-
The International Journal of... 2014This review aimed to evaluate the documented clinical success of zirconia based crowns in clinical trials. (Review)
Review
PURPOSE
This review aimed to evaluate the documented clinical success of zirconia based crowns in clinical trials.
MATERIALS AND METHODS
Electronic databases were searched for original studies reporting on the clinical performance of tooth- or implant-supported zirconia-based crowns, including PubMed, Cochrane Library, and Science Direct. The electronic search was complemented by manual searches of the bibliographies of all retrieved full-text articles and reviews as well as a hand search of the following journals: International Journal of Prosthodontics, Journal of Oral Rehabilitation, International Journal of Oral & Maxillofacial Implants, and Clinical Oral Implants Research.
RESULTS
The search yielded 3,216 titles. Based on preestablished criteria, 42 full-text articles were obtained. While 16 studies fulfilled the inclusion criteria, only 3 randomized controlled trials were reported. Seven studies reported on tooth-supported and 4 on implant-supported crowns, and 5 studies reported on both types of support. Ten studies on tooth-supported and 7 on implant supported crowns provided sufficient material for statistical analysis. Life table analysis revealed cumulative 5-year survival rates of 95.9% for tooth-supported and 97.1% for implant-supported crowns. For implant-supported crowns, the most common reasons for failure were technical (veneering material fractures). For tooth-supported crowns, technical (veneering material fractures, loss of retention) and biologic (endodontic/ periodontic) reasons for failure were equally common. The most common complications for implant-supported crowns were veneering material fractures and bleeding on probing. For tooth-supported crowns, the most common complications were loss of retention, endodontic treatment, veneering material fractures, and bleeding on probing.
CONCLUSION
The results suggest that the success rate of tooth-supported and implant-supported zirconia-based crowns is adequate, similar, and comparable to that of conventional porcelain-fused-to-metal crowns. These results are, however, based on a relatively small number of studies, many that are not controlled clinical trials. Well-designed studies with large patient groups and long follow-up times are needed before general recommendations for the use of zirconia-based restorations can be provided.
Topics: Clinical Trials as Topic; Crowns; Dental Materials; Dental Prosthesis Design; Dental Prosthesis, Implant-Supported; Dental Restoration Failure; Humans; Randomized Controlled Trials as Topic; Treatment Outcome; Zirconium
PubMed: 24392475
DOI: 10.11607/ijp.3647 -
BMC Oral Health Sep 2017The continuous development in dental processing ensures new opportunities in the field of fixed prosthodontics in a complete virtual environment without any physical... (Review)
Review
BACKGROUND
The continuous development in dental processing ensures new opportunities in the field of fixed prosthodontics in a complete virtual environment without any physical model situations. The aim was to compare fully digitalized workflows to conventional and/or mixed analog-digital workflows for the treatment with tooth-borne or implant-supported fixed reconstructions.
METHODS
A PICO strategy was executed using an electronic (MEDLINE, EMBASE, Google Scholar) plus manual search up to 2016-09-16 focusing on RCTs investigating complete digital workflows in fixed prosthodontics with regard to economics or esthetics or patient-centered outcomes with or without follow-up or survival/success rate analysis as well as complication assessment of at least 1 year under function. The search strategy was assembled from MeSH-Terms and unspecific free-text words: {(("Dental Prosthesis" [MeSH]) OR ("Crowns" [MeSH]) OR ("Dental Prosthesis, Implant-Supported" [MeSH])) OR ((crown) OR (fixed dental prosthesis) OR (fixed reconstruction) OR (dental bridge) OR (implant crown) OR (implant prosthesis) OR (implant restoration) OR (implant reconstruction))} AND {("Computer-Aided Design" [MeSH]) OR ((digital workflow) OR (digital technology) OR (computerized dentistry) OR (intraoral scan) OR (digital impression) OR (scanbody) OR (virtual design) OR (digital design) OR (cad/cam) OR (rapid prototyping) OR (monolithic) OR (full-contour))} AND {("Dental Technology" [MeSH) OR ((conventional workflow) OR (lost-wax-technique) OR (porcelain-fused-to-metal) OR (PFM) OR (implant impression) OR (hand-layering) OR (veneering) OR (framework))} AND {(("Study, Feasibility" [MeSH]) OR ("Survival" [MeSH]) OR ("Success" [MeSH]) OR ("Economics" [MeSH]) OR ("Costs, Cost Analysis" [MeSH]) OR ("Esthetics, Dental" [MeSH]) OR ("Patient Satisfaction" [MeSH])) OR ((feasibility) OR (efficiency) OR (patient-centered outcome))}. Assessment of risk of bias in selected studies was done at a 'trial level' including random sequence generation, allocation concealment, blinding, completeness of outcome data, selective reporting, and other bias using the Cochrane Collaboration tool. A judgment of risk of bias was assigned if one or more key domains had a high or unclear risk of bias. An official registration of the systematic review was not performed.
