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Journal of Biomedical Materials... Nov 2021Additive manufacturing (AM) of high temperature polymers, specifically polyaryletherketones (PAEK), is gaining significant attention for medical implant applications. As...
Additive manufacturing (AM) of high temperature polymers, specifically polyaryletherketones (PAEK), is gaining significant attention for medical implant applications. As 3D printing systems evolve toward point of care manufacturing, research on this topic continues to expand. Specific regulatory guidance is being developed for the safe management of 3D printing systems in a hospital environment. PAEK implants can benefit from many advantages of AM such as design freedom, material and antibacterial drug incorporation, and enhanced bioactivity provided by cancellous bone-like porous designs. In addition to AM PAEK bioactivity, the biomechanical strength of 3D printed implants is crucial to their performance and thus widely studied. In this review, we discuss the printing conditions that have been investigated so far for additively manufactured PAEK implant applications. The effect of processing parameters on the biomechanical strength of implants is summarized, and the bioactivity of PAEKs, along with material and drug incorporation, is also covered in detail. Finally, the therapeutic areas in which 3D printed PAEK implants are investigated and utilized are reviewed.
Topics: Biocompatible Materials; Bone Substitutes; Humans; Osseointegration; Polymers; Porosity; Printing, Three-Dimensional; Prostheses and Implants
PubMed: 33856114
DOI: 10.1002/jbm.b.34845 -
Graefe's Archive For Clinical and... Feb 2022This meta-analysis was conducted to evaluate the efficacy and safety of single-dose dexamethasone implantation for treating persistent DME (diabetic macular edema)... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
This meta-analysis was conducted to evaluate the efficacy and safety of single-dose dexamethasone implantation for treating persistent DME (diabetic macular edema) refractory to anti-VEGF (anti-vascular endothelial growth factor) drugs over a period of 6 months.
METHODS
All related clinical trials were reviewed by searching electronic databases of PubMed, Medline, Web of Science, Cochrane Library, and EMBASE. The primary outcome parameters were best-corrected visual acuity (BCVA) and central macular thickness (CMT). We performed this meta-analysis by using Stata15.0.
RESULTS
Ten clinical trials involving 362 eyes from 328 patients were eligible in the final analysis. After single-dose dexamethasone implantation, there was a significant improvement in BCVA from baseline to 1, 3, and 6 months with an average increase of - 0.15 logMAR (p < 0.001), - 0.14 logMAR (p < 0.001), and - 0.07 logMAR (p = 0.004), respectively. Further, mean CMT decreased significantly with an average reduction of 249.18 μm (p < 0.001), 217.66 μm (p < 0.001), and 91.56 μm (p < 0.001) at months 1, 3, and 6, respectively.
CONCLUSIONS
Our results indicate that switching to a dexamethasone implant could achieve significant anatomical and functional improvement among patients with refractory DME. Clinicians should be aware of this treatment option in refractory DME.
Topics: Dexamethasone; Diabetes Mellitus; Diabetic Retinopathy; Drug Implants; Glucocorticoids; Humans; Intravitreal Injections; Macular Edema; Retrospective Studies; Treatment Outcome; Visual Acuity
PubMed: 34550419
DOI: 10.1007/s00417-021-05369-9 -
Clinical Oral Investigations Jul 2020The aim of this study was to conduct a systematic review and meta-analysis on the efficacy of growth factors (GF) on clinical outcomes after treatment... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The aim of this study was to conduct a systematic review and meta-analysis on the efficacy of growth factors (GF) on clinical outcomes after treatment (surgical/non-surgical) of peri-implant diseases (peri-implant mucositis and peri-implantitis).
MATERIALS AND METHODS
A protocol was developed to answer the following focused question: Is there any difference for the use of GF for treatment of peri-implant diseases versus comparative GF treatment or without GF? Electronic database and manual searches were independently conducted to identify randomized controlled trials (RCTs). Publications were selected based on eligibility criteria and then assessed for risk-of-bias using the Cochrane Handbook. The primary outcome was probing depth (PD) and bleeding on probing (BOP) reduction along with changes in vertical defect depth (VDD). Changes in clinical attachment level, gingival recession, and plaque index, among others, were studied as secondary outcomes. Based on primary outcomes, random-effects meta-analysis was conducted.
