Long-term Clinical Performance Research Articles

Long-term performance of ceramic in/-onlays vs. cast gold partial crowns – a retrospective clinical study

ObjectivesTo assess the long-term clinical performance of ceramic in-/onlays (CIOs) and cast gold partial crowns (CGPCs) in posterior teeth in terms of success, survival, complications (biological, technical) and quality.Material and methodsIn a retrospective study, a total of 325 patients were recorded after up to 24.8 years (mean 13.9 ± 3.8 years) having (pre-)molars restored with CIO (Empress I, Ivoclar Vivadent, n = 161) and CGPC (Degunorm, DeguDent, n = 164) by supervised undergraduate students. A total of 296 restorations were assessed clinically and radiologically in healthy and endodontically treated teeth using modified United States Public Health Service (USPHS) criteria. Cumulative success and survival rates of the restorations were calculated using Kaplan–Meier estimates. Biological and technical complications were recorded. Status of oral health comprising caries risk and localized periodontitis were assessed.ResultsThe cumulative success rates of CIOs were 92.1% and of CGPCs 84.2% after mean service times of 14.5 years. The annual failure rates of total service times were 0.5% in teeth restored with CIO (n = 155) and 0.7% in teeth restored with CGPC (n = 163). The cumulative survival rates of CIOs were 93.9% after a mean service time of 15.2 years and decreased to 91.7% after 23.5 years. The cumulative survival rates of CGPCs were 92.6% after a mean service time of 14.9 years and 91.8% after 23.5 years. Complications in CIOs (n = 149) were ceramic fracture (6.7%), secondary caries (4.7%), endodontic complication (2.7%) and tooth fracture (1.3%) compared to CGPCs (n = 147) with endodontic complication (8.8%), secondary caries (4.8%) and decementation (2.0%). Endodontically treated teeth restored with CIO or CGPC revealed significantly less often success compared with corresponding vital teeth (p = .02). CIOs and CGPCs revealed clinically and radiographically good and excellent qualities with 71.8% (107/149) and 68% (100/147) without any significant differences regarding type of restoration.ConclusionsBoth CIOs and CGPCs achieved high survival rates up to 24.8 years when performed by supervised undergraduate students. The longevity of the restorations may benefit from the intraoral repair of accessible defects and, in case of pulp infection or necrosis, an adequate endodontic management.Clinical relevanceCIOs and CGPCs made by supervised undergraduate students are proper restoration types in posterior teeth in the long-term. An adequate preparation design, meticulous care in the inserting technique and constant biofilm removal due to proper oral hygiene combined with professional maintenance care are substantial. The clinical long-term performance was mostly limited by ceramic fractures in CIOs and endodontic complications in CGPCs.

Lithium Silicate-Based Glass Ceramics in Dentistry: A Narrative Review

Considering the rapid evolution of lithium silicate-based glass ceramics (LSCs) in dentistry, this review paper aims to present an updated overview of the recently introduced commercial novel LSCs. The clinical and in vitro English-language literature relating to the microstructure, manufacturing, strengthening, properties, surface treatments and clinical performance of LSC materials was obtained through an electronic search. Findings from relevant articles were extracted and summarised for this manuscript. There is considerable evidence supporting the mechanical and aesthetic competency of LSC variants, namely zirconia-reinforced lithium silicates and lithium–aluminium disilicates. Nonetheless, the literature assessing the biocompatibility and cytotoxicity of novel LSCs is scarce. An exploration of the chemical, mechanical and chemo-mechanical intaglio surface treatments—alternative to hydrofluoric acid etching—revealed promising adhesion performance for acid neutralisation and plasma treatment. The subtractive manufacturing methods of partially crystallised and fully crystallised LSC blocks and the additive manufacturing modalities pertaining to the fabrication of LSC dental restorations are addressed, wherein that challenges that could be encountered upon implementing novel additive manufacturing approaches using LSC print materials are highlighted. Furthermore, the short-term clinical performance of zirconia-reinforced lithium silicates and lithium–aluminium disilicates is demonstrated to be comparable to that of lithium disilicate ceramics and reveals promising potential for their long-term clinical performance.