RESULTS
The systematic search identified 67 titles, 32 abstracts thereof were screened, and subsequently, three full-texts included for data extraction. Analysed RCTs were heterogeneous without follow-up. One study demonstrated that fully digitally produced dental crowns revealed the feasibility of the process itself; however, the marginal precision was lower for lithium disilicate (LS2) restorations (113.8 μm) compared to conventional metal-ceramic (92.4 μm) and zirconium dioxide (ZrO2) crowns (68.5 μm) (p < 0.05). Another study showed that leucite-reinforced glass ceramic crowns were esthetically favoured by the patients (8/2 crowns) and clinicians (7/3 crowns) (p < 0.05). The third study investigated implant crowns. The complete digital workflow was more than twofold faster (75.3 min) in comparison to the mixed analog-digital workflow (156.6 min) (p < 0.05). No RCTs could be found investigating multi-unit fixed dental prostheses (FDP).
CONCLUSIONS
The number of RCTs testing complete digital workflows in fixed prosthodontics is low. Scientifically proven recommendations for clinical routine cannot be given at this time. Research with high-quality trials seems to be slower than the industrial progress of available digital applications. Future research with well-designed RCTs including follow-up observation is compellingly necessary in the field of complete digital processing.
Topics: Computer-Aided Design; Dental Prosthesis Design; Dental Prosthesis, Implant-Supported; Humans; Workflow
PubMed: 28927393
DOI: 10.1186/s12903-017-0415-0 -
Clinical Oral Implants Research Oct 2018The aim of the present systematic review was to analyze the survival and complication rates of zirconia-based and metal-ceramic implant-supported single crowns (SCs).
OBJECTIVES
The aim of the present systematic review was to analyze the survival and complication rates of zirconia-based and metal-ceramic implant-supported single crowns (SCs).
MATERIALS AND METHODS
An electronic MEDLINE search complemented by manual searching was conducted to identify randomized controlled clinical trials, prospective cohort and retrospective case series on implant-supported SCs with a mean follow-up time of at least 3 years. Patients had to have been clinically examined at the follow-up visit. Assessment of the identified studies and data extraction was performed independently by two reviewers. Failure and complication rates were analyzed using robust Poisson's regression models to obtain summary estimates of 5-year proportions.
RESULTS
The search provided 5,263 titles and 455 abstracts, full-text analysis was performed for 240 articles, resulting in 35 included studies on implant-supported crowns. Meta-analysis revealed an estimated 5-year survival rate of 98.3% (95% CI: 96.8-99.1) for metal-ceramic implant supported SCs (n = 4,363) compared to 97.6% (95% CI: 94.3-99.0) for zirconia implant supported SCs (n = 912). About 86.7% (95% CI: 80.7-91.0) of the metal-ceramic SCs (n = 1,300) experienced no biological/technical complications over the entire observation period. The corresponding rate for zirconia SCs (n = 76) was 83.8% (95% CI: 61.6-93.8). The biologic outcomes of the two types of crowns were similar; yet, zirconia SCs exhibited less aesthetic complications than metal-ceramics. The 5-year incidence of chipping of the veneering ceramic was similar between the material groups (2.9% metal-ceramic, 2.8% zirconia-ceramic). Significantly (p = 0.001), more zirconia-ceramic implant SCs failed due to material fractures (2.1% vs. 0.2% metal-ceramic implant SCs). No studies on newer types of monolithic zirconia SCs fulfilled the simple inclusion criteria of 3 years follow-up time and clinical examination of the present systematic review.
