Clinical efficacy of a novel radiofrequency toothbrush for tooth stain reduction and tooth whitening: A randomized controlled trial.

BACKGROUND: The authors aimed to evaluate the effect of a novel radiofrequency (RF) toothbrush on tooth stains and shades compared with a sonic vibrating toothbrush (CVS Health SmileSonic Pro Advanced Clean Sonic Toothbrush, Ranir) that earned the American Dental Association Seal of Acceptance. METHODS: The authors conducted a single-blind prospective study over 6 weeks. Participants were randomized to 1 of 2 study groups to receive either an RF toothbrush (ToothWave, Home Skinovations [test]) or a sonic vibrating toothbrush (SmileSonic powered toothbrush, Ranir [control]) and performed twice-daily toothbrushing with fluoridated toothpaste (Crest Cavity Protection, Procter & Gamble) for 6 weeks. Tooth stains and shades were assessed using the Lobene Stain Index and VITA Bleachedguide 3D-MASTER shade guide (VITA North America) at baseline and after 4 and 6 weeks of toothbrushing. In addition, the VITA Easyshade Advance 4.0 spectrophotometer (VITA North America) was used for shade evaluation. Safety was evaluated by means of oral soft-tissue examinations at each visit. Percentage reduction from baseline was compared between the groups. Statistical analyses were conducted using Mann-Whitney nonparametric model. RESULTS: Eighty-six participants (43 in each group) completed the study with fully evaluable data. At baseline, the groups did not differ significantly in mean measurement scores. Percentage reductions of the measured scores were significantly greater (more extrinsic stain removal and whitening) in the test group than in the control group (P < .001). Both toothbrushes were well-tolerated, and no device-related adverse events were reported during the study. CONCLUSIONS: The RF toothbrush produced substantial benefits in the reduction of tooth stains and whitening of tooth shade compared with a powered toothbrush (CVS Health SmileSonic Pro Advanced Clean Sonic Toothbrush, Ranir) that earned the American Dental Association Seal of Acceptance. PRACTICAL IMPLICATIONS: The novel RF toothbrush is a safe and effective tool for stain removal and tooth whitening and can serve as an alternative to other whitening agents. This clinical trial was registered at ClinicalTrials.gov. The registration number is NCT03885609.

Intraoperative use of the machine learning-derived nociception level monitor results in less pain in the first 90†min after surgery.

In this pooled analysis of two randomized clinical trials, intraoperative opioid dosing based on the nociception level-index produced less pain compared to standard care with a difference in pain scores in the post-anesthesia care unit of 1.5 (95% CI 0.8-2.2) points on an 11-point scale. The proportion of patients with severe pain was lower by 70%. Severe postoperative pain remains a significant problem and associates with several adverse outcomes. Here, we determined whether the application of a monitor that detects intraoperative nociceptive events, based on machine learning technology, and treatment of such events reduces pain scores in the post-anesthesia care unit (PACU). To that end, we performed a pooled analysis of two trials in adult patients, undergoing elective major abdominal surgery, on the effect of intraoperative nociception level monitor (NOL)-guided fentanyl dosing on PACU pain was performed. Patients received NOL-guided fentanyl dosing or standard care (fentanyl dosing based on hemodynamic parameters). Goal of the intervention was to keep NOL at values that indicated absence of nociception. The primary endpoint of the study was the median pain score obtained in the first 90 min in the PACU. Pain scores were collected at 15 min intervals on an 11-point Likert scale. Data from 125 patients (55 men, 70 women, age range 21-86 years) were analyzed. Sixty-one patients received NOL-guided fentanyl dosing and 64 standard care. Median PACU pain score was 1.5 points (0.8-2.2) lower in the NOL group compared to the standard care; the proportion of patients with severe pain was 70% lower in the NOL group (p = 0.045). The only significant factor associated with increased odds for severe pain was the standard of care compared to NOL treatment (OR 6.0, 95% CI 1.4 -25.9, p = 0.017). The use of a machine learning-based technology to guide opioid dosing during major abdominal surgery resulted in reduced PACU pain scores with less patients in severe pain.

