Infliximab versus interferon-alpha in the treatment of Behçet's Syndrome: Clinical data from the BIO-BEHÇET'S randomised controlled trial.

OBJECTIVES: Whilst biologic therapy is used for Behçet's Syndrome of all subtypes refractory to first-line immunomodulation, there has been an absence of high-quality evidence-and no predictive biomarkers to optimally inform choice. BIO-BEHÇET'S was a randomised, controlled, head-to-head clinical trial comparing the two most frequently used biologics in active refractory Behçet's. METHODS: Bayesian-designed, pragmatic, standard of care, two-arm, parallel head-to-head trial at four UK centres. Patients with active disease randomised to infliximab or interferon-α2a, and received follow-up with symptom-directed examination at Weeks 12 and 24. Primary outcome was Behçet's Disease Activity Index (BDAI) at 12 weeks. Secondary outcomes included BDAI at 24 weeks and significant improvement in individual organ systems, including ocular symptoms, oral and genital ulcers, arthritis pain, quality of life, disease activity, and steroid use. Biomarkers were also investigated but are reported elsewhere. RESULTS: 79 patients were recruited. Both treatments were equally effective, with a mean difference of 0.13 in BDAI (80% CI: -0.19, 0.46). No significant differences were observed for secondary outcomes, though there were clinically significant within-group reductions for each over time. A modest steroid-sparing effect was observed, with complete cessation of steroids in 20% and 44% of those randomised to infliximab and interferon-α2a, respectively. There was a trend for minor benefit in favour of infliximab in terms of tolerability and persistence. CONCLUSION: In this first reported, high-quality, head-to-head trial of two biologics in Behçet's, both infliximab and interferon-α2a showed comparable short-term clinical efficacy and safety in refractory active disease of all subtypes. TRIAL REGISTRATION: EudraCT: 2014-005390-36; ISRCTN: ISRCTN49793874.

A Comparison of Dry Bean and Pea Consumption on Serum Cholesterol: A Randomized Controlled Trial in Adults with Mild Hypercholesterolemia.

BACKGROUND: Diets including pulses are associated with better cardiovascular profiles, including lipid, glycemia, and hemodynamics; however, evidence is lacking regarding the contributions of individual pulse varieties. OBJECTIVES: This randomized, controlled trial examined the effects of beans or peas individually, relative to rice, on LDL-cholesterol levels (primary outcome) and other indices of cardiovascular disease risk (secondary outcomes) at 6 wk in adults with mild hypercholesterolemia. METHODS: This randomized, controlled, single-blind, 3-arm parallel-group study was conducted in 2 Canadian cities (Edmonton, Alberta; Winnipeg, Manitoba). Participants (n = 60 per group) were randomly assigned to 6 wk of regular consumption of foods containing either 120 g (∼0.75 cups) of beans (mixture of black, great northern, navy, and pinto) or 120 g (∼0.75 cups) peas (mixture of yellow and green), or identical foods containing white, parboiled rice (control foods). LDL-cholesterol (primary outcome) and indices of lipid metabolism, glycemia, and hemodynamics (secondary outcomes) were assessed. RESULTS: Mean LDL-cholesterol was lower in the bean group (-0.21; 95% CI: -0.39, -0.03) but not the pea group (-0.11; 95% CI: -0.29, 0.07) relative to rice after 6 wk. Non-HDL-cholesterol (-0.20; 95% CI: -0.40, -0.002) and total cholesterol (-0.28; 95% CI: -0.49, -0.06) were also lower in the bean compared with rice groups. No changes were noted in triglycerides (-0.07; 95% CI: -0.28, 0.14), glucose (0.02; 95% CI: -0.17, 0.14), insulin (4.94; 95% CI: -5.51, 11.38), or blood pressure (systolic: -1.39; 95% CI: -5.18, 2.40; diastolic: -1.89; 95% CI: -4.65, 0.88). Dietary fiber intake (grams per day or grams per 1000 kcal) was not correlated with LDL-cholesterol (grams per day: r2 = 0.209, P = 0.142; grams per 1000 kcal: r2 =0.126, P = 0.379) in the bean group. Gastrointestinal effects were transient and most often not related to the study foods. CONCLUSIONS: Beans, but not peas, lowered LDL-cholesterol, relative to rice, in adults with mild hypercholesterolemia. Fiber may not be responsible for the effect of beans, suggesting other phytochemicals may be the active component(s). Strategies incorporating 120 g of pulses in a meal are feasible for managing some cardiometabolic risk factors. This trial was registered at clinicaltrials.gov as NCT01661543.

