Is zirconia surface etching a viable alternative to airborne particle abrasion? A systematic review and meta-analysis of in vitro studies.

OBJECTIVES: This systematic review aimed to determine the effectiveness of various etching surface treatments on zirconia bond strength with the following research question: "Can zirconia etching serve as a viable alternative to airborne particle abrasion (APA) for achieving reliable bonding?". DATA: In vitro studies comparing APA, performed with either conventional or silica-coated aluminum oxide (Al2O3) particles, with various etching protocols in terms of bonding performance were included. The risk of bias of the included studies was assessed using the QUIN's tool for in vitro studies. Meta-analyses were performed using RevMan; random-effects models were applied, and heterogeneity was tested using the I2 index. The significance level was set at p<0.05. SOURCES: A comprehensive literature search was conducted across electronic databases, including Clarivate Analytics' Web of Science, Cochrane Library, EMBASE, PubMed, Scopus and ProQuest. STUDY SELECTION: Fifty-four relevant articles were included in this systematic review. According to the QUIN's tool, 7 studies were rated as "high risk of bias", 46 studies were rated as "medium risk", and 1 study was rated as "low risk". Nineteen studies were used for meta-analyses. Mostly, APA demonstrated significantly higher bond strength compared to various etching protocols (p<0.05). However, no statistical difference was found between APA and high concentrations (40-48%) of hydrofluoric acid (HF) in terms of immediate- and medium-term bond strength to resin composite (p>0.05). On enamel, an experimental hot etching solution performed significantly better than APA in short-term follow-up (p<0.05). A novel multi-acid solution exhibited significantly higher immediate shear bond strength to resin cement than APA (p<0.05). Variable heterogeneity, ranging from low to high, was observed. CONCLUSIONS: APA remains the surface treatment with the strongest evidence in the literature and it is usually more efficacious than zirconia etching. However, highly concentrated HF and an experimental hot etching solution have demonstrated similar or significantly higher bond strength values over time compared to APA, depending on the adhesive substrate. A recently introduced multi-acid solution (Zircos-E) needs to be further explored. CLINICAL SIGNIFICANCE: This systematic review provides a comprehensive analysis of the existing in vitro evidence on the potential of zirconia etching and the bond durability of resin-based materials after artificial aging. Selecting appropriate surface treatment protocols is crucial for achieving optimal clinical outcomes.

Sex-specific post-inflammatory dysbiosis mediates chronic visceral pain in colitis.

BACKGROUND: Despite achieving endoscopic remission, over 20% of inflammatory bowel disease (IBD) patients experience chronic abdominal pain. Visceral pain and the microbiome exhibit sex-dependent interactions, while visceral pain in IBD shows a sex bias. Our aim was to evaluate whether post-inflammatory microbial perturbations contribute to visceral hypersensitivity in a sex-dependent manner. METHODS: Males, cycling females, ovariectomized, and sham-operated females were given dextran sodium sulfate to induce colitis and allowed to recover. Germ-free recipients received sex-appropriate and cross-sex fecal microbial transplants (FMT) from post-inflammatory donor mice. Visceral sensitivity was assessed by recording visceromotor responses to colorectal distention. The composition of the microbiota was evaluated via 16S rRNA gene V4 amplicon sequencing, while the metabolome was assessed using targeted (short chain fatty acids - SCFA) and semi-targeted mass spectrometry. RESULTS: Post-inflammatory cycling females developed visceral hyperalgesia when compared to males. This effect was reversed by ovariectomy. Both post-inflammatory males and females exhibited increased SCFA-producing species, but only males had elevated fecal SCFA content. FMT from post-inflammatory females transferred visceral hyperalgesia to both males and females, while FMT from post-inflammatory males could only transfer visceral hyperalgesia to males. CONCLUSIONS: Female sex, hormonal status as well as the gut microbiota play a role in pain modulation. Our data highlight the importance of considering biological sex in the evaluation of visceral pain.

Cardiac arrest centres for patients with non-traumatic cardiac arrest: A systematic review.

