Immunogenicity of High-Dose Versus MF59-Adjuvanted Versus Standard Influenza Vaccine in Solid Organ Transplant Recipients: The Swiss/Spanish Trial in Solid Organ Transplantation on Prevention of Influenza (STOP-FLU Trial).

BACKGROUND: The immunogenicity of the standard influenza vaccine is reduced in solid-organ transplant (SOT) recipients, so new vaccination strategies are needed in this population. METHODS: Adult SOT recipients from 9 transplant clinics in Switzerland and Spain were enrolled if they were >3 months after transplantation. Patients were randomized (1:1:1) to a MF59-adjuvanted or a high-dose vaccine (intervention), or a standard vaccine (control), with stratification by organ and time from transplant. The primary outcome was vaccine response rate, defined as a ≥4-fold increase of hemagglutination-inhibition titers to at least 1 vaccine strain at 28 days postvaccination. Secondary outcomes included polymerase chain reaction-confirmed influenza and vaccine reactogenicity. RESULTS: A total of 619 patients were randomized, 616 received the assigned vaccines, and 598 had serum available for analysis of the primary endpoint (standard, n = 198; MF59-adjuvanted, n = 205; high-dose, n = 195 patients). Vaccine response rates were 42% (84/198) in the standard vaccine group, 60% (122/205) in the MF59-adjuvanted vaccine group, and 66% (129/195) in the high-dose vaccine group (difference in intervention vaccines vs standard vaccine, 0.20; 97.5% confidence interval [CI], .12-1); P < .001; difference in high-dose vs standard vaccine, 0.24 [95% CI, .16-1]; P < .001; difference in MF59-adjuvanted vs standard vaccine, 0.17 [97.5% CI, .08-1]; P < .001). Influenza occurred in 6% of the standard, 5% in the MF59-adjuvanted, and 7% in the high-dose vaccine groups. Vaccine-related adverse events occurred more frequently in the intervention vaccine groups, but most of the events were mild. CONCLUSIONS: In SOT recipients, use of an MF59-adjuvanted or a high-dose influenza vaccine was safe and resulted in a higher vaccine response rate. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov NCT03699839.

Immune Monitoring-Guided Versus Fixed Duration of Antiviral Prophylaxis Against Cytomegalovirus in Solid-Organ Transplant Recipients: A Multicenter, Randomized Clinical Trial.

BACKGROUND: The use of assays detecting cytomegalovirus (CMV)-specific T cell-mediated immunity may individualize the duration of antiviral prophylaxis after transplantation. METHODS: In this randomized trial, kidney and liver transplant recipients from 6 centers in Switzerland were enrolled if they were CMV-seronegative with seropositive donors or CMV-seropositive receiving antithymocyte globulins. Patients were randomized to a duration of antiviral prophylaxis based on immune monitoring (intervention) or a fixed duration (control). Patients in the control group were planned to receive 180 days (CMV-seronegative) or 90 days (CMV-seropositive) of valganciclovir. Patients were assessed monthly with a CMV ELISpot assay (T-Track CMV); prophylaxis in the intervention group was stopped if the assay was positive. The co-primary outcomes were the proportion of patients with clinically significant CMV infection and reduction in days of prophylaxis. Between-group differences were adjusted for CMV serostatus. RESULTS: Overall, 193 patients were randomized (92 in the immune-monitoring group and 101 in the control group), of whom 185 had evaluation of the primary outcome (87 and 98 patients). CMV infection occurred in 26 of 87 (adjusted percentage, 30.9%) in the immune-monitoring group and in 32 of 98 (adjusted percentage, 31.1%) in the control group (adjusted risk difference, -0.1; 95% confidence interval [CI], -13.0% to 12.7%; P = .064). The duration of prophylaxis was shorter in the immune-monitoring group (adjusted difference, -26.0 days; 95%, CI, -41.1 to -10.8 days; P < .001). CONCLUSIONS: Immune monitoring resulted in a significant reduction of antiviral prophylaxis, but we were unable to establish noninferiority of this approach on the co-primary outcome of CMV infection. CLINICAL TRIALS REGISTRATION: NCT02538172.