Clinical evaluation of Giomer and self-etch adhesive compared with nanofilled resin composite and etch-and-rinse adhesive – Results at 8 years

ObjectiveThis study aimed to evaluate the long-term clinical performance of Giomer and a self-etch adhesive system compared with a nanofilled resin composite and etch-and-rinse adhesive system in Class I and Class II restorations. MethodThe study was designed to be double-blinded with intra-individual control. 48 patients with 54 pairs of cavities (class I or class II) were recruited. Each pair of restorations was placed with either BEAUTIFIL II (BF) and FL-BOND II (FL) or Filtek Z350 (Z350) and Scotchbond Multi-Purpose (SMP). Clinical evaluation was performed at baseline, 6-month, 18-month, 4-year and 8-year after placement according to modified USPHS criteria. Kaplan-Meier survival analysis and log rank tests were performed (SPSS 20.0, IBM Corporation, US) to compare the survival probability of different restorations.A generalized linear mixed model (GLMM) was adopted to assess the performance of the materials. The McNemar test was used to show significant changes for all the evaluation criteria and difference between them. ResultsAt the eight-year recall, 32 patients with 67 restorations were present. There were twelve restorations in total recorded as failure due to loss of retention, restoration fracture, secondary caries, tooth fracture or endodontic treatment due to pulp necrosis. The survival probabilities and calculated annual failure rate(AFR) of BF and Z350 restorations at 8-year were 87.2 % vs 87.8 % and 1.6 % vs 1.5 % respectively with no significant difference (p > 0.05)between the two materials. Over the recall time range of eight years, decreased possibility of alpha rating was observed for retention, marginal adaptation, marginal staining and surface roughness for both materials (p < 0.05). Decreased possibility of alpha rating was observed for surface staining and secondary caries for Z350 (p < 0.05) and restoration fracture for BF (p < 0.05), respectively. Comparing the two restorative systems over eight years, no significant difference was seen for linear decline of the possibility of alpha rating for any of the criteria evaluated (p > 0.05). ConclusionGiomer material and the self-etch adhesive system had comparable clinical performance with nanofilled resin composite and etch-and-rinse adhesive system over the observation period of eight years.

Comparative Long-Term Clinical Performance of Mechanical Aortic Valve Prostheses

Aggregated data and long-term follow-up in national health data registers offer the opportunity to compare the performance of mechanical aortic prostheses within the same population. To investigate the clinical performance of mechanical aortic valve prostheses. This nationwide cohort study included all 5224 patients who underwent primary mechanical aortic valve replacement in Sweden between January 1, 2003, and December 31, 2018. Statistical analysis was performed between May and September 2023. Surgical aortic valve replacement with the On-X, Carbomedics, Bicarbon, Standard, Regent, Open Pivot, Masters, or Advantage valve models. The primary outcome was all-cause mortality, and secondary outcomes were reintervention, heart failure, major bleeding, stroke, and embolic events. Regression standardization was used to account for baseline differences. Overall, 5224 patients (mean [SD] age, 56.8 [11.7] years; 3908 men [74.8%]) were included. Total follow-up time was 43 982 person-years (mean [SD], 8.4 [4.6] years; maximum, 17.2 years). After regression standardization, there was a significant difference in 10-year mortality between the Carbomedics model group (17%; 95% CI, 15%-18%), Regent model group (17%; 95% CI, 13%-20%), and Standard model group (17%; 95% CI, 14%-19%) compared with the Bicarbon model group (27%; 95% CI, 21%-34%). In this cohort study of mechanical valve surgical aortic replacement outcomes in Sweden, the rate of all-cause mortality was higher in the Bicarbon group than in the Carbomedics, Regent, and Standard model groups. These findings warrant further research on the long-term clinical performance of the Bicarbon valve.

How Does Ethylenediaminetetraacetic Acid Irrigation Affect Biodentine? A Multimethod Ex Vivo Study.