Efficacy and safety of oral ivermectin in the treatment of mild to moderate Covid-19 patients: a multi-centre double-blind randomized controlled clinical trial.

BACKGROUND: Evidence on ivermectin as a treatment for Covid-19 is controversial. A Cochrane review concluded that the efficacy and safety of ivermectin is uncertain (evidence up to April 2022) and WHO recommended its use only in the setting of clinical trials. This study aimed to assess the efficacy and safety of oral ivermectin in hospitalized patients with mild to moderate Covid-19. TRIAL DESIGN AND METHODS: A double-blind, randomized placebo-controlled clinical trial was conducted among RT-PCR-confirmed, adults, hospitalised within the first four days of symptoms. Patients received oral ivermectin 24 mg or placebo daily for five days. RT-PCR was repeated on days five and ten. Clinical progression was monitored using the World Health Organization Clinical Progression Scale. Serum ivermectin levels were measured on days three, five, and seven. The primary outcome was the difference in the viral load between day zero and ten in the two groups. RESULTS: Out of 1699 patients screened, 249 underwent randomization and 127 received ivermectin, and 122 placebo. D10 median viral load for E gene (IQR) was 2,000 copies/mL (100 - 20,500) with ivermectin (n = 80) and 4,100 copies/mL (1,000-65,600) with placebo (n = 81, p = 0.028), per protocol analysis. The difference in Log viral load between day zero and ten between ivermectin and placebo was 3.72 and 2.97 respectively (p = 0.022). There was no significant difference in the WHO clinical progression scale or the adverse effects. Ivermectin blood levels taken before or with meals were not significantly different. Only 7 and 17 patients achieved blood levels above 160ng/ML and 100ng/ML respectively and they did not achieve a significantly lower viral load. CONCLUSION: Although ivermectin resulted in statistically significant lower viral load in patients with mild to moderate Covid-19, it had no significant effect on clinical symptoms. TRIAL REGISTRATION NUMBER: SLCTR/2021/020, Sri Lanka Clinical Trials Registry. 19/07/2021.

Randomized controlled multi-centre study comparing shorter dental implants (6 mm) to longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 10-year data.

AIM: To compare implant survival and complication rates between shorter and standard-length implants with sinus augmentation and restored with single crowns, at 10 years of loading. MATERIALS AND METHODS: One-hundred and one patients (137 implants) with a ridge height of 5-7 mm in the posterior maxilla were randomly assigned to two treatment modalities: shorter implants (6 mm) (group short [GS]) or standard-length implants (11-15 mm) with sinus grafting (group graft [GG]). Following the insertion of final restorations, patients were regularly recalled for up to 10 years. Assessed outcomes encompassed implant survival, marginal bone levels (MBLs), biological and technical parameters and patient-reported outcome measures (OHIP-49 = Oral Health Impact Profile). Non-parametric statistical analysis was used to analyse the data. RESULTS: For the 5- to 10-year follow-up period, 77 patients with 105 implants (GS: 36 patients/48 implants; GG: 41/57) were available for re-examination (drop-out rate 21%). Implant survival rates at the patient level were 96.0% (GS; 2 failures) and 100% (GG) (inter-group p = .24). Median MBLs amounted to 0.00 mm (min 0.00; max 3.25; GS) and 0.00 mm (min 0.00; max 4.55; GG) (inter-group p = .73). Technical complications predominantly occurred within the first 5 years (inter-group p > .05). Peri-implantitis rates were 4.2% (GS) and 13.3% (GG) (intergroup p = .37). Median OHIP-49 scores were 7.00 (0.00; 39.00; GS) and 9.00 (0.00; 196; GG) (inter-group p = .61) at 10 years. CONCLUSIONS: Based on similar 10-year implant survival rates, reduced patient morbidity and lower costs, the use of shorter dental implants might well serve as an alternative treatment concept to longer implants placed in conjunction with sinus grafting for patients with a limited ridge height in the posterior maxilla. Study register: https://clinicaltrials.gov/ct2/show/NCT01030523.

Investigation the effect of Acceptance and Commitment Therapy (ACT) training on stigma and family functioning in family members of patients with psychiatric disorders: a randomized controlled clinical trial.

