Datasets:

dmariko

/

init_data

like 0

Freedom from reintervention and aortic events

Freedom from valve, ascending aorta and arch reintervention at 5 years was similar with 98% for PEARS vs 94.6% for VSRR (p=0.1) (Kaplan-Meier estimate of freedom from aortic valve (AV) and ascending aorta/arch reintervention for total (A) and matched (B) cohorts, including 95% CIs. Graphs were truncated when less than 15% of patients remained at risk. PEARS, personalised external aortic root support; VSRR, valve-sparing root replacement.

PMC10313978

Aortic regurgitation

AORTIC REGURGITATION

At last follow-up after PEARS (median 21 months, IQR 4–42), nearly 90% of patients had no AR and only one patient had an Both preoperatively and at discharge, patients undergoing VSRR were significantly more likely to have mild (1/4) AR. After PS matching, there was no significant difference in AR grade at these time points (For the total population, freedom from AR ≥2/4 at 5 years was significantly greater after PEARS: 98.2% (n=23 at risk) vs 88.9% for VSRR (n=46 at risk) (p=0.02) (Kaplan-Meier estimate of freedom AR ≥2/4 for the total (A) and matched (B) population, including 95% CIs. Graphs were truncated when less than 15% of patients remained at risk. AR, aortic regurgitation; PEARS, personalised external aortic root support; VSRR, valve-sparing root replacement.

PMC10313978

Discussion

death, stiff interposition, bleeding, external annuloplasty, deaths

DISEASE PROGRESSION, BLEEDING, AORTIC DISSECTION, EVENT, DISEASE, EVENTS, COMPLICATIONS

While the perioperative outcomes of PEARS and root replacement have been compared,Our study cohort was derived from real-world clinical data and consists of a selected population of young patients with predominantly MFS, normal ejection fraction and at most mild AR undergoing elective surgery. The PEARS 200 Database represents the most extensive follow-up on PEARS to date, starting from patient 1 as the procedure was disseminated worldwide.Patients undergoing VSRR were further along in their disease progression or had a more severe CTD phenotype than those undergoing PEARS. Most remarkable were differences in age, root diameter, EuroSCORE II and preoperative AR (With no perioperative deaths and a median EuroSCORE II of 1.6, VSRR was safe in this study, yet 7% of patients required a reintervention for bleeding. There was a 4.4% incidence of coronary complications observed with PEARS, including one death. This may be partially related to the learning curve of this emerging procedure, reflected by the fact that these events occurred early in the experience. On the other hand, this issue may not be wholly abolished as the procedure is technically challenging.In this selected group of patients, both PEARS and VSRR seem to offer favourable and statistically similar mid-term survival and freedom from reintervention, both in the total and matched populations. While the reintervention rate after PEARS was 0.55% per year, the reintervention rate for VSRR was 1.4% per year, higher than the 0.6% per year found in a recent meta-analysis on the outcomes of root replacement in MFS.The absence of type A dissections after PEARS in 159 patients with 542 years of follow-up indicates that this procedure has the potential to prevent aortic dissection, yet continued follow-up is needed. The elevated risk of type B dissection and reintervention, while not significant, in patients undergoing VSRR suggests that earlier intervention or more aggressive management of the distal aorta may be indicated. Furthermore, a stiff interposition graft as used in VSRR causes a marked increase in wall stress distally, while the PEARS mesh becomes incorporated histologically and has a gradual reduction in hoop strength from proximal to distal.There are several important limitations to our study. This retrospective, multicentre study used two different databases, including 301 patients operated at 33 centres between 1996 and 2021. While outcomes after PEARS were reported according to intention to treat, data were extracted from the AVIATOR Database per completed procedure. We could therefore not identify patients who underwent an intraoperative conversion during VSRR. Due to low event rates and differences in follow-up, our description of late outcomes was predominantly descriptive. While the outcomes of VSRR are influenced by procedure type (reimplantation and remodelling with or without external annuloplasty in this study) and patient selection, our study does not factor procedure type into the comparison with PEARS. As we did not have data on aortic valve morphology in the PEARS group, we were unable to compare patients accordingly. Furthermore, we only had data on one late echocardiography for PEARS patients while VSRR patients had more extensive follow-up. Our echocardiographic data should be interpreted in the setting of a multicentre study. Using a PS analysis, we aimed to quantify differences between patient populations and correct for selection bias between groups, yet, are unable to determine whether differences in AR grade after PEARS or VSRR are related to uncorrected confounders, different follow-up duration or the development of AR after VSRR. Using our matching approach, patients with outlying aortic root diameters may be excluded. We focused on variables indicative of disease severity while not including CTD phenotype in the PS model as we did not have data available on the underlying genetic mutations which are strongly related to disease severity.

PMC10313978

Data availability statement

Data are available upon reasonable request.