CONCLUSION
Zirconia-ceramic implant-supported SCs are a valid treatment alternative to metal-ceramic SCs, with similar incidence of biological complications and less aesthetic problems. The amount of ceramic chipping was similar between the material groups; yet, significantly more zirconia crowns failed due to material fractures.
Topics: Ceramics; Crowns; Databases, Factual; Dental Implants; Dental Materials; Dental Prosthesis Design; Dental Prosthesis, Implant-Supported; Dental Restoration Failure; Esthetics, Dental; Humans; Metal Ceramic Alloys; Survival Analysis; Zirconium
PubMed: 30328190
DOI: 10.1111/clr.13306 -
Current Therapeutic Research, Clinical... 2021Patiromer and sodium zirconium cyclosilicate (SZC) are newer options for hyperkalemia treatment. This systematic review and meta-analysis were conducted to assess the... (Review)
Review
BACKGROUND
Patiromer and sodium zirconium cyclosilicate (SZC) are newer options for hyperkalemia treatment. This systematic review and meta-analysis were conducted to assess the safety and side effect profile of patiromer and SZC compared with placebo or other standards of care in the management of hyperkalemia.
METHODS
We searched electronic databases for relevant articles. The screening was performed independently and data were extracted among the selected studies. We performed a statistical analysis on Revman 5.4 software. The odds ratio (OR) was used for outcome estimation with a 95% CI.
RESULTS
Patiromer had lower rates of hyperkalemia (OR = 0.44; 95% CI, 0.22-0.89) compared with standard of care. The analysis showed no significant differences between the 2 groups in terms of overall adverse effects, any serious/specific adverse effects, or treatment discontinuation as a result of adverse effects. Comparing the SZC-10 group with standard of care showed no significant differences in the occurrence of hyperkalemia during treatment, overall adverse effects, any serious/specific adverse effects, or treatment discontinuation as a result of adverse effects but showed a higher rate of edema in the treatment group (OR = 6.77; 95% CI, 1.03-44.25). Similarly, no significant differences were seen between the 2 SZC doses for the occurrence of any adverse effects, hyperkalemia, constipation, diarrhea, or urinary tract infection, whereas edema was higher among patients receiving SZC-10 (OR = 3.13; 95% CI, 1.19-8.27).
CONCLUSIONS
In patients with acute hyperkalemia, SZC is the drug of choice due to its more rapid reduction of serum potassium level, whereas in patients with chronic hyperkalemia, patiromer appears to be the drug of choice because SZC is associated with an increase in edema, likely due to an increase in sodium absorption, which could have important adverse consequences in patients with chronic kidney disease and or heart failure. Thus, both drugs were found to be safe while treating hyperkalemia. (Curr Ther Res Clin Exp. 2021; 82:XXX-XXX).
PubMed: 34367383
DOI: 10.1016/j.curtheres.2021.100635 -
International Journal of Environmental... Feb 2022The aim of this systematic review was to summarize the literature regarding the clinical performance of zirconia crowns for primary teeth. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The aim of this systematic review was to summarize the literature regarding the clinical performance of zirconia crowns for primary teeth.
