALS AND METHODS: We analyzed prospective, multicenter, international data from 1288 women with breast lesions rated by conventional 2âD B-mode ultrasound as BI-RADS 3 to 4c and undergoing 2D-SWE. After reclassification with SWE the proportion of undetected malignancies should be <â2â%. All patients underwent histopathologic evaluation (reference standard). RESULTS: Histopathologic evaluation showed malignancy in 368 of 1288 lesions (28.6â%). The assessment with B-mode breast ultrasound resulted in 1.39â% (6 of 431) undetected malignancies (malignant lesions in BI-RADS 3) and 53.80â% (495 of 920) unnecessary biopsies (biopsies in benign lesions). Re-classifying BI-RADS 4a patients with a SWE cutoff of 2.55âm/s resulted in 1.98â% (11 of 556) undetected malignancies and a reduction of 24.24â% (375 vs. 495) of unnecessary biopsies. CONCLUSION: A SWE value below 2.55âm/s for BI-RADS 4a lesions could be used to downstage these lesions to follow-up, and therefore reduce the number of unnecessary biopsies by 24.24â%. However, this would come at the expense of some additionally missed cancers compared to B-mode breast ultrasound (rate of undetected malignancies 1.98â%, 11 of 556, versus 1.39â%, 6 of 431) which would, however, still be in line with the ACR BI-RADS 3 definition (<â2â% of undetected malignancies).
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Neoplasias de la Mama , Diagnóstico por Imagen de Elasticidad , Femenino , Humanos , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/patología , Diagnóstico por Imagen de Elasticidad/métodos , Estudios Prospectivos , Sensibilidad y Especificidad , Diagnóstico Diferencial , Reproducibilidad de los Resultados , Ultrasonografía Mamaria/métodos , BiopsiaRESUMEN
BACKGROUND: Acute aortic Stanford type A dissection remains a frequent and life-limiting event for patients with Marfan syndrome. Outcome results in this high-risk group are limited. METHODS: The German Registry for Acute Aortic Dissection Type A collected the data of 56 centers between July 2006 and June 2015. Of 3385 patients undergoing operations for acute aortic Stanford type A dissection, 117 (3.5%) were diagnosed with Marfan syndrome. We performed a propensity score match comparing patients with Marfan syndrome with patients without Marfan syndrome in a 1:2 fashion. RESULTS: Patients with Marfan syndrome were significantly younger (42.9 vs 62.2 years; P < .001), predominantly male (76.9% vs 62.9%; P = .002), and less catecholamine dependent (9.4% vs 20.3%; P = .002) compared with the unmatched cohort. They presented with aortic regurgitation (41.6% vs 23.0%; P < .001) and involvement of the supra-aortic vessels (50.4% vs 39.5%; P = .017) more often. Propensity matching revealed 82 patients with Marfan syndrome (21 female) with no significant differences in baseline characteristics compared with patients without Marfan syndrome (n = 159, 36 female; P = .607). Although root preservation was more frequent in patients with Marfan syndrome, procedure types did not differ significantly (18.3% vs 10.7%; P = .256). Aortic arch surgery was performed more frequently in matched patients (87.5% vs 97.8%; P = .014). Thirty-day mortality did not differ between patients with and without Marfan syndrome (19.5% vs 20.1%; P = .910). Multivariate regression showed no influence of Marfan syndrome on 30-day mortality (odds ratio, 0.928; 95% confidence interval, 0.346-2.332; P = .876). CONCLUSIONS: Marfan syndrome does not adversely affect 30-day outcomes after surgical repair for acute aortic Stanford type A dissection compared with a matched cohort. Long-term outcome analysis is needed to account for the influence of further downstream interventions.
