Peri-implantitis in patients without regular supportive therapy: Prevalence and risk indicators.

OBJECTIVES: To determine the prevalence of peri-implant diseases in patients treated in a university setting without a regular peri-implant supportive therapy schedule, and to identify the risk indicators associated with peri-implantitis. MATERIAL AND METHODS: A retrospective cohort study was made of patients with dental implants with at least 12 months of functional loading who did not receive regular peri-implant supportive therapy. Patient- and implant-related variables were retrieved, and clinical and radiological examinations were performed. Descriptive and bivariate analyses and multilevel logistic regression analyses were performed to identify factors associated with peri-implantitis. RESULTS: A total of 213 implants in 88 patients were analyzed. The patient-level prevalence of peri-implantitis and peri-implant mucositis was 26.1% (95%CI: 16.7%-35.5%) and 44.3% (95%CI: 34.0%-54.6%), respectively. Peri-implant diseases were significantly more frequent when the width of the keratinized mucosa was < 2 mm (OR = 5.26; 95%CI: 1.24-22.26; p = 0.024), and when there was 12 month post-loading bone loss (OR = 2.96; 95%CI: 1.35-6.52; p = 0.007). CONCLUSIONS: Peri-implantitis is a common finding in patients without regular peri-implant supportive therapy (prevalence 16.7-35.5%). A thin peri-implant keratinized mucosa (< 2 mm) and a higher degree of bone remodeling after loading seem to be the main risk factors for peri-implantitis in this patient profile. CLINICAL RELEVANCE: Patients who do not engage in supportive peri-implant maintenance have a higher risk of peri-implantitis. A thin keratinized mucosa and bone loss during the first year of loading are predisposing factors for peri-implantitis.

Continuation versus discontinuation of treatment for severe dementia: randomized, pragmatic, open-label, clinical trial to evaluate the efficacy of continuing drug treatment in patients with severe dementia (STOP-DEM).

BACKGROUND: Previous observational studies and clinical trials have shown that cholinesterase inhibitors (with or without memantine) provide benefit for patients with mild-to-moderate Alzheimer's disease. However, the impact of treatment continuation after progression to severe disease is unknown. The main aim of this study is to evaluate the effect and safety of continuing treatment with ChEIs (with or without memantine) for patients with severe dementia. METHODS: This randomized, pragmatic, open-label clinical trial with blinded evaluators will evaluate the efficacy of continuing drug treatment in patients with advanced dementia. A total of 302 community-dwelling patients with severe dementia, Alzheimer's disease, with or without a coexisting diagnosis of vascular dementia, and a score of 10 or less on the Mini-Mental State Examination who received previous treatment with a cholinesterase inhibitor (with or without memantine) for at least 3 months, will be randomized to continue or discontinue drug treatment. Follow-up will be 12 months or until the primary endpoint is achieved. The primary endpoint is entry into institutional care and progression of disability, defined as a loss of 2 of 4 basic functions, or 6 of 11 instrumental functions, according to the Bristol Activities of Daily Living Scale at 12 months. The secondary outcomes are patient changes in functional and cognitive state, quality of life, and caregiver burden. DISCUSSION: We expect that the results of our study will allow to identify if there is clinical relevant impact for patients and caregivers between maintaining or halting pharmacological treatment. TRIAL REGISTRATION: The study was prospectively registered in the REec (2017-000042-22) on May 11 2017 and ID ISRCTN12134230 on February 25 2019.

Effectiveness and safety of moderate-intensity aerobic water exercise during pregnancy for reducing use of epidural analgesia during labor: protocol for a randomized clinical trial.

BACKGROUND: Epidural analgesia during labor can provide effective pain relief, but can also lead to adverse effects. The practice of moderate exercise during pregnancy is associated with an increased level of endorphins in the blood, and this could also provide pain relief during labor. Aerobic water exercises, rather than other forms of exercise, do not negatively impact articulations, reduce edema, blood pressure, and back pain, and increase diuresis. We propose a randomized controlled trial (RCT) to evaluate the effectiveness and safety of a moderate water exercise program during pregnancy on the need for epidural analgesia during labor. METHODS: A multi-center, parallel, randomized, evaluator blinded, controlled trial in a primary care setting. We will randomised 320 pregnant women (14 to 20 weeks gestation) who have low risk of complications to a moderate water exercise program or usual care. DISCUSSION: The findings of this research will contribute toward understanding of the effects of a physical exercise program on pain and the need for analgesia during labor. TRIAL REGISTRATION: ISRCTN Registry identifier: 14097513 register on 04 September 2017. Retrospectively registered.