BACKGROUND: Regarding the prevalence and pervasiveness of psychiatric disorders, which significantly affect not only the patients themselves, but also their families, family therapy has emerged as a promising intervention. This research examined the effects of Acceptance and Commitment Therapy (ACT) on stigma and family functioning in family members of patients with psychiatric illnesses, demonstrating effectiveness in improving family functioning and coping strategies in the face of mental illness. METHODS: This randomized controlled clinical trial without blinding. Forty family members of patients with psychiatric disorders were randomly assigned to an intervention group (N = 20) or a control group (N = 20). The intervention group received ACT in eight weekly sessions, each lasting 90 min, while control group remained on a waiting list. Both groups were assessed at three time points: pre-intervention, post-intervention, and at a one-month follow-up. Data collection instruments included a demographic information questionnaire, a stigma assessment, and a family functioning measure. Data were analyzed using SPSS software version 23. RESULTS: A statistically significant difference was observed between the mean post-test and follow-up stigma scores of the intervention and control groups (P < 0.05). The intervention group's mean scores showed a rising trend, whereas the control group's mean scores showed a declining trend. This was evident from within-group comparisons of the mean post-test and follow-up stigma scores. Repeated measures ANOVA indicated that the pattern of change in stigma for the intervention group was significant, in contrast to control group, suggesting a reduction in stigma (P < 0.001). CONCLUSION: In light of the findings presented in this study, ACT emerges as a promising intervention for mitigating stigma, and enhancing the family functioning of individuals afflicted with mental disorders. To improve the generalizability of the study results, comparable studies using this therapy method should be undertaken on family caregivers of patients with mental illnesses. IRANIAN REGISTRY OF CLINICAL TRIALS: IRCT registration number: IRCT20190917044802N10. REGISTRATION DATE: 14/9/2023.

Clinical outcome of guided endodontics versus freehand drilling: A controlled clinical trial, single arm with external control group.

AIM: High-quality, prospective clinical studies are needed to increase evidence for guided endodontics. This study aims to assess the clinical outcome of guided endodontics for treatment of teeth presenting with pulp canal obliteration (PCO) in comparison with freehand treatment. METHODOLOGY: This trial was registered in the ISRCTN.com registry (ISRCTN75277265) and designed as a controlled clinical trial: Single arm trial, prospective, nonrandomized, single-centre study (ethical approval number S64630). Inclusion criteria were; tooth presenting with PCO and symptoms and/or signs of apical periodontitis (AP). An external control group was selected from clinical records of patients presenting the same criteria but treated freehanded. Guided root canal treatments were performed by the same operator on all patients. Freehanded treatments were performed by a specialist in endodontics under microscope with pre-operative CBCT available. Primary outcome for both groups was evaluated as: canal found, canal not found, or perforation. As secondary outcome, the qualitative accuracy of the drill path was assessed as: optimal precision, acceptable precision or technical failure. Patients were followed up yearly. Descriptive statistics on the study patient's demographics and healing outcome were performed and specific statistical analysis was performed on each outcome variable. RESULTS: A total of 133 teeth were included (n = 60 guided, n = 73 freehanded) from 128 patients (n = 59 guided, n = 69 freehanded). The primary outcome for the guided group was: 59 teeth canals found and 1 tooth canal not found. No perforations were recorded. In the freehanded group, the root canal was successfully found in 59 teeth, seven were not found, and seven had a perforation. An analysis of all data showed that guided endodontics presented statistically significant better outcome than freehand treatment (p < .05). CONCLUSION: Guided endodontics showed a statistically significant better outcome than freehanded treatment resulting in less technical failures. However, it is a complex procedure which should be carried out by an experienced endodontist with the aid of a dental microscope.

Repeated local delivery of hyaluronic acid gel as adjunctive treatment of residual pockets in periodontitis patients undergoing supportive periodontal care. A randomized controlled clinical trial.

OBJECTIVES: To assess the effect of hyaluronic acid (HyA) application as adjunct to re-instrumentation of residual pockets in patients undergoing regular supportive periodontal care (SPC). METHODS: Chronic periodontitis patients (stage III and IV, grade B and C) with 4 interproximal residual pockets were randomly assigned to the test (HyA gel) or control (saline) group. After subgingival instrumentation, test or control substance was applied subgingivally, then daily supragingivally for 3 months, and if required a second time after subgingival re-instrumentation after 3 months. Clinical and patient reported outcome parameters were recorded every 3 months for 12 months. Pocket closure [probing pocket depth (PPD) ≤ 4mm with absence of bleeding on probing (BoP) at PPD = 4mm] was the main outcome parameter. RESULTS: Fifty-six patients (221 experimental sites) were analysed. Pocket closure was achieved in 56.8 and 46.6% of the experimental sites in the test and control group, respectively (p > 0.05), while median PPD and PPD distribution (< 5mm/5mm/ > 5mm) differed significantly between groups in favour of the test group, at 12 months. Further, significantly fewer sites in the HyA group required re-instrumentation at 3 months, and sites in the HyA group showed a tendency for lower odds to remain diseased compared to the control group (OR 0.48, 95%CI 0.22-1.06). The odds for a site to remain diseased after 12 months increased significantly in the presence of plaque (OR 7.94, 95%CI 4.12-15.28), but in general, decreased significantly over time (OR 0.48, 95%CI 0.28-0.81). CONCLUSION: Re-instrumentation of residual pockets in SPC patients, per se, leads to a significant increase in pocket closure over time; this was impeded by poor plaque control. Repeated local application of HyA results in fewer sites requiring re-instrumentation and might slightly improve the rate of pocket closure. (clinicaltrials.gov registration nr. NCT04792541). CLINICAL RELEVANCE: HyA gel is easy to apply, well accepted by patients, and may have some positive effect in terms of fewer sites requiring re-instrumentation at 3 months and higher pocket closure rate at 12 months.