MATERIALS AND METHODS
Four electronic databases, Ovid, PubMed, Scopus, and Web of Science were searched. Clinical, observational, and laboratory studies were included. Studies that assessed the performance of zirconia crowns for primary teeth using outcomes such as gingival and periodontal health, parental satisfaction, color stability, crown retention, contour, fracture resistance, marginal integrity, surface roughness, and recurrent caries were included. Risk of bias was assessed using different assessment tools depending on the type of the assessed study.
RESULTS
Out of the 2400 retrieved records, 73 full-text records were assessed for eligibility. Thirty-six studies were included for qualitative analysis. The included studies reported that zirconia crowns for primary teeth were associated with better gingival and periodontal health, good retention, high fracture resistance, color stability, high parental acceptance, good marginal adaptation, smooth cosmetic surface, and no recurrent caries.
CONCLUSION
Zirconia crowns are promising alternative to other restorative materials and crowns in the field of pediatric dentistry. They showed higher properties and performance in different clinical aspects and great parental satisfaction.
Topics: Child; Crowns; Gingiva; Humans; Tooth, Deciduous; Zirconium
PubMed: 35270531
DOI: 10.3390/ijerph19052838 -
Clinical Oral Implants Research Oct 2018The aim of the present review was to compare the outcomes, that is, survival and complication rates of zirconia-ceramic and/or monolithic zirconia implant-supported... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The aim of the present review was to compare the outcomes, that is, survival and complication rates of zirconia-ceramic and/or monolithic zirconia implant-supported fixed dental prostheses (FDPs) with metal-ceramic FDPs.
MATERIALS AND METHODS
An electronic MEDLINE search complemented by manual searching was conducted to identify randomized controlled clinical trials, prospective cohort studies and retrospective case series on implant-supported FDPs with a mean follow-up of at least 3 years. Patients had to have been examined clinically at the follow-up visit. Assessment of the identified studies and data extraction was performed independently by two reviewers. Failure and complication rates were analyzed using robust Poisson regression models to obtain summary estimates of 5-year proportions.
RESULTS
The search provided 5,263 titles and 455 abstracts. Full-text analysis was performed for 240 articles resulting in 19 studies on implant FDPs that met the inclusion criteria. The studies reported on 932 metal-ceramic and 175 zirconia-ceramic FDPs. Meta-analysis revealed an estimated 5-year survival rate of 98.7% (95% CI: 96.8%-99.5%) for metal-ceramic implant-supported FDPs, and of 93.0% (95% CI: 90.6%-94.8%) for zirconia-ceramic implant-supported FDPs (p < 0.001). Thirteen studies including 781 metal-ceramic implant-supported FDPs estimated a 5-year rate of ceramic fractures and chippings to be 11.6% compared with a significantly higher (p < 0.001) complication rate for zirconia implant-supported FDPs of 50%, reported in a small study with 13 zirconia implant-supported FDPs. Significantly (p = 0.001) more, that is, 4.1%, of the zirconia-ceramic implant-supported FDPs were lost due to ceramic fractures compared to only 0.2% of the metal-ceramic implant-supported FDPs. Detailed analysis of factors like number of units of the FDPs or location in the jaws was not possible due to heterogeneity of reporting. No studies on monolithic zirconia implant-supported FDPs fulfilled the inclusion criteria of the present review. Furthermore, no conclusive results were found for the aesthetic outcomes of both FDP-types.
CONCLUSION
For implant-supported FDPs, conventionally veneered zirconia should not be considered as material selection of first priority, as pronounced risk for framework fractures and chipping of the zirconia veneering ceramic was observed. Monolithic zirconia may be an interesting alternative, but its clinical medium- to long-term outcomes have not been evaluated yet. Hence, metal ceramics seems to stay the golden standard for implant-supported multiple-unit FDPs.