Mental Health and Psychological Wellbeing during the COVID-19 Lockdown: A Longitudinal Study in the Balearic Islands (Spain).

Confining the entire population to a lockdown after the outbreak of SARS-CoV-2 was an unprecedented measure designed to protect the health of those living in Spain. The objective of the present study is to assess the evolution of mental health and psychological wellbeing during lockdown. To do this, we carried out a longitudinal study, via an online survey over the eight weeks of lockdown (weekly assessments). Sociodemographic variables were recorded, along with data related to COVID-19, psychological wellbeing (anxiety, depression, psychotropic drugs, consultations made to improve mood or anxiety), life satisfaction, and self-perceived health. A total of 681 individuals participated in the study, 76.8% were women; the mean age was 43 years old (SD = 12.7). Initially, high scores were reported for anxiety, depression, and the number of consultations to improve mood, but these decreased significantly over the study period. The reverse seems to be true for life satisfaction, perceived good health, and intake of psychotropic drugs. We also identified groups whose psychological wellbeing was more susceptible to the effects of lockdown. Women, those worried about their jobs after the pandemic, and those afraid of being infected were the most affected individuals. More generally, after the initial negative effect on psychological wellbeing, various indicators improved over the lockdown period.

Effectiveness of Moderate-Intensity Aerobic Water Exercise during Pregnancy on Quality of Life and Postpartum Depression: A Multi-Center, Randomized Controlled Trial.

BACKGROUND: The global prevalence of postpartum depression is about 20%. This disease has serious consequences for women, their infants, and their families. The aim of this randomized clinical trial was to analyze the effectiveness and safety of a moderate-intensity aerobic water exercise program on postpartum depression, sleep problems, and quality of life in women at one month after delivery. METHODS: This was a multi-center, parallel, randomized, evaluator blinded, controlled trial in a primary care setting. Pregnant women (14-20 weeks gestational age) who had low risk of complications and were from five primary care centers in the area covered by the obstetrics unit of Son Llatzer Hospital (Mallorca, Spain) were invited to participate. A total of 320 pregnant women were randomly assigned to two groups, an intervention group (moderate aquatic aerobic exercise) and a control group (usual prenatal care). One month after birth, sleep quality (MOS sleep), quality of life (EQ-5D), and presence of anxiety or depression (EPDS) were recorded. FINDINGS: Women in the intervention group were less likely to report anxiety or depression on the EQ5D (11.5% vs. 22.7%; p < 0.05) and had a lower mean EPDS score (6.1 ± 1.9 vs. 6.8 ± 2.4, p < 0.010). The two groups had no significant differences in other outcomes, maternal adverse events, and indicators of the newborn status. CONCLUSION: Moderate-intensity aquatic exercise during pregnancy decreased postpartum anxiety and depressive symptoms in mothers and was safe for mothers and their newborns.

Effect of aerobic water exercise during pregnancy on epidural use and pain: A multi-centre, randomised, controlled trial.

OBJECTIVE: The physical and psychological benefits of exercise during pregnancy are well established. However, the impact of exercise on pain during labour and the use of epidural analgesia has been less explored. The main aim of this study was to analyse the effectiveness and safety of moderate aerobic water exercise by pregnant women on the subsequent use of epidural analgesia during labour, induction of labour, mode of delivery, and pain perception. DESIGN: A multi-centre, parallel, randomised, evaluator blinded, controlled trial in a primary care setting. SETTING: Primary care centres in a health district of a tertiary obstetric metropolitan hospital in Mallorca, Spain. PARTICIPANTS: Pregnant women (14 to 20 weeks' gestation) who had low risk of complications. METHODS: Three hundred and twenty pregnant women were randomly assigned to two groups: women who practiced moderate aquatic aerobic exercise with usual antenatal care, and those who received usual prenatal care alone. The gynaecologist, anaesthesiologist and midwife who assisted the women during labour were blinded to group allocations. Principal outcome: use of epidural analgesia during labour. Other outcomes: use of epidural analgesia before 6 cm cervical dilation, labour pain, type of delivery, time of active labour, episiotomy or perineal tear, and induction of labour. RESULTS: The exercise program did not affect the use of epidural analgesia (OR = 0.79, 95% CI = 0.44 to 1.40), vaginal delivery (OR = 1.35, 95% CI = 0.73 to 2.41), or caesarean section (OR = 0.94, 95% CI = 0.47 to 1.89). However, women in the exercise group reported less pain during labour (mean difference: -0.6, 95% CI = -1.11 to -0.09). The two groups (moderate aquatic aerobic exercise versus usual antenatal care) showed no significant differences in maternal or newborn adverse events. CONCLUSION: Aquatic aerobic exercise during pregnancy had no effect on the use of epidural analgesia during labour, whereas pain perception was lower after aquatic exercise compared to usual care in pregnancy. The intervention was safe for pregnant women and their newborns.