INTRODUCTION: Regionalisation and organised pathways of care using specialist centre hospitals can improve outcomes for critically ill patients. Cardiac arrest centre hospitals (CAC) may optimise the delivery of post-resuscitation care. The International Liaison Committee on Resuscitation (ILCOR) has called for a review of the current evidence base. AIM: This systematic review aimed to assess the effect of cardiac arrest centres for patients with non-traumatic cardiac arrest. METHODS: Articles were included if they met the prospectively registered (PROSPERO) inclusion criteria. These followed the PICOST framework for ILCOR systematic reviews. A strict definition for a CAC was used, reflecting current position statements and clinical practice. MEDLINE, Embase and the Cochrane Library were searched using pre-determined criteria from inception to 31 December 2023. Risk of bias was assessed using Cochrane's Risk of Bias tool and ROBINS-I. The certainty of evidence for each outcome was assessed using the GRADE approach. Substantial heterogeneity precluded meta-analysis and a narrative synthesis with visualisation of effect estimates in forest plots was performed. RESULTS: Sixteen studies met eligibility criteria, including data on over 145,000 patients. One was a randomised controlled trial (RCT) at low risk of bias and the remainder were observational studies, all at moderate or serious risk of bias. All studies included adults with out-of-hospital cardiac arrest. One study used initial shockable rhythm as an inclusion criterion and most studies (n = 12) included patients regardless of prehospital ROSC status. Two studies, including the RCT, excluded patients with ST elevation. Survival to hospital discharge with a favourable neurological outcome was reported by 11 studies and favoured CAC care in all observational studies, but the RCT showed no difference. Survival to 30 days with a favourable neurological outcome was reported by two observational studies and favoured CAC care in both. Survival to hospital discharge was reported by 13 observational studies and generally favoured CAC care. Survival to 30 days was reported by two studies, where the observational study favoured CAC care, but the RCT showed no difference. CONCLUSION: This review supports a weak recommendation that adults with out-of-hospital cardiac arrest are cared for at CACs based on very low certainty of evidence. Randomised evidence has not confirmed the benefits of CACs found in observational studies, however this RCT was a single trial in a very specific setting and a population without ST elevation on post-ROSC ECG. The role of CACs in shockable and non-shockable subgroups, direct versus secondary transfer, as well as the impact of increased transport time and bypassing local hospitals remains unclear.

The "Smile Design and Space" Concept for Altering Vertical Dimension of Occlusion and Esthetic Restorative Material Selection.

OBJECTIVE: This article introduces the smile design and space (SDS) concept for managing the vertical dimension of occlusion (VDO) in full-mouth reconstructions and its influence on the selection of esthetic restorative materials. Limitations of traditional VDO adjustment methods are being addressed through a facially driven treatment approach that enhances esthetics improves function and minimizes invasiveness. CLINICAL CONSIDERATIONS: The SDS concept involves detailed evaluations of the incisal edges of the maxillary central incisors in relation to the upper lip at rest and at full smile. This includes analyzing variations in incisal exposure due to differing lip mobility, which can significantly impact gingival esthetics, particularly in cases with gingival exposure during smiling. The concept employs a strategic formula to determine the necessary alterations in VDO based on specific dental relationships and wear patterns. CONCLUSIONS: The SDS concept provides guidelines for full-mouth reconstructions, emphasizing minimal invasiveness and the integration of esthetics with functional dynamics to enhance the predictability of clinical outcomes and reduce complications associated with traditional restoration techniques. CLINICAL SIGNIFICANCE: The SDS concept enhances the precision of full-mouth reconstructions through individualized adjustment of the VDO, tailored to the esthetic and functional requirements of each patient.

A Survey of Preferences for Ceramic Materials on Tooth-Supported Crowns Among Dental Practitioners in Chile.