Topics: Ceramics; Databases, Factual; Dental Implants; Dental Materials; Dental Prosthesis Design; Dental Prosthesis, Implant-Supported; Dental Restoration Failure; Denture, Partial, Fixed; Esthetics, Dental; Humans; Metal Ceramic Alloys; Survival Analysis; Zirconium
PubMed: 30328185
DOI: 10.1111/clr.13277 -
The Cochrane Database of Systematic... Dec 2017Fixed prosthodontic treatment (crowns, fixed dental prostheses (FDPs), complete arch prostheses) involves the use of several different materials to replace missing tooth... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Fixed prosthodontic treatment (crowns, fixed dental prostheses (FDPs), complete arch prostheses) involves the use of several different materials to replace missing tooth structure. Traditionally full metal or metal frameworks veneered with ceramic (metal-ceramic (MC)) have been used. In recent years several different metal-free systems have become available to clinicians and patients. In general, metal-free restorations should allow practitioners to better reproduce natural tooth colour, avoiding shortcomings of MC restorations. The comparative in service clinical performance of fixed prosthodontic treatments of different materials is unclear.
OBJECTIVES
To assess the effects of metal-free materials for prosthodontic restorations compared to metal-ceramic or other conventional all-metal materials.
SEARCH METHODS
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (searched 3 May 2017), Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4) in the Cochrane Library (searched 3 May 2017), MEDLINE Ovid (1946 to 3 May 2017), and Embase Ovid (1980 to 3 May 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials (searched 3 May 2017). No restrictions were placed on the language or date of publication when searching the electronic databases.
SELECTION CRITERIA
Randomised controlled trials (RCTs) in which the clinical performance of metal-free fixed prosthodontic restorations was compared with metal-ceramic (MC) or other conventional restorations in adult patients requiring prosthodontic treatment. RCTs in which the clinical performance of different kinds of metal-free systems were compared among themselves were also considered.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted independently and in duplicate. Trial authors were contacted for missing information. Available results for the outcomes of interest of the systematic review of the studies included were tabulated as they could not be included in a formal meta-analysis.
MAIN RESULTS
Nine trials involving a total of 448 participants were included. We judged two trials to be at unclear risk of bias and seven to be at high risk of bias. The majority of items of risk of bias were evaluated to be at unclear or high risk level in more than 50% of the included trials. Each trial except two was addressing a different type of intervention. All evidence was rated as being of very low quality due to problems with risk of bias and imprecision of results, the latter being due to very small sample sizes, low event rates, 95% confidence intervals including the possibility of benefit for both the test and control groups, or combinations of these problems. This means that we are very uncertain about all of the results presented in this review.One trial compared metal-free single crowns (full contour zirconia) to cast gold single crowns in 224 participants and found insufficient evidence of a difference in failure rate after one year, but after five years there was some evidence of a benefit for the gold crowns. There was insufficient evidence of a difference for crown complications at either time of assessment.One trial compared three-unit metal-free FDPs (lithium disilicate) to three-unit metal-ceramic FDPs in 37 participants. There was insufficient evidence of a difference in bridge failure at one and six years, but some evidence of a benefit for the lithium disilicate group in terms of bridge complications at six years. One trial compared zirconia-ceramic FDPs to metal-ceramic FDPs in 34 participants but found insufficient evidence of a difference in bridge failures (i.e. no failures in either treatment group), bridge complications or patients' aesthetic evaluation at any time of assessment up to three years.One trial compared metal-free cantilevered FDPs to metal-ceramic cantilevered FDPs in 21 participants. There was insufficient evidence of a difference for any primary outcome: bridge failures (i.e. no failures in either treatment group), bridge complications, or patients' aesthetic evaluation at any time of assessment up to three years.One trial compared metal-free implant-supported screw retained single crowns (zirconia veneered with feldspathic ceramic) to metal-ceramic implant-supported screw-retained single crowns in 20 participants. There was insufficient evidence of a difference for any primary outcome: crown failures (i.e. no failures in either treatment group), crown complications, or satisfaction/aesthetic evaluation at any time of assessment up to two years.Two trials compared metal-free implant abutments (zirconia) to metal implant abutments both supporting single crowns in 50 participants. There was insufficient evidence of a difference in abutment failure at one year.One trial compared metal-free implant-supported FDPs made of two different types of zirconia ceramic in 18 participants. There was insufficient evidence of a difference in failures at any time of assessment up to 10 years (i.e. no failures in either treatment group). There was some evidence of a benefit for the zirconia-toughened alumina group in terms of complications (chipping).One trial compared metal-free tooth-supported FDPs made with two different veneering techniques (pressed versus layered) in 40 participants. There was insufficient evidence of a difference for failures (i.e. no failures in either treatment group) or complications at any time of assessment up to three years.