RESULTS
A total of five RCTs were included. GF enhance the reduction of PD (standardized mean difference (SMD) = - 1.28; 95% confidence interval (CI) - 1.75, - 0.79; p = < 0.0001) and BOP (SMD = - 1.23; 95% CI - 1.70, - 0.76; p = < 0.0001) in the management of peri-implant mucositis. For the treatment of peri-implantitis, the use of GF yielded to significantly greater improvement in VDD (SMD = 0.68; 95% CI 0.22, 1.14; p = 0.004); however, there were no significant differences in terms of PD (SMD = 0.08; 95% CI - 1.08, 1.26; p = 0.887) and BOP (SMD = 0.211; 95% CI - 0.20, 0.63; p = 0.317). The overall risk of bias of the included studies was low to unclear.
CONCLUSION
The results of the present systematic review suggest that the addition of GF might enhance the outcomes in the treatment of peri-implant mucositis. However, there is a lack of evidence for supporting additional benefit of GF managing peri-implantitis.
CLINICAL RELEVANCE
Within the limitations of the current systematic review and based on the meta-analyses, (1) the addition of GF for the treatment peri-implant mucositis might be associated with better outcomes in terms of PD and BOP, and (2) an additional benefit of GF for the treatment peri-implantitis could not be determined on the basis of the selected evidence.
Topics: Dental Implants; Humans; Peri-Implantitis; Stomatitis
PubMed: 32418012
DOI: 10.1007/s00784-020-03240-5 -
Ocular Immunology and Inflammation Jan 2022To compare different existent implants for noninfectious uveitis. (Meta-Analysis)
Meta-Analysis
BACKGROUND/AIMS
To compare different existent implants for noninfectious uveitis.
METHODS
We performed a systematic review of randomized clinical trials (RCTs), searching in five electronic databases and screening reference lists of included studies and relevant reviews. We performed network meta-analysis to compare 0.18 mg fluocinolone acetonide implants, 0.70 mg and 0.35 mg dexamethasone implants, and sham procedures.
RESULTS
Eight RCTs were included in this systematic review, of which three articles from two studies (n = 358 patients) were included in network meta-analysis. The 0.70 mg dexamethasone implant (at 1.5 months) was associated with better results than the 0.18 mg fluocinolone acetonide implant (at 1 month) at improving vitreous haze grading (RR = 2.96; 95%CI = 1.23-7.07), and with less frequently development of cataracts at 12 (RR = 0.36; 95%CI = 0.17; 0.79) and 36 months (RR = 0.37; 95%CI = 0.20; 0.71).
CONCLUSIONS
In the short term, the 0.70 mg dexamethasone implant is superior at improving vitreous haze, and shows lower risk of cataracts. However, additional RCTs with standardized outcomes are needed.
Topics: Adrenal Cortex Hormones; Drug Implants; Fluocinolone Acetonide; Glucocorticoids; Humans; Network Meta-Analysis; Uveitis
PubMed: 32809890
DOI: 10.1080/09273948.2020.1787463 -
The American Journal of Cardiology Sep 2023Intracoronary imaging (ICI) facilitates stent implant by characterizing the lesion calcification, providing accurate vessel dimensions, and optimizing the stent results.... (Meta-Analysis)
Meta-Analysis
Intracoronary Imaging Versus Coronary Angiography Guidance for Implantation of Second and Third Generation Drug Eluting Stents in a Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Intracoronary imaging (ICI) facilitates stent implant by characterizing the lesion calcification, providing accurate vessel dimensions, and optimizing the stent results. We sought to investigate the outcomes of routine ICI versus coronary angiography (CA) to guide percutaneous coronary intervention (PCI) with second- and third-generation drug-eluting stents. A systematic search of PubMed, Medline, and Cochrane databases was conducted from their inception to July 16, 2022 for randomized controlled trials comparing routine ICI with CA. The primary outcome was major adverse cardiovascular events. The secondary outcomes of interest were target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis, and cardiac and all-cause mortality. A random-effects model was used to calculate the pooled incidence and relative risk (RR) with 95% confidence intervals (CIs). A total of 9 randomized controlled trials with 5,879 patients (2,870 ICI-guided and 3,009 CA-guided PCI) met the inclusion criteria. The ICI and CA groups were similar in demographic characteristics and co-morbidity profiles. Compared with CA, patients in the routine ICI-guided PCI group had lower rates of major adverse cardiovascular events (RR 0.61, 95% CI 0.48 to 0.78, p <0.0001), target lesion revascularization (RR 0.60, 95% CI 0.43 to 0.83, p = 0.002), target vessel revascularization (RR 0.72, 95% CI 0.51 to 1.00, p = 0.05), and myocardial infarction (RR 0.48, 95% CI 0.25 to 0.95, p = 0.03). There were no significant differences in stent thrombosis or cardiac/all-cause mortality between the 2 strategies. In conclusion, routine ICI-guided PCI strategy, compared with CA guidance alone, is associated with improved clinical outcomes, largely driven by lower repeat revascularization.