Purpose: To evaluate the preferences of dental practitioners for tooth-supported crowns dental ceramics by means of an online survey and to assess the influence of age, gender, years of experience, and dental specialty on those preferences. Materials and Methods: An anonymous questionnaire was delivered online through Google Surveys, targeting 796 dentists. It contained 17 dichotomous, closed questions with two sections. The first section dealt with general characteristics, including age, gender, years of experience, training in prosthodontics, and hours worked per week. The second section included questions regarding preferences of different materials for crowns, and the use of digital workflows. Analyses were carried out with Stata 14.0 software (StataCorp, TX, USA). A significance level of p=0.05 was adopted. Results: 248 surveys were answered. Practitioners in Chile preferred lithium disilicate for the anterior region (55.2%) but also for the posterior area (40.7%), regardless of their age, gender, years since graduation, hours worked per week or any training in prosthodontics. Chilean dentists over 50 years old considered zirconia almost 4 times more than those under 30 years old for anterior crowns (51.85%). 59.68% of dentists take digital impressions, and 37.10% have access to chairside CAD/CAM technology. In this group, 54.4% preferred feldspathic ceramic for anterior and 23.9% for posterior crowns. Conclusions: While there is a wide range of dental ceramic materials, these results provide a snapshot of the current trends in Chile where lithium disilicate is the most preferred ceramic material for tooth-supported crowns, and metal-ceramic is the least preferred material.

Effect of acidic media on surface characteristics of highly filled flowable resin-based composites: An in vitro study.

OBJECTIVE: To analyze and compare the impact of acidic media on the surface characteristics of highly filled flowable resin-based composites. MATERIALS AND METHODS: Two hundred fifty-six specimens were divided into four groups: GUF (G-aenial Universal Flo), GUI (G-aenial Universal Injectable), TEF (Tetric EvoFlow), and FSF (Filtek Supreme Flowable Restorative). Surface characteristics were analyzed before (T0) and after specimens immersion in different media, such as gastric juice (GJ), fizzy drink (FD), citric juice (CJ), or artificial saliva (AS), for 9 h (T1) and 18 h (T2). The analyses included surface roughness (SR) measurements, where average roughness (Ra) was obtained, scanning electron microscopy (SEM) analysis, and surface hardness (SH) evaluation, with Vickers numbers (HV) reported. The differences in values among groups/subgroups within the same stage were assessed using two-way ANOVA and Tukey's post hoc test, whereas repeated measures ANOVA with Bonferroni post hoc test was performed to compare the changes in values through the stages. Data were presented as mean ± standard deviation (SD). RESULTS: At T0, GUI and GUF revealed lower Ra values (p < 0.05), more evenness in SEM micrographs, and higher HV values (p < 0.05) than FSF and TEF. At T1 and T2, specimens of all groups/subgroups demonstrated an increase in Ra and a decrease in HV compared with T0 (p < 0.05), as well as the changes in surface morphology on SEM micrographs. The lowest Ra and highest HV values were observed in GUI group, in contrast to FSF group, and in specimens immersed in GJ. CONCLUSIONS: GUI revealed lower SR and higher SH compared to GUF and FSF both before and after exposure to acidic media. The presence of acidic media, especially GJ, significantly increases SR and decreases SH of tested materials. CLINICAL SIGNIFICANCE: Information on the changes in the surface characteristics of highly filled resin-based composites after exposure to acidic media may be essential for the longevity of restorations like composite veneers fabricated from these materials.

Interdisciplinary Delphi study by PROSEC North America: Recommendations on single indirect restorations made from ceramic and nonmetallic biomaterials for posterior teeth.