Randomized Trial to Assess the Clinical Utility of Renal Allograft Monitoring by Urine CXCL10 Chemokine.

SIGNIFICANCE STATEMENT: This study is the first randomized controlled trial to investigate the clinical utility of a noninvasive monitoring biomarker in renal transplantation. Although urine CXCL10 monitoring could not demonstrate a beneficial effect on 1-year outcomes, the study is a rich source for future design of trials aiming to explore the clinical utility of noninvasive biomarkers. In addition, the study supports the use of urine CXCL10 to assess the inflammatory status of the renal allograft. BACKGROUND: Urine CXCL10 is a promising noninvasive biomarker for detection of renal allograft rejection. The aim of this study was to investigate the clinical utility of renal allograft monitoring by urine CXCL10 in a randomized trial. METHODS: We stratified 241 patients, 120 into an intervention and 121 into a control arm. In both arms, urine CXCL10 levels were monitored at three specific time points (1, 3, and 6 months post-transplant). In the intervention arm, elevated values triggered performance of an allograft biopsy with therapeutic adaptations according to the result. In the control arm, urine CXCL10 was measured, but the results concealed. The primary outcome was a combined end point at 1-year post-transplant (death-censored graft loss, clinical rejection between month 1 and 1-year, acute rejection in 1-year surveillance biopsy, chronic active T-cell-mediated rejection in 1-year surveillance biopsy, development of de novo donor-specific HLA antibodies, or eGFR <25 ml/min). RESULTS: The incidence of the primary outcome was not different between the intervention and the control arm (51% versus 49%; relative risk (RR), 1.04 [95% confidence interval, 0.81 to 1.34]; P = 0.80). When including 175 of 241 (73%) patients in a per-protocol analysis, the incidence of the primary outcome was also not different (55% versus 49%; RR, 1.11 [95% confidence interval, 0.84 to 1.47]; P = 0.54). The incidence of the individual end points was not different as well. CONCLUSIONS: This study could not demonstrate a beneficial effect of urine CXCL10 monitoring on 1-year outcomes (ClinicalTrials.gov_ NCT03140514 ).

Surgical site infections after kidney transplantation are independently associated with graft loss.

Surgical site infections (SSIs) are common health care-associated infections. SSIs after kidney transplantation (K-Tx) can endanger patient and allograft survival. Multicenter studies on this early posttransplant complication are scarce. We analyzed consecutive adult K-Tx recipients enrolled in the Swiss Transplant Cohort Study who received a K-Tx between May 2008 and September 2020. All data were prospectively collected with the exception of the categorization of SSI which was performed retrospectively according to the Centers for Disease Control and Prevention criteria. A total of 58 out of 3059 (1.9%) K-Tx recipients were affected by SSIs. Deep incisional (15, 25.9%) and organ/space infections (34, 58.6%) predominated. In the majority of SSIs (52, 89.6%), bacteria were detected, most frequently Escherichia coli (15, 28.9%), Enterococcus spp. (14, 26.9%), and coagulase-negative staphylococci (13, 25.0%). A BMI ≥25 kg/m2 (multivariable OR 2.16, 95% CI 1.07-4.34, P = .023) and delayed graft function (multivariable OR 2.88, 95% CI 1.56-5.34, P = .001) were independent risk factors for SSI. In Cox proportional hazard models, SSI was independently associated with graft loss (multivariable HR 3.75, 95% CI 1.35-10.38, P = .011). In conclusion, SSI was a rare complication after K-Tx. BMI ≥25 kg/m2 and delayed graft function were independent risk factors. SSIs were independently associated with graft loss.

Performance of synacthen test in chronic hemodialysis patients.