PMC10313978

Ethics statements

PMC10313978

Patient consent for publication

Not required.

PMC10313978

Ethics approval

For this retrospective study, the need for additional patient consent was waived (Ethical Committee of the University Hospitals Leuven, S63787).

PMC10313978

References

PMC10313978

Background

Healthy aging for all in the community is a shared public health agenda for countries with aging populations, but there is a lack of empirical evidence on community-wide preventive models that promote the health of older people residing in socially-disadvantaged communities. The Health and Wellness Program for Seniors (HWePS) is a technology-enhanced, multi-level, integrated health equity intervention model. This study evaluates the effect of the HWePS on the health and well-being of older adults residing in urban, low-income communities. 

PMC9813466

Methods/design

HWePS is a prospective, non-randomized comparison trial conducted in an intervention and a control neighborhood (

PMC9813466

Discussion

As a multi-level health equity project, HWePS has adopted a novel study design that simultaneously targets individual- and community-level factors known to contribute to health inequality in later life in the community. The study will provide insights into the effectiveness and implementation process of an integrated, multi-level, preventive community care model, which in turn can help improve the health outcomes of older residents and reduce disparities in underserved urban communities.

PMC9813466

Trial registration

ISRCTN29103760. Registered 2 September 2021,

PMC9813466

Keywords

PMC9813466

Background

Healthy aging is a widely accepted common goal of most countries with aging populations, regardless of income level. The proportion of older adults in the world’s population is expected to reach 16% by 2050 [Health equity is a critical goal of public health policy and practice. Beyond mere surveillance and monitoring of health disparities, heath equity interventions aiming to reduce and/or eliminate health disparities have been designed and tested [To address such gaps in the healthy aging and health disparity literature, public health interventions promoting health equity for community-dwelling older adults are needed. This study aims to develop and evaluate an integrated health equity intervention promoting the health and wellness of older people in an urban, low-income community in Seoul, South Korea (henceforth

PMC9813466

Theoretical rationale

HL

The Health and Wellness Program for Seniors (HWePS) is a technology-enhanced, multi-level, integrated health equity intervention model that aims to promote the health and wellness of older people in an urban, low-income community. As a small-area, public-health equity program (intervention), the HWePS was designed based on several theoretical and conceptual models. The components and process of the HWePS intervention are guided by the expanded chronic care model (ECCM) [The Bay Area Regional Health Inequities Initiative’s (BARHII’s) public health framework for reducing health inequalities is a decision-making framework for the California Department of Public Health [Along with this community-level healthy aging initiative, the HWePS addresses determinants of health inequality at the individual and interpersonal (social) levels, which assumes each older adult has unique needs and preferences in developing their optimal healthy aging trajectory [The individual-level intervention components of the HWePS were designed by adopting and modifying the components and process of the Systems for Person-centered Elder Care (SPEC) [Lastly, the HWePS was guided by the comprehensive health literacy (HL) intervention model emphasizing the critical role of health literacy in reducing heath inequalities and promoting healthy aging [During the COVID-19 pandemic, delivering valid and reliable information tailored to the community and population’s needs can help promote heath literacy and better communication with the health system [

PMC9813466

Objectives

Improving health equity in later life should be a top priority of public health officials, especially considering the possibility of extended later life due to increasing longevity and the proportion of older age groups. In order to advance healthy aging for all, it is imperative to reduce health disparities among older people residing in urban, low-income communities in Korea, for which effective community-based health promotion strategies considering social determinants of health are needed. Given the context, this study aims to evaluate whether or not the HWePS, a community-based, multi-level, preventive and integrated elder care model will improve the health and quality of life of older residents in an urban, low-income community, compared to usual-plus care. The HWePS is well-aligned with a nationwide policy goal of building community-based integrated care systems for older people and promoting an aging-in-place policy [

PMC9813466

Methods/design

PMC9813466

Study design

The Health and Wellness Program for Seniors (HWePS) is a two-arm, non-randomized, controlled cluster trial that seeks to evaluate a theory-guided, technology-enhanced, integrated health-equity intervention model for older residents in urban, low-income communities in Seoul, Korea, during the COVID-19 pandemic. The HWePS targets complex, multi-level factors influencing disparities, including factors at the individual, interpersonal (social), and community levels [The schedule of enrollment, interventions, and assessments of the HWePS program

PMC9813466

Study setting and participants

The HWePS is being conducted in two urban neighborhoods (Study participants include older adults residing in the intervention and control areas who consent to participate in the research study. Participants come from a pool of individuals who participated in a community-wide community health and wellness survey conducted in late 2020 [

PMC9813466

Intervention

PMC9813466

Process measures

The goal of process evaluation in this study is to understand the factors that can influence the success of complex interventions [Process evaluation constructs and data collection methods adapted from the UK Medical Research Council (MRC) [