Association between sensory modulation and sleep difficulties in children with Attention Deficit Hyperactivity Disorder (ADHD).

BACKGROUND: Sleep difficulties have been reported in up to 85% of children with Attention Deficit hyperactivity disorder (ADHD). Children with ADHD exhibit commonly sensory modulation difficulties (SMD) and experience more significant functional difficulties. Sleep difficulties have also been associated with SMD. The aim of this study was to evaluate whether SMD are associated with sleep difficulties in children with ADHD. METHODS: We assessed sleep difficulties using the Children's Sleep Habits Questionnaire, and SMD using the Short Sensory Profile (SSP) questionnaire. A total of 25 children with ADHD and atypical sensory profiles, 13 children with ADHD and typical sensory profiles and 38 children used as controls (all children aged 8-11 years) were included. RESULTS: Sleep difficulties were detected in 86.4% of children with ADHD and atypical SSPs, as compared to 30.8% of children with ADHD and typical SSPs, and 16.7% of controls. A multivariate logistic regression revealed that children with ADHD and atypical SSPs had significantly increased odds for sleep difficulties as compared to controls (OR = 32.4; 95% CI 4.0-260.1, p = 0.001), while children with ADHD and typical SSPs were indistinguishable from controls. Suspected confounders (gender, age, mother's education, and stimulant therapy) did not contribute to sleep difficulties. CONCLUSION: In this pilot study, SMD were associated with sleep difficulties in children with ADHD.

Reduction in complication and revision rates for robotic-guided short-segment lumbar fusion surgery: results of a prospective, multi-center study.

Studies evaluating robotic guidance in lumbar fusion are limited primarily to evaluation of screw accuracy and perioperative complications. This is the first study to evaluate granular differences in short and long-term complication and revision rate profiles between robotic (RG) fluoroscopic (FG) guidance for minimally invasive short-segment lumbar fusions. A retrospective analysis of a prospective, multi-center database was performed. Complications were subdivided into surgical (further subcategorized into adjacent segment disease, new-onset back pain, radiculopathy, motor-deficit, hardware failure, pseudoarthrosis), wound, and medical complications. Complication and revision rates were compared between RG and FG groups cumulatively at 30, 90 days, and 1 year. 374 RG and 111 FG procedures were performed. RG was associated with an 86.25, 83.20, and 69.42% cumulative reduction in complication rate at 30, 90 days, and 1 year, respectively, compared to FG (p < 0.001). At all follow-up points, new-onset radiculopathy and medical complications were most prevalent in both groups. The greatest reductions in complication rates were seen for new-onset back pain (88.13%; p = 0.001) and wound complications (95.05%; p < 0.001) at 30 days, new-onset motor deficits (90.11%; p = 0.004) and wound complications (85.16%; p < 0.001) at 90 days, and new-onset motor deficits (85.16%; p = 0.002), wound (85.16%; p < 0.001), and medical complications (75.72%; p < 0.001) at 1 year. RG was associated with a 92.58% (p = 0.002) reduction in revision rate at 90 days and a 66.08% (p = 0.026) reduction at 1 year. RG was associated with significant reductions in postoperative complication rates at all follow-up time points and significant reductions in revision rates at 90 days and 1 year.

Fluoroscopy time analysis of a prospective, multi-centre study comparing robotic- and fluoroscopic-guided placement of percutaneous pedicle screw instrumentation for short segment minimally invasive lumbar fusion surgery.