BACKGROUND: Adrenal function tests (Synacthen test) in chronic hemodialysis (HD) patients are currently performed off dialysis. The study aimed to demonstrate equivalence of serum cortisol concentrations pre- and during HD, each for standard-dose (250 µg) and low-dose (1 µg) Synacthen test. METHODS: In a single-center cross-over diagnostic equivalence study, Synacthen tests were performed in four settings, in standard- and low-dose as well as pre- and during HD. Serum cortisol concentration was measured at 30 and 60 min after Synacthen administration, and additionally at 20 min in low dose test. Based on a multivariable linear mixed model the means of cortisol concentration on log-scale were estimated in each dose and test time combination. Differences in means were calculated and the TOST approach was applied to test for equivalence. Equivalence was proven if the 90% confidence interval of the difference of two cortisol means was entirely between - 0.22 and 0.22. RESULTS: In 28 chronic HD patients, serum cortisol concentrations at 30 and 60 min after Synacthen administration in both standard- and low-dose were shown to be equivalent pre- and during HD. In 10 of 56 low-dose tests, the cortisol peak was already reached after 20 min. However, cortisol concentrations at 20 and 30 min after low-dose Synacthen test pre- and during HD showed no significant difference. CONCLUSION: These results suggest that the adrenal function test may be carried out during an ongoing HD session, leading to a more patient-friendly performance of the test, less organizational effort and potentially earlier diagnosis of adrenal insufficiency.

Epidemiology and outcomes of bone and joint infections in solid organ transplant recipients.

Bone and joint infection (BJI) epidemiology and outcomes in solid organ transplant recipients (SOTr) remain largely unknown. We aim to describe BJI in a multi-center cohort of SOTr (Swiss Transplant Cohort Study). All consecutive SOTr with BJI (01.05.2008-31.12.2019) were included. A nested case-control study to identify risk factors for BJI was performed. Among 4482 patients, 61 SOTr with 82 BJI were included, at an incidence of 1.4% (95% CI 1.1-1.7), higher in heart and kidney-pancreas SOTr (Gray's test p < .01). Although BJI were predominately late events (median of 18.5 months post-SOT), most infections occurred during the first year post-transplant in thoracic SOTr. Diabetic foot osteomyelitis was the most frequent infection (38/82, 46.3%), followed by non-vertebral osteomyelitis (26/82, 31.7%). Pathogens included Gram-positive cocci (70/131, 53.4%), Gram-negative bacilli (34/131, 26.0%), and fungi (9/131, 6.9%). BJI predictors included male gender (OR 2.94, 95% CI 1.26-6.89) and diabetes (OR 2.97, 95% CI 1.34-6.56). Treatment failure was observed in 25.9% (21/81) patients and 1-year mortality post-BJI diagnosis was 14.8% (9/61). BJI remain a rare event in SOTr, associated with subtle clinical presentations, high morbidity and relapses, requiring additional studies in the future.

Recurrence of IgA nephropathy after kidney transplantation: experience from the Swiss transplant cohort study.

BACKGROUND: Recurrence of IgA nephropathy (IgAN) after kidney transplantation occurs in about 30% of patients. The relevance of recurrence for the long-term graft survival is expected to increase, since graft survival continues to improve. METHODS: In a nested study within the Swiss Transplant Cohort Study the incidence of IgAN recurrence, predictive factors, graft function and graft and patient survival were evaluated. Serum concentration of total IgA, total IgG, Gd-IgA1 and IgA-IgG immune complex were measured using ELISA-based immunologic assays. RESULTS: Between May 2008 and December 2016, 28 women and 133 men received their kidney allograft for end-stage kidney disease due to IgAN in Switzerland. Over a median follow-up time of 7 years after transplantation, 43 out of 161 patients (26.7%) developed an IgAN recurrence, of which six (13.9%) had an allograft failure afterwards and further four patients (9.3%) died. During the same follow-up period, 6 out of 118 patients (5%) each experienced allograft failure or died without prior IgAN recurrence. After 11 years the risk for IgAN recurrence was 27.7% (95%-CI: 20.6-35.3%). Renal function was similar in patients with and without recurrence up to 7 years after transplantation, but worsened thereafter in patients with recurrence (eGFR median (interquartile range) at 8 years: 49 ml/min/1.73m2 (29-68) vs. 60 ml/min/1.73m2 (38-78)). Serum concentration of total IgA, total IgG, Gd-IgA1 and IgA-IgG immune complex within the first year posttransplant showed no significant effect on the recurrence of IgAN. Younger recipients and women had a higher risk of recurrence, but the latter only in the short term. CONCLUSIONS: Our study showed a recurrence risk of 28% at 11 years after transplantation, which is consistent with previous literature. However, the predictive value of known biomarkers, such as serum Gd-IgA1 and IgA-IgG IC, for IgAN recurrence could not be confirmed.

