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Frontiers in Pharmacology 2022To compare the efficacy and safety of advanced intravitreal therapeutic regimens, including a dexamethasone implant at 350 and 700 μg; a fluocinolone acetonide (FA)...
To compare the efficacy and safety of advanced intravitreal therapeutic regimens, including a dexamethasone implant at 350 and 700 μg; a fluocinolone acetonide (FA) implant, 0.2 µg/day, 0.59 and 2.1 mg; intravitreal bevacizumab, 1.25 mg; intravitreal ranibizumab, 0.5 mg; intravitreal triamcinolone acetonide (IVTA), 2 and 4 mg; and standard of care (SOC, systemic therapy) for noninfectious uveitis. We searched the Cochrane Library database, EMBASE, Medline, clinicaltrials.gov until April 2021 with 13 RCTs (1806 participants) identified and conducted a pairwise and Bayesian network meta-analysis with random effects. No specific regimen showed a statistically significant advantage or disadvantage to another treatment regimen with regard to efficacy. However, the FA implant, 0.59 mg was associated with a higher risk of cataract (RR 4.41, 95% CI 1.51-13.13) and raise in intraocular pressure (IOP) (RR 2.53 95% CI 1.14-6.25) compared with SOC at 24 months. IVTA, 4 mg at 6 months was associated with lower risk of IOP rising compared with FA implant, 0.2 µg/day at 36 months (RR 3.43 95% CI 1.12-11.35). No intravitreal therapeutic regimens showed a significant advantage or disadvantage with regard to efficacy. However, SOC was associated with lower risk of side effects compared with FA implants. IVTA, 4 mg, might be the best choice with lowest risk of IOP rising. clinicaltrials.gov, identifier CRD42020172953.
PubMed: 35450045
DOI: 10.3389/fphar.2022.749312 -
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 -
The Cochrane Database of Systematic... Aug 2020Primary congenital glaucoma (PCG) is an optic neuropathy with high intraocular pressure (IOP) that manifests within the first few years of a child's life and is not... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Primary congenital glaucoma (PCG) is an optic neuropathy with high intraocular pressure (IOP) that manifests within the first few years of a child's life and is not associated with other systemic or ocular abnormalities. PCG results in considerable morbidity even in high-income countries.
OBJECTIVES
To compare the effectiveness and safety of different surgical techniques for PCG.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2020, Issue 4); Ovid MEDLINE; Embase.com; PubMed; metaRegister of Controlled Trials (mRCT) (last searched 23 June 2014); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search. We last searched the electronic databases on 27 April 2020.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-RCTs comparing different surgical interventions in children under five years of age with PCG.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodology.
MAIN RESULTS
We included 16 trials (13 RCTs and three quasi-RCTs) with 587 eyes in 446 children. Eleven (69%) trials were conducted in Egypt and the Middle East, three in India, and two in the USA. All included trials involved children younger than five years of age, with follow-up ranging from six to 80 months. The interventions compared varied across trials. Three trials (on 68 children) compared combined trabeculotomy and trabeculectomy (CTT) with trabeculotomy. Meta-analysis of these trials suggests there may be little to no evidence of a difference between groups in mean IOP (mean difference (MD) 0.27 mmHg, 95% confidence interval (CI) -0.74 to 1.29; 88 eyes; 2 studies) and surgical success (risk ratio (RR) 1.01, 95% CI 0.90 to 1.14; 102 eyes; 3 studies) at one year postoperatively. We assessed the certainty of evidence as very low for these outcomes, downgrading for risk of bias (-1) and imprecision (-2). Hyphema was the most common adverse outcome in both groups (no meta-analysis due to considerable heterogeneity; I = 83%). Two trials (on 39 children) compared viscotrabeculotomy to conventional trabeculotomy. Meta-analysis of 42 eyes suggests there is no evidence of between groups difference in mean IOP (MD -1.64, 95% CI -5.94 to 2.66) and surgical success (RR 1.11, 95% CI 0.70 to 1.78) at six months postoperatively. We assessed the certainty of evidence as very low, downgrading for risk of bias and imprecision due to small sample size. Hyphema was the most common adverse outcome (38% in viscotrabeculotomy and 28% in conventional