BACKGROUND: As minimally invasive spine surgery becomes more widespread, concerns regarding radiation exposure to surgeons and patients alike have become a growing concern. Robotic guidance has been developed as a way to increase the accuracy of instrumentation while decreasing radiation burden. METHODS: A retrospective analysis of a large, multi-centre, prospective study comparing robotic-guided (RG) to fluoroscopic-guided (FG) (Multi-centre, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries) was performed to evaluate for differences in radiation exposure between study groups. RESULTS: RG was associated with 78.3% (p < 0.001) and 79.8% (p < 0.001) reduction in total and per screw fluoroscopy times, respectively, as compared to FG. RG was also associated with a 50.8% (p < 0.001) reduction in total operative fluoroscopy time. CONCLUSIONS: RG was associated with significantly lower fluoroscopy times compared to FG. This suggests that utilization of robotic navigation systems may result in decreased operative radiation exposure, which is a growing concern for surgeons performing minimally invasive spine surgery.

Indeterminate nodules by the Bethesda system for reporting thyroid cytopathology in Israel: Frequency, and risk of malignancy after reclassification of follicular thyroid neoplasm with papillary-like features.

OBJECTIVE: We aimed to determine the frequency and risk of malignancy (ROM) for indeterminate thyroid nodules, categories III (B3) and IV (B4) of the Bethesda System for Reporting Thyroid Cytopathology (BSRTC), at a large institution in Israel. Additionally, we investigated the impact of redefining follicular neoplasm with papillary-like nuclear features (NIFTP) as non-malignant on malignancy rates. METHODS: In this retrospective study of all thyroid fine needle aspirations (FNAs) performed at Tel Aviv-Sourasky Medical Center between January 2013 and December 2015, we assessed ROM for B3 and B4 nodules. Potential risk factors thought to affect a-priori ROM were assessed. Suspected NIFTP lesions were re-examined, and if proven, reclassified as benign. RESULTS: 3701 nodules were sampled in 2919 FNAs performed on 2674 patients. B3 reports comprised 7.7% of all nodules (n = 284); B4 represented 3.6% (n = 132). In multivariate logistic regression, male gender, being of former Soviet Union origin, and smoking increased ROM for B3 nodules by a factor of 7.97 (P = 0.002; CI: 2.2-23.4), 9.15 (P = 0.021; CI:1.4-60.0), and 11.0 (P = 0.001; CI 2.8-44.8), respectively. Reclassifying NIFTP decreased ROM from 14% to 12.5% for B3, and from 26.7% to 25% for B4 nodules. NIFTP comprised 9.5% of previously diagnosed resected malignant tumors. CONCLUSIONS: The relative frequencies of B3 and B4 nodules and their associated malignancy rates were consistent with previous series. Risk factors identified for malignancy may help characterize patients most likely to benefit from surgery. Reclassifying NIFTP had a substantial impact on the ROM in the resected tumors previously diagnosed as malignant.

Association between sensory modulation and daily activity function of children with attention deficit/hyperactivity disorder and children with typical development.

BACKGROUND: The severity of the functional difficulties of children with attention-deficit/hyperactivity disorder (ADHD) is heterogeneous and may be affected by measurable factors. AIMS: To characterize subgroups of children with ADHD with or without sensory modulation difficulties (SMD) and the association between sensory modulation and daily activity function in children with ADHD and children with typical development. METHODS: 38 children with ADHD and 39 controls (ages 8-11) were recruited and assessed, using the Conner's Parent Rating Scale-Revised: Short Form, the Short Sensory Profile (SSP) and the Children Activity Scale for Parents (ChAS-P). RESULTS: The total SSP score of the ADHD group was lower (142.13 vs. 180.08; t=-8.23, p < 0.001) with a higher proportion of SMD (65.8% vs. 2.6%, χ2 = 34.46, p < 0.001). The daily function of children with ADHD was lower than controls (mean ChAS-P: 3.95 vs. 4.78, p < 0.001). The difference was significant for children with ADHD and SMD (3.70 versus 4.81, p < 0.001), but not significant for children with ADHD and typical SSP (4.42 versus 4.81, p=0.35). CONCLUSION: In this pilot study, we found that SMD, in children with ADHD is correlated with daily activity consequences. Hence, it should be evaluated in children with ADHD and addressed in their treatment plan.