The activity of biomaterials used during endodontic treatment can be affected by various factors. One of them is the chemical action of the irrigant that they are exposed to. The aim of this multimethod ex vivo study was to evaluate the influence of ethylenediaminetetraacetic acid (EDTA) on the surface appearance and chemical composition of Biodentine used in perforation repair. Twenty material specimens were prepared according to manufacturers' recommendations and divided into two setting-time-based groups, tested after 45 min (group A) and 24 h (group B) of setting. Material was irrigated with 17% EDTA solution with or without simultaneous ultrasonic activation. The surface characteristics and the chemical composition analysis of the Biodentine specimens were performed with the aid of a scanning electron microscope (SEM) and an energy dispersive spectroscopy (EDS) method, respectively. The volumetric loss of material was measured by dedicated digital software in an optical microscope. Statistical analysis was performed. The EDS study confirmed that after the rinsing protocol, the percentage content of elements differed between the groups. The EDTA rinse, whether ultrasonically activated or not, visibly affected the surface appearance and chemical composition of Biodentine. The specimens' surface subjected to irrigation was more irregular under SEM than in a control group. The US activation of the liquid amplified its impact on the tested material. The average volume loss in group A after 5 min irrigation was 3.98 µm3 for each µm2 of the chosen area and it increased up to 7.74 µm3/μm2 after the ultrasonic activation. In group B, indicated volume loss values were 6.30 and 11.70 µm3/μm2 for 5 min irrigation without and with US activation, respectively. Using a 20 min irrigation time and ultrasonic activation increased it up to 32.71 µm3/µm2. Each rinsing protocol involving irrigation with ethylenediaminetetraacetic acid modified the surface features and the chemical composition of the evaluated hydraulic tricalcium silicate cement. Further research is needed to indicate the possible impact of the observed changes on its long-term clinical performance.

Novel high-efficiency plasma nitriding process utilizing a high power impulse magnetron sputtering discharge

Lifetime and biocompatibility of orthopedic implants are crucial in meeting the new challenges brought about by the fall in the patient age and the aging population. The high-load surfaces in contact with the biological environment must display enhanced tribological properties, biocompatibility, and reduced metal ion release in long-term clinical performance. Surface modification techniques such as nitriding can significantly improve the in-service behavior of the medical-grade alloys in current use. We report on a novel approach for nitriding of CoCrMo alloys using high power impulse magnetron sputtering (HIPIMS) discharge. The new nitriding process has been successfully carried out at the National HIPIMS Technology Centre at Sheffield Hallam University, UK, in an industrial size Hauzer 1000-4 system enabled with HIPIMS technology. While the nitriding ion flux is controlled by the HIPIMS magnetron plasma source, the ion energy can be independently set via the substrate bias. Implementing the HIPIMS source allows reducing the operational pressure by one order of magnitude compared to conventional dc plasma nitriding (DCPN). Plasma analyses have identified significantly enhanced production of ions of molecular nitrogen (N2+), atomic nitrogen (N+), and N2H+ radicals in the HIPIMS discharge compared to DCPN. Because of the low pressure of operation of the HIPIMS process, the energy of ions is similar to the bias voltage, whereas the high pressures used in DCPN cause severe losses in ion energy due to scattering collisions within the sheath. The high flux and high ion energy are primarily responsible for achieving a fourfold increase in process productivity as compared to state-of-the-art plasma nitriding processes. The nitrided surface layers exhibit excellent mechanical and tribological properties, which bring about significant improvements in hardness, fracture toughness, and wear. The protective function of the nitrided layer against corrosion in the aggressive environments of simulated body fluid is remarkably augmented. The barrier properties of the nitrided layer have been demonstrated through a reduction in metal ion release by as much as a factor of 2, 4, and 10 for Co, Cr, and Mo, respectively.

A single-center experience on long-term clinical performance of a rapid SARS-CoV-2 Antigen Detection Test, STANDARD Q COVID-19 Ag Test