Dynamic salivary cytokine profile of recurrent aphthous stomatitis patients in thalidomide maintenance treatment.

OBJECTIVE: To dynamically compare the longitudinal (time axis) and transverse (between groups) differences of the salivary cytokines during thalidomide maintenance treatment of recurrent aphthous stomatitis. METHODS: A randomized, controlled, clinical trial was performed. After the initial prednisone treatment, thalidomide (50 mg/d vs. 25 mg/d) was used as a maintenance drug for 4 or 8 weeks. The salivary IL-4, 5, 6, 10, TNF-α, and IFN-γ were dynamically detected with a cytometric bead array. RESULTS: Overall, the level of six elevated salivary cytokines after prednisone treatment was significantly downregulated, remained low during thalidomide maintenance, and rebounded at recurrence. The effect of 50 mg/d thalidomide on the salivary cytokines was not superior to 25 mg/d medication. The relapse-free period following drug withdrawal was the longest in the subgroup using 25 mg/d thalidomide for 8 weeks. The order of magnitude of IL-6 was the most obvious, and at week 8, only the level of IL-6 in the group (25 mg/d thalidomide for 8 weeks) continued to decline compared with the other groups. CONCLUSION: Thalidomide maintenance treatment can effectively sustain low levels of salivary IL-4, 5, 6, 10, TNF-α, and IFN-γ of recurrent aphthous stomatitis patients. IL-6 displayed a good correlation with the disease and is expected to become an index for diagnosis and follow-up. CLINICAL RELEVANCE: Low-dose long-term thalidomide maintenance treatment was supported for recurrent aphthous stomatitis. TRIAL REGISTRATION: Trial registration number of ChiCTR-IPR-16009759 at http://www.chictr.org/index.aspx .

Individual and organizational interventions to reduce burnout in resident physicians: a systematic review and meta-analysis.

BACKGROUND: Burnout among resident physicians during training has been prevalent, prompting training centers to introduce interventions at the individual or organizational level. However, empirical evidence is crucial before implementing such programs in practice. METHODS: A systematic review and meta-analysis was carried out to evaluate the effectiveness of individual and organizational interventions in reducing burnout among resident physicians. Searching was done across five databases-PubMed, Scopus, ScienceDirect, Embase, and Cochrane Library from 1 December 2023 to 26 August 2024. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used for our reporting of study selection process. Eligibility criteria were randomized or non-randomized designs, with prospective intervention, with a comparator group focused on individual or organizational interventions reducing burnout, in any language and publication date. The Maslach Burnout Inventory scores for emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA) were the three outcome measures. Two investigators independently extracted the data. The risk of bias was evaluated using Cochrane risk-of-bias tool for randomized trials (RoB2) and non-randomized studies of interventions (ROBINS-I). Cohen's d and heterogeneity was estimated using a random-effects DerSimonian-Laird model and visualized by forest plots. Sensitivity analyses were carried out by leave-one-out meta-analysis. RESULTS: We identified 33 eligible studies (n = 2536), comprising 25 (75.8%) individual intervention studies and 8 (24.2%) organizational intervention studies. Cohen's d for individual intervention versus control were as follows: EE -0.25 (95% CI -0.40 to -0.11, p < 0.01, I2 = 49.3%), and DP -0.17 (95% CI -0.32 to -0.03, p = 0.02, I2 = 50.0%). The organizational intervention showed no significant association with any domain. Sensitivity analyses were robust in all outcomes, with differences in intervention description and design identified as potential contributors to heterogeneity. CONCLUSIONS: Various interventions, including individual coaching, meditation, and organization interventions, have been implemented to improve resident burnout. The effectiveness of intervention demonstrated none to small practical significance in improving burnout. Data inconsistency and high risk of bias across studies limited the validity of the pooled results. Further studies should focus on a combined approach. REGISTRATION: The study was registered on PROSPERO, under PROSPERO registration number CRD42022349698.

Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial).

BACKGROUND: Cervical radiculopathy occurs when a nerve root is compressed in the spine, if symptoms fail to resolve after 6 weeks surgery may be indicated. Anterior Cervical Discectomy (ACD) is the commonest procedure, Posterior Cervical Foraminotomy (PCF) is an alternative that avoids the risk of damage to anterior neck structures. This prospective, Phase III, UK multicentre, open, individually randomised controlled trial was performed to determine whether PCF is superior to ACD in terms of improving clinical outcome as measured by the Neck Disability Index (NDI) 52 weeks post-surgery. METHOD: Following consent to participate and collection of baseline data, subjects with cervical brachialgia were randomised to ACD or PCF in a 1:1 ratio on the day of surgery. Clinical outcomes were assessed on day 1 and patient reported outcomes on day 1 and weeks 6, 12, 26, 39 and 52 post-operation. A total of 252 participants were planned to be randomised. Statistical analysis was limited to descriptive statistics. Health economic outcomes were also described. RESULTS: The trial was closed early (n = 23). Compared to baseline, the median (interquartile range (IQR)) NDI score at 52 weeks reduced from 44.0 (36.0, 62.0) to 25.3 (20.0, 42.0) in the PCF group and increased from 35.6 (34.0, 44.0) to 45.0 (20.0, 57.0) in the ACD group. ACD may be associated with more swallowing, voice and other complications and was more expensive; neck and arm pain scores were similar. CONCLUSIONS: The trial was closed early, therefore no definitive conclusions on clinical or cost-effectiveness could be made.

The efficacy of hypnosis compared with the tell/show/do technique for the reduction of anxiety/pain in children undergoing pulpotomies: a randomized controlled trial.

Anxiety/pain is a combined experience that can hinder dental treatment in children and lead to the development of negative behaviours in any form of surgical treatment. Hypnosis is a suitable option with which to reduce anxiety and pain during dental treatment. In this study, we aimed to evaluate the efficacy of hypnosis compared to the tell/show/do technique for the reduction of anxiety and pain as measured by Face, Legs, Activity, Crying, Consolability (FLACC) scale in children undergoing pulpotomies. We performed a randomized and controlled clinical trial involving 60 children aged 5 to 7 years without previous dental experiences but with clinical and radiographic indications for pulpotomy in the primary mandibular right or left first or second molar. The children were divided into two groups: a control group (treated by conventional behaviour management techniques) and an experimental group (treated by hypnosis). The FLACC scale was used to evaluate anxiety/pain during preoperative, transoperative and postoperative pulpotomy treatment; we also analysed variations in heart rate and skin conductance. The trial was registered at ClinicalTrials.gov (NCT03739346). Statistical analysis was performed in R Studio version 1.2.1335. The FLACC scale was significantly lower in the experimental group (p = 0.022) throughout the entire treatment duration. In addition, heart rate and global skin conductance were both significantly lower in the experimental group when measured at different times (p = 0.005 and p = 0.032, respectively). When compared to conventional behavioural management techniques, the FLACC scale demonstrated that hypnosis was associated with significant reductions in heart rate, skin conductance and anxiety/pain throughout the entire duration of treatment. decreases anxiety/pain during the entire operative procedure. There was clear improvements in anxiety and pain control in patients receiving hypnotic therapy.

Effects of newer kidney protective agents on kidney endpoints provide implications for future clinical trials.

Doubling of serum creatinine (equivalent to a 57% decline in the estimated glomerular filtration rate (eGFR)) is an accepted component of a composite kidney endpoint in clinical trials. Smaller declines in eGFR (40%, 50%) have been applied in several recently conducted clinical trials. Here, we assessed the effects of newer kidney protective agents on endpoints including smaller proportional declines in eGFR to compare relative event rates and the magnitude of observed treatment effects. We performed a post hoc analysis of 4401 patients in the CREDENCE, 4304 in the DAPA-CKD, 5734 in the FIDELIO-DKD, and 3668 in the SONAR trials, which assessed the effects of canagliflozin, dapagliflozin, finerenone and atrasentan in patients with chronic kidney disease. Effects of active therapies versus placebo on alternative composite kidney endpoints incorporating different eGFR decline thresholds (40%, 50%, or 57% eGFR reductions from baseline) with kidney failure or death due to kidney failure were compared. Cox-proportional hazards regression models were used to assess and compare treatment effects. During follow-up, event rates were higher for endpoints incorporating smaller versus larger eGFR decline thresholds. Compared to the treatment effects on kidney failure or death due to kidney failure, the magnitude of relative treatment effects was generally similar when considering composite endpoints incorporating smaller declines in eGFR. Hazard ratios for the four interventions ranged from 0.63 to 0.82 for the endpoint incorporating 40% eGFR decline and 0.59 to 0.76 for the endpoint incorporating 57% eGFR decline. Clinical trials incorporating a 40% eGFR decline in a composite endpoint would require approximately half the number of participants compared to a 57% eGFR decline with equivalent statistical power. Thus, in populations at high risk of CKD progression, the relative effects of newer kidney protective therapies appear generally similar across endpoints based on varying eGFR decline thresholds.