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Disección Aórtica , Síndrome de Marfan , Humanos , Masculino , Femenino , Síndrome de Marfan/complicaciones , Síndrome de Marfan/diagnóstico , Resultado del Tratamiento , Estudios Retrospectivos , Aorta/cirugía , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/etiología , Disección Aórtica/cirugíaRESUMEN
INTRODUCTION: Donor-derived modified immune cells (MIC) induced long-term specific immunosuppression against the allogeneic donor in preclinical models of transplantation. In a phase I clinical trial (TOL-1 Study), MIC treatment resulted in a cellular phenotype that was directly and indirectly suppressive to the recipient's immune system allowing for reduction of conventional immunosuppressive therapy. Here, we describe a protocol for a randomised controlled, multicentre phase-IIb clinical trial of individualised immunosuppression with intravenously administered donor MIC compared with standard-of-care (SoC) in living donor kidney transplantation (TOL-2 Study). METHODS AND ANALYSIS: Sixty-three living donor kidney transplant recipients from six German transplant centres are randomised 2:1 to treatment with MIC (MIC group, N=42) or no treatment with MIC (control arm, N=21). MIC are manufactured from donor peripheral blood mononuclear cells under Good Manufacturing Practice conditions. The primary objective of this trial is to determine the efficacy of MIC treatment together with reduced conventional immunosuppressive therapy in terms of achieving an operational tolerance-like phenotype compared with SoC 12 months after MIC administration. Key secondary endpoints are the number of patient-relevant infections as well as a composite of biopsy-proven acute rejection, graft loss, graft dysfunction or death. Immunosuppressive therapy of MIC-treated patients is reduced during follow-up under an extended immunological monitoring including human leucocyte antigen-antibody testing, and determination of lymphocyte subsets, for example, regulatory B lymphocytes (Breg) and antidonor T cell response. A Data Safety Monitoring Board has been established to allow an independent assessment of safety and efficacy. ETHICS AND DISSEMINATION: Ethical approval has been provided by the Ethics Committee of the Medical Faculty of the University of Heidelberg, Heidelberg, Germany (AFmu-580/2021, 17 March 2022) and from the Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Institute, Langen, Germany (Vorlage-Nr. 4586/02, 21 March 2022). Written informed consent will be obtained from all patients and respective donors prior to enrolment in the study. The results from the TOL-2 Study will be published in peer-reviewed medical journals and will be presented at symposia and scientific meetings. TRIAL REGISTRATION NUMBER: NCT05365672.
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Trasplante de Riñón , Humanos , Trasplante de Riñón/efectos adversos , Donadores Vivos , Nivel de Atención , Leucocitos Mononucleares , Terapia de Inmunosupresión , Inmunosupresores/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto , Ensayos Clínicos Fase II como AsuntoRESUMEN
To investigate the predictability and the outcome of surface modification techniques, including anodization. Four surface modification techniques were evaluated in this in-vitro study: sandblasting (S), polishing+anodizing (PA), sandblasting+anodizing (SA), polishing+etching+ anodizing (PEA). Color coordinates L*, a* and b* were collected using a spectroradiometer. Color differences between all groups were quantified by use of ΔE00. A possible influence of group membership was evaluated using 1-way ANOVA. Pair-wise inter-group comparisons were performed using post-hoc Tukey tests. PA specimens were the brightest and showed a pronounced yellowish and reddish hue. S and SA groups were significantly darker and predictability of outcome was higher compared to another groups. The most predictable surface treatment method is sandblasting. Anodizing techniques come along with the brightest and most chromatic color impression of the titanium.
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Titanio , Oxidación-ReducciónRESUMEN
PURPOSE: To evaluate the long-term clinical quality of subgingivally placed composite resin restorations and the inflammatory status of surrounding supracrestal gingival and periodontal tissues. MATERIALS AND METHODS: Patients with at least one subgingival restoration with deep-margin elevation placed between 2010 and 2020 at Heidelberg University Hospital and Tübingen University Hospital were identified. A sound tooth was used as control. Intraoral examination including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival bleeding index (GBI), and plaque control record (PCR) was conducted. The clinical quality of the restorations was evaluated using the modified FDI criteria. For comparison between control and test teeth, a logistic mixed-effects model was used for GBI, PCR, and BOP, while a linear mixed-effects model was used for CAL. Multivariable linear and logistic regressions were used to examine the influence of smoking, age of restoration, number of decayed, missing and filled teeth, use of interdental brushes, and CAL. RESULTS: Sixty-three patients were included in the study. The mean age of the restorations was 2.70 ± 1.90 years. There were no significant differences between test and control teeth with respect to inflammatory parameters BOP, GBI, and PCR. CAL was significantly higher in test teeth than in controls (p = 0.027). The regression models revealed that CAL has a significant influence on GBI (p = 0.008) and BOP (p < 0.001). A significantly increased GBI occurred especially on test teeth in patients who did not use interdental brushes daily (p = 0.010). The clinical quality of restorations was rated excellent or good in 70%, an no restoration was rated unacceptable. CONCLUSION: No increased inflammation was observed on sites with subgingivally placed composite restorations over an observation period of approximately 3 years. Regular interdental brush use was associated with less gingival inflammation.