trabeculotomy), with no evidence of difference difference (RR 1.33, 95% CI 0.63 to 2.83). Two trials (on 95 children) compared microcatheter-assisted 360-degree circumferential trabeculotomy to conventional trabeculotomy. Meta-analysis of two trials suggests that mean IOP may be lower in the microcatheter group at six months (MD -2.44, 95% CI -3.69 to -1.19; 100 eyes) and at 12 months (MD -1.77, 95% CI -2.92 to -0.63; 99 eyes); and surgical success was more likely to be achieved in the microcatheter group compared to the conventional trabeculotomy group (RR 1.59, 95% CI 1.14 to 2.21; 60 eyes; 1 trial at 6 months; RR 1.54, 95% CI 1.20 to 1.97; 99 eyes; 2 trials at 12 months). We assessed the certainty of evidence for these outcomes as moderate due to small sample size. Hyphema was the most common adverse outcome (40% in the microcatheter group and 17% in the conventional trabeculotomy group), with greater likelihood of occurring in the microcatheter group (RR 2.25, 95% CI 1.25 to 4.04); the evidence was of moderate certainty due to small sample size (-1). Of the nine remaining trials, no two trials compared the same two surgical interventions: one trial compared CTT versus CTT with sclerectomy; three trials compared various suturing techniques and adjuvant use including mitomycin C, collagen implant in CTT; one trial compared CTT versus Ahmed valve implant in previously failed surgeries; one trial compared CTT with trabeculectomy; one trial compared trabeculotomy to goniotomy; and two trials compared different types of goniotomy. No trials reported quality of life or economic data. Many of the included trials had limitations in study design, implementation, and reporting, therefore the reliability and applicability of the evidence remains unclear.
AUTHORS' CONCLUSIONS
The evidence suggests that there may be little to no evidence of difference between CTT and routine conventional trabeculotomy, or between viscotrabeculotomy and routine conventional trabeculotomy. A 360-degree circumferential trabeculotomy may show greater surgical success than conventional trabeculotomy. Considering the rarity of the disease, future research would benefit from a multicenter, possibly international trial, involving parents of children with PCG and with a follow-up of at least one year.
Topics: Child, Preschool; Glaucoma; Glaucoma Drainage Implants; Humans; Hyphema; Infant; Infant, Newborn; Intraocular Pressure; Mitomycin; Postoperative Complications; Randomized Controlled Trials as Topic; Sclera; Trabecular Meshwork; Trabeculectomy; Treatment Outcome
PubMed: 32816311
DOI: 10.1002/14651858.CD008213.pub3 -
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 -
Frontiers in Cellular and Infection... 2023Peri-implant diseases are pathological conditions that affect the survival of dental implants. Etiological studies are limited, accepting a prevalence of 20% at the... (Meta-Analysis)
Meta-Analysis Review
Peri-implant diseases are pathological conditions that affect the survival of dental implants. Etiological studies are limited, accepting a prevalence of 20% at the implant level and 24% at the patient level. The benefits of adjuvant metronidazole are controversial. A systematic review and meta-analysis of RCTs according to PRISMA and PICOS was performed with an electronic search over the last 10 years in MEDLINE (PubMed), WOS, Embase, and Cochrane Library. The risk of bias was measured using the Cochrane Risk of Bias tool and the methodological quality using the Jadad scale. Meta-analysis was performed with RevMan version 5.4.1, based on mean difference and standard deviation, with 95% confidence intervals; the random-effects model was selected, and the threshold for statistical significance was defined as < 0.05. A total of 38 studies were collected and five were selected. Finally, one of the studies was eliminated because of unanalyzable results. All studies reached a high methodological quality. A total of 289 patients were studied with follow-up periods from 2 weeks to 1 year. Statistical significance was only found, with respect to the use of adjunctive metronidazole, in the pooled analysis of the studies ( = 0.02) and in the analysis of the radiographic values reported on peri-implant marginal bone levels, in the studies with a 3-month follow-up ( = 0.03). Discrepancies in the use of systemic metronidazole require long-term randomized clinical trials (RCTs) to determine the role of antibiotics in the treatment of peri-implantitis.