Topics: Humans; Drug-Eluting Stents; Coronary Angiography; Coronary Artery Disease; Percutaneous Coronary Intervention; Risk Factors; Randomized Controlled Trials as Topic; Myocardial Infarction; Stents; Thrombosis; Treatment Outcome
PubMed: 37423173
DOI: 10.1016/j.amjcard.2023.06.073 -
PloS One 2021In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
In 2002 a pyrocarbon interphalangeal joint implant was granted Food and Drug Administration approval with limited evidence of effectiveness. It is important to understand device use and outcomes since this implant entered clinical practice in order to establish incremental evidence, appropriate study design and reporting. This systematic review summarised and appraised studies reporting pyrocarbon proximal interphalangeal joint arthroplasty.
METHODS
Systematic review of MEDLINE, EMBASE, SCOPUS, Web of Science, BIOSIS, CINAHL and CENTRAL from inception to November 2020. All study designs reporting pyrocarbon proximal interphalangeal joint arthroplasty in humans were included. Data extracted included information about study characteristics, patient selection, regulatory (gaining research ethics approval) and governance issues (reporting of conflicting interests), operator and centre experience, technique description and outcome reporting. Descriptive and narrative summaries were reported.
RESULTS
From 4316 abstracts, 210 full-text articles were screened. A total of 38 studies and 1434 (1-184) patients were included. These consisted of three case reports, 24 case series, 10 retrospective cohort studies and one randomised trial. Inclusion and exclusion criteria were stated in 25 (66%) studies. Most studies (n = 27, 71%) gained research ethics approval to be conducted. Six studies reported conflicting interests. Experience of operating surgeons was reported in nine (24%) and caseload volume in five studies. There was no consensus about the optimal surgical approach. Technical aspects of implant placement were reported frequently (n = 32) but the detail provided varied widely. Studies reported multiple, heterogenous outcomes. The most commonly reported outcome was range of motion (n = 37).
CONCLUSIONS
This systematic review identified inconsistencies in how studies describing the early use and update of an innovative procedure were reported. Incremental evidence was lacking, risking the implant being adopted without robust evaluation. This review adds to evidence highlighting the need for more rigorous evaluation of how implantable medical devices are used in practice following licencing.
Topics: Arthroplasty; Biocompatible Materials; Carbon; Evaluation Studies as Topic; Humans; Joint Prosthesis; Medical Device Legislation; Patient Selection
PubMed: 34665802
DOI: 10.1371/journal.pone.0257497 -
Clinical Breast Cancer Apr 2024Neoadjuvant chemotherapy (NAC) is a standard modality of treatment for breast cancer. The exposure of patients to drugs that effect the cells and processes involved in... (Meta-Analysis)
Meta-Analysis Review
Neoadjuvant chemotherapy (NAC) is a standard modality of treatment for breast cancer. The exposure of patients to drugs that effect the cells and processes involved in healing prior to reconstructive surgical procedures is a source of concern for reconstructive surgeons. The reported effects of NAC on autologous and tissue expander to implant-based breast reconstruction vary from study to study and have not been comprehensively reviewed on a large scale. There is also significant variation from study to study regarding which outcomes are evaluated. The primary aim of this systematic review and meta-analysis is to evaluate the effect of neoadjuvant chemotherapy (NAC) on common and significant outcomes including total complication, reconstruction loss, and SSI (Surgical Site Infection) rates in breast reconstruction. The second aim of this study is to evaluate whether NAC has differing effects on implant-based reconstruction compared with autologous flap reconstruction. A systematic review of the literature published from 1991 to 2019 in the PubMed and Scopus library database was performed to identify studies reporting outcomes of breast reconstruction in patients receiving NAC. A meta-analysis was then performed. Primary outcomes reviewed included overall complication rates, SSI rates, and total loss of reconstruction (flap necrosis or premature tissue expander or implant removal). Outcomes were analyzed using a random effects model and chi-square statistical test. Our literature search yielded 22 manuscripts with a total of 3680 patients that fit our inclusion criteria, of which 12 reported on reconstruction loss, 14 reported on SSI rates, and 10 reported on overall complication rates. There was no significant difference in overall breast reconstruction loss rate (OR 1.30, P = .35), complication rate (OR 1.21, P = .06), and rate of SSI (OR 1.28, P = .85) between NAC vs. non-NAC groups. In patients undergoing autologous flap reconstruction there were no significant differences in complication (23.4% vs. 17.7%, P = 0.076), loss of reconstruction (3.1% vs. 4.4%, P = .393), or SSI (5.3% vs. 3.4%, P = .108) rates in patients who were treated with NAC compared to those who were not. Likewise, in patients undergoing TE/implant-based reconstruction there were no significant differences in complication (19.6 vs. 24.2 P = .069), loss of reconstruction (17.4% vs. 13.3%, P = .072), or SSI (7.9% vs. 5.1%, P = .073) rates in patients who were treated with NAC compared to those who were not. NAC was not associated with any significant differences in overall complication, reconstruction loss, or SSI rates in patients receiving implant-based or autologous flap breast reconstruction. Additionally, the lack of effect of NAC on overall complication, reconstruction loss or SSI rates did not differ with or depend on the type of reconstruction.