PMC9813466

Sample size and recruitment

RECRUITMENT

This HWePS intervention study is part of a larger community-wide health equity initiative, starting with a community-wide health and wellness survey conducted from November 2020 to January 2021. The sample for the community-wide survey consisted of approximately 700 older adults in the intervention area and 500 older adults in the control area, which is approximately 19.2% and 7.6% of all older adults in each area, respectively (as of October 2020). Informed consent concerning the entire study was obtained by the research team prior to initiating the survey.The recruitment of participants into the HWePS intervention is based on the roster of older adults who participated in the community survey. The sample size of the HWePS intervention is calculated using the G*Power 3.1.9.2 program as follows. We hypothesize an effect size (as the input parameter for G*Power) of 0.2 based on previous community-based health and wellness interventions for older adults’ self-rated health [Enrollment into the study will progress sequentially by clusters based on residents’

PMC9813466

Assignment of interventions and blinding

Participant assignment into the intervention group or the control group is solely based on area of residence. Participants reside in 15 Considering the nature of the study, limited single-blinding is applied to the intervention, as participants will not be told whether they reside in the intervention or control area, but researchers will be aware of the allocation. Upon giving informed consent, participants in the intervention group will receive an explanation of the entire HWePS intervention, while control group participants will receive an explanation of only the health information component. Assignments will not be explicitly expressed to external assessors but may be inferred throughout the course of the study. An independent data analyst blinded to the assignments will receive a cleaned dataset without any identifiable information.

PMC9813466

Data collection

infection, mass infection

INFECTION, HAND INFECTION

Data collection is carried out by external assessors. The research team provides a one-day intensive education program consisting of survey procedures, safety and infection education, and an item-by-item explanation. The education session is followed by a Q&A session and three mandatory practice sessions with mock cases of older adults. All outcome data are collected using a tablet PC in which survey instruments have been embedded as a weblink and/or smartphone application. Prior to data collection, all external assessors are obliged to sign to an agreement form for confidentiality concerning information about the participants obtained during the survey.The procedure for data collection is as follows. Upon enrollment into this intervention study, the recruiting researcher schedules each participant to meet with an external assessor who will visit the participant’s house (or any place that the participant feels comfortable) to conduct the baseline survey. Except for unavoidable circumstances (e.g., resignation of assessor, scheduling issues, etc.), the same assessor is assigned to the participant for the follow-up surveys at Week 13. The contents of the data collected at each time point are described in Table As the intervention is being conducted during the COVID-19 pandemic, special precautions are to be taken during face-to-face interviews. All assessors are given an infection prevention protocol: 1) ensuring the use of facial masks and hand sanitizers for both assessor and participant; 2) daily personal screening for any symptoms; 3) screening at the participant’s doorstep before entry for COVID-19 symptoms, a history of foreign travel within the past 14 days, or visits to a site of mass infection; 4) taking the temperature of participants and nearby family members; 5) sterilizing any equipment used during the interview before moving to the next household. Assessors are required to submit temperature logs for themselves and all participants that they interview.

PMC9813466

Data analysis plan

PMC9813466

Effect evaluation

SENSITIVITY

Descriptive statistics will be used to analyze data concerning the participants’ demographic and baseline characteristics. Baseline differences between the intervention and control group will be analyzed using an independent sample t-test or the Mann–Whitney U-test for continuous data and the Chi-square test for categorical data. The primary analysis is an evaluation of the interventional effect of the HWePS program in the intervention area as compared to the control area. We will apply mixed effects models and generalized estimating equations adjusting for sample characteristics. In case there are significant baseline differences between groups, propensity score matching methods will be used. Subgroup analyses will be performed for sociodemographic factors (e.g., age, sex, income, etc.) and health status (e.g., frailty), and two paired t-tests will be applied for those variables collected only in the intervention group. All statistical analyses will be carried out using SAS 9.4 (Cary, NC, USA) and p-values with α ≤ 0.05 will be considered significant.Effect analysis will be conducted based on the intention-to-treat (ITT) principle, in which all participants who participated in the HWePS study will be included regardless of intervention dose or protocol adherence. Imputation methods will be implemented to handle missing data to enable ITT analysis. Sensitivity analyses will be conducted to assess the effects of inclusion in various groups within the samples.

PMC9813466

Process analysis

Quantitative data will be analyzed using simple descriptive analyses using SAS 9.4 (Cary, NC, USA), including the logs from the HWePS ICT system, the HWePS app, and the Walk-On app (a community walking tracking app) in order to monitor delivery of the intervention. We will also analyze the standardized-questionnaire item responses from participants and lay-leaders, participants’ attendance documents, participants’ self-practice records, etc.In addition, qualitative data will be analyzed using thematic analysis in MAXQDA qualitative software. These data include the semi-structured questionnaire responses from lay-leaders/multidisciplinary teams, focus group interviews with multidisciplinary teams/lay-leaders/participants, case studies from multidisciplinary team meetings, lay-leader documents, meeting/event reports, etc.