A multicentre, randomized, double-blind, parallel, active- and placebo-controlled Phase 3 clinical study of the glucokinase activator PB-201 in treatment-naive patients with type 2 diabetes mellitus: A study protocol.

AIM: To report the rationale for using PB-201, a partial glucokinase activator (GKA), for a Phase 3 study (NCT05102149) assessing its efficacy and safety in a Chinese population and to describe the design of this GKA Phase 3 trial, the first to involve both an active control and a placebo control arm. MATERIALS AND METHODS: This is an ongoing, multicentre, randomized, double-blind, three-arm placebo and active control study to be carried out among 672 Chinese treatment-naive participants with type 2 diabetes mellitus (T2DM) to assess the efficacy and safety of PB-201 for approximately 60 weeks, including a screening period and a safety follow-up period. RESULTS: The primary objective of this study was to monitor change in glycated haemoglobin levels with PB-201 in treatment-naive T2DM participants from baseline to 24 weeks in comparison with vildagliptin and placebo. The key secondary objective was to assess the efficacy and safety of PB-201 following treatment for a time period of 52 weeks. CONCLUSION: This pivotal study will offer critical information regarding the efficacy and safety of PB-201 in Chinese treatment-naive T2DM participants that would help to establish robust evidence for the benefit-risk evaluation of this drug.

Maxillary overdentures supported by four or six implants in the anterior region: 10-year randomized controlled trial results.

AIM: To evaluate bar-supported maxillary implant overdenture treatment when supported by either four or six implants after 10 years. MATERIALS AND METHODS: Edentulous subjects with maxillary denture complaints and ample bone volume to facilitate implants in the anterior region of the maxilla were planned for implant overdenture treatment, randomized to receive either four implants (n = 25) or six implants (n = 25) and subsequently evaluated after 10 years of function. Outcome variables included peri-implant bone-level changes, implant and overdenture survival, complications, presence of plaque, calculus and bleeding, degree of peri-implant inflammation, probing depth and patient satisfaction. Differences between the groups and between evaluation periods were tested with a Student's t-test. RESULTS: Fourteen patients with totally 72 implants were lost to follow-up. Two patients from the six-implant group experienced implant loss (four implants), resulting in 96.1% implant survival in this group versus 100% survival in the four-implant group. Clinical, radiographical and patient-reported outcome measures did not differ statistically significant between the two groups. Patients from both groups were generally quite satisfied with the result after 10 years. CONCLUSIONS: Similar and favourable outcomes are seen in bar-supported maxillary overdentures on either four or six anteriorly placed implants after a 10-year evaluation period.

Clinical and radiographic outcomes of customized allogeneic bone block versus autogenous bone block for ridge augmentation: 6 Month results of a randomized controlled clinical trial.

AIM: To evaluate the efficacy of customized allogeneic bone block (CABB) for ridge augmentation compared with autogenous bone block. MATERIALS AND METHODS: Patients (N = 24) in need of ridge augmentation were randomly assigned to one of two treatment modalities: CABBs (CABB group) and autogenous bone blocks (ABB group). The primary outcome of the present study was the horizontal bone gain at 1 mm below the alveolar ridge crest (HBG1 ). Secondary outcomes were the bone gain at other levels, bone resorption rate, ridge width, operative time, postoperative pain score, and histological results. The data obtained from the current study were analysed using a generalized linear mixed effects model, two-sample t-test, or a Mann-Whitney U-test. RESULTS: Twenty-four patients completed a 6-month follow-up. One patient in the CABB group exhibited block exposure. The CABB group had significantly more horizontal bone gain (HBG1 ) and less horizontal bone resorption (HBRR1 ) at 1 mm below the alveolar ridge crest when compared with those in the ABB group (HBG1 : CABB group [4.29 ± 1.48 mm] and ABB group [1.12 ± 3.25 mm]; HBRR0 : CABB group [42.15 ± 14.03%] and ABB group [92.52 ± 55.78%], p < .05). In addition, a longer operative time was reported in the ABB group compared with the CABB group (p < .05). The histological observation indicated a new bone formation in both groups. CONCLUSIONS: The use of CABBs resulted in more horizontal bone gain and less horizontal bone resorption at 1 mm below the alveolar ridge crest at 6 months post-surgery compared with ABBs while reducing the operative time in the treatment of ridge augmentation.