The COVID-19 pandemic in Korea has dynamically changed with the occurrence of more easily transmissible variants. A rapid and reliable diagnostic tool for detection of SARS-CoV-2 is needed. While RT-PCR is currently the gold standard for detecting SARS-CoV-2, the procedure is time-consuming and requires expert technicians. The rapid antigen detection test (RADT) was approved as a confirmatory test on 14 March 2022 due to rapid dissemination of the Omicron variant. The benefits of the RADT are speed, simplicity, and point-of-care feasibility. The aim of our study was to evaluate the clinical performance of RADT compared to RT-PCR in a single center over 15 months, fully covering the SARS-CoV-2 ‘Variants of Concern (VOC).’ A total of 14,194 cases was simultaneously tested by RT-PCR and RADT from January 2021 to March 2022 in Gangnam Severance Hospital and were retrospectively reviewed. PowerChek SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit, and STANDARD Q COVID-19 Ag Test were used. Positive rates, sensitivities, specificities, positive predictive values (PPV), and negative predictive values (NPV) were estimated for five periods (3 months/period). Receiver operator characteristic curve (ROC) analysis was performed, and Spearman’s rank test assessed the correlation between RT-PCR Ct values and semi-quantitative RADT results. The overall positive rate of RT-PCR was 4.64%. The overall sensitivity and specificity were 0.577 [95% confidence interval (CI) 0.539–0.614] and 0.991 [95% CI 0.989–0.993], respectively. ROC analysis resulted in an area under the curve of 0.786 (P < 0.0001, Yuden’s index = 0.568). The PCR positive rates were estimated as 0.11%, 0.71%, 4.51%, 2.02%, and 13.72%, and PPV was estimated as 0.045, 0.421, 0.951, 0.720, and 0.798 in Periods 1, 2, 3, 4, and 5, respectively. A significant and moderate negative correlation between PCR Ct values and semi-quantitative RADT results was observed (Spearman’s ρ = − 0.646, P < 0.0001). The RADT exhibited good performance in specimens with low Ct values (Ct ≤ 25.00) by RT-PCR. The PPV was significantly higher in Periods 3 and 5, which corresponds to rapid dissemination of the Delta and Omicron variants. The high PPV implies that individuals with a positive RADT result are very likely infected with SARS-CoV-2 and would require prompt quarantine rather than additional RT-PCR testing. The sensitivity of 0.577 indicates that RADT should not replace RT-PCR. Nonetheless, given the high PPV and the ability to track infected persons through rapid results, our findings suggest that RADT could play a significant role in control strategies for further SARS-CoV-2 variants.

Long-term clinical outcome of three-unit fixed-fixed posterior zirconia ceramic inlay-retained FDPs with a modified design

ObjectivesTo assess the long-term clinical outcome of posterior inlay-retained fixed dental prostheses (IRFDPs) with a modified design made from zirconia ceramic. MethodsIn 30 patients thirty 3-unit IRFDPs were placed to replace 7 premolars (4 in the maxilla, 3 in the mandible), and 23 first molars (15 in the maxilla, 8 in the mandible). Preparations were accomplished in agreement with the general principles for ceramic inlay restorations and modified with a short retainer-wing bevel preparation within the enamel at the buccal and oral sides. The frameworks were milled from 3Y-TZP ceramic, and the pontics were veneered with feldspathic ceramic. All IRFDPs were bonded with a phosphate monomer containing luting resin after air-abrasion of the intaglio surfaces. The patients were recalled 6–12 months after placement, and then annually. Kaplan-Meier analysis was used to calculate the survival and complication rates of the IRFDPs. ResultsThe mean observation time was 10.6 ± 1.5 years. The 10-year cumulative survival rate was 89% with 4 failures, two of them were due to deep secondary caries with loss of retention, one due to repeated debonding with enamel fractures, and one due to generalized progressive periodontitis. The most common complication was chipping of the veneering ceramic (20.1%). Eighteen IRFDPs were free of any type of complication up to 15.4 years, which corresponds to a 10-year cumulative success rate of 70.4%. ConclusionThe long-term clinical performance of modified IRFDPs made of veneered zirconia ceramics was favorable after 10 years, therefore, they represent a treatment alternative to replace posterior single missing teeth. Clinical significanceZirconia-based IRFDPs fabricated in the modified design may represent a substance-preserving alternative to conventional posterior FDPs to replace posterior single missing teeth, particularly in cases where implants cannot be placed, and when the adjacent teeth already have small restorations or defects.

One-year clinical outcomes and the impact of procedural configurations in patients with left atrial appendage occlusion