PMC9813466

Ethics and dissemination

This study was approved by the institutional review board (IRB) of human subjects at Seoul National University (SNU IRB 2011/002–016). No critical modifications have been made to the protocol thus far and any changes in the future will be reported to the relevant parties. All data including personal information is saved on a password-protected computer within a locked laboratory, and only the PI and those with permission from the PI will receive access to the final dataset. None of the investigators have financial or competing interests.The HWePS model is being tested within the context of designing a community care model in preparation for a super-aged society. From the initiation of the study, the contents of the intervention have been designed with community-level dissemination of the model in mind. input from various stakeholders has been sought in the design and implementation process of the intervention. Jungnang-gu and Seoul are planning administrative and educational activities to disseminate the HWePS model, either in part or in whole, into other areas in the district (

PMC9813466

Trial status

The study has been rolled out to the intervention and control communities, and data collection is ongoing at the submission of this manuscript. Data analysis has not yet started.

PMC9813466

Discussion

infection

INFECTION

While healthy aging for all is widely accepted public health agenda, few multi-faceted, multi-level health equity interventions promoting health and wellness exist, especially ones targeting relatively healthy older adults residing in an urban, low-income community in a non-Western country. In Korea, public health centers typically offer provider-driven, individual-level, health behavior monitoring or modification programs for people who are willing to participate [We designed the HWePS to develop and rigorously test the effectiveness of an intervention that simultaneously engages older people and neighbors (as CLHLs) and enlists community-level resources and strengths to promote the health and wellness of older people in a low-income urban community during COVID-19. If effective, the intervention, as a preventive, integrated community care model, may add great value to current efforts to reduce health disparities among urban, lower-income older populations with double (age- and income-related) risks for inequality. First, instead of a professional-driven model, the intervention is an older person-led, community-engaged, professional-support model. As a theory-driven, evidence-based public health model, the HWePS will address health inequality by empowering older adults to recognize that they are responsible for their own health, understand their own health status and risks using a decision-support tool, develop with a nurse coach their own plan for self-care skill-building, and practice it daily with peer support enhanced by ICT tools. Second, the intervention educates and empowers participating CHNs for the “visiting community service center service” program in Seoul [Third, peer support is a key mechanism to promote health equity for the community [There are several expected challenges. One major challenge is the ongoing COVID-19 pandemic; public health measures to stop the infection’s spread could negatively influence various parts of the intervention implementation process (e.g., participation and retention rates) [Another challenge is that the multi-channel heath information delivery service is designed to be an essential communication channel between the community and the wellness center during COVID-19. However, the basic unidirectional communication approach with limited feedback channels may reduce the intervention effects. While the components and duration of the 12-week (self-)care management intervention are based on existing evidence from successful intervention studies, they may not be enough to motivate older adults to continue healthy lifestyles for prolonged periods. A “companion” program has been organized at the wellness center and is designed as a self-help club in the community run by older people who have completed the 12-week intervention along with support from CLHLs. It is beyond the scope of this intervention study, but the research team plans to assess the effects of the companion program. There are also limited resources, time, and political/administrative networks and support for implementing the community-wide healthy aging initiative in ways that could lead to more meaningful changes. For example, while participants have expressed income-based health-related social needs, there are limited income-earning opportunities available in the community for older people; changing upstream social/structural determinants of health inequality is hard to address in this equity intervention study. If the intervention is effective, we will help facilitate the public health center’s continuation of the HWePS program in the intervention area, promoting it as a signature program for improving the living conditions of the area, and support the program’s dissemination to other areas of Jungnang-gu and beyond; we will also encourage the Community Residence Council to enact bylaws making a new health committee under its purview.

PMC9813466

Acknowledgements

None.

PMC9813466

Authors’ contributions

WL

HK and HC conceived and initiated conceptualization and design of the study. HK, HC, YJ, JL, EK contributed to the refinement of the study design and developed implementation strategies. WL provided statistical expertise in the clinical trial design. HK, JY, HC wrote the first draft of the study protocol, and all authors contributed to the revision of the protocol and read and approved the final manuscript.

PMC9813466

Funding

DISEASE

This work was based on the Project to Empower Communities to Reduce Health Disparities, supported by the Korea Disease Control and Prevention Agency and the Seoul Metropolitan Government; the project was executed in Jungnang-gu (district) in Seoul. The funding sources had no role in the study design; data collection and management; writing the manuscript; or the decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding sources.