How Did the COVID-19 Lockdown Affect Children and Adolescent's Well-Being: Spanish Parents, Children, and Adolescents Respond.

Background: During the COVID-19 pandemic, lockdown strategies have been widely used to contain SARS-CoV-2 virus spread. Children and adolescents are especially vulnerable to suffering psychological effects as result of such measures. In Spain, children were enforced to a strict home lockdown for 42 days during the first wave. Here, we studied the effects of lockdown in children and adolescents through an online questionnaire. Methods: A cross-sectional study was conducted in Spain using an open online survey from July (after the lockdown resulting from the first pandemic wave) to November 2020 (second wave). We included families with children under 16 years-old living in Spain. Parents answered a survey regarding the lockdown effects on their children and were instructed to invite their children from 7 to 16 years-old (mandatory scholar age in Spain) to respond a specific set of questions. Answers were collected through an application programming interface system, and data analysis was performed using R. Results: We included 1,957 families who completed the questionnaires, covering a total of 3,347 children. The specific children's questionnaire was completed by 167 kids (7-11 years-old), and 100 adolescents (12-16 years-old). Children, in general, showed high resilience and capability to adapt to new situations. Sleeping problems were reported in more than half of the children (54%) and adolescents (59%), and these were strongly associated with less time doing sports and spending more than 5 h per day using electronic devices. Parents perceived their children to gain weight (41%), be more irritable and anxious (63%) and sadder (46%). Parents and children differed significantly when evaluating children's sleeping disturbances. Conclusions: Enforced lockdown measures and isolation can have a negative impact on children and adolescent's mental health and well-being. In future waves of the current pandemic, or in the light of potential epidemics of new emerging infections, lockdown measures targeting children, and adolescents should be reconsidered taking into account their infectiousness potential and their age-specific needs, especially to facilitate physical activity and to limit time spent on electronic devices.

Language disintegration in spontaneous speech in Huntington's disease: a more fine-grained analysis.

Huntington's disease (HD) is a neurodegenerative disease causing motor symptoms along with cognitive and affective problems. Recent evidence suggests that HD also affects language across core levels of linguistic organization, including at stages of the disease when standardized neuropsychological test profiles are still normal and motor symptoms do not yet reach clinical thresholds ('pre-manifest HD'). The present study aimed to subject spontaneous speech to a more fine-grained linguistic analysis in a sample of 20 identified HD gene-carriers, 10 with pre-manifest and 10 with early manifest HD. We further explored how language performance related to non-linguistic cognitive impairment, using standardized neuropsychological measures. A distinctive pattern of linguistic impairments marked off participants with both pre-manifest and manifest HD from healthy controls and each other. Fluency patterns in premanifest HD were marked by prolongations, filled pauses, and repetitions, which shifted to a pattern marked by empty (unfilled) pauses, re-phrasings, and truncations in manifest HD. Both HD groups also significantly differed from controls and each other in how they grammatically connected clauses and used noun phrases referentially. Functional deficits in language occurred in pre-manifest HD in the absence of any non-linguistic neuropsychological impairment and did largely not correlate with standardized neuropsychological measures in manifest HD. These results further corroborate that language can act as a fine-grained clinical marker in HD, which can track disease progression from the pre-manifest stage, define critical remediation targets, and inform the role of the basal ganglia in language processing.

Efficacy of gabapentin for prevention of postherpetic neuralgia: study protocol for a randomized controlled clinical trial.