OBJECTIVE: This article puts forward consensus recommendations from PROSEC North America regarding single indirect restorations made from ceramic and nonmetallic biomaterials in posterior teeth. OVERVIEW: The consensus process involved a multidisciplinary panel and three consensus workshops. A systematic literature review was conducted across five databases to gather evidence. The recommendations, informed by findings from systematic reviews and formulated based on a two-phase e-Delphi survey, emphasize a comprehensive treatment strategy that includes noninvasive measures alongside restorative interventions for managing dental caries and tooth wear. The recommendations advocate for selecting between direct and indirect restorations on a case-by-case basis, favoring inlays and onlays over crowns to align with minimally invasive dentistry principles. The recommendations highlight the critical role of selecting restorative biomaterials based on clinical performance, esthetic properties, and adherence to manufacturer guidelines. They emphasize the importance of precision in restorative procedures, including tooth preparation, impression taking, contamination control, and luting. Regular follow-up and maintenance tailored to individual patient needs are crucial for the longevity of ceramic and nonmetallic restorations. CONCLUSIONS: These PROSEC recommendations provide a framework for dental practitioners to deliver high-quality restorative care, advocating for personalized treatment planning and minimally invasive approaches to optimize oral health outcomes. CLINICAL SIGNIFICANCE: The PROSEC North America recommendations highlight the importance of minimally invasive techniques in posterior tooth restorations using ceramic and non-metallic biomaterials. These principles prioritize tooth structure conservation and personalized treatment planning, essential for enhancing clinical outcomes and long-term oral health.

Controlling Drug Partitioning in Individual Protein Condensates through Laser-Induced Microscale Phase Transitions.

Gelation of protein condensates formed by liquid-liquid phase separation occurs in a wide range of biological contexts, from the assembly of biomaterials to the formation of fibrillar aggregates, and is therefore of interest for biomedical applications. Soluble-to-gel (sol-gel) transitions are controlled through macroscopic processes such as changes in temperature or buffer composition, resulting in bulk conversion of liquid droplets into microgels within minutes to hours. Using microscopy and mass spectrometry, we show that condensates of an engineered mini-spidroin (NT2repCTYF) undergo a spontaneous sol-gel transition resulting in the loss of exchange of proteins between the soluble and the condensed phase. This feature enables us to specifically trap a silk-domain-tagged target protein in the spidroin microgels. Surprisingly, laser pulses trigger near-instant gelation. By loading the condensates with fluorescent dyes or drugs, we can control the wavelength at which gelation is triggered. Fluorescence microscopy reveals that laser-induced gelation significantly further increases the partitioning of the fluorescent molecules into the condensates. In summary, our findings demonstrate direct control of phase transitions in individual condensates, opening new avenues for functional and structural characterization.

Increased expression of human endogenous retrovirus K in endomyocardial biopsies from patients with cardiomyopathy - a transcriptomics meta-analysis.

Most studied, investigating transcriptional changes in myocardial biopsies focus on human genes. However, the presence and potential consequence of persistent expression of viral genes within the myocardium is unclear. The aim of the study was to analyze viral gene expression in RNAseq data from endomyocardial biopsies. The NCBI Bioproject library was screened for published projects that included bulk RNA sequencing data from endomyocardial biopsies from both healthy and diseased patients with a sample size greater than 20. Diseased patients with hypertrophic, dilated, and ischemic cardiomyopathies were included. A total of 507 patients with 507 samples from 6 bioprojects were included and mapped to the human genome (hg38). Unmappable sequences were extracted and mapped to an artificial 'super-virus' genome comprising 12,182 curated viral reference genomes. Subsequently, the sequences were reiteratively permutated and mapped again to account for randomness. In total, sequences from 68 distinct viruses were found, all of which were potentially human pathogenic. No increase in cardiotropic viruses was found in patients with dilated cardiomyopathy. However, the expression levels of the particle forming human endogenous retrovirus K were significantly increased (q < 0.0003, ANOVA). Higher expression levels were associated with increased expression in mitochondrial pathways such as oxidative phosphorylation (p < 0.0001). In Conclusion, expression of human endogenous retrovirus K is significantly increased in patients with dilated cardiomyopathy, which in turn was associated with transcriptional alterations in major cellular pathways.

Investigating the role of a Tannerella forsythia HtrA protease in host protein degradation and inflammatory response.