Topics: Humans; Female; Mastectomy; Breast Implants; Breast Neoplasms; Neoadjuvant Therapy; Mammaplasty; Retrospective Studies; Postoperative Complications
PubMed: 38228449
DOI: 10.1016/j.clbc.2023.12.004 -
Orthopaedics & Traumatology, Surgery &... Apr 2023Atypical periprosthetic/peri-implant fractures are not recognised in any widely used classification and therefore little focus is given to them. Multiple case reports... (Meta-Analysis)
Meta-Analysis
Is bisphosphonate use a risk factor for atypical periprosthetic/peri-implant fractures? - A metanalysis of retrospective cohort studies and systematic review of the current evidence.
INTRODUCTION
Atypical periprosthetic/peri-implant fractures are not recognised in any widely used classification and therefore little focus is given to them. Multiple case reports and case series demonstrate these fractures exist and are related to bisphosphonate (BP) use.
HYPOTHESIS
Are patients taking long-term BPs at an increased risk of developing an atypical periprosthetic/peri-implant fracture? Is a particular BP drug causing an increased risk of fracture? Is there a correlation between the time of BP use and the incidence of fractures? Do vitamin D analogues or parathyroid hormones reduce the time to union?
MATERIAL AND METHODS
Systematic review of all available evidence on the existence of periprosthetic/peri-implant atypical fractures in patients taking long-term BPs and metanalysis of available retrospective cohort studies. Selected 1 systematic review, 7 retrospective cohort studies (5 used for metanalysis) and 32 case reports.
RESULTS
Metanalysis reported a risk ratio of 14.1, p=0.25, suggesting bisphosphonates are a risk factor in the development of periprosthetic/peri-implant atypical fractures. The secondary outcomes couldn't be reliably identified due to the small size of available studies and risk of significant bias.
DISCUSSION
Atypical periprosthetic/peri-implant fractures are an entity and seem to be associated with the use of bisphosphonates. The benefits of bisphosphonates use outweigh the risks, but clinicians should be aware of atypical fractures and actively search for them when patients on long-term bisphosphonates attend with non-specific pain close to the implant/prosthesis or reduced mobility.
LEVEL OF EVIDENCE
II, Systematic review and metanalysis.
Topics: Humans; Diphosphonates; Femoral Fractures; Periprosthetic Fractures; Retrospective Studies; Risk Factors
PubMed: 36347461
DOI: 10.1016/j.otsr.2022.103475 -
Lasers in Medical Science Jun 2023Photodynamic therapy (PDT) has been suggested as an adjunctive therapeutic approach for peri-implantitis. This systematic review aimed to assess the clinical and... (Meta-Analysis)
Meta-Analysis
Clinical and radiographic outcomes of adjunctive photodynamic therapy for treating peri-implantitis among diabetics and cigarette smokers: a systematic review of randomized controlled trials.