PMC9813466

Availability of data and materials

The datasets generated and/or analyzed during the current study are not publicly available due to the policy of the SNU IRB, which does not allow the opening and sharing of research data with any third party, but are available from the corresponding author upon reasonable request.

PMC9813466

Declarations

PMC9813466

Ethics approval and consent to participate

This study was approved by the institutional review board for human subjects at Seoul National University, Seoul, South Korea (SNU IRB 2011/002–016). Written informed consent is to be obtained from all study participants.

PMC9813466

Consent for publication

Not applicable.

PMC9813466

Competing interests

The authors declare that they have no competing interests.

PMC9813466

References

PMC9813466

Purpose

occlusal caries lesions

To evaluate and compare the clinical effectiveness of alkasite with nanofilled resin composite restorations for occlusal caries lesions in permanent molar teeth of children, at one-year follow-up.

PMC10317863

Methods

occlusal caries lesions

In this randomized controlled clinical trial with parallel design, 38 children aged 7–13 years with occlusal caries lesions on 59 first permanent molars were randomly allocated into two groups, Group 1: Filtek™ Z350XT (nanocomposite) and Group 2: Cention N

PMC10317863

Results

fracture, caries

SECONDARY, CARIES

All restorations had either Alpha or Bravo scores at one-year follow-up. In Group 1, all restorations scored Alpha, while one restoration each (3.6%) in Group 2 scored Bravo for fracture and marginal adaptation. All restorations in both groups scored Alpha for retention, secondary caries, and post-operative sensitivity. For anatomic form, all restorations in Group 1 scored Alpha, while three (10.7%) restorations in Group 2 had Bravo scores. For marginal discolouration, three restorations in both groups scored Bravo (11.5% and 10.7%, respectively). For surface roughness, one restoration (3.8%) in Group 1 and three restorations in Group 2 (10.7%) scored Bravo. The comparative results between the two groups for all the variables in the USPHS criteria were not statistically significantly different.

PMC10317863

Conclusions

occlusal caries lesions

The performances of the nanofilled composite and alkasite were clinically acceptable and comparable. Alkasite can be an alternative material for the restoration of occlusal caries lesions in permanent molars of children.

PMC10317863

Clinical trial registration

The clinical trial was registered at Clinical Trials Registry—India (CTRI Reg no: CTRI/2020/12/029830 Dated: 15/12/2020).

PMC10317863

Keywords

Open access funding provided by Manipal Academy of Higher Education, Manipal

PMC10317863

Introduction

carious lesions, fracture

Dental resin composites have gradually replaced amalgam as the standard restorative material for permanent teeth in following the principles of minimally invasive dentistry and the treaty of the Minamata Convention on Mercury in 2013 that encourages phase down of amalgam (Celik et al. Recently, an alkasite-based tooth-coloured material, Cention NIn-vitro studies conducted in the recent past with alkasite resin composite show that alkasite has better or similar mechanical and biological properties such as microleakage, microhardness, fracture resistance and bond strength, to those of other resin composites (George and Bhandary Therefore, the aim of the current study was to evaluate the clinical effectiveness of an alkasite with nanofilled resin composite in the restoration of occlusal carious lesions in permanent molar teeth of children. The null hypothesis was that there is no difference between the clinical effectiveness of alkasite resin composite and nanofilled resin composite as a permanent restorative material for occlusal carious lesions in permanent molar teeth of children.

PMC10317863

Material and methods

This clinical study had a randomised controlled, two-arm parallel design and is reported according to the Consolidated Standards of Reporting Clinical Trials (CONSORT) guidelines and is registered in the database for the registration of clinical studies (Clinical Trial registry of India, Reg. No.: CTRI/2020/12/029830). The participants selected for this study were outpatients of the Department of Paediatric and Preventive Dentistry.

PMC10317863

Compliance with ethical Standards

The Institutional Ethics Committee approved the research protocol (Protocol Reference: 19084). Parents of the participants were informed about the procedure using a patient information sheet and written informed consent was obtained by the principal investigator. Written informed assent from the participating children was also obtained. Participation or non-participation in the study did not interfere with their dental treatment and no compensation was provided to the participants.

PMC10317863

Sample size

fracture

The sample size calculation was performed at a 90% confidence interval and power of 80%, assuming the effect size to be 25% and a failure rate (fracture of restoration) of 3% (Loguerico et al.

PMC10317863

Eligibility criteria

carious lesions, pulpal disease, dentinal caries, mental disabilities, allergy, abnormal parafunctional, pain

SYSTEMIC ILLNESS, ALLERGY, HYPOPLASIA

Children aged 7–13 years, with carious lesions on the occlusal surface in any one of the first permanent molars with ICDAS score ranging from 3–5 (Ismail et al. The exclusion criteria were as follows: permanent molars with deep dentinal caries or presence of any pulpal disease with or without pain, permanent molars with developmental defects such as hypomineralisation or hypoplasia, participants with a history of allergy to any material being used in the study, a history of abnormal parafunctional activity, and participants with mental disabilities and systemic illness.