Abstract Background To evaluate the long-term clinical performance, the impact of procedural configurations and post-procedure medications in atrial fibrillation patients with percutaneous left atrial appendage occlusion (LAAO). Methods The RECORD study was a prospective, all-comers registry conducted in 39 Chinese centers that consecutively enrolling patients who received LAAO between 1st April 2019 and 31st October 2020 with minimum inclusion and exclusion criteria. Events including any death, any stroke, systemic embolism and bleeding event were collected at 1 year and adjudicated by an independent clinical event committee. Cox proportional hazard models with multivariable adjustments were applied to estimate hazard ratios (HRs) for each outcome. Results Of the 3,096 participants, 3,082 successfully received an LAAO implant and 3,013 (97.8%) completed the 1-year follow-up. Participants had a high risk of stroke (mean CHA2DS2-VASc score of 4.0) and a moderate-to-high risk of bleeding (mean HAS-BLED score of 2.4). Local anesthetic was performed in 1,287 (41.6%) patients and fluoroscopy guidance in 492 (16.0%) patients. In 1295 (42.0%) cases, one-stage combination procedures of LAAO and radiofrequency ablation or cryoablation (CA) were performed. At 1 year, the composite ischemic endpoint of death, stroke, and systemic embolism occurred in 133 (4.51%) patients. Any life-threatening, disabling or major bleeding events occurred in 71 (2.36%) patients. There was no significant association between the type of anesthesia (general versus local), modality of image guidance (TEE, ICE, or fluoroscopy) with the ischemic or bleeding events. Combination procedures of LAAO plus CA was associated with a significantly lower rate of death, stroke, or systemic embolism than performing LAAO only (3.5% versus 5.2%, HRadjusted:0.69, 95%CI:0.48-0.98, P=0.041). The commonest antithrombotic strategy was OAC | APT | APT (38.1%; corresponded to medication prescribed at discharge | 45 days | 6 months), followed by OAC | OAC | APT (27.0%). Compared with OAC | APT | APT, the OAC | OAC | APT group was associated with a higher risk of life-threatening, disabling or major bleeding (1.2% versus 2.5%, HRadjusted:0.50, 95%CI: 0.25-0.99, P=0.47); whereas the risk of death, stroke and SE was numerically similar (2.9% versus 3.0%, HRadjusted:1.05, 95%CI: 0.61-1.78, P=0.867). There was no significant difference between OAC | APT | APT and OAC+APT | APT | APT groups regarding ischemic events; however, in patients with HAS-BLED ≥ 3, OAC | APT | APT was associated with lower rates of life-threatening, disabling or major bleeding events (1.1% versus 4.8%, HRadjusted:4.55, 95%CI: 1.31-15.81, P=0.017). Conclusion In Chinese centers, patients with a WATCHMAN LAAO device had low rates of ischemic and bleeding events at 1 year. One-stage combination procedures of LAAO and catheter ablation was associated with a significantly lower rate of ischemic events than performing LAAO only.Procedural configurations to outcomesPost-LAAO antithrombotic medications

Clinical Performance of Minimally Invasive Monolithic Ultratranslucent Zirconia Veneers: A Case Series up to Five Years of Follow-up

SUMMARY There is a lack of reports in the literature on the long-term clinical performance of ultratranslucent zirconia, especially considering its use in manufacturing monolithic veneers. The purpose of this case series is to describe the aesthetic treatment steps of three patients with minimally invasive ultratranslucent zirconia veneers and to report the clinical findings up to five years. Three patients (woman: 2, man: 1; mean age: 30 years) unsatisfied with their dental aesthetics sought dental treatment. The treatment plan involved cementing ultratranslucent zirconia veneers. Air-abrasion was performed on the internal surface of zirconia with alumina particles coated by silica (silicatization), followed by silane and adhesive applications for the adhesive cementation. All veneers were adhesively cemented to enamel with resin cement (Variolink Esthetic, Ivoclar). The patients were clinically evaluated annually considering the Ryge modified/ California Dental Association criteria. After a mean follow-up of 4.33 years (4-5 years), a survival rate of 100% was detected for the 28 minimally invasive ultratranslucent zirconia veneers cemented in the 3 patients. There were no absolute failures such as debonding, veneer fracture, or secondary caries. Superficial marginal discoloration was observed in one element (maxillary left lateral incisor) of one patient. Ultratranslucent zirconia is a viable option for manufacturing veneers due to its excellent clinical performance and longevity. However, further long-term clinical studies are essential to consolidate this material as an option for esthetic restorations.

Applications, benefits, and limitations of fiber-reinforced composites in fixed prosthodontics

This study offers a comprehensive evaluation of the efficacy, benefits, and limitations of fiber-reinforced composites (FRCs) in fixed prosthodontics. Emerging as a substitute for conventional dental materials such as metals and ceramics, FRCs are now used in a variety of applications, from dental crowns and bridges to veneers. The study is based on an exhaustive literature review and explores various properties of FRCs, such as mechanical, optical, viscoelastic, adhesive, and thermal attributes. The strength and rigidity of constructions made from FRC are dependent on the polymer matrix of the FRC and the type of fiber reinforcement. In dental appliances of relatively small sizes, the quality of the load bearing FRC sub-structure is very important. A special emphasis is placed on the clinical applications and future potential of these materials. The advantages of using FRCs include their biocompatibility, light weight, durability, and aesthetic superiority. However, there are limitations, such as higher costs and concerns about long-term clinical performance, specifically related to interface degradation. The study concludes that FRCs hold significant promise in the domain of fixed prosthodontics, although further research is needed for optimizing their long-term effectiveness.