Photodynamic therapy (PDT) has been suggested as an adjunctive therapeutic approach for peri-implantitis. This systematic review aimed to assess the clinical and radiographic outcomes of adjunctive PDT (aPDT) for the treatment of peri-implantitis among diabetics and cigarette smokers. Randomized controlled trials (RCTs), which assessed the clinical and radiographic outcomes of aPDT versus other intervention(s) and/or MD alone among diabetics and smokers with peri-implantitis, were considered eligible for the review. Meta-analysis was performed for calculating the standard mean difference (SMD) with a 95% confidence interval (CI). The methodological quality of the included studies was evaluated using the modified Jadad quality scale. The meta-analysis revealed no significant differences between the influence of aPDT and other intervention/MD alone on the peri-implant PI among diabetics at the final follow-up. However, statistically significant improvements in the peri-implant PD, BOP, and CBL were observed after the application of aPDT among diabetics. Similarly, no significant differences were found between the influence of aPDT and other interventions/MD alone on the peri-implant PD among smokers with peri-implant diseases at the final follow-up. However, statistically significant improvements in the peri-implant PI, BOP, and CBL were observed after the application of aPDT among smokers. Significant improvements in the peri-implant PD, BOP, and CBL among diabetics and the peri-implant PI, BOP, and CBL among smokers after the application of aPDT at the final follow-up. However, large-scale, well-designed, and long-term RCTs are recommended in this domain.
Topics: Humans; Diabetes Mellitus; Peri-Implantitis; Photochemotherapy; Randomized Controlled Trials as Topic; Smokers; Tobacco Products
PubMed: 37335369
DOI: 10.1007/s10103-023-03807-0 -
Oxidative Medicine and Cellular... 2022Peri-implant mucositis (PiM) is characterized as a reversible inflammatory change of the peri-implant soft tissues without alveolar bone loss or continuing marginal bone... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Peri-implant mucositis (PiM) is characterized as a reversible inflammatory change of the peri-implant soft tissues without alveolar bone loss or continuing marginal bone loss. Without proper control of PiM, the reversible inflammation may advance to peri-implantitis (PI). Mechanical debridement (MD) by the implant surface is the most common and conventional nonsurgical approach to treat PiM but with limitations in complete resolution of diseases. For more than a decade, chlorhexidine (CHX) and active compounds has been investigated in the treatment of PiM. Therefore, the aim of this systematic review and meta-analysis was to evaluate the efficacy of CHX treatment in combination with MD versus MD alone or MD+placebo in patients with PiM on their oral health problems.
METHODS
A search using electronic databases (Ovid MEDLINE, EMBASE, Science Direct databases, and Cochrane Central Register of Controlled Trials) and a manual search up to May 2022 were performed independently by 2 reviewers and included eligible randomized controlled trials (RCTs) comparing MD+CHX versus MD alone or MD+placebo. The assessment of quality for all the selected RCTs was conducted according to the Cochrane Handbook for Systematic Reviews of Interventions. Disease resolution of PiM (absence of BOP), IPPD reduction, IBOP% reduction, and PI% reduction after treatment as primary outcomes were selected as the primary outcomes. Weighted mean differences (WMD) and 95% confidence interval (CI) were for continuous outcomes, and odds ratio (OR) and 95% CI was for dichotomous outcomes using random effect models. This review is registered on the PROSPERO database (CRD42020221989).
RESULTS
After independent screening, nine eligible studies were included in this systematic review and meta-analysis. Meta-analysis showed OR of disease resolution between test and control groups amounted to 1.41 (95% CI (0.43, 4.65), = 0.57, = 65%) not favoring adjunctive CHX treatment over MD alone. Through subgroup analysis, the results indicated that oral irrigation of CHX may have more benefits on the resolution of PiM. Similarly, CHX did not significantly improve IPPD reduction at both short-, medium-, and long-term follow-up. Only a short-term effect has been observed at IBOP% reduction (WMD = 13.88, 95% CI (10.94, 16.81), < 0.00001, = 9%), IPI reduction (WMD = 0.12, 95% CI (0.09, 0.14), < 0.00001, = 0%), and FMPPD reduction (WMD = 0.19 mm, 95% CI (0.03, 0.35), = 0.02, = 0%) with adjunctive CHX application.
CONCLUSION
Adjunctive CHX application may have some benefits to improve the efficacy of MD in PiM treatment by reducing IBOP%, IPI, and FMPPD in short-term. But these benefits disappeared at medium- and long-term follow-up. In order to achieve better disease resolution of PiM, adjunctive CHX irrigation with MD may be suggested and has positive potential. Well-designed large clinical trials are needed in future.
Topics: Chlorhexidine; Humans; Mucositis; Oral Health; Peri-Implantitis
PubMed: 36065438
DOI: 10.1155/2022/2312784