A Single Radioactive Iodine Treatment Has a Deleterious Effect on Ovarian Reserve in Women with Thyroid Cancer: Results of a Prospective Pilot Study.

BACKGROUND: Women of reproductive age with differentiated thyroid cancer (DTC) often need radioactive iodine (RAI) treatment after surgery. In contrast to the well-documented effect of RAI on testicular function, the potential negative effects of this treatment on ovarian reserve have been largely dismissed. The objective of this pilot study was to examine the possibility that RAI treatment is deleterious to the ovarian reserve by prospectively measuring the concentration of anti-Müllerian hormone (AMH) after RAI treatment. METHODS: Thirty premenopausal women (Mage = 34 years; range 20-45 years) with a new diagnosis of DTC scheduled to undergo RAI ablation were recruited for this study. All of them had TNM stage 1 disease (T1-3, N0, or N1, M0), and were scheduled to receive RAI activities ranging from 30 to 150 mCi. AMH was measured at baseline and at 3, 6, 9, and 12 months after the administration of RAI. RESULTS: Of the 30 women, only 24 returned after the baseline assessment. RAI treatment resulted in a significant decrease in AMH concentrations at three months, from 3.25 ± 2.75 to 1.9 ± 1.74 ng/mL (p < 0.0001). Only partial recovery was subsequently documented. Eighty-two percent of subjects had final values below baseline levels, such that at one year, serum AMH was still 32% lower than prior to treatment (2.36 ± 1.88 ng/mL; p < 0.005). The only two continuous variables that correlated with the extent of AMH reduction at three months were the woman's age (r = 0.51; p = 0.02) and the age at menarche (r = 0.48; p = 0.03). Importantly, the RAI dose was not associated with the extent of AMH reduction and neither were smoking or the use of birth control pills. Older subjects (≥35 years) were significantly more likely to experience a marked AMH reduction at three months (63.7 ± 18.5% vs. 33.1 ± 29.2%; p = 0.01). The only predictor of recovery after one year was the extent of AMH decrease at three months: the lower the decline, the higher the chances for recovery. CONCLUSIONS: RAI in DTC has a rapid and profound effect on ovarian reserve, with only a partial recovery potential. In an era of declining human fertility, it is of relevance to recognize the potentially adverse effect of RAI in women of reproductive age. AMH measurement may be useful as a tool in this decision-making process.

Cerebral Autoregulation Real-Time Monitoring.

Cerebral autoregulation is a mechanism which maintains constant cerebral blood flow (CBF) despite changes in mean arterial pressure (MAP). Assessing whether this mechanism is intact or impaired and determining its boundaries is important in many clinical settings, where primary or secondary injuries to the brain may occur. Herein we describe the development of a new ultrasound tagged near infra red light monitor which tracks CBF trends, in parallel, it continuously measures blood pressure and correlates them to produce a real time autoregulation index. Its performance is validated in both in-vitro experiment and a pre-clinical case study. Results suggest that using such a tool, autoregulation boundaries as well as its impairment or functioning can be identified and assessed. It may therefore assist in individualized MAP management to ensure adequate organ perfusion and reduce the risk of postoperative complications, and might play an important role in patient care.

Tectal Lesions in Children: A Long-Term Follow-Up Volumetric Tumor Growth Analysis in Surgical and Nonsurgical Cases.

BACKGROUND/AIMS: Different tectal masses have been described; most are low-grade gliomas. Only 20-30% of all lesions grow, as shown on follow-up MRIs, requiring surgical resection at some point. The aim of this study is to describe the experience of a single institution managing pediatric patients with tectal lesions. METHODS: We retrospectively studied and analyzed 40 children with tectal lesions managed from 1990 to 2006; the mean age at diagnosis was 9.4 years. A volumetric classification was used to analyze tumor growth trends. More than 1 year of imaging follow-up was available for 23 patients. RESULTS AND CONCLUSION: Medium- and large-volume-size lesions were associated with the need for surgery. About half of the nonsurgical lesions grew at least 50% over a period of 4.5 years and did not require surgical resection.