BACKGROUND: Postherpetic neuralgia (PHN) is a chronic neuropathic pain that results from alterations of the peripheral nervous system in areas affected by the herpes zoster virus. The symptoms include pain, paresthesia, dysesthesia, hyperalgesia, and allodynia. Despite the availability of pharmacological treatments to control these symptoms, no treatments are available to control the underlying pathophysiology responsible for this disabling condition. METHODS/DESIGN: Patients with herpes zoster who are at least 50 years old and have a pain score of 4 or higher on a visual analogue scale (VAS) will be recruited. The aim is to recruit 134 patients from the practices of general physicians. Participants will be randomized to receive gabapentin to a maximum of 1800 mg/day for 5 weeks or placebo. Both arms will receive 1000-mg caplets of valacyclovir three times daily for 7 days (initiated within 72 h of the onset of symptoms) and analgesics as needed. The primary outcome measure is the percentage of patients with a VAS pain score of 0 at 12 weeks from rash onset. The secondary outcomes measures are changes in quality of life (measured by the SF-12 questionnaire), sleep disturbance (measured by the Medical Outcomes Study Sleep Scale), and percentage of patients with neuropathic pain (measured by the Douleur Neuropathique in 4 Questions). DISCUSSION: Gabapentin is an anticonvulsant type of analgesic that could prevent the onset of PHN by its antihypersensitivity action in dorsal horn neurons. TRIAL REGISTRATION: ISRCTN Registry identifier: ISRCTN79871784 . Registered on 2 May 2013.

Suspected cross-hepatotoxicity of flutamide and cyproterone acetate.

Flutamide and cyproterone acetate (CPA) are both oral anti-androgens commonly used to treat advanced prostatic cancer. We report a case of drug-induced hepatotoxicity after consecutive treatment with flutamide and CPA. A 78-year-old male with advanced prostatic adenocarcinoma had been treated with flutamide 750 mg/day p.o. and leuproleride acetate 22.5 mg/3 months i.m. Three months later, the patient complained of choluria and jaundice. Laboratory examination revealed severe hepatocellular insufficiency. Flutamide-induced hepatotoxicity was suspected and therefore flutamide was withdrawn. His liver function abnormalities resolved after drug discontinuation. He was subsequently started on CPA 150 mg/day and again developed hepatotoxicity with severe hepatocellular impairment, which completely recovered after drug discontinuation. Other causes of acute liver failure were appropriately ruled out in both episodes and there was no evidence of active prostate cancer or liver metastases in both episodes. The occurrence of hepatotoxicity associated with flutamide and CPA on separated occasions suggests the possibility of a common mechanism of injury. It may become necessary to reassess the common practice of switching to another anti-androgen when hepatotoxicity appears. A closer monitoring of liver enzymes might be necessary in such cases, as an increased risk of a new severe hepatotoxicity event cannot be ruled out.

Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period.

BACKGROUND & AIMS: Progress in the understanding of susceptibility factors to drug-induced liver injury (DILI) and outcome predictability are hampered by the lack of systematic programs to detect bona fide cases. METHODS: A cooperative network was created in 1994 in Spain to identify all suspicions of DILI following a prospective structured report form. The liver damage was characterized according to hepatocellular, cholestatic, and mixed laboratory criteria and to histologic criteria when available. Further evaluation of causality assessment was centrally performed. RESULTS: Since April 1994 to August 2004, 461 out of 570 submitted cases, involving 505 drugs, were deemed to be related to DILI. The antiinfective group of drugs was the more frequently incriminated, amoxicillin-clavulanate accounting for the 12.8% of the whole series. The hepatocellular pattern of damage was the most common (58%), was inversely correlated with age (P < .0001), and had the worst outcome (Cox regression, P < .034). Indeed, the incidence of liver transplantation and death in this group was 11.7% if patients had jaundice at presentation, whereas the corresponding figure was 3.8% in nonjaundiced patients (P < .04). Factors associated with the development of fulminant hepatic failure were female sex (OR = 25; 95% CI: 4.1-151; P < .0001), hepatocellular damage (OR = 7.9; 95% CI: 1.6-37; P < .009), and higher baseline plasma bilirubin value (OR = 1.15; 95% CI: 1.09-1.22; P < .0001). CONCLUSIONS: Patients with drug-induced hepatocellular jaundice have 11.7% chance of progressing to death or transplantation. Amoxicillin-clavulanate stands out as the most common drug related to DILI.