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Resinas Compuestas , Placa Dental , Preescolar , Placa Dental/etiología , Restauración Dental Permanente/métodos , Humanos , Lactante , Inflamación/etiología , Estudios RetrospectivosRESUMEN
OBJECTIVES: After a successful Marketing Authorization Application for clinical trials with time-to-event endpoints, the degree of the added benefit from new treatments remains unknown and needs to be assessed. Unfortunately, until now no clear definition for added benefit determination of a treatment exists. Nevertheless, European authorities / societies have developed 2 "additional benefit assessment" methods, which have up to now not been compared: the European Society for Medical Oncology (ESMO) developed a dual rule considering relative and absolute benefit. The German Institute for Quality and Efficiency in Health Care (IQWiG) developed a method using upper 95% hazard ratio confidence interval. METHODS: We evaluate and compare both methods in an extensive simulation study including different censoring rates, failure time distributions, and treatment effects for sample size calculation. The methods' performance is assessed via Receiver Operating Characteristic curves, Spearman correlation, and percentage of achieved maximal scores. RESULTS: The results show that IQWiG's method has in many situations a lower maximal scoring proportion than ESMO's rule, that is, up to 28.5% versus 94.7%. Various failure time distributions lead to strongly changed maximal scoring percentages for ESMO. High positive correlation between the methods is present for moderate treatment effects. CONCLUSIONS: IQWiG's method is usually more conservative than ESMO's. ESMO's rule tends to be more susceptible for various failure time distributions. Using the lower confidence interval limit seems to be a better solution resulting in a higher true-positive rate without increasing the false-positive rate. Thus, IQWiG's method might need to be adapted accordingly to achieve a better overall classification.
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OBJECTIVES: This comparative study aimed to evaluate intraoral digital photography (IODP) as assessment-tool for DMFT and number of implants (IMPL) compared to clinical diagnosis (CLIN) in an elderly population with high restorative status. Secondary research questions were whether an additional evaluation of panoramic radiographs (PAN-X) or raters' clinical experience influence the agreement. METHODS: Fifty patients (70.98±7.60 years) were enrolled for standardized CLIN and IODP. The clinical reference examiner and ten blinded raters evaluated the photographs without and with a PAN-X regarding DMFT and IMPL. CLIN were used as reference standard and differences to IODP and IODP-PAN-X findings were analysed descriptively. To assess intra-rater agreement, pairwise Gwet's AC1s of the three diagnostic methods CLIN, IODP and IODP+PAN-X were calculated. RESULTS: Compared to a DMFT of 22.10±3.75 (CLIN), blinded raters evaluated a DMFT of 21.54±3.40 (IODP) and 22.12±3.45 (IODP+PAN-X). Mean values for "Decayed" were 0.18±0.52 (CLIN), 0.45±0.46 (IODP) and 0.48±0.47 (IODP-PAN-X), while 11.02±5.97 (CLIN), 10.66±5.78 (IODP) and 10.93±5.91 (IODP+PAN-X) were determined for "Missing" and 10.90±5.61 (CLIN), 10.43±4.85 (IODP) and 10.71±5.11 (IODP+PAN-X) for "Filled". IMPL were 0.78±2.04 (CLIN), 0.58±1.43 (IODP), 0.78±2.04 (IODP+PAN-X). Gwet's AC1 using the mode of the blinded raters' assessment of "Decayed", "Missing" and IMPL compared to CLIN ranged from 0.81 to 0.89 (IODP) and 0.87 to 1.00 (IODP+PAN-X), while for "Filled" and DMFT they were 0.29 and 0.36 (IODP) as well as 0.33 and 0.36 (IODP+PAN-X), respectively. Clinical experience did not influence the agreement. CONCLUSIONS: Assessment of "Decayed", "Missing" and IMPL by IODP showed almost perfect agreement, whereas of "Filled" and DMFT revealed fair to moderate agreement with clinical findings. Additional PAN-X-evaluation increased agreement compared to IODP-diagnostics alone. IODP for the assessment of DMFT and IMPL might be a suitable method in large-scale epidemiological studies, considering high agreement in total values and miscellaneous agreement at patient-level.