Long-term clinical performance of short 6-mm implants supporting single crowns in the posterior region: A 10-year cohort study.

Long-term clinical success of non-splinted, posterior, and short implants still is unclear. This prospective cohort study reports the 10-year follow-up of 6-mm implants supporting single crowns in the posterior region, and patient-reported outcomes. Baseline sample comprised 20 patients treated with 46 screw-retained crowns supported by 6-mm implants with moderately rough implant surface. Participants were recalled for a 10-year clinical follow-up to assess survival rates, biologic and mechanic conditions, quality of life (OHIP-14), and treatment satisfaction. Data were collected with clinical-radiographic exams and analyzed using descriptive and inferential statistics. Fourteen patients with 35 implant-crown units were examined after 127.6 ± 11.8 months. For the entire cohort period, 7/46 implants were lost (survival estimate: 77.7% at 133 months), and mechanic complications occurred in 14/46 units (survival estimate: 66.4% at 116 months). In the Cox models, "maximum occlusal force" had a significant effect for implant loss (p = 0.038) and for prosthetic screw loosening (p = 0.038); "arch" and "bruxism" were not significant. Peri-implant bone loss was 0.4 ± 0.6 mm at 10 years. For peri-implant bone level, "crown-to-implant ratio" (p < 0.001) and "time" (p = 0.001) were significant. Bone levels differed from baseline to 12, 48, and 120 months. Satisfaction VAS was 94.0 ± 7.9 mm and OHIP-14 was 2.3 ± 2.2. Single screw-retained crowns supported by 6-mm implants have an acceptable long-term clinical performance, with stable peri-implant bone levels after 10 years of function.

Retrospective evaluation of factors affecting long-term clinical performance of CAD-CAM laminate veneers.

The purpose of the study was to assess the clinical performance of CAD-CAM laminate veneers placed by a single operator and systematically evaluated for up to 10 years. A total of 197 laminate veneers fabricated using either feldspathic ceramic (VMII) or lithium disilicate ceramic (EmaxCAD) were followed up to 10 years in 32 patients. Technical, esthetical, and biological findings of each restoration were evaluated using modified United States Public Health Service criteria. The survival and complication rates were assessed using Kaplan-Meier survival analysis and compared using the Log Rank test. Statistical significance was set at p<0.05. The estimated Kaplan-Meier survival rate was 91.9% after the mean observation period. According to ceramic system used, the estimated Kaplan-Meier survival rate amounted to 92.7% for Emax-CAD and to 89.1% for VMII. Survival rates were significantly affected by the location of veneer according to Log Rank test (p < 0.05). A range of survival rates between 83.3% and 98.6% were observed based on the location of veneer. CAD-CAM laminate veneers milled of feldspathic or lithium disilicate ceramics have comparable long-term survival rates. Oral positioning affects the survival of veneer. Veneers of incisors have higher survival rates than the veneers of maxillary canines and premolars.

Present Status of the Effectiveness of the Patch Test Reagent for Titanium Hypersensitivity

Titanium and titanium alloys have been used for dental implants, due to their excellent biocompatibility and suitable mechanical properties. The frequency in use of titanium and titanium alloys for dental applications has gradually increased. For example, in 2020, a Japanese insurance approved the use of pure titanium for posterior molars as a metallic cast crown. Titanium alloys have also been used for frameworks of removable partial denture. Allergic reactions to titanium and titanium alloys are rare but do occur. One theory of unexplained implant loss is that the patient is hypersensitive to titanium. The hypersensitivity causes an inflammatory reaction to the implant body and failure to osseointegrate, resulting in implant failure. The patch test for diagnosis of titanium hypersensitivity has been unreliable because the result of the patch test does not match the clinical symptoms. Standard titanium reagents for patch tests are needed for accurate diagnosis of titanium hypersensitivity to prevent the failure of implants.&#x0D; The objective of this review was to evaluate literature reporting the status of allergic diagnosis for titanium hypersensitivity and analyze the results mentioned. Based on these results, a possible standardization of the titanium reagent for the patch test were discussed. These searched literatures indicated that further national and/or registry based studies will be needed to better inform clinical practice and to identify the scale of metal sensitivity, clear diagnostic criteria, and long-term clinical performance data on hypoallergenic implants.