Introduction: Degradation of host proteins by bacterial proteases leads to the subversion of the host response and disruption of oral epithelial integrity, which is considered an essential factor in the progression of periodontitis. High-temperature requirement A (HtrA) protease, which is critical for bacterial survival and environmental adaptation, is found in several oral bacteria, including the periodontal pathogen Tannerella forsythia. This study investigated the proteolytic activity of HtrA from T. forsythia and its ability to modulate the host response. Methods: HtrA of T. forsythia was identified bioinformatically and produced as a recombinant protein. T. forsythia mutants with depleted and restored HtrA production were constructed. The effect of T. forsythia wild-type, mutants and recombinant HtrA on the degradation of casein and E-cadherin was tested in vitro. Additionally, the responses of human gingival fibroblasts and U937 macrophages to the different HtrA-stimuli were investigated and compared to those triggered by the HtrA-deficient mutant. Results: T. forsythia wild-type producing HtrA as well as the recombinant enzyme exhibited proteolytic activity towards casein and E-cadherin. No cytotoxic effect of either the wild-type, T. forsythia mutants or rHtrA on the viability of host cells was found. In hGFB and U937 macrophages, both T. forsythia species induced an inflammatory response of similar magnitude, as indicated by gene and protein expression of interleukin (IL)-1ß, IL-6, IL-8, tumour necrosis factor α and monocyte chemoattractant protein (MCP)-1. Recombinant HtrA had no significant effect on the inflammatory response in hGFBs, whereas in U937 macrophages, it induced a transient inflammatory response at the early stage of infection. Conclusion: HtrA of T. forsythia exhibit proteolytic activity towards the host adhesion molecule E-cadherin and has the potential to influence the host response. Its role in the progression of periodontitis needs further clarification.

A fully digital workflow involving 3D printed tooth reduction guides and injection resin-indexes to restore an impacted canine.

OBJECTIVE: The present clinical report describes a long-term temporary restorative approach using injectable composite to reshape a canine into a central incisor, within the context of an ongoing orthodontic treatment. This treatment protocol describes a fully-digital workflow, incorporating digital designed and 3D printed diagnostic wax up, reduction guides and resin-injection index. CLINICAL CONSIDERATIONS: Effective planning is important when aiming to deliver a comprehensive and multidisciplinary workflow, and digital tools serve as invaluable aids. CONCLUSION: The use of a fully digital workflow in a comprehensive dental treatment resulted in a predictable and successful outcome for a restoration of a canine that was transformed into a central incisor. CLINICAL SIGNIFICANCE: This approach highlights the efficacy of digital technology in achieving precise and successful dental restorations, emphasizing its significance in modern dental practice.

A national surveillance system for continuous monitoring of blood transfusion safety: German haemovigilance data.

BACKGROUND AND OBJECTIVES: Haemovigilance (HV) systems aim to improve transfusion outcomes in patients and donor safety. An important question for blood regulators is how to ensure an effective HV system. MATERIALS AND METHODS: We retrospectively analysed the HV reports submitted to Paul-Ehrlich-Institut over the last two decades. RESULTS: Between 2011 and 2020, 50.86 million units of blood components were used, and 8931 suspected serious donor and recipient adverse reactions (SARs), 874 serious adverse events (SAEs) and 12,073 donor look-backs were reported. Following implementation of specific risk-minimization measures (RMMs) between 2000 and 2010, SAR reporting rates decreased for transfusion-transmitted viral infections (TTVIs), transfusion-related acute lung injury (TRALI) and transfusion-transmitted bacterial infections (TTBIs), while increasing for other serious adverse transfusion reactions. Within this decade, the overall blood component use decreased. CONCLUSION: Long-term data collection forms the basis to establish trends and changes in reporting and to evaluate the effect of RMM. Standardized criteria for reaction types, seriousness and imputability assessments and availability of a denominator are important elements. Central data collection and independent assessment allow for monitoring HV data in a nationwide context over time. Stakeholder involvement and transparent feedback on the benefit of RMM will help to achieve the objectives of HV.

Long-Term Quality of Life After Pediatric Traumatic Brain Injury Treated in the Intensive Care Unit.