Outcome of kidney transplantation from very senior donors in Switzerland - a national cohort study.

Kidney transplantation from older and marginal donors is effective to confront organ shortage. However, limitations after transplantation of kidneys from very marginal kidney donors remain unclear. We compared patient and graft outcome, achieved allograft function and quality of life of renal transplantations from Very Senior Donors (VSD, defined as donors aged 70 years and older) with Senior Donors (SD, aged 60-70 years) and Regular Donors (RD, aged younger than 60 years) in Switzerland. We evaluated the outcome of 1554 adult recipients of deceased donor kidney transplantations from 05/2008 to 12/2019; median follow-up was 4.7 years. Failure-free survival (freedom from graft loss or death), glomerular filtration rate (eGFR), and quality of life at 12 months were analyzed for RD (reference group, n = 940), SD (n = 404), and VSD (n = 210). Failure-free survival decreased with increasing donor age, mainly attributable to premature graft loss. Still, overall 5-year failure-free survival reached 83.1%, 81.0%, and 64.0% in the RD, SD, and VSD subgroups, respectively. eGFR 12 months post-transplantation was significantly higher in RD compared with SD and VSD. The acceptance rate of donor candidates for kidney TPL was 78% for the entire cohort (87% for RD, 79% for SD, and 56% for VSD). Deceased donor kidney transplantation from donors aged 70 years or older is associated with an inferior, yet acceptable failure-free outcome, with sustained quality of life.

Skin Cancer Development in Solid Organ Transplant Recipients in Switzerland (Swiss Transplant Cohort Study).

IMPORTANCE: Skin cancer, in particular squamous cell carcinoma, is the most frequent malignancy among solid organ transplant recipients with a higher incidence compared to the general population. OBJECTIVE: To determine the skin cancer incidence in organ transplant recipients in Switzerland and to assess the impact of immunosuppressants and other risk factors. DESIGN: Prospective cohort study of solid organ transplant recipients in Switzerland enrolled in the Swiss Transplant Cohort Study from 2008 to 2013. PARTICIPANTS: 2,192 solid organ transplant recipients. MATERIALS AND METHODS: Occurrence of first and subsequent squamous cell carcinoma, basal cell carcinoma, melanoma and other skin cancers after transplantation extracted from the Swiss Transplant Cohort Study database and validated by medical record review. Incidence rates were calculated for skin cancer overall and subgroups. The effect of risk factors on the occurrence of first skin cancer and recurrent skin cancer was calculated by the Cox proportional hazard model. RESULTS: In 2,192 organ transplant recipients, 136 (6.2%) developed 335 cases of skin cancer during a median follow-up of 32.4 months, with squamous cell carcinoma as the most frequent one. 79.4% of skin cancer patients were male. Risk factors for first and recurrent skin cancer were age at transplantation, male sex, skin cancer before transplantation and previous transplantation. For a first skin cancer, the number of immunosuppressive drugs was a risk factor as well. CONCLUSIONS AND RELEVANCE: Skin cancer following solid organ transplantation in Switzerland is greatly increased with risk factors: age at transplantation, male sex, skin cancer before transplantation, previous transplantation and number of immunosuppressive drugs.

Burden and Timeline of Infectious Diseases in the First Year After Solid Organ Transplantation in the Swiss Transplant Cohort Study.