6 mm short versus 11 mm long inter-foraminal implants in the full-arch rehabilitation of edentulous non-atrophic mandibles: 5-year results from a multicenter randomized controlled trial.

OBJECTIVE: The aim of this multicenter parallel-group randomized controlled trial is to compare, in the same clinical scenario, 6 mm short with 11 mm long implants for the rehabilitation of completely edentulous non-atrophic mandibles. MATERIALS AND METHODS: Thirty patients in three study centers received a fixed full-arch mandibular rehabilitation supported by five inter-foraminal implants, with no need for bone augmentation procedures. Patients were randomly allocated (1:1 ratio), at the time of surgery, to test (6 mm implants) or control group (11 mm implants). After 3 months, a screw-retained full-arch prosthesis was positioned (baseline). Peri-implant marginal bone level change (MBLc, primary outcome) together with implant and prosthesis survival rate, and biological/technical complications (secondary outcomes) were evaluated up to 5 years. RESULTS: Twenty seven patients were controlled at 5 years (3 drop-outs). No implant or prosthesis loss occurred. No significant intergroup difference for biological/technical complications (p > .05, Fisher's exact test) and no significant intragroup and intergroup difference in the MBLc values were registered (test -0.03 ± 0.17 mm and control -0.13 ± 0.32 mm at 5-years; p > .025, one-sided Mann-Whitney U-test). CONCLUSIONS: When used in comparable anatomic, surgical, and prosthetic conditions, no difference in the clinical and radiographic outcomes between 6-mm and 11-mm implants was observed at 5 years of follow-up. Short implants showed to be a reliable option for the rehabilitation of completely edentulous non-atrophic mandibles. There is growing clinical evidence supporting the use of short implants, even in the case of non-atrophic sites.

Radiographic outcomes of ridge reconstruction with autogenous bone block versus collagenated xenogeneic bone block: A randomized clinical trial.

AIM: To compare, at different levels from the alveolar crest, the radiographic outcomes of equine-derived collagenated xenogeneic bone blocks (CXBB) and autogenous bone blocks (ABB) used for lateral alveolar ridge augmentation. MATERIALS AND METHODS: Sixty-four patients with tooth gaps in atrophic alveolar ridges with ≤4 mm were randomly assigned to lateral augmentation using CXBB or ABB. The lateral bone thickness (LBT) was measured 2, 4, 6, 8, and 10 mm below the alveolar crest using CBCT scans obtained before augmentation surgery and at 30 weeks, prior to implant placement. Statistical analysis was performed using Shapiro-Wilk, Fisher's exact, Mann-Whitney, and Wilcoxon signed-rank tests. RESULTS: Both CXBB and ABB resulted in significant total and buccal LBT gains at 2, 4, 6, 8, and 10 mm. LBT gains were similar between CXBB- and ABB-augmented sites, except for greater buccal LBT gains at 8 mm at CXBB-augmented sites. While ABB-augmented sites gained vertical bone height, CXBB-treated sites suffered vertical bone loss (CXBB: -0.16 mm; ABB: 0.38 mm, p < .0009). CONCLUSIONS: CXBB and ABB were both associated with significant and similar LBT gains at 30 weeks.

Expanded nursing roles to promote person-centred care for people with cognitive impairment in acute care (ENROLE-acute): study protocol for a controlled clinical trial, process and economic evaluation.

BACKGROUND: For people with cognitive impairment, hospitalisation is challenging and associated with adverse events as well as negative outcomes resulting in a prolonged hospital stay. Person-centred care can improve the quality of care and the experience of people with cognitive impairment during hospitalisation. However, current care processes in German hospitals are rarely person-centred. To enable successful implementation of person-centred care on hospital wards, change agents within the interprofessional team are key. The aim of this study is to test the feasibility and initial effects of a newly developed complex person-centred care intervention for people with cognitive impairment provided by expanded practice nurses in acute care. METHODS: We will conduct an exploratory non-randomised controlled clinical trial with accompanying process and cost evaluation with three intervention and three control wards at one university hospital. The person-centred care intervention consists of 14 components reflecting the activities of expanded practice nurses within the interprofessional team on the intervention wards. The intervention will be implemented over a six-month period and compared with optimised care on the control wards. We will include people aged 65 years and older with existing cognitive impairment and/or at risk of delirium. The estimated sample size is 720 participants. The primary outcome is length of hospital stay. Secondary outcomes include prevalence of delirium, prevalence of agitation, sleep quality, and person-centred care. We will collect patient level data at six time points (t1 admission, t2 day 3, t3 day 7, t4 day 14, t5 discharge, t6 30 days after discharge). For secondary outcomes at staff level, we will collect data before and after the intervention period. The process evaluation will examine degree and quality of implementation, mechanisms of change, and the context of the complex intervention. The economic evaluation will focus on costs from the hospital's perspective. DISCUSSION: The ENROLE-acute study will provide insights into the effectiveness and underlying processes of a person-centred care intervention for people with cognitive impairment provided by expanded practice nurses on acute hospitals wards. Results may contribute to intervention refinement and evidence-based decision making. TRIAL REGISTRATION: Current controlled trials: ISRCTN81391868. Date of registration: 12/06/2023. URL: https://doi.org/10.1186/ISRCTN81391868.