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Fotografía Dental , Fotograbar , Anciano , Humanos , Prótesis e ImplantesRESUMEN
OBJECTIVES: Surgery of the aortic root in acute aortic dissection type A (AADA) remains a topic of vague evidence since the extend of dissection and surgeons' capability and interpretation of the disease vary remarkably. We aimed to interpret root operation strategies in the German Registry for Acute Aortic Dissection cohort. METHODS: German Registry for Acute Aortic Dissection collected the data of 56 centres between July 2006 and June 2015. A total of 3382 patients undergoing operations for AADA were included and divided into 3 groups according to aortic root procedure types: supracommissural replacement (SCR), conduit replacement (CR) and valve sparing root replacement (VSRR). RESULTS: Patients in SCR (2425, 71.7%) were significantly older than CR (681, 20.1%) and VSRR (276, 8.2%) (63.4 vs 57.5 vs 54.2 years; P < 0.001), more female (38.9% vs 32.0% vs 26.1%; P < 0.001) and presented with less aortic regurgitation (26.3% vs 57.1% vs 56.5%; P < 0.001). VSRR presented with slightly less multiple organ malperfusion (11.6% vs 12.0% vs 10.9%; P = 0.045) and were more often diagnosed for Marfan syndrome (2.4% vs 5.1% vs 9.1%; P < 0.001). Thirty-day mortality was lower for VSRR (11.6%) compared to SCR (16.1%) and CR (19.8%; P = 0.010). Despite longer procedural times, multivariable regression showed no influence of total arch replacement for VSRR on mortality compared to CR (odds ratio 0.264; 95% confidence interval, 0.033-2.117; P = 0.21). CONCLUSIONS: SCR remains the procedure of choice in elderly and compromised patients. Extended root preservation techniques may be applied even in combination with extended aortic arch surgery for selected patients for AADA with promising early outcomes.
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OBJECTIVES: Surgery of the aortic root in acute aortic dissection type A (AADA) remains a topic of vague evidence since the extend of dissection and surgeons' capability and interpretation of the disease vary remarkably. We aimed to interpret root operation strategies in the German Registry for Acute Aortic Dissection (GERAADA) cohort. PATIENTS AND METHODS: GERAADA collected the data of 56 centers between July 2006 and June 2015. A total of 3382 patients undergoing operations for AADA were included and divided into three groups according to aortic root procedure types: supracommissural replacement (SCR), conduit replacement (CR) and valve sparing root replacement (VSRR). RESULTS: Patients in SCR (2425, 71.7%) were significantly older than CR (681, 20.1%) and VSRR (276, 8.2%) (63.4 vs 57.5 vs 54.2 yrs; p < 0.001), more female (38.9 vs 32.0 vs 26.1%; p < 0.001) and presented with less aortic regurgitation (26.3 vs 57.1 vs 56.5%; p < 0.001). VSRR presented with slightly less multiple organ malperfusion (11.6 vs 12.0 vs 10.9%; p = 0.045) and were more often diagnosed for Marfan syndrome (2.4 vs 5.1 vs 9.1%; p < 0.001). Thirty-day mortality was lower for VSRR (11.6%) compared to SCR (16.1%) and CR (19.8%; p = 0.010). Despite longer procedural times multivariable regression showed no influence of total arch replacement for VSRR on mortality compared to CR (OR 0.264; 95% CI, 0.033-2.117; p = 0.21). CONCLUSIONS: SCR remains the procedure of choice in elderly and compromised patients. Extended root preservation techniques may be applied even in combination with extended aortic arch surgery for selected patients for AADA with promising early outcomes.
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The objective of this study was to investigate oral health-related quality of life (OHRQoL) in times of the COVID-19 pandemic and to examine a possible association to psychosocial factors like psychological stress and symptoms of depression and anxiety disorders. Secondary research questions were whether people changed oral hygiene regimens during the COVID-19 pandemic and to what extent dental symptoms existed and developed compared to pre-pandemic. For this cross-sectional study a survey has been conceptualized to determine OHRQoL, stress, depression and anxiety and their specific confounders in a German cohort. Validated questionnaires as OHIP-G14, PHQ-Stress and PHQ-4 have been implemented. Altogether 1178 participants completed the survey between May and August 2020. The overall OHIP-G14 sum score of 4.8 ± 7.5 indicated good OHRQoL. 21% of the participants (n = 248) reported toothache, 23% (n = 270) mucosal problems, 31% (n = 356) hypersensitivity of the teeth and 27% (n = 305) myofacial pain. The PHQ-Stress score (4.5 ± 3.5) demonstrated a mild severity of stress. Depression and anxiety level has been mild to moderate (PHQ-4 score: 2.4 ± 2.6). 38% of the participants stated subjectively greater emotional burden compared to pre-pandemic. Statistically significant differences exist for OHRQoL, stress, anxiety and depression levels between participants with greater, equal or less emotional burden compared to pre-pandemic. COVID-19 history and aggravated levels of depression, anxiety, and stress seem to associate with lower OHRQoL. Psychosocial consequences during pandemic times and their association to oral health should be further investigated.