BACKGROUND: The burden and timeline of posttransplant infections are not comprehensively documented in the current era of immunosuppression and prophylaxis. METHODS: In this prospective study nested within the Swiss Transplant Cohort Study (STCS), all clinically relevant infections were identified by transplant-infectious diseases physicians in persons receiving solid organ transplant (SOT) between May 2008 and December 2014 with ≥12 months of follow-up. RESULTS: Among 3541 SOT recipients, 2761 (1612 kidney, 577 liver, 286 lung, 213 heart, and 73 kidney-pancreas) had ≥12 months of follow-up; 1520 patients (55%) suffered 3520 infections during the first year posttransplantation. Burden and timelines of clinically relevant infections differed between transplantations. Bacteria were responsible for 2202 infections (63%) prevailing throughout the year, with a predominance of Enterobacteriaceae (54%) as urinary pathogens in heart, lung, and kidney transplant recipients, and as digestive tract pathogens in liver transplant recipients. Enterococcus spp (20%) occurred as urinary tract pathogens in kidney transplant recipients and as digestive tract pathogens in liver transplant recipients, and Pseudomonas aeruginosa (9%) in lung transplant recipients. Among 1039 viral infections, herpesviruses predominated (51%) in kidney, liver, and heart transplant recipients. Among 263 fungal infections, Candida spp (60%) prevailed as digestive tract pathogens in liver transplant recipients. Opportunistic pathogens, including Aspergillus fumigatus (1.4%) and cytomegalovirus (6%), were rare, scattering over 12 months across all SOT recipients. CONCLUSIONS: In the current era of immunosuppression and prophylaxis, SOT recipients experience a high burden of infections throughout the first year posttransplantation, with rare opportunistic pathogens and a predominance of bacteria.

New-onset obesity after liver transplantation-outcomes and risk factors: the Swiss Transplant Cohort Study.

Weight gain after liver transplantation (LTx) facilitates development of new-onset obesity; however, its risk factors and outcomes are poorly understood. We identified the impact of new-onset obesity on cardiovascular events (CVEs) and patient survival, and risk factors for new-onset obesity. Multiple Cox regression models examined risk factors for CVEs, patient survival, and new-onset obesity in 253 adults (mean age 52.2 ± 11.6 years, male gender 63.6%, mean follow up 5.7 ± 2.1 years). Cumulative incidence of post-LTx CVE was 28.1%; that of new-onset obesity was 21.3%. Regardless of CVE at LTx, post-LTx CVEs were predicted by new-onset obesity [Hazard Ratio (HR), 2.95; P = 0.002] and higher age at LTx (HR, 1.05; P < 0.001). In patients without known pre-LTx CVEs (n = 214), risk factors for post-LTx CVEs were new-onset obesity (HR, 2.59; P = 0.014) and higher age (HR, 1.04; P = 0.001). Survival was not associated with new-onset obesity (P = 0.696). Alcoholic liver disease predicted new-onset obesity (HR, 3.37; P = 0.025), female gender was protective (HR, 0.39; P = 0.034). In 114 patients with available genetic data, alcoholic liver disease (HR, 12.82; P = 0.014) and hepatocellular carcinoma (HR, 10.02; P = 0.048) predicted new-onset obesity, and genetics remained borderline significant (HR, 1.07; P = 0.071). Early introduction of post-LTx weight management programs may suggest a potential pathway to reduce CVE risk.

Incidence and outcome of invasive fungal diseases after allogeneic hematopoietic stem cell transplantation: A Swiss transplant cohort study.

Contemporary, comprehensive data on epidemiology and outcomes of invasive fungal disease (IFD) including breakthrough IFD among allogeneic hematopoietic stem cell transplantation (HSCT) recipients are scarce. We included 479 allogeneic HSCT recipients with 10 invasive candidiasis (IC) and 31 probable/proven invasive mold disease (IMD) from the Swiss Transplant Cohort Study from 01.2009 to 08.2013. Overall cumulative incidence was 2.3% for IC and 8.5% for probable/proven IMI: 6% for invasive aspergillosis (IA) and 2.5% for non-AspergillusIMI. Among 41 IFD, 46% IFD were breakthrough, with an overall incidence of 4.6%, more frequently caused by other-than-Aspergillus fumigatus molds than primary IFD (47.6% (10/21) vs 13% (3/23), P = 0.04). Twelve-week mortality among patients with IC was 20% and 58.6% for probable/proven IMD (60% IA and 54.6% non-Aspergillus). Our results reveal that breakthrough IFD represent a marked burden of probable/proven IFD postallogeneic HSCT and mortality remains above 50% in patients with probable/proven IMD, underscoring the ongoing challenges to prevent and treat IFD in these patients.

Implant-retained prostheses: ball vs. conus attachments - A randomized controlled clinical trial.