PMC10317863

Randomisation

CAVITY

Permuted block randomisation with block sizes 4 and 8 was used. Blocks were randomly allocated using a random table of numbers. An operator who was otherwise not participating in the study assigned participants to one of the groups. The allocation ratio was 1:1. The group to be assigned was marked on cards enclosed in sequentially numbered, opaque, sealed envelopes. After the cavity preparation and before the commencement of the restorative treatment, the assigned group was disclosed to the lead investigator who conducted the restorative treatment. Each participant was a unit of randomisation. For a given participant, all eligible permanent molars were restored with the same restorative material, as per group allocation as follows:Group 1: Nanofilled resin composite material Filtek™ Z350XT (3 M ESPE, St. Paul, MN, USA, A2 shade).Group 2: Alkasite resin composite material Cention NThe composition of the materials used for the study is given in Table Composition of principal materials used in the studyFiller: Barrium–aluminium silicate glass (20–30%)Calcium fluorosilicate glass (25–35%), Isofiller (15–25%)Ytterbium fluoride (5–10%)Monomer: Di-methacrylate (95–97%)Stabilizer (< 1%), Initiator (< 1%), Pigment (< 0.1%), Additive (1–2%)Organic phase: UDMA, BisGMA, BisEMA, TEGDMAInorganic matrix: Silica (20 nm non-agglomerated and/or aggregated), zirconia (4–11 nm non-agglomerated and/or aggregated and agglomerated), clusters (size of the cluster ranging from 0.6 to 1.4 μm, 59.5 in volume percentage), zirconia/silica aggregated particles (20 nm particles of silica along-with with 4–11 nm sized zirconia

PMC10317863

Clinical procedure

PLAQUE

All the restorative procedures were done under rubber dam isolation by a single operator (Principal Investigator). The included molars were cleaned, polished with non-fluoridated prophylaxis paste, rubber cup and micromotor handpiece to remove any plaque and debris. A topical anaesthetic (10% lidocaine spray) (Neon Laboratories Limited, Mumbai, India) was applied before rubber dam isolation (Hygenic

PMC10317863

Cavity preparation

carious lesion, Carious

CAVITY

Carious tissue was removed using a conservative cavity preparation method. The outline form of the cavity was defined by the extent of the carious lesion. Unsupported enamel (enamel unsupported by dentin) was preserved, while undermined enamel (thin or loose enamel) margins were removed. Extensions towards the marginal ridge retained at least 2 mm of the remaining tooth surface (Manhart et al.

PMC10317863

Etching and bonding

Group 1: The tooth surface was etched with 3M ESPE Scotch-bond Etchant (37% phosphoric acid gel) (3M ESPE, St. Paul, MN, USA) with an applicator brush for 15 s. The tooth surface was washed with a three-way syringe for 10 s and gently dried by blotting with a mini sponge to give a moist, glistening appearance, which ensured that the tooth structure was not overdried. Using an applicator brush, two even coats of etch-and-rinse dental adhesive (3M single bond 2 adhesive) (3M ESPE, St. Paul, MN, USA) were applied to enamel and dentin, gently agitated for 20 s to facilitate better penetration of the adhesive into the dentinal structure, followed by drying gently for a period of 2–5 s to evaporate the solvent and then light curing for 10 s.Group 2: Alkasite was bonded after selective etching of enamel. 3M ESPE Scotch-bond Etchant (37% phosphoric acid gel) (3M ESPE, St. Paul, MN, USA) was applied with an applicator brush only on the enamel for a period of 15 s. The tooth surface was then washed with a three-way syringe for 10 s and gently dried to give a moist, glistening appearance. Tetric N-Bond Universal (Ivoclar Vivadent Inc, New York, USA), a multimode dental adhesive, was applied to the surface of both enamel and dentin using an applicator brush, agitated for 20 s, dried with compressed air for 2 s to evaporate the solvent, followed by light curing for 10 s.

PMC10317863

Placement of restorative material

CAVITY

For both groups, the material was placed into the cavity with help of a plastic filling instrument, followed by condensation with a composite condenser.Group 1: Composite material was placed in split horizontal increments of 1.5 mm.Group 2: Composite material was placed as a single increment. The powder and liquid of the alkasite composite were mixed as per the instructions of the manufacturer until a homogeneous consistency was obtained and condensed within 3-min working time.