Topics: Humans; Peri-Implantitis; Metronidazole; Anti-Bacterial Agents; Combined Modality Therapy; Bias
PubMed: 37287463
DOI: 10.3389/fcimb.2023.1149055 -
International Journal of Environmental... Nov 2022The implementation of adjunctive antibiotics has been recommended for the therapy of peri-implantitis (PI). In this review, antibiotic resistance patterns in PI patients... (Review)
Review
The implementation of adjunctive antibiotics has been recommended for the therapy of peri-implantitis (PI). In this review, antibiotic resistance patterns in PI patients were assessed. A systematic scoping review of observational studies and trials was established in conjunction with the PRISMA extension for scoping reviews. The SCOPUS, PubMed/MEDLINE, EMBASE, SCIELO, Web of Science, and LILACS databases were reviewed along with the gray literature. The primary electronic examination produced 139 investigations. Finally, four observational studies met the selection criteria. These studies evaluated 214 implants in 168 patients. and mainly presented high resistance to tetracycline, metronidazole, and erythromycin in PI patients. Similarly, was also highly resistant to clindamycin and doxycycline. Other microorganisms such as , , and also presented significant levels of resistance to other antibiotics including amoxicillin, azithromycin, and moxifloxacin. However, most microorganisms did not show resistance to the combination amoxicillin metronidazole. Although the management of adjunctive antimicrobials in the therapy of PI is controversial, in this review, the resistance of relevant microorganisms to antibiotics used to treat PI, and usually prescribed in dentistry, was observed. Clinicians should consider the antibiotic resistance demonstrated in the treatment of PI patients and its public health consequences.
Topics: Humans; Peri-Implantitis; Aggregatibacter actinomycetemcomitans; Drug Resistance, Microbial; Fusobacterium nucleatum; Porphyromonas gingivalis; Amoxicillin; Metronidazole; Anti-Bacterial Agents
PubMed: 36497685
DOI: 10.3390/ijerph192315609 -
Alzheimer's Research & Therapy Feb 2022The NIA-AA research framework proposes a purely biological definition of Alzheimer's disease (AD). This implies that AD can be diagnosed based on biomarker...
BACKGROUND
The NIA-AA research framework proposes a purely biological definition of Alzheimer's disease (AD). This implies that AD can be diagnosed based on biomarker abnormalities, irrespective of clinical manifestation. While this brings opportunities, it also raises challenges. We aimed to provide an overview of considerations regarding the disclosure of AD pathology before the onset of dementia.
METHODS
A systematic literature review was conducted and reported according to PRISMA guidelines. We searched PubMed, Embase, APA PsycINFO, and Web of Science Core Collection (on 10 December 2020) for references on conveying AD biomarker results to individuals without dementia. Our query combined variations on the terms Alzheimer's disease, disclosure, or diagnosis, preclinical or prodromal, and biomarkers. Two reviewers independently screened the resulting 6860 titles and abstracts for eligibility and examined 162 full-text records for relevance. We included theoretical articles in English, on communicating amyloid and/or tau results to individuals with mild cognitive impairment, subjective cognitive decline, or normal cognition. MAXQDA-software was used for inductive data analysis.
RESULTS
We included 27 publications. From these, we extracted 26 unique considerations, which we grouped according to their primary relevance to a clinical, personal, or societal context. Clinical considerations included (lack of) validity, utility, and disclosure protocols. Personal considerations covered psychological and behavioral implications, as well as the right to (not) know. Finally, societal considerations comprised the risk of misconception, stigmatization, and discrimination. Overall, views were heterogeneous and often contradictory, with emphasis on harmful effects.