AUTHORS' CONCLUSIONS
There is insufficient evidence to support or refute the effectiveness of metal-free materials for fixed prosthodontic treatment over metal-ceramic or other type of standard restorations. The overall quality of existing evidence was very low, therefore great caution should be exercised when generalising the results of the included trials. Until more evidence becomes available clinicians should continue to base decisions on which material to use for fixed prosthodontic treatment on their own clinical experience, whilst taking into consideration the individual circumstances and preferences of their patients. There is urgent need of properly designed RCTs.
Topics: Crowns; Dental Alloys; Dental Materials; Dental Restoration, Permanent; Humans; Randomized Controlled Trials as Topic; Zirconium
PubMed: 29261853
DOI: 10.1002/14651858.CD009606.pub2 -
Clinical Oral Implants Research Jan 2022To analyze the clinical outcomes of all-ceramic single crowns (SCs) and fixed dental prostheses (FDPs) supported by ceramic implants. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To analyze the clinical outcomes of all-ceramic single crowns (SCs) and fixed dental prostheses (FDPs) supported by ceramic implants.
MATERIALS AND METHODS
Based on a focused question and customized PICO framework, electronic (Medline/EMBASE/Cochrane) and manual searches for studies reporting the clinical outcomes of all-ceramic SCs and FDPs supported by ceramic implants ≥12 months were performed. The primary outcomes were reconstruction survival and the chipping proportion. The secondary outcomes were implant survival, technical complications, and patient-related outcome measurements. Meta-analyses were performed after 1, 2, and 5 years using random-effect meta-analyses.
RESULTS
Eight of the 1,403 initially screened titles and 55 full texts were included. Five reported on monolithic lithium disilicate (LS2) SCs, one on veneered zirconia SCs, and two on veneered zirconia SCs and FDPs, which reported all on cement-retained reconstructions (mean observation: 12.0-61.0 months). Meta-analyses estimated a 5-year survival rate of 94% (95% confidence interval [CI]: 82%-100%) for overall implant survival. Reconstruction survival proportions after 5 years were: monolithic LS2, 100% (95%CI: 95%-100%); veneered zirconia SCs, 89% (95%CI: 62%-100%); and veneered zirconia FDPs 94% (95%CI: 81%-100%). The chipping proportion after 5 years was: monolithic LS2, 2% (95%CI: 0%-11%); veneered zirconia SCs, 38% (95%CI: 24%-54%); and veneered zirconia FDPs, 57% (95%CI: 38%-76%). Further outcomes were summarized descriptively.
CONCLUSIONS
Due to the limited data available, only tendencies could be identified. All-ceramic reconstructions supported by ceramic implants demonstrated promising survival rates after mid-term observation. However, high chipping proportions of veneered zirconia SCs and, particularly, FDPs diminished the overall outcome. Monolithic LS2 demonstrated fewer clinical complications. Monolithic reconstructions could be a valid treatment option for ceramic implants.
Topics: Ceramics; Crowns; Dental Implants; Dental Porcelain; Dental Prosthesis Design; Dental Prosthesis, Implant-Supported; Dental Restoration Failure; Humans; Metal Ceramic Alloys; Zirconium
PubMed: 34665900
DOI: 10.1111/clr.13871 -
Journal of Prosthodontic Research Jul 2022The purpose of this systematic review was to evaluate the survival rate, biological complications, technical complications, and clinical behavior of single crowns... (Meta-Analysis)
Meta-Analysis
PURPOSE
The purpose of this systematic review was to evaluate the survival rate, biological complications, technical complications, and clinical behavior of single crowns supported by teeth made up in monolithic zirconia with CAD/CAM technology.