PMC10317863

Curing time

LED light curing device (Bluedent, BG Light Ltd, Plovdiv, Bulgaria) was used at a constant intensity of ≥ 500 mW/cm

PMC10317863

Evaluation

After one year, the restorations were evaluated by two examiners who were previously trained and calibrated, using Modified Ryge/USPHS (United States Public Health Service) criteria (Bayne and Schmalz

PMC10317863

Calibration of examiners

Both the examiners were trained and calibrated for the USPHS criteria before the evaluation of the restorations (Table Description of the criteria for clinical evaluation of the restorations at follow-up using the USPHS criteria (modified from Canali et al.

PMC10317863

Blinding

The study participants, the examiners who performed the follow-up examination and the statistician who carried out the analysis were blinded to group allocation. However, the operator who had carried out the restorative procedures was not blinded to the group allocation.

PMC10317863

Statistical analysis

Data were entered and analyzed using IBM SPSS Statistics for Windows, version 20 (IBM, Armonk, NY, USA). Descriptive statistics were tabulated. The baseline data and the outcomes were compared between the groups using the Students

PMC10317863

Results

At the beginning of the study, 38 children with 59 erupted first permanent molars were recruited from December 2020 to February 2021(Fig. Flow diagram representing flow of participants until 12 months in the studyComparison of Mean Age, Baseline Mean DMFT and dmft scores between the groupsComparison of frequencies of various characteristics of the groups at baseline*Fisher’s Exact testThe follow-up period lasted from December 2021 to March 2022. After a one-year follow-up, 33 participants (54 molars) were evaluated using USPHS criteria. Five participants (number of molars = 5) did not report on the days of examination and were untraceable due to migration to other cities during the follow-up period. The results are shown in Table Number (percentage) of evaluated restorations for each experimental group, classified according to the modified USPHS criteria*Fisher’s Exact test

PMC10317863

Discussion

Loss of retention, fracture, bond failure, tooth

ADHESION

In this study, two different classes of resin composites were utilised for the restoration of occlusal surfaces of the first permanent molars in paediatric dental patients. The clinical effectiveness of a nanofill (Filtek™ Z350XT) resin composite was compared with an alkasite (Cention NDespite both groups demonstrating clinically acceptable outcomes, some results were noteworthy in both groups. In Group 1 (nanocomposite), Bravo scores were obtained in three restorations for marginal discolouration and one restoration for surface texture at the end of the evaluation. In Group 2 (alkasite), three restorations scored Bravo for anatomic form, surface roughness and marginal discolouration each, while one restoration each had a Bravo score for marginal adaptation and fracture at the end of the evaluation.A fracture is a complete or incomplete break in the restorative material, during the application of force and has been the primary cause of failure of resin composite restorations (Jayashankara et al. Both materials showed clinically acceptable levels of marginal discolouration and marginal integrity in all restorations, which is explained by their low polymerisation shrinkage properties. Marginal adaptation of the material depends on forces produced due to polymerisation shrinkage that causes debonding of the material at the tooth interface, often leading to discolouration at the margins (Yazici et al. Similar results for nanofilled composite have been reported in a study, where most of the nanocomposite restorations received Alpha and Bravo scores for marginal adaptation after a 30-month follow-up (de Andrade et al. Loss of marginal adaptation can also occur due to localised bond failure. While etching with phosphoric acid increases the bond strength to enamel, it decreases the bond strength to dentin leading to adhesion failures. Hence, it is recommended that only enamel should be selectively etched (van Landuyt et al. Loss of retention was not reported in both groups, which is explained by the bond strength of both the restorative materials and their mechanical properties such as wear resistance, modulus of elasticity and flexural strength reported in earlier studies on nanocomposite and alkasite (Alzraikat et al. Filtek™ Z350 nanocomposite has higher filler loading and smaller-sized filler particles, enabling a reduction in the interstitial spaces. This preserves the soft resin matrix and lowers filler particle loss on the surfaces, improving wear resistance and maintaining the smooth surface texture of the restoration (de Paula et al. The results of our research showed that the clinical effectiveness of Cention NBased on the literature search done for this study, this randomised controlled trial with nanocomposite as the positive control group is the first of its kind conducted among paediatric dental patients. Composite resin restoration on a permanent first molar in children has more limitations than in adult patients, due to its proximity to the gingiva and lack of patient compliance, both of which affect isolation (Donly and Garcia-Godoy The limitations of the study include a short follow-up period and an assessment of post-operative sensitivity subjectively based on the participant’s response. The study used a parallel design that results in inter-participant variability, thus introducing selection bias (Lesaffre et al.

PMC10317863

Author contributions

RS

Conceptualization, methodology: HS, BSS, RS; Investigation: HS, BSS, RS; Data curation: HS and BSS; Statistical Analysis: RS and HK; Writing—original draft preparation: HS and BSS; Writing—review and editing: RS, HK and AR; Supervision: BSS. All authors read and approved the final manuscript.

PMC10317863

Funding

Open access funding provided by Manipal Academy of Higher Education, Manipal. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

PMC10317863

Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

PMC10317863

Declarations

PMC10317863

Conflict of interest

The authors declare that they have no conflict of interest.