CONCLUSIONS
We found 26 diverse and opposing considerations, related to a clinical, personal, or societal context, which are relevant to diagnosing AD before dementia. The theoretical literature tended to focus on adverse impact and rely on common morality, while the motivation for and implications of biomarker testing are deeply personal. Our findings provide a starting point for clinicians to discuss biomarker-based diagnosis with their patients, which will become even more relevant in light of the conditional approval of a first disease-modifying drug for AD.
Topics: Alzheimer Disease; Amyloid; Biomarkers; Cognitive Dysfunction; Dementia; Disease Progression; Humans
PubMed: 35144684
DOI: 10.1186/s13195-022-00971-3 -
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 -
Photodiagnosis and Photodynamic Therapy Feb 2024The presence of peri‑implant inflammation including peri‑implant mucositis and peri‑implantitis, is a crucial factor that impacts the long-term stability and... (Review)
Review
BACKGROUND
The presence of peri‑implant inflammation including peri‑implant mucositis and peri‑implantitis, is a crucial factor that impacts the long-term stability and success of dental implants. This review aimed to evaluate the safety and effectiveness of antimicrobial photodynamic therapy (aPDT) as an adjuvant therapy option for managing peri‑implant mucositis and peri‑implantitis.
METHODS
We systematically searched the PubMed/MEDLINE, Cochrane Library, Scopus, and Google Scholar databases (no time limitation). The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and the quality of the studies was assessed using the Cochrane Collaboration tool.
RESULTS
Of 322 eligible articles, 14 studies were included in this review. The heterogeneity and poor quality of the articles reviewed prevented a meta-analysis. The reviewed articles used a light source (60 s, 1 session) with a wavelength of 635 to 810 nm for optimal tissue penetration. These studies showed improved clinical parameters such as probing depth, bleeding on probing (BOP), and plaque index after aPDT treatment. However, in smokers, BOP increased after aPDT. Compared to conventional therapy, aPDT had a longer-term antimicrobial effect and reduced periopathogens like Porphyromonas gingivalis, as well as inflammatory factors such as Interleukin (IL)-1β, IL-6, and Tumor necrosis factor alpha (TNF-α). No undesired side effects were reported in the studies.
CONCLUSION
Although the reviewed articles had limitations, aPDT showed effectiveness in improving peri‑implant mucositis and peri‑implantitis. It is recommended as an adjunctive strategy for managing peri‑implant diseases, but further high-quality research is needed for efficacy and long-term outcomes.
Topics: Humans; Photochemotherapy; Peri-Implantitis; Mucositis; Photosensitizing Agents; Randomized Controlled Trials as Topic; Anti-Infective Agents
PubMed: 38278339
DOI: 10.1016/j.pdpdt.2024.103990 -
Dentistry Journal Jun 2023This systematic review synthesizes the existing evidence in the literature regarding the association of propolis with controlled delivery systems (DDSs) and its... (Review)
Review
This systematic review synthesizes the existing evidence in the literature regarding the association of propolis with controlled delivery systems (DDSs) and its potential therapeutic action in dental medicine. Two independent reviewers performed a literature search up to 1 June 2023 in five databases: PubMed/Medline, Web of Science, Cochrane Library, Scopus, and Embase, to identify the eligible studies. Clinical, in situ, and in vitro studies that investigated the incorporation of propolis as the main agent in DDSs for dental medicine were included in this study. Review articles, clinical cases, theses, dissertations, conference abstracts, and studies that had no application in dentistry were excluded. A total of 2019 records were initially identified. After carefully examining 21 full-text articles, 12 in vitro studies, 4 clinical, 1 animal model, and 3 in vivo and in vitro studies were included (n = 21). Relevant data were extracted from the included studies and analyzed qualitatively. The use of propolis has been reported in cariology, endodontics, periodontics, stomatology, and dental implants. Propolis has shown non-cytotoxic, osteoinductive, antimicrobial, and anti-inflammatory properties. Moreover, propolis can be released from DDS for prolonged periods, presenting biocompatibility, safety, and potential advantage for applications in dental medicine.
PubMed: 37504228
DOI: 10.3390/dj11070162