Single-Center Experience on the Elective Hybrid Combination of Single Perclose + Angio-Seal VIP 8F Compared With Standard Dual Perclose During Percutaneous Endovascular Aortic Aneurysm Repair.

PURPOSE: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis. RESULTS: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days. CONCLUSIONS: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions. CLINICAL IMPACT: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure.

GeMI: interactive interface for transformer-based Genomic Metadata Integration.

The Gene Expression Omnibus (GEO) is a public archive containing >4 million digital samples from functional genomics experiments collected over almost two decades. The accompanying metadata describing the experiments suffer from redundancy, inconsistency and incompleteness due to the prevalence of free text and the lack of well-defined data formats and their validation. To remedy this situation, we created Genomic Metadata Integration (GeMI; http://gmql.eu/gemi/), a web application that learns to automatically extract structured metadata (in the form of key-value pairs) from the plain text descriptions of GEO experiments. The extracted information can then be indexed for structured search and used for various downstream data mining activities. GeMI works in continuous interaction with its users. The natural language processing transformer-based model at the core of our system is a fine-tuned version of the Generative Pre-trained Transformer 2 (GPT2) model that is able to learn continuously from the feedback of the users thanks to an active learning framework designed for the purpose. As a part of such a framework, a machine learning interpretation mechanism (that exploits saliency maps) allows the users to understand easily and quickly whether the predictions of the model are correct and improves the overall usability. GeMI's ability to extract attributes not explicitly mentioned (such as sex, tissue type, cell type, ethnicity and disease) allows researchers to perform specific queries and classification of experiments, which was previously possible only after spending time and resources with tedious manual annotation. The usefulness of GeMI is demonstrated on practical research use cases. Database URL http://gmql.eu/gemi/.

Accurate and highly interpretable prediction of gene expression from histone modifications.

BACKGROUND: Histone Mark Modifications (HMs) are crucial actors in gene regulation, as they actively remodel chromatin to modulate transcriptional activity: aberrant combinatorial patterns of HMs have been connected with several diseases, including cancer. HMs are, however, reversible modifications: understanding their role in disease would allow the design of 'epigenetic drugs' for specific, non-invasive treatments. Standard statistical techniques were not entirely successful in extracting representative features from raw HM signals over gene locations. On the other hand, deep learning approaches allow for effective automatic feature extraction, but at the expense of model interpretation. RESULTS: Here, we propose ShallowChrome, a novel computational pipeline to model transcriptional regulation via HMs in both an accurate and interpretable way. We attain state-of-the-art results on the binary classification of gene transcriptional states over 56 cell-types from the REMC database, largely outperforming recent deep learning approaches. We interpret our models by extracting insightful gene-specific regulative patterns, and we analyse them for the specific case of the PAX5 gene over three differentiated blood cell lines. Finally, we compare the patterns we obtained with the characteristic emission patterns of ChromHMM, and show that ShallowChrome is able to coherently rank groups of chromatin states w.r.t. their transcriptional activity. CONCLUSIONS: In this work we demonstrate that it is possible to model HM-modulated gene expression regulation in a highly accurate, yet interpretable way. Our feature extraction algorithm leverages on data downstream the identification of enriched regions to retrieve gene-wise, statistically significant and dynamically located features for each HM. These features are highly predictive of gene transcriptional state, and allow for accurate modeling by computationally efficient logistic regression models. These models allow a direct inspection and a rigorous interpretation, helping to formulate quantifiable hypotheses.

Identification, semantic annotation and comparison of combinations of functional elements in multiple biological conditions.

MOTIVATION: Approaches such as chromatin immunoprecipitation followed by sequencing (ChIP-seq) represent the standard for the identification of binding sites of DNA-associated proteins, including transcription factors and histone marks. Public repositories of omics data contain a huge number of experimental ChIP-seq data, but their reuse and integrative analysis across multiple conditions remain a daunting task. RESULTS: We present the Combinatorial and Semantic Analysis of Functional Elements (CombSAFE), an efficient computational method able to integrate and take advantage of the valuable and numerous, but heterogeneous, ChIP-seq data publicly available in big data repositories. Leveraging natural language processing techniques, it integrates omics data samples with semantic annotations from selected biomedical ontologies; then, using hidden Markov models, it identifies combinations of static and dynamic functional elements throughout the genome for the corresponding samples. CombSAFE allows analyzing the whole genome, by clustering patterns of regions with similar functional elements and through enrichment analyses to discover ontological terms significantly associated with them. Moreover, it allows comparing functional states of a specific genomic region to analyze their different behavior throughout the various semantic annotations. Such findings can provide novel insights by identifying unexpected combinations of functional elements in different biological conditions. AVAILABILITY AND IMPLEMENTATION: The Python implementation of the CombSAFE pipeline is freely available for non-commercial use at: https://github.com/DEIB-GECO/CombSAFE. SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.