Acousto-Optic Cerebral Blood Flow Monitoring During Induction of Anesthesia in Humans.

BACKGROUND: Past transcranial Doppler (TCD) studies have documented the effects of the sequence of anesthesia induction followed by intubation on cerebral blood flow (CBF) velocity. The purpose of this study was to determine whether acousto-optic CBF monitoring would detect changes in CBF which are known to occur with propofol and subsequent endotracheal intubation. METHODS: Seventy-two patients scheduled for elective non-intracranial surgery were evaluated. A Cerox 3215F (Ornim Medical) acousto-optic CBF monitor was used. The acousto-optic transducers were applied bifrontally prior to induction. Baseline cerebral flow index (CFI) values were obtained for at least 2 min prior to induction, set to a unitless value of 100. Subsequent relative changes in CFI from baseline were determined at the lowest value over 3 min after propofol injection but before laryngoscopy; and the highest value over 5 min after the start of laryngoscopy. CFI data were evaluated using Friedman's test. RESULTS: The median dose of propofol [interquartile range] given was 200 mg [160-250]. CFI decreased to 84 % of baseline after propofol and increased to 147 % of baseline after endotracheal intubation (both p < 0.001); MAP decreased after intravenous induction of anesthesia from 103 ± 15 to 86 ± 15 mmHg (p < 0.001) and then returned following endotracheal intubation to 104 ± 20 mmHg. CONCLUSIONS: Our data are congruent with previous observations made with TCD under similar experimental conditions. Such observations support the notion that acousto-optic monitoring yields valid real-time measures of changes in CBF in humans. Further validation against other quantitative measures of CBF would be appropriate.

Evaluating Computer Screen Time and Its Possible Link to Psychopathology in the Context of Age: A Cross-Sectional Study of Parents and Children.

BACKGROUND: Several studies have suggested that high levels of computer use are linked to psychopathology. However, there is ambiguity about what should be considered normal or over-use of computers. Furthermore, the nature of the link between computer usage and psychopathology is controversial. The current study utilized the context of age to address these questions. Our hypothesis was that the context of age will be paramount for differentiating normal from excessive use, and that this context will allow a better understanding of the link to psychopathology. METHODS: In a cross-sectional study, 185 parents and children aged 3-18 years were recruited in clinical and community settings. They were asked to fill out questionnaires regarding demographics, functional and academic variables, computer use as well as psychiatric screening questionnaires. Using a regression model, we identified 3 groups of normal-use, over-use and under-use and examined known factors as putative differentiators between the over-users and the other groups. RESULTS: After modeling computer screen time according to age, factors linked to over-use were: decreased socialization (OR 3.24, Confidence interval [CI] 1.23-8.55, p = 0.018), difficulty to disengage from the computer (OR 1.56, CI 1.07-2.28, p = 0.022) and age, though borderline-significant (OR 1.1 each year, CI 0.99-1.22, p = 0.058). While psychopathology was not linked to over-use, post-hoc analysis revealed that the link between increased computer screen time and psychopathology was age-dependent and solidified as age progressed (p = 0.007). Unlike computer usage, the use of small-screens and smartphones was not associated with psychopathology. CONCLUSIONS: The results suggest that computer screen time follows an age-based course. We conclude that differentiating normal from over-use as well as defining over-use as a possible marker for psychiatric difficulties must be performed within the context of age. If verified by additional studies, future research should integrate those views in order to better understand the intricacies of computer over-use.

Intraoperative Cerebral Autoregulation Assessment Using Ultrasound-Tagged Near-Infrared-Based Cerebral Blood Flow in Comparison to Transcranial Doppler Cerebral Flow Velocity: A Pilot Study.