OBJECTIVE: To evaluate implant survival, peri-implant tissue conditions, prosthodontic maintenance requirements and patient satisfaction of two differently retained implant-supported mandibular overdentures (IOD) after the 3 years of observation. MATERIALS AND METHODS: Twenty-five patients with edentulous mandibles received two implants each. Twelve patients were randomly selected to receive ball attachments, whereas 13 patients received prefabricated coni. Implant survival, peri-implant parameters (modified Plaque Index, Bleeding on Probing, modified Gingival Index, probing depth and marginal bone loss) and patient satisfaction were assessed. Additionally, prosthodontic maintenance was monitored. Clinical and radiographic follow-ups were performed 1, 2 and 3 years after prosthetic delivery. The Kaplan-Meier method was used to calculate complication rates. RESULTS: After a mean observation period of 29.6 months, an implant survival rate of 100% could be observed. There were no significant differences in the peri-implant parameters. During the observation period, six patients with conus attachment refused to further participate in follow-ups due to dissatisfaction with their treatment and had to be regarded as dropouts. Based on the Kaplan-Meier method, inacceptable retention was calculated for 80% and 75% of the patients in the ball and the conus groups, respectively. Patient satisfaction was 64% for the ball- and 100% for the conus-retained IODs, the latter only respecting five of initially 13 patients. CONCLUSION: The evaluated treatment method revealed high implant survival rates, but the prosthetic reconstruction required intensive maintenance. Therefore, a trend toward the reduced patient satisfaction was observed, and the promoted economy of the evaluated attachment systems should be questioned. For the conical attachment, the recommendation of the manufacturer is to use four interforaminal implants to support a removable prostheses.

Alumina reinforced zirconia implants: 1-year results from a prospective cohort investigation.

OBJECTIVE: The objective of this investigation was to determine the clinical and radiographic outcome of a one-piece alumina-toughened zirconia (ATZ) oral implant for single tooth replacement after 1 year. MATERIALS AND METHODS: A total of 27 patients received one ATZ implant each in a one-stage implant surgery with immediate temporization. Standardized radiographs were taken at implant insertion and after 1 year to monitor peri-implant bone loss. Several soft tissue parameters were evaluated at prosthesis insertion and at the 1-year follow-up. RESULTS: Three patients did not receive a prosthetic reconstruction due to implant loss during the healing period. As a result, 24 patients were seen at the 1-year follow-up, giving a cumulative survival rate of 88.9%. The average marginal bone loss after 1 year was 0.77 mm. Only two implants (8.3%) lost at least 2 mm bone, whereas none of the implants lost more than 3 mm. Probing depth and clinical attachment level increased over 1 year at the implant sites, whereas gingival recession remained stable. Mombelli's bleeding and plaque indices showed no statistically significant change within the first year. CONCLUSION: Owing to a total of 27 inserted implants, three failures within the first 4 months after implant placement carry weight. Therefore, the cumulative survival rate of the presented ceramic implant was slightly below reported survival rates of titanium implants when immediately restored. The recorded radiographic bone loss and peri-implant soft tissue parameters showed promising short-term results. The presented ATZ implant seems to be a candidate for clinical usage.

Effect of two different healing times on the mineralization of newly formed bone using a bovine bone substitute in sinus floor augmentation: a randomized, controlled, clinical and histological investigation.

PURPOSE: To investigate the amount of the mineralization of a bovine bone substitute material in sinus floor augmentation after healing times of 3 and 6 months. MATERIALS AND METHODS: Fifty-one patients were randomized into two healing time groups and received sinus floor augmentations with a bovine bone material. After 3 or 6 months of healing, trephine bone biopsies were retrieved. The biopsies were processed for histological and histomorphometric evaluations to primarily investigate the amount of mineralized bone in the augmented area and secondarily compare the amount of mineralized bone in the augmented area and in the pristine bone. Statistical tests were performed to analyse the fraction of the mineralized bone (p < 0.05). RESULTS: The biopsies of both groups showed remnants of the well-integrated bone substitute material. The histology revealed osteoblasts, osteocytes with osteoid, and osteoclasts. The mean percentage of mineralized bone in the augmented area was 23.8% (3 months group) and 23.6% (6 months group; p = 0.9246); the amount of remaining bone substitute material was 35% (3 months group) and 33.9% (6 months group; p = 0.6325). CONCLUSION: It can be concluded that the bone maturation in the augmented sinus using the bovine bone material is similar after 3 and 6 months. Thus, implant installation after 3 months following a lateral window sinus floor augmentation approach using a bovine bone material seems to be clinically acceptable.