Safety and Efficacy of the Sientra Silicone Gel Round and Shaped Breast Implants: 6-Year Results of the US Post-Approval Study.

After approval of Sientra silicone gel breast implants in March of 2012, the U.S. Food and Drug Administration required completion of a 10-year U.S. post-approval study. We present results from the first 6 years of this study. An ongoing, open-label, prospective, multicenter study is being conducted to evaluate the long-term clinical performance of Sientra implants in patients receiving breast augmentation, reconstruction, and revision in the post-market environment. Enrollment of 5197 patients (10,327 implants) was completed on March 6, 2015, (4046 primary augmentation, 895 revision-augmentation, 149 primary reconstruction, and 107 revision-reconstruction). Analyses were conducted at year 6 (database lock: January 24, 2022). Across all cohorts who received an implant, the Kaplan-Meier risk of investigator-reported Baker grade III/IV capsular contracture was 4.1 percent (3.9 percent with submuscular placement and 6.7 percent with subglandular placement), the risk of reoperation was 11.6 percent, and the risk of implant removal was 7.8 percent (5.9 percent with implant replacement and 2.0 percent without replacement). The primary reason (over 50 percent) for reoperation was aesthetic (e.g., style/size change). The Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8 percent. Overall, 82.6 percent of patients were highly satisfied/happy with their implant. No cases of breast implant-associated anaplastic large cell lymphoma were reported. Six-year results of the post-approval study were consistent with the 10-year core study and provide additional evidence in a large dataset supporting the comprehensive safety and effectiveness profile of the Sientra implants.

Total Rehabilitation Using Adhesive Dental Restorations in Patients with Severe Tooth Wear: A 5-Year Retrospective Case Series Study.

Currently, there is little clinical evidence to support the medium- and long-term survival and clinical performance of ultraconservative approaches using adhesive restorations in full-mouth restorations. The aim of this case series study was to evaluate the medium-term clinical performance of anterior and posterior adhesive restorations applied with direct and indirect techniques using resin composites and glass-ceramic-based materials. The inclusion criteria were an esthetic problem as the main reason for consultation and severe generalized wear of grade 2 to 4 according to the Tooth Wear Evaluation System (TWES 2.0). In addition, at each follow-up appointment, patients were required to submit a clinical-parameter-monitoring record according to the modified United States Public Health Service (USPHS) criteria. Eight patients with severe tooth wear were treated through full rehabilitation in a private dental clinic in Spain by a single operator (AFC). A total of 212 restorations were performed, which were distributed as follows: 66 occlusal veneers, 26 palatal veneers and 120 vestibular veneers. No signs of marginal microleakage or postoperative sensitivity were observed in any occlusal, vestibular and/or palatal restoration after the follow-up period. The estimated survival rate of the 212 restorations was 90.1% over 60 months of observation, with a survival time of 57.6 months. Only 21 restorations had complications, which were mostly resolved with a direct composite resin. The dichotomous variables of the restoration type (posterior veneer, anterior veneer) and the type of restored tooth (anterior, posterior) were the risk predictors with statistically significant influences (p < 0.005) on the survival of the restorations. According to the results of this study, there is a significantly higher risk of restorative complications in posterior teeth compared to anterior teeth. Also, it can be concluded that the indication of adhesive anterior and posterior restorations is justified in the total oral rehabilitation of patients with severe multifactorial tooth wear, as they are associated with a low risk of failure.

Randomized Clinical Split-Mouth Study on Partial Ceramic Crowns Luted with a Self-adhesive Resin Cement with or without Selective Enamel Etching: Long-Term Results after 15 Years.