OBJECTIVE: This was a pilot study comparing the ability of a new ultrasound-tagged near-infrared (UT-NIR) device to detect cerebral autoregulation (CA) in comparison to transcranial Doppler (TCD). DESIGN: An unblinded, prospective, clinical feasibility study. SETTING: Tertiary-care university hospital cardiac surgical operating rooms. PARTICIPANTS: Twenty adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). INTERVENTIONS: There were no clinical interventions based on study monitoring devices, but a continuous correlation analysis of digital data from transcranial Doppler (TCD) velocity was compared with a novel UT-NIR device and correlation analysis of change signals versus mean arterial pressure was performed in order to detect presence or absence of intact CA and for determination of the lower limit of cerebral autoregulation during CPB. MEASUREMENTS AND MAIN RESULTS: Similar and highly significant concordance (κ = 1.00; p<0.001) was demonstrated between the 2 methodologies for determination of CA, indicating good correlation between the 2 methodologies. Intact CA was absent in 2 patients during CPB, and both devices were able to detect this. CONCLUSIONS: To the authors' knowledge this is the first clinical report of a UT-NIR device that shows promise as a clinically useful modality for detection of CA and the lower limit of cerebral autoregulation. The utility of UT-NIR was demonstrated further during times at which extensive usage of electrocautery or functional absence of the transcranial window rendered TCD uninterpretable.

Macrophage subpopulations are essential for infarct repair with and without stem cell therapy.

OBJECTIVES: This study sought to investigate the hypothesis that the favorable effects of mesenchymal stromal cells (MSCs) on infarct repair are mediated by macrophages. BACKGROUND: The favorable effects of MSC therapy in myocardial infarction (MI) are complex and not fully understood. METHODS: We induced MI in mice and allocated them to bone marrow MSCs, mononuclear cells, or saline injection into the infarct, with and without early (4 h before MI) and late (3 days after MI) macrophage depletion. We then analyzed macrophage phenotype in the infarcted heart by flow cytometry and macrophage secretome in vitro. Left ventricular remodeling and global and regional function were assessed by echocardiography and speckle-tracking based strain imaging. RESULTS: The MSC therapy significantly increased the percentage of reparative M2 macrophages (F4/80(+)CD206(+)) in the infarcted myocardium, compared with mononuclear- and saline-treated hearts, 3 and 4 days after MI. Macrophage cytokine secretion, relevant to infarct healing and repair, was significantly increased after MSC therapy, or incubation with MSCs or MSC supernatant. Significantly, with and without MSC therapy, transient macrophage depletion increased mortality 30 days after MI. Furthermore, early macrophage depletion produced the greatest negative effect on infarct size and left ventricular remodeling and function, as well as a significant incidence of left ventricular thrombus formation. These deleterious effects were attenuated with macrophage restoration and MSC therapy. CONCLUSIONS: Some of the protective effects of MSCs on infarct repair are mediated by macrophages, which are essential for early healing and repair. Thus, targeting macrophages could be a novel strategy to improve infarct healing and repair.

Clustering women's health behaviors.

This study attempts to characterize health lifestyles by subgrouping women with similar behavior patterns. Data on background, health behaviors, and perceptions were collected via phone interview from 1,075 Israeli women aged 50 to 74. From a cluster analysis conducted on health behaviors, three clusters emerged: a "health promoting" cluster (44.1%), women adhering to recommended behaviors; an "inactive" cluster (40.3%), women engaging in neither health-promoting nor compromising behaviors; and an "ambivalent" cluster (15.4%), women engaging somewhat in both health-promoting and compromising behaviors. Clustering was cross-tabulated by demographic and perceptual variables, further validating the subgrouping. The cluster solution was also validated by predicting another health behavior (mammography screening) for which there was an external validating source. Findings are discussed in comparison to published cluster solutions, culminating in suggestions for intervention alternatives. The concept of lifestyle was deemed appropriate to summarize the clustering of these behavioral, perceptual, and structural variables.