Oral hygiene-related self-efficacy as a predictor of oral hygiene behaviour: a prospective cohort study.

AIM: The aim of this study was to assess whether oral hygiene-related self-efficacy is correlated with current oral hygiene and might influence the outcome of oral hygiene instruction. MATERIALS AND METHODS: Hundred and twenty-six patients filled out questionnaires about oral hygiene-related self-efficacy, general self-efficacy, oral hygiene-related knowledge and demographic variables. Plaque and gingival inflammation were measured and an individual oral hygiene plan was conducted. After 6 months, oral hygiene indices were assessed again. RESULTS: Women had significantly higher scores in oral hygiene-related self-efficacy than men (women mean 60.40 ± 9.41; men mean 56.04 ± 11.55; p = 0.039) and oral hygiene-related self-efficacy was significantly correlated with general self-efficacy independent from the age of the patients (r = 0.3114, p = 0.0004). Higher scores in oral hygiene-related self-efficacy were significantly correlated with lower scores of gingival bleeding for non-smoking patients (r = -0.301, p = 0.0066), usage of a professional tooth cleaning within these 6 months (p = 0.0406), reappearance to the follow-up appointment (p = 0.0303), and higher goals in inter-dental cleaning plans (p = 0.0189). CONCLUSION: Oral hygiene-related self-efficacy is an influencing factor in the oral hygiene behaviour and has the potential to predict patients' oral hygiene outcomes.

Software-based evaluation of human age: a pilot study.

PURPOSE: This pilot study was to assess a smartphone application regarding its use as an objective evaluation tool for subject age in comparison to human raters and to identify potential factors influencing the estimation of age. MATERIALS AND METHODS: Ten Caucasian participants (six females, four males, mean age 42.1 ± 22.6 years) were randomly chosen, and frontal facial pictures of each participant were taken. The smartphone application PhotoAge (Version 1.5, ©2012, Percipo Inc., San Francisco, CA, USA) was used to evaluate the age of the participants. For comparison, 100 randomly selected raters (60 females, 40 males, mean age 29.3 ± 1.3 years) were asked to evaluate the age of the same participants. The influence of participants' facial expression, age, and sex as well as raters' age, sex, and profession was investigated as well. Statistical analyses (linear mixed models with random intercepts; least square means, confidence interval 95%; p < 0.05) were implemented. RESULTS: PhotoAge resulted in a mean age of 43.1 ± 18.2 years, with a difference from the true mean age of 1.0 ± 8.2 years (p = 0.5996). The evaluation by the raters revealed a mean age of 41.5 ± 19.0 years, with a difference from the true mean age of -0.6 ± 8.5 years (p = 0.6078). There was no statistical significance between the two groups (p = 0.2783). CONCLUSION: The evaluation of age with the software application PhotoAge seems to be a reliable procedure with comparable results to human raters. CLINICAL SIGNIFICANCE: This study gives a better understanding about the reliability of a software-based evaluation tool for age and identifies factors (e.g., the visibility of the teeth) potentially affecting the estimation of age. Naturally looking teeth seem to have no influence on the evaluation of a person's age. Thus, the application of this specific application for dental purposes is questionable; however, in forensics, it might be a valuable tool for estimating a person's age.

Water sorption and water solubility of self-etching and self-adhesive resin cements.