STUDY SELECTION
An extensive electronic search was conducted through Medline/PubMed, Embase, and Cochrane Library databases. Additional manual search was performed on the references of included articles to identify relevant publications. Two reviewers independently performed the selection and electronic and manual search.
RESULTS
From nine articles included, there was a total of 594 participants and 1657 single-tooth restorations with a mean exposure time of 1.07 years, and follow-up period between 0.3 and 2.1 years. All studies showed a moderate level of quality, with a consequent moderate possibility of associated bias, using the Newcastle-Ottawa Scale (NOS), with survival rate (SR) ranging between 91% to 100%. Bleeding on probing (BOP) were reported with an average value of 29.12%. Marginal integrity showed high success rate values for the observation periods, except for one that included patients with bruxism which obtained a SR of 31.60%. Failures and/or fractures, mostly total and requiring replacement, were observed in three studies. Linear regression showed that there was no statistical correlation between survival rate and type of cementation and the average years of follow-up (p=0.730 e p=0.454). There was high heterogeneity between studies (I2 = 93.74% and Q = 79.672).
CONCLUSION
Within the limitation of this study, monolithic zirconia might be considered as a possible option for restoring single crowns, especially in the posterior zone.
Topics: Computer-Aided Design; Crowns; Dental Prosthesis Design; Dental Restoration Failure; Humans; Zirconium
PubMed: 34615842
DOI: 10.2186/jpr.JPR_D_21_00081 -
The Cochrane Database of Systematic... Jun 2020Hyperkalaemia is a common electrolyte abnormality caused by reduced renal potassium excretion in patients with chronic kidney diseases (CKD). Potassium binders, such as... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Hyperkalaemia is a common electrolyte abnormality caused by reduced renal potassium excretion in patients with chronic kidney diseases (CKD). Potassium binders, such as sodium polystyrene sulfonate and calcium polystyrene sulfonate, are widely used but may lead to constipation and other adverse gastrointestinal (GI) symptoms, reducing their tolerability. Patiromer and sodium zirconium cyclosilicate are newer ion exchange resins for treatment of hyperkalaemia which may cause fewer GI side-effects. Although more recent studies are focusing on clinically-relevant endpoints such as cardiac complications or death, the evidence on safety is still limited. Given the recent expansion in the available treatment options, it is appropriate to review the evidence of effectiveness and tolerability of all potassium exchange resins among people with CKD, with the aim to provide guidance to consumers, practitioners, and policy-makers.
OBJECTIVES
To assess the benefits and harms of potassium binders for treating chronic hyperkalaemia among adults and children with CKD.
SEARCH METHODS
We searched the Cochrane Kidney and Transplant Register of Studies up to 10 March 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-randomised controlled studies (quasi-RCTs) evaluating potassium binders for chronic hyperkalaemia administered in adults and children with CKD.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed risks of bias and extracted data. Treatment estimates were summarised by random effects meta-analysis and expressed as relative risk (RR) or mean difference (MD), with 95% confidence interval (CI). Evidence certainty was assessed using GRADE processes.