PMC10317863

Ethics approval

The Institutional Ethics Committee of Manipal College of Dental Sciences, Mangalore, approved this study (Protocol Reference: 19084). The study was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki (2013 amendment).

PMC10317863

Consent to participate

The authors confirm that written informed consent was obtained from all the parents of the children included in the study, and written informed assent was obtained from all the children who participated in the study, with the information provided on participation and publication of data.

PMC10317863

References

PMC10317863

Background

NSCLC

NON-SMALL CELL LUNG CANCER, PULMONARY METASTASIS, NSCLC

Prognostic factors and survival outcomes of non-small cell lung cancer (NSCLC) with Ipsilateral pulmonary metastasis (IPM) are not well-defined. Thus, this study intended to identify the prognostic factors for these patients and construct a predictive nomogram model.

PMC10614355

Methods

REGRESSION

One thousand, seven hundred thirty-two patients with IPM identified between 2000 to 2019 were from the Surveillance, Epidemiology, and End Results (SEER) database. Independent prognostic factors were identified using multivariate Cox regression analyses. Nomograms were constructed to predict the overall survival (OS), C-index, the area under the curve (AUC), and the calibration curve to determine the predictive accuracy and discrimination; the decision curve analysis was used to confirm the clinical utility.

PMC10614355

Results

Patients were randomly divided into training (

PMC10614355

Conclusion

NSCLC

NSCLC

We constructed and internally validated a nomogram to predict 1-year, 3-year, and 5-year OS for NSCLC patients with IPM according to independent prognostic factors. This nomogram demonstrated good calibration, discrimination, clinical utility, and practical decision-making effects for the prognosis of NSCLC patients with IPM.

PMC10614355

Keywords

PMC10614355

Introduction

NSCLC, tumor, tumors

NON-SMALL CELL LUNG CANCER, TUMOR, METASTASIS, PULMONARY METASTASIS, MALIGNANT TUMOR, NSCLC, PRIMARY TUMOR, TUMORS

Ipsilateral pulmonary metastasis (IPM), also known as separate or additional tumor nodule(s), is a form of intrapulmonary metastasis in non-small cell lung cancer (NSCLC), including tumors with additional nodule(s) in the same lobe (PM1) and tumors with additional nodule(s) in the ipsilateral different lobe (PM2) [Although the current AJCC staging system still relies on the location relationship between IPM and the primary tumor [Nomogram is a convenient and accurate method to predict survival outcomes, which has become very popular in malignant tumor survival prediction in recent years [

PMC10614355

Methods

PMC10614355

Data sources

cancer

CANCER

One thousand, seven hundred thirty-two patients with IPM were identified between 2000 to 2019 from the database "Incidence – SEER Research Plus Data, 17 Registries, Nov 2021 Sub (2000–2019)”. The SEER database was publicly available and established in 1973. The database currently collects and publishes cancer incidence and survival data from population-based cancer registries covering approximately 48.0% of the U.S. population. Data from the SEER database includes demographic and follow-up information.

PMC10614355

Patient selection

NSCLC, non-small-cell carcinoma, tumor, Tumor, pulmonary metastasis, adenocarcinoma, primary lung cancer

NON-SMALL CELL LUNG CANCER, TUMOR, LUNG, TUMOR, PULMONARY METASTASIS, ADENOCARCINOMA, NSCLC, SQUAMOUS CELL CARCINOMA, LARGE CELL CARCINOMA

The inclusion criteria were: (1) primary lung cancer; (2) tumor descriptor with ipsilateral pulmonary metastasis [based on Separate Tumor Nodules Ipsilateral Lung Recode (2010 +) with the information of separate nodules of the same hist type in the ipsilateral lung, same or different lobe]; (3) no overlapping primary sites; (4) histological confirmation of adenocarcinoma (histologic codes 8244, 8245, 8250–8255, 8260, 8290, 8310, 8323, 8333, 8480, 8481, 8490, 8507, 8550, 8570, 8571, 8574, and 8576), squamous cell carcinoma (histologic codes 8052, 8070–8075, 8083, 8084, 8123), large cell carcinoma (histologic codes 8012–8014), and other non-small-cell carcinoma (8046, 8050, 8003,8004, 8022, 8031–8035, 8082, 8200, 8240, 8249, 8430, 8560, 8562, 8980); (6) history of surgery (sublobectomy, lobectomy or pneumonectomy); and (7) survival time should be at least one month.The exclusion criteria were: (1) unknown tumor location and laterality; (2) without any treatment; and (4) incomplete demographic data. More details of the data extraction process are presented in Fig. Flow diagram of the data extraction process. SEER, the Surveillance, Epidemiology, and End Results; NSCLC