SMfinder: Small Molecules Finder for Metabolomics and Lipidomics Analysis.

Metabolomics and lipidomics studies are becoming increasingly popular but available tools for automated data analysis are still limited. The major issue in untargeted metabolomics is linked to the lack of efficient ranking methods allowing accurate identification of metabolites. Herein, we provide a user-friendly open-source software, named SMfinder, for the robust identification and quantification of small molecules. The software introduces an MS2 false discovery rate approach, which is based on single spectral permutation and increases identification accuracy. SMfinder can be efficiently applied to shotgun and targeted analysis in metabolomics and lipidomics without requiring extensive in-house acquisition of standards as it provides accurate identification by using available MS2 libraries in instrument independent manner. The software, downloadable at www.ifom.eu/SMfinder, is suitable for untargeted, targeted, and flux analysis.

Large-Scale Transdisciplinary Collaboration for Adaptation Research: Challenges and Insights.

An increasing number of research programs seek to support adaptation to climate change through the engagement of large-scale transdisciplinary networks that span countries and continents. While transdisciplinary research processes have been a topic of reflection, practice, and refinement for some time, these trends now mean that the global change research community needs to reflect and learn how to pursue collaborative research on a large scale. This paper shares insights from a seven-year climate change adaptation research program that supports collaboration between more than 450 researchers and practitioners across four consortia and 17 countries. The experience confirms the importance of attention to careful design for transdisciplinary collaboration, but also highlights that this alone is not enough. The success of well-designed transdisciplinary research processes is also strongly influenced by relational and systemic features of collaborative relationships. Relational features include interpersonal trust, mutual respect, and leadership styles, while systemic features include legal partnership agreements, power asymmetries between partners, and institutional values and cultures. In the new arena of large-scale collaborative science efforts, enablers of transdisciplinary collaboration include dedicated project coordinators, leaders at multiple levels, and the availability of small amounts of flexible funds to enable nimble responses to opportunities and unexpected collaborations.

Immediate loading of two (fixed-on-2) vs four (fixed-on-4) implants placed with a flapless technique supporting mandibular cross-arch fixed prostheses: 3-year results from a pilot randomised controlled trial.

PURPOSE: To evaluate the outcome of two vs four implants placed flapless in fully edentulous mandibles and immediately restored with metal-resin screw-retained cross-arch prostheses. MATERIALS AND METHODS: A total of 60 patients from two different centres were randomised: 30 to the fixed-on-2 group and 30 to the fixed-on-4 group according to a parallel group design. To be immediately loaded implants had to be inserted with a minimum torque of 40 Newton/cm (Ncm). Outcome measures were prosthesis and implant failures, complications, and marginal bone level changes. RESULTS: Flaps were raised in 18 patients. Two implants in two patients did not reach the planned insertion torque and were replaced immediately by larger diameter ones. Three years after loading, two patients dropped out from the fixed-on-2 group and one from the fixed-on-4 group. No implant failure or prosthetic failure occurred. A total of 12 fixed-on-2 patients were affected by one complication each vs 13 fixed-on-4 patients. There were no statistically significant differences for complications between groups (difference in proportion = -0.03; 95% CI -29 to 0.22; P [Fisher's exact test] =1.000). There were no statistically significant differences for marginal peri-implant bone loss between the two groups (mean difference = 0.14; CI 95% -0.17 to 0.45; P [ANCOVA] = 0.356), with both groups losing marginal bone in a statistically significant way (1.70 mm for fixed-on-2 implants and 1.56 mm for fixed-on-4 implants). There were statistically significant differences between the two centres, with more bone being lost for the Bologna centre (2.18 vs 1.13 mm; P (ANCOVA) < 0.001). CONCLUSIONS: Up to 3 years after loading, these preliminary results suggest that immediately loaded mandibular cross-arch fixed prostheses can be supported by only two dental implants. Longer follow-ups (about 10 years) are needed to properly evaluate this therapeutic option. Conflict of interest statement: This study was completely self-financed and no funding from the implant manufacturers has been sought or obtained, not even in the form of free materials.