This follow-up of a randomized clinical split-mouth study aimed to investigate the influence of selective enamel etching on the long-term clinical performance of partial ceramic crowns (PCCs) luted with a self-adhesive resin cement. 43 patients received two PCCs (Vita Mark II; Cerec 3D) each for the restoration of extensive lesions with multiple cusp coverage, inserted with a self-adhesive resin cement (RelyX Unicem, RXU). Using a split-mouth design, one PCC received additional selective enamel etching (RXU+E) and one did not (RXU-E). Patients were clinically evaluated at baseline and after up to 15 years (median observation period 176 months) using modified USPHS and FDI criteria. The data were analyzed non-parametrically (chi-squared tests, α = 0.05). Clinical survival of all restorations after 15 years was evaluated using the Kaplan-Meier analysis. After 15 years, 19 patients were available for clinical assessment (recall rate: 56%). Kaplan-Meier analysis showed a cumulative survival of 78.1% for RXU+E and of 42.9% for RXU-E, indicating a significantly higher survival rate for RXU+E (p = 0.004). Regarding the clinical performance of PCCs available for the 15-year evaluation, no statistically significant differences were found between RXU+E and RXU-E using modified USPHS and FDI criteria. Both groups revealed significant deterioration over time regarding surface luster, marginal adaptation, and marginal discoloration. RXU+E resulted in significantly inferior anatomic form over time and a significant improvement in post-operative hypersensitivity compared to baseline. For posterior PCCs, selective enamel etching can be recommended based on higher survival rates after 15 years. Clinically, deterioration due to aging is similar in both groups.

Clinical application of direct composite resin in esthetic restoration

The direct composite resin bonding is widely used in the esthetic restorations of anterior teeth. Due to the technique sensitive procedure, the esthetic effect and long-term clinical performance of direct composite resin restoration have long been the focus of dental clinicians. This article will analyze the influencing factors of esthetic effect of composite resin from three aspects, including materials, teeth and technology. Also, it will summarize the clinical performance of direct composite resin from the perspective of esthetic evaluation. Eventually, this article will provide guidance for the clinical application of esthetic restoration of direct composite resin bonding.

Clinical survival and performance of premolars restored with direct or indirect cusp-replacing resin composite restorations with a mean follow-up of 14 years.

The objective is to evaluate the long-term clinical survival and performance of direct and indirect resin composite restorations replacing cusps in vital upper premolars. Between 2001 and 2007, 176 upper premolars in 157 patients were restored with 92 direct and 84 indirect resin composite restorations as part of an RCT. Inclusion criteria were fracture of the buccal or palatal cusp of vital upper premolars along with a class II cavity or restoration in the same tooth. Forty patients having 23 direct and 22 indirect composite restorations respectively, were lost to follow-up (25.6%). The cumulative Kaplan-Meier survival rates were 63.6% (mean observation time: 15.3 years, SE 5.6%) with an AFR of 2.4% for direct restorations and 54.5% (mean observation time: 13.9 years, SE: 6.4%) with an AFR of 3.3% for indirect restorations. The Cox regression analysis revealed a statistically significant influence of the patient's age at placement on the survival of the restoration (HR 1.036, p=0.024), the variables gender, type of upper premolar, type of restoration, and which cusp involved in the restoration had no statistically significant influence. Direct composite restorations failed predominantly due to tooth fracture, indirect restorations primarily by adhesive failure (p<0.05). There was no statistically significant difference in survival rates between direct and indirect composite cusp-replacing restorations. Both direct and indirect resin composite cusp-replacing restorations are suitable options to restore compromised premolars. The longer treatment time and higher costs for the indirect restoration argue in favor of the direct technique.

15-Year Post-Market Clinical Follow-up Study of 1,828 Ceramic (Zirconia) Implants in Humans.

Purpose: To evaluate the 15-year survival rate of zirconia (Y-TZP) implants with a roughened acid-etched surface in a retrospective post-market clinical follow-up (PMCF) study. Materials and Methods: One-piece ceramic implants (CeraRoot) with a roughened acid-etched surface (ICE) were used. Six different implant shapes/sizes were used in this study. Either a standard or flapless surgical approach was used for implant placement. Simultaneous bone augmentation or sinus elevation was performed when bone height or width was deficient. Definitive zirconia restorations were placed after 2 months or later if the Periotest value was > -3. The implants were followed up for up to 15 years. Results: A total of 1,828 implants were placed in 771 patients with a mean age of 51.18 years. The overall implant survival rate after 15 years of follow-up was 98.69%. Conclusion: From this long-term investigation, it can be concluded that CeraRoot ceramic implants showed a 15-year long-term clinical performance with a survival rate of 98.69% under the described protocol, without significant differences between the six implant shapes/sizes.