STATEMENT OF PROBLEM: The long-term success of indirect restorations depends on the clinical behavior of luting cements. In the oral environment, properties such as water sorption and solubility negatively affect the cements' clinical performance over time, jeopardizing the restoration's longevity. PURPOSE: The purpose of this in vitro study was to compare the water sorption and solubility characteristics of self-etching, self-adhesive, and conventional resin cements. MATERIAL AND METHODS: One conventional (Calibra), 1 self-etching (Panavia F), and 2 self-adhesive (Clearfil SA, G-Cem Automix) dual-polymerized resin cements were used. Fourteen disks of each material were prepared. Water sorption and solubility were calculated according to International Organization for Standards (ISO) specification 4049:2009. RESULTS: According to the water sorption test, all materials were found to interact with water. No statistically significant differences were found between the water sorption of Panavia F and Clearfil SA (P=.911). These cements exhibited higher water sorption values than the other materials (P<.05), whereas Calibra exhibited the lowest values (P<.05). Statistically significant differences were found among all materials regarding their water solubility (P<.05). Panavia F and Clearfil SA were found to have higher solubility values than the other materials. G-Cem Automix and Calibra exhibited negative solubility. However, all water sorption and solubility values were below the threshold values proposed by the ISO standard. CONCLUSIONS: Within the limitations of the present in vitro study, the interaction of resin cements with water is not type-related (conventional, self-etching, or self-adhesive).

Clinical efficacy and patients' acceptance of a rubber interdental bristle. A randomized controlled trial.

OBJECTIVES: Interdental cleaning is an essential component of home plaque control to prevent periodontitis and caries. There is limited data on the efficacy of commonly used metal-core interdental brushes in comparison to metal-free interdental brushes. The aim of this study was to compare a new rubber interdental bristle (Fuchs®) with a standard metal-core interdental brush (TePe®) for their impact upon gingival bleeding, plaque removal, and patient experience. MATERIALS AND METHODS: A single-blind, prospective, randomized, and controlled clinical trial with a crossover design was used to measure plaque index (Turesky-Modified Quigley & Hein Index), bleeding index (Eastman Interdental Bleeding Index by Caton & Polson), and patient satisfaction by means of questionnaires in 39 patients. Each patient was randomly assigned with regard to the sequence of interdental product used and recalled. RESULTS: Both groups showed statistically significant decreases of plaque after a single usage, respectively. Bleeding was statistically significantly reduced after 4 weeks, with no statistically significant differences concerning between the two tested interdental brushes. Rubber interdental bristles reached significantly higher scores with regard to patient acceptance in overall assessment and in sub-items for less pain during usage, comfort of brushing, and willingness to buy the product. CONCLUSION: Rubber interdental bristles were similarly effective compared to the interdental brushes. In addition, rubber interdental bristles were significantly more comfortable for participants than metal-core brushes. CLINICAL RELEVANCE: Rubber interdental bristles can be used as an alternative interdental cleaning product which may be more accepted by patients.

Accuracy of full-arch scans using intraoral scanners.

OBJECTIVES: This study aimed to evaluate the accuracy of intraoral scanners in full-arch scans. MATERIALS AND METHODS: A representative model with 14 prepared abutments was digitized using an industrial scanner (reference scanner) as well as four intraoral scanners (iTero, CEREC AC Bluecam, Lava C.O.S., and Zfx IntraScan). Datasets obtained from different scans were loaded into 3D evaluation software, superimposed, and compared for accuracy. One-way analysis of variance (ANOVA) was implemented to compute differences within groups (precision) as well as comparisons with the reference scan (trueness). A level of statistical significance of p < 0.05 was set. RESULTS: Mean trueness values ranged from 38 to 332.9 µm. Data analysis yielded statistically significant differences between CEREC AC Bluecam and other scanners as well as between Zfx IntraScan and Lava C.O.S. Mean precision values ranged from 37.9 to 99.1 µm. Statistically significant differences were found between CEREC AC Bluecam and Lava C.O.S., CEREC AC Bluecam and iTero, Zfx Intra Scan and Lava C.O.S., and Zfx Intra Scan and iTero (p < 0.05). CONCLUSIONS: Except for one intraoral scanner system, all tested systems showed a comparable level of accuracy for full-arch scans of prepared teeth. Further studies are needed to validate the accuracy of these scanners under clinical conditions. CLINICAL RELEVANCE: Despite excellent accuracy in single-unit scans having been demonstrated, little is known about the accuracy of intraoral scanners in simultaneous scans of multiple abutments. Although most of the tested scanners showed comparable values, the results suggest that the inaccuracies of the obtained datasets may contribute to inaccuracies in the final restorations.