BACKGROUND: To examine the long-term health-related quality of life (HRQL) after pediatric traumatic brain injury (TBI) treated in the intensive care unit (ICU). METHODS: This retrospective cohort study was conducted using data from four university hospital ICUs in Finland. Children aged < 18 years with TBI treated in the ICU during 2003 to 2013 were included. Patients alive at the end of 2020 were sent two different HRQL questionnaires 15/16-dimensional (15D/16D) and RAND-36  and questions regarding chronic diseases, socioeconomical status, and the need for health care support. HRQL was defined as poor when the 15D/16D score total score was below the age- and sex-matched mean population score in Finland minus the minimal clinically important difference. RESULTS: A total of 150 of 337 (44%) patients responded (n = 144 15D/16D responses). Median follow-up time was 11 years. Seventy patients (49%) had a poor HRQL according to 15D/16D score. Patients with TBI had significantly poorer 15D scores in every dimension when compared with the matched population mean values. A higher Helsinki CT score, mechanical ventilation, and female sex were associated with poor long-term HRQL according to the 15D/16D. Patients with poor 15D/16D scores also needed significantly more health care services and medications and had more comorbidities than patients with normal scores. A poor 15D/16D score was associated with lower socioeconomic status. CONCLUSIONS: Half of long-term pediatric ICU-treated TBI survivors had poor HRQL 11 years after injury. More severe head computed tomographic findings at admission and female sex associated with poor HRQL.

Effect of Phosphate on the Molecular Properties, Interactions, and Assembly of Engineered Spider Silk Proteins.

Phosphate plays a vital role in spider silk spinning and has been utilized in numerous artificial silk spinning attempts to replicate the remarkable mechanical properties of natural silk fiber. Its application in artificial processes has, however, yielded varying outcomes. It is thus necessary to investigate the origins and mechanisms behind these differences. By using recombinant silk protein SC-ADF3 derived from the garden spider Araneus diadematus, here, we describe its conformational changes under various conditions, elucidating the effect of phosphate on SC-ADF3 silk protein properties and interactions. Our results demonstrate that elevated phosphate levels induce the irreversible conformational conversion of SC-ADF3 from random coils to ß-sheet structures, leading to decreased protein solubility over time. Furthermore, exposure of SC-ADF3 to phosphate stiffens already formed structures and reduces the ability to form new interactions. Our findings offer insights into the underlying mechanism through which phosphate-induced ß-sheet structures in ADF3-related silk proteins impede fiber formation in the subsequent phases. From a broader perspective, our studies emphasize the significance of silk protein conformation for functional material formation, highlighting that the formation of ß-sheet structures at the initial stages of protein assembly will affect the outcome of material forming processes.

The Selective Enamel Etch Technique.

Adhesive dentistry is an essential component in the delivery of direct and indirect restorations. Ongoing discussions among scientists and clinicians have focused on whether or not current self-etch and universal adhesives adequately prepare enamel surfaces to achieve optimal bond strengths. To address these concerns, a selective enamel etch technique has been recommended. The definition of a selective enamel etch technique is as its name suggests. The clinician selectively etches the enamel of a cavity preparation by applying phosphoric acid etchant to the enamel surfaces of the preparation while refraining from applying the etchant to the dentin. This article explores the current research to help guide clinicians to achieve ideal outcomes when using dental adhesives. With few exceptions, the current scientific evidence recommends a selective enamel etch technique in conjunction with the clinician's adhesive system of choice.

Understanding parental secure base support across youth sport contexts in Sweden.

The notion of secure base explains how a child can grow and become independent through access to a significant other (i.e., parent) who is available, encouraging, and noninterfering. The purpose of the current study was to develop an understanding of parental secure base support within the context of youth sport in Sweden, with a specific focus on: (a) what parental behaviors constitute a secure base, and (b) how these behaviors differ across contexts (at home before and after sport, at practice and during competitions). An interpretive descriptive methodology (Thorne, 2016) was used. Interviews were conducted with 13 family triads (children aged 12-15 years) and 1 dyad living in Sweden. Analysis was conducted to illuminate associations, patterns, and relationships within the sample. Analysis led to the development of nine categories of parental behaviors that were perceived to underpin a secure base. Availability was seen to comprise physical presence and support provision, being responsive, and developing positive mental representations. Encouragement encompassed demonstrating that sport participation is valued, motivating to explore sporting endeavors, and reinforcing and rewarding persistence in sports. Interference was described as unrequested interference, requested interference, and intentionally constrained involvement. Additionally, influencing factors such as communication, family structure and culture, were identified. The findings provide an empirical illustration for several behaviors that have been perceived as positive in previous literature, as well as highlighting numerous further complexities, particularly as it relates to interference.