MAIN RESULTS
Fifteen studies, randomising 1849 adult participants were eligible for inclusion. Twelve studies involved participants with CKD (stages 1 to 5) not requiring dialysis and three studies were among participants treated with haemodialysis. Potassium binders included calcium polystyrene sulfonate, sodium polystyrene sulfonate, patiromer, and sodium zirconium cyclosilicate. A range of routes, doses, and timing of drug administration were used. Study duration varied from 12 hours to 52 weeks (median 4 weeks). Three were cross-over studies. The mean study age ranged from 53.1 years to 73 years. No studies evaluated treatment in children. Some studies had methodological domains that were at high or unclear risks of bias, leading to low certainty in the results. Studies were not designed to measure treatment effects on cardiac arrhythmias or major GI symptoms. Ten studies (1367 randomised participants) compared a potassium binder to placebo. The certainty of the evidence was low for all outcomes. We categorised treatments in newer agents (patiromer or sodium zirconium cyclosilicate) and older agents (calcium polystyrene sulfonate and sodium polystyrene sulfonate). Patiromer or sodium zirconium cyclosilicate may make little or no difference to death (any cause) (4 studies, 688 participants: RR 0.69, 95% CI 0.11, 4.32; I = 0%; low certainty evidence) in CKD. The treatment effect of older potassium binders on death (any cause) was unknown. One cardiovascular death was reported with potassium binder in one study, showing that there was no difference between patiromer or sodium zirconium cyclosilicate and placebo for cardiovascular death in CKD and HD. There was no evidence of a difference between patiromer or sodium zirconium cyclosilicate and placebo for health-related quality of life (HRQoL) at the end of treatment (one study) in CKD or HD. Potassium binders had uncertain effects on nausea (3 studies, 229 participants: RR 2.10, 95% CI 0.65, 6.78; I = 0%; low certainty evidence), diarrhoea (5 studies, 720 participants: RR 0.84, 95% CI 0.47, 1.48; I = 0%; low certainty evidence), and vomiting (2 studies, 122 participants: RR 1.72, 95% CI 0.35 to 8.51; I = 0%; low certainty evidence) in CKD. Potassium binders may lower serum potassium levels (at the end of treatment) (3 studies, 277 participants: MD -0.62 mEq/L, 95% CI -0.97, -0.27; I = 92%; low certainty evidence) in CKD and HD. Potassium binders had uncertain effects on constipation (4 studies, 425 participants: RR 1.58, 95% CI 0.71, 3.52; I = 0%; low certainty evidence) in CKD. Potassium binders may decrease systolic blood pressure (BP) (2 studies, 369 participants: MD -3.73 mmHg, 95%CI -6.64 to -0.83; I = 79%; low certainty evidence) and diastolic BP (one study) at the end of the treatment. No study reported outcome data for cardiac arrhythmias or major GI events. Calcium polystyrene sulfonate may make little or no difference to serum potassium levels at end of treatment, compared to sodium polystyrene sulfonate (2 studies, 117 participants: MD 0.38 mEq/L, 95% CI -0.03 to 0.79; I = 42%, low certainty evidence). There was no evidence of a difference in systolic BP (one study), diastolic BP (one study), or constipation (one study) between calcium polystyrene sulfonate and sodium polystyrene sulfonate. There was no difference between high-dose and low-dose patiromer for death (sudden death) (one study), stroke (one study), myocardial infarction (one study), or constipation (one study). The comparative effects whether potassium binders were administered with or without food, laxatives, or sorbitol, were very uncertain with insufficient data to perform meta-analysis.
AUTHORS' CONCLUSIONS
Evidence supporting clinical decision-making for different potassium binders to treat chronic hyperkalaemia in adults with CKD is of low certainty; no studies were identified in children. Available studies have not been designed to measure treatment effects on clinical outcomes such as cardiac arrhythmias or major GI symptoms. This review suggests the need for a large, adequately powered study of potassium binders versus placebo that assesses clinical outcomes of relevance to patients, clinicians and policy-makers. This data could be used to assess cost-effectiveness, given the lack of definitive studies and the clinical importance of potassium binders for chronic hyperkalaemia in people with CKD.
Topics: Aged; Cause of Death; Chelating Agents; Chelation Therapy; Chronic Disease; Humans; Hyperkalemia; Middle Aged; Polymers; Polystyrenes; Potassium; Quality of Life; Randomized Controlled Trials as Topic; Renal Insufficiency, Chronic; Silicates
PubMed: 32588430
DOI: 10.1002/14651858.CD013165.pub2