Efficacy of curcumin plus piperine co-supplementation in moderate-to-high hepatic steatosis: A double-blind, randomized, placebo-controlled clinical trial.

Non-alcoholic Fatty Liver Disease (NAFLD) is a global health problem that can progress to steatohepatitis and cirrhosis. The aim of this study was to determine the effect of curcumin + piperine on cardiometabolic risk factors, as well as hepatic steatosis and fibrosis in NAFLD patients with moderate-to-high hepatic steatosis. Patients diagnosed with moderate-to-high NAFLD by liver sonography were randomized to either curcumin + piperine (500 mg/day curcumin plus 5 mg/day piperine) for 12 weeks (n = 30) or placebo groups (n = 30). Liver fibroscan, anthropometric measurements, dietary intake, physical activity, blood pressure, lipid profile, high-sensitivity C-reactive protein, fasting blood glucose (FBG), and liver enzymes were assessed at baseline and after 12 weeks of follow-up. Intention-to-treat analysis was undertaken. Curcumin + piperine decreased waist circumference (p = 0.026), systolic blood pressure (p = 0.001), total cholesterol (p = 0.004), low-density lipoprotein-cholesterol (p = 0.006), FBG (p = 0.002), alanine transaminase (p = 0.007) and aspartate transaminase (p = 0.012) compared with placebo. However, fibroscan measurement did not differ between curcumin + piperine and placebo groups (p > 0.05). Fibroscan measurement as a marker of NAFLD improvement did not differ after 12 weeks of curcumin + piperine; however, curcumin + piperine may be considered as an adjunct therapy to improve anthropometric measures, blood pressure, lipid profile, blood glucose, and liver function in NAFLD patients.

Efficacy of curcumin gel as an adjunct to scaling and root planing on salivary procalcitonin level in the treatment of patients with chronic periodontitis: a randomized controlled clinical trial.

THE AIM OF THE STUDY: To evaluate the effect of curcumin gel combined with scaling and root planing (SRP) on salivary procalcitonin in periodontitis treatment. MATERIALS AND METHODS: seventy patients were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, and sixteen patients were excluded. Patients in groups II and III included stage II grade A periodontitis. The participants were classified into three groups: group I as a negative control group (individuals with healthy gingiva), group II (SRP) were treated with SRP, and group III (curcumin gel) which was applied weekly for four weeks after SRP. Clinical indices (plaque index (PI), gingival index (GI), clinical attachment level (CAL), and probing depth (PD)) and saliva samples for procalcitonin (PCT) assessment using an enzyme-linked immunosorbent assay (ELISA) test were collected and measured at both baselines and after six weeks. RESULTS: This randomized controlled clinical trial registered on ClinicalTrials.gov (NCT05667376) and first posted at 28/12/2022 included Fifty-four patients (20 male; 34 female). Regarding the age and sex distribution, there was no statistically significant difference between the three studied groups (p > 0.05). There was no significant statistical difference regarding PI, GI, PPD, and CAL between group II and group III at baseline p (> 0.05). However, there was a significant statistical difference regarding the clinical parameters at baseline of both group II and group III as compared to group I (p ≤ 0.05). At six weeks after treatment, group III showed greater improvement in the PI, PD, and CAL as opposed to group II (p ≤ 0.05). Regarding PCT values, at baseline, there wasn't a statistically significant difference between group II and group III (p > 0.05). However, there was a significant statistical difference between group II, group III, and group I (p ≤ 0.05). At six weeks after treatment, there was a statistically significant decrease in PCT levels of both group II and III (p ≤ 0.05). CONCLUSION: The application of curcumin gel was found to have a significant effect on all clinical indices as opposed to SRP.