Peri-implant soft tissue volume changes after microsurgical envelope technique with a connective tissue graft. A 5-year retrospective case series.

AIM: The aim of the present retrospective case series was to longitudinally assess soft tissue volume changes on the vestibular aspect of implants in relation to keratinized mucosa thickness (KMT) and width (KMW) after the application of the microsurgical envelope technique combined with a connective tissue graft (CTG). MATERIALS AND METHODS: A total of 12 healthy patients received 12 dental implants placed either in the posterior maxilla or mandible. The study involved the harvesting of 12 CTGs with a minimally invasive single-incision technique, grafted to the vestibular peri-implant soft tissue utilizing the envelope technique, followed by the insertion of 12 screw-retained IPS e.max crowns. RESULTS: The healing process was uneventful across all areas, and all patients were followed up for a period of 5 years. The evaluation of KMT showed the highest decrease in the first 6 weeks after surgery (5.5 ± 0.79 to 4.59 ± 0.62 mm), then dropped slightly to 4 ± 0.85 mm, after which it maintained at 4 ± 0.36 mm until the 2-year time point. Between the second and third years after surgery, a further decrease of 3.59 ± 0.42 mm was recorded for KMT, which then remained constant until the end of the 5-year research period. The observations regarding KMW were slightly different, with the measurements demonstrating the greatest decrease in first 6 weeks (from 2.5 ± 0.42 to 1.5 ± 0.42 mm), which was maintained until the 1-year time point. Between the first and second years after surgery, the KMW increased to 2 ± 0.60 mm and remained level for the next 3 years, at 2 ± 0.85 mm. CONCLUSIONS: The current research demonstrated the advantages of using a combination of a minimally invasively harvested CTG and the microsurgical envelope technique for a duration of 5 years.

Multi-center safety and efficacy study of a negative-pressure intraoral device in obstructive sleep apnea.

BACKGROUND: Intraoral devices, with or without negative oral pressure, can stabilize the oropharynx and reduce obstructive sleep apneas. We tested the hypothesis that treatment with the iNAP® Sleep Therapy System, which applies negative oral pressure through an intra-oral appliance, would reduce the severity of obstructive sleep apnea in a multi-center, prospective, first-night-randomized-order cross-over study. METHODS/PATIENTS: 130 patients fulfilled the entry criteria (age <75, AHI 15-55, BMI <33), and 63 entered the primary endpoint cohort (Total Sleep Time ≥4 h/night on the baseline polysomnogram and an oral negative vacuum time maintained by iNAP® ≥ 4 h/night and total sleep time ≥4 h/night during the first treatment study). 54 patients completed a second treatment sleep study at least 28 days after the first sleep study. RESULTS: Among the primary endpoint cohort (n = 63, age = 53.2 ± 11.3, BMI = 27.1 ± 2.8), 33 patients (52 %; 95 % confidence interval = 40%-64 %, p < 0.001) responded to iNAP treatment according to the Sher criteria (>50 % reduction in AHI and an AHI ≤20 events/hr). The average oxy-hemoglobin saturation increased by 1-2%, and the average percent oxygen desaturation decreased (was less severe) by 1 % while using the iNAP device. The incidence of adverse events, all self-limited, was low. The reduction in the apnea-hypopnea index was durable over the 28-day study. Patients used iNAP on average 5.6 h per night during the study period. CONCLUSION: The iNAP® Sleep Therapy System achieved a durable benefit in more than half the patients with moderate to severe obstructive sleep apnea and may be considered in patients who object to or failed continuous positive airway pressure. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02698059.