Immediate loading of two (fixed-on-2) versus three (fixed-on-3) implants placed flapless supporting cross-arch fixed prostheses: One-year results from a randomised controlled trial.

PURPOSE: To evaluate the outcome of two (fixed-on-2 = FO2) versus three (fixed-on-3 = FO3) implants placed flapless in fully edentulous jaws and immediately restored with metal-resin screw-retained crossarch prostheses. MATERIALS AND METHODS: Forty edentulous or to be rendered edentulous patients (20 in the maxilla and 20 in the mandible) were randomised to the FO2 group (20 patients: 10 in the maxilla and 10 in the mandible) and to the FO3 group (20 patients: 10 in the maxilla and 10 in the mandible) according to a parallel group design. To be immediately loaded, implants had to be inserted with a minimum torque of 60 Ncm. Outcome measures were prosthesis and implant failures, complications and periimplant marginal bone level changes evaluated up to 1-year post-loading. RESULTS: Flaps were raised in four patients and two prostheses were loaded early at 8 weeks in the FO2 group. One year after loading no dropout or implant failure occurred, however one FO2 maxillary prosthesis had to be remade because of repeated screw-loosening (risk difference = 0.05; 95% CI: -0.05 to 0.15; Fisher's exact test P = 1.000). Three FO2 patients were affected by complications versus five FO3 patients (risk difference = -0.1; 95% CI: -0.35 to 0.15; Fisher's exact test; P = 0.695). There were no statistically significant differences for prosthetic failures and complications between groups. There were no statistically significant differences for marginal peri-implant bone levels between the two groups (estimate of the difference = 0.031 mm; 95% Cl: -0.22 to 0.28; P (ancova) = 0.803), with both groups losing marginal bone in a statistically significant way (0.27 mm for FO2 patients and 0.24 mm for FO3 patients). CONCLUSIONS: These preliminary results suggest that immediately loaded cross-arch prostheses can be supported by only two or three dental implants at least up to 1-year post-loading. Longer follow-ups are needed to properly evaluate both these therapeutic options.

Immediate loading of two flapless placed mandibular implants supporting cross-arch fixed prostheses: A 5-year follow-up prospective single cohort study.

PURPOSE: To evaluate the clinical outcome of two implants placed flapless in fully edentulous mandibles and immediately restored with metal-resin screw-retained cross-arch prostheses 5 years after loading. MATERIALS AND METHODS: Eighty consecutive patients were recruited. To be immediately loaded, implants had to be inserted with a minimum torque of 80 Ncm. Forty-six laser-welded titanium and 34 cast silver-palladium frameworks with resin teeth were initially delivered within 8 and 48 h, respectively. Outcome measures, evaluated by two independent assessors included prosthesis and implant failures, complications, marginal bone level changes, implant stability quotient (ISQ) values and patient satisfaction. RESULTS: Five years after loading one patient did not return to the control and 10 prostheses were remade. Two implants failed early in two patients, but they were successfully replaced. Thirty-six complications occurred in 28 patients but were all successfully treated. After 5 years, mean marginal bone loss was 0.69 mm, mean ISQ values decreased from 75.4 to 73.8, and all patients were fully satisfied with the therapy. A post-hoc comparison between the outcome of laser-welded and cast frameworks showed that laser-welded frameworks were affected by significantly more complications (19 patients out of 46 and 6 patients out of 34, respectively; difference in proportion = 0.23, 95% CI: 0.03 to 0.43; Pearson's chi-square test, P = 0.032), therefore such a framework construction should be considered as a long-term temporary prosthesis and not a definitive prosthesis. CONCLUSIONS: Immediately loaded mandibular cross-arch prostheses can be supported by only two implants up to 5 years, if made with a robust cast framework. Longer follow-ups (around 10 years) are still needed to know the prognosis of this treatment modality.

Machined versus roughened immediately loaded and finally restored single implants inserted flapless: Preliminary 6-month data from a split- mouth randomised controlled trial.

PURPOSE: To compare the outcome of immediately loaded single implants with a machined or a roughened surface. MATERIALS AND METHODS: Fifty patients had two implant sites randomly allocated to receive flaplessplaced single Syra implants (Sweden & Martina), one with a machined and one with a roughened surface (sand-blasted with zirconia powder and acid etched), according to a split-mouth design. To be loaded immediately, implants had to be inserted with a torque superior to 50 Ncm. Implants were restored with definitive crowns in direct occlusal contact within 48 h. Patients were followed for 6 months after loading. Outcome measures were prosthetic and implant failures and complications. RESULTS: Two machined implants and four roughened implants were not loaded immediately. Six months after loading no dropout occurred. One implant loaded late, which had a rough implant surface, failed 20 days after loading (P (McNemar test) = 0.625; difference in proportions = -0.04; 95% CI: -0.15 to 0.07). Three crowns had to be remade on machined implants and four on roughened implants (P (McNemar test) = 1.000; difference in proportions = -0.02; 95% CI: -0.12 to 0.08). Three machined and five roughened implants experienced complications (P (McNemar test) = 0.625; difference in proportions = -0.04; 95% CI: -0.15 to 0.07). There were no statistically significant differences between groups for crown and implant losses as well as complications. CONCLUSIONS: Up to 6 months after loading both machined and roughened flapless-placed and immediately loaded single implants provided good and similar results, however, longer follow-ups are needed to evaluate the long-term prognosis of implants with different surfaces.

Immediate loading of bimaxillary total fixed prostheses supported by five flapless-placed implants with machined surfaces: A 6-month follow-up prospective single cohort study.

PURPOSE: To evaluate the clinical outcome of fully edentulous patients rehabilitated with immediately loaded bimaxillary screw-retained metal-resin prostheses supported by five implants placed flapless: two in the mandible and three in the maxillae. MATERIALS AND METHODS: Twenty-five consecutively treated patients were recruited. To be immediately loaded, implants had to be inserted with a minimum torque of 80 Ncm. Outcome measures were prosthesis and implant failures, and complications. RESULTS: Six months after loading no patients dropped out and no prosthesis or implant failed. Two maxillary prostheses were loaded early at 8 weeks because implants were inserted with a torque inferior to 45 Ncm. Three complications occurred in two patients but they were all successfully treated. CONCLUSIONS: Six months after loading, immediately loaded bimaxillary cross-arch prostheses can be supported by only two mandibular and three maxillary flapless-placed dental implants. Longer follow-ups of approximately 10 years are needed to understand the prognosis of this treatment modality.

A comparison of femorocrural bypasses performed with modified heparin-bonded expanded polytetrafluorethylene grafts and those with great saphenous vein grafts to treat critical limb ischemia.

BACKGROUND: The purpose of this study was to evaluate our results involving femorocrural bypasses by comparing heparin-bonded expanded polytetrafluoroethylene (HePTFE) graft (Propaten) modified with handmade distal compliant HePTFE cuffs (mHePTFE graft) to great saphenous vein (GSV) graft. METHODS: A retrospective study involving 74 femorocrural bypasses performed from January 2010 to May 2013 at a single institution was carried out. The indication for revascularization was critical limb ischemia (Rutherford stages 4-6. Forty-one femorocrural bypasses were created in 37 patients with unavailable GSVs using modified ringed HePTFE grafts with a handmade distal radial stretch HePTFE cuff to reduce the mismatch compliance between the graft and the artery wall. Thirty-three femorocrural bypasses were created using a reversed GSV graft. The results were analyzed in terms of primary graft patency, limb salvage, and patient survival using univariate (Kaplan-Meier curves and log-rank test) and multivariate (Cox regression) analyses. RESULTS: The 2 groups were statistically comparable for main risk factors, Rutherford stage, and target artery for distal anastomoses. The run-off anatomy did not significantly differ between the prosthetic and the vein bypass group. The cumulative 30-day operative mortality rate was 2.9%. At 1, 2, and 3 years, the 2 groups were equivalent in primary graft patency (the mHePTFE group: 84%, 80%, and 70%, respectively; the GSV group: 84%,71%, and 71%, respectively; P = 0.93) and were also equivalent in terms of limb salvage (the mHePTFE group: 87%, 87%, and 76%, respectively; the GSV group: 84%, 75%, and 75%, respectively; P = 0.78) and patient survival (the mHePTFE group: 87%, 75%, and 75%, respectively; the GSV group: 87%, 73%, and 65%, respectively; P = 0.86). At Cox regression analysis, only postoperative treatment with warfarin therapy compared with double antiplatelet therapy was independently associated with poorer primary patency (P = 0.003; 95% confidence interval, 1.80-18.00; hazard ratio, 5.7). CONCLUSIONS: In this retrospective study regarding femorocrural bypasses, the mHePTFE grafts had 1-, 2-, and 3-year primary patency and limb salvage results which were not significantly different from those in the GSV grafts. Additional randomized data and larger studies are needed to confirm these results.

Immediate loading of fixed cross-arch prostheses supported by flapless-placed supershort or long implants: 1-year results from a randomised controlled trial.

PURPOSE: To compare the outcome of cross-arch prostheses supported either by supershort (5 mm) or long (11.5 mm) implants, placed flapless and immediately restored with metal-resin screw-retained cross-arch prostheses. MATERIALS AND METHODS: Thirty patients with edentulous (or to be rendered edentulous) mandibles and 30 with edentulous maxillas, who had sufficient bone to allow the placement of four and six implants respectively, which were at least 11.5 mm-long, were randomised according to a parallel group design into 2 equal groups, where they received either 5 mm or 11.5 mm-long implants at one centre. Implants with a diameter of 5 mm, were to be placed flapless with an insertion torque of at least 50 Ncm. Mandibles received four implants between the mental foramina. Implants were to be immediately loaded with metal-resin-definitive prostheses on the same day of implant placement. Patients were followed up to 1 year after loading and the outcome measures were: prosthesis and implant failures, complications, and peri-implant marginal bone level changes. RESULTS: No patients dropped-out. Two prostheses were remade, one on short maxillary implants and one on long mandibular implants. Two 5 mm maxillary implants which did not achieve 50 Ncm torque in soft bone of one patient, but were immediately loaded anyway, failed after 3 weeks compared to one mandibular 11.5 mm-long implant that failed after 60 days. Two complications occurred in each group. There were no statistically significant differences for prosthesis failures, implant failures and complications. Patients with mandibular short implants lost on average 0.08 mm of peri-implant bone at 1 year and patients with long mandibular implants lost 0.51 mm. Patients with short maxillary implants lost on average 0.15 mm of peri-implant bone at 1 year and patients with long maxillary implants lost 0.62 mm. Short implants showed less bone loss when compared to long implants and the differences up to 1 year were statistically significant both in maxillae (mean difference = 0.48 mm, 95% CI 0.22 to 0.73, P = 0.0011) and in mandibles (mean difference = 0.44 mm, 95% CI 0.21 to 0.66, P = 0.0009). CONCLUSIONS: Flapless-placed 5 mm-long implants achieved similar results as 11.5 mm-long implants when supporting immediately loaded cross-arch prostheses both in maxillae and mandibles up to 1 year after loading. These preliminary results must be confirmed by other trials, and 5- to 10-year post-loading data is necessary before making reliable recommendations.

Immediate loading of two flapless placed mandibular implants supporting cross-arch fixed prostheses: a 3-year follow-up prospective single cohort study.

PURPOSE: To evaluate the clinical outcome of two implants placed flapless in fully edentulous mandibles and immediately restored with a metal-resin screw-retained cross-arch prostheses 3 years after loading. MATERIALS AND METHODS: Eighty consecutively patients were recruited. Implants for immediate loading had to be inserted with a minimum torque of 80 Ncm. Outcome measures, evaluated by two independent assessors, were: prosthesis and implant failures, complications, marginal bone level changes, implant stability quotient (ISQ) values and patient satisfaction. RESULTS: Three years after loading, all prostheses were in function although one patient did not come back for the 1- and 3-year follow-ups. Two implants failed early in two patients, but were successfully replaced and their prostheses remade. Twelve complications occurred in 10 patients but were all successfully treated. After 3 years, mean marginal bone loss was 0.43 mm, mean ISQ values decreased from 75.4 to 75.3, and all but four patients were fully satisfied with the therapy. Four patients were partially satisfied because, lacking molars, they could not chew as they wished. CONCLUSION: Immediately loaded mandibular cross-arch partial dentures can be supported by only two dental implants up to 3 years. Longer follow-ups (around 10 years) are needed to know the prognosis of this treatment modality.

Immediate loading of 2(all-on-2) versus 4 (all-on-4) implants placed with a flapless technique supporting mandibular cross-arch fixed prostheses: 1-year results from a pilot randomised controlled trial.

PURPOSE: To evaluate the outcome of 2 versus 4 implants placed flapless in fully edentulous mandibles and immediately restored with metal-resin screw-retained cross-arch prostheses. MATERIALS AND METHODS: Sixty patients from two different centres were randomised: 30 to the allon- 2 group and 30 to the all-on-4 group according to a parallel group design. To be immediately loaded, implants had to be inserted with a minimum torque of 40 Ncm. Outcome measures were prosthesis and implant failures, complications, and marginal bone level changes. RESULTS: Flaps were raised in 18 patients. A total of 2 implants in 2 patients did not reach the planned insertion torque and were immediately replaced by larger diameter ones. One year after loading, no drop-out or implant failure occurred. Eight biomechanical complications occurred in the all-on-2 group versus 8 complications in the all-on-4 group. There were no statistically significant differences for complications between groups. There were no statistically significant differences for marginal peri-implant bone levels between the two groups (estimate of the difference = -0.16; 95%CI -0.40 to 0.08; P (ANCOVA) = 0.074), with both groups losing a statistically significant amount of marginal bone (0.74 mm for all-on-2 implants and 0.58 mm for all-on-4 implants). There were statistically significant differences between the two centres, with more bone being lost for the Bologna centre (0.26 mm versus 1.07 mm). CONCLUSIONS: These preliminary results, up to 1 year after loading, suggest that immediately loaded mandibular cross-arch fixed prostheses can be supported by only 2 dental implants. Longer followups (approximately 10 years) are needed to properly evaluate this therapeutic option.

Early implant loading in the atrophic posterior maxilla: 1-stage lateral versus crestal sinus lift and 8 mm hydroxyapatite-coated implants. A 5-year randomised controlled trial.

PURPOSE: To evaluate the efficacy of long implants (10-16 mm) inserted in maxillary sinuses augmented according to a lateral approach versus short (8 mm) implants placed in crestally augmented sinuses, early loaded after 45 days. MATERIALS AND METHODS: Forty partially or fully edentulous patients having 3 to 6 mm of residual crestal height and at least 4 mm in thickness below the maxillary sinuses were randomised according to a parallel group design to receive either one to three 10 to 16 mm-long hydroxyapatite-coated implants (20 patients) after lateral sinus lifting with 50% an organic bovine (Bio-Oss) and 50% autogenous bone, or 8 mm implants (20 patients) after crestal sinus lifting with autogenous bone. Implants were submerged and left healing for 45 days before loading the implants. Within 1 week after abutment connection, implants were loaded with screw-retained full acrylic provisional prostheses. Definitive metal-ceramic prostheses were provisionally cemented 45 days after abutment connection. Outcome measures were prosthesis and implant failures, any complications, and radiographic periimplant marginal bone level changes. In addition, the stability of individual implants was assessed with Osstell and Periotest at abutment connection (baseline), and at 1 and 5 years after loading by blinded outcome assessors. All patients were followed up to 5 years after loading. RESULTS: One patient dropped out (death) from the longer implant group. One implant failed in the short implant group versus 5 implants in 3 patients of the longer implant group. The difference was not statistically significant. Four complications occurred in 4 patients of the short implant group versus 8 complications in 7 patients of the long implant group, the difference being not statistically significantly different. However, the 2 major postoperative complications occurred in the longer implant group: 1 abscess, and 1 sinusitis that led to the complete failure of the treatment in 2 patients (4 implants lost). A total of 0.72 mm of peri-implant marginal bone was lost after 5 years at long implants and 0.41 mm at short implants, the difference between the two groups was statistically significant (P = 0.028). Osstell values increased and Periotest decreased over time and there were no differences between groups at any time points. CONCLUSIONS: In atrophic maxillary sinuses with a residual bone height of 3 to 6 mm, 8 mm short implants placed in a simultaneously crestally lifted sinus might be a preferable choice than a 1-stage lateral sinus lift for placing longer implants since they appear to be associated with less morbidity. If these implants are placed with an insertion torque >35 Ncm and are joined together under the same prosthesis, they can be early loaded at 6 weeks.

Immediate versus early loading of 6.5 mm-long flapless-placed single implants: a 4-year after loading report of a split-mouth randomised controlled trial.

PURPOSE: To evaluate the medium-term effectiveness of 6.5 mm-long flapless-placed single implants immediately or early loaded at 6 weeks. MATERIALS AND METHODS: Thirty patients received two single NanoTite external hex Biomet 3i implants each, which were then randomly allocated to be immediately or early loaded according to a splitmouth design. Implants had to be inserted with a minimum torque of >40 Ncm. Provisional crowns were put in slight occlusal contact and replaced by definitive crowns 3 months after loading. Patients were followed for 4 years after loading. Outcome measures were implant failures, biological and biomechanical complications, peri-implant marginal bone level changes, and patient preference. RESULTS: Twenty-nine implants were immediately loaded and 31 early loaded. Four years after loading, no drop-outs occurred. One implant failed in each group within 2 months after loading. Seven patients experienced complications at immediately loaded implants and 6 at early loaded implants. There were no statistically significant differences between groups for implant losses, complications, mean marginal bone level changes and patient preference. CONCLUSIONS: Flapless-placed 6.5 mm-long single implants can be immediately loaded and remain successful up to 4 years after loading. Even longer follow-ups are still needed to evaluate the longterm prognosis of short implants.

Immediate loading of 2 (all-on-2) flapless-placed mandibular implants supporting cross-arch fixed prostheses: interim data from a 1-year follow-up prospective single cohort study.

PURPOSE: To evaluate the clinical outcome of 2 implants placed flapless in fully edentulous mandibles and immediately restored with a metal-resin screw-retained cross-arch prosthesis 1 year after loading. MATERIALS AND METHODS: Eighty consecutive patients were recruited. To be immediately loaded, implants had to be inserted with a minimum torque of 80 Ncm. Outcome measures, evaluated by two independent assessors, were prosthesis and implant failures, complications, marginal bone level changes, implant stability quotient (ISQ) values and patient satisfaction. RESULTS: Flaps were raised in 7 patients. Twelve implants in 7 patients did not reach the planned insertion torque. Four implants in 3 patients were immediately replaced by larger diameter implants and achieved the desired torque, whereas the remaining implants were immediately loaded anyway. Two implants failed early in 2 patients, but were successfully replaced and their prostheses remade. One month after loading, 72 (90%) patients declared to be completely satisfied with the therapy, 7 (9%) partially satisfied and 1 (1%) unsatisfied. One year after loading, all prostheses were in function, though one patient did not attend the 1-year control. Eight (10%) complications occurred, all successfully treated. After 1 year, the mean marginal bone loss was 0.3 mm and mean ISQ values decreased from 75.4 to 72.4. CONCLUSIONS: These short-term results at 1 year after loading suggest that immediately loaded mandibular cross-arch fixed prostheses can be supported by only 2 dental implants. Longer follow-ups (around 10 years) are needed to know the prognosis of this treatment modality.

Immediate loading of single implants inserted flapless with medium or high insertion torque: a 6-month follow-up of a split-mouth randomised controlled trial.

PURPOSE: To compare the outcome of immediately loaded single implants inserted with medium (from 25 to 35 Ncm) or high insertion torques (>80 Ncm). MATERIALS AND METHODS: Fifty patients received two single non-adjacent implants, each randomly inserted flapless with a torque between 25 to 35 Ncm or >80 Ncm according to a split-mouth design. Non-occluding temporary crowns were immediately placed on provisional abutments and definitive crowns were delivered after 6 weeks. Patients were followed for 6 months after initial loading. Outcome measures were crown/implant failures, complications, peri-implant marginal bone level changes, postoperative pain and presence of peri-implant apical radiolucency. RESULTS: No drop-out occurred. Seven implants inserted with a torque between 25 to 35 Ncm failed versus none of the implants inserted with a torque >35 Ncm. With the exception of crown/implant failures (exact McNemar significance P = 0.0156, difference in proportions: -0.12; 95% CI -0.21 to -0.02) there were no statistically significant differences between groups for the other outcome measures. CONCLUSIONS: It is preferable to insert single implants with a high insertion torque (>80 Ncm), to minimise early implant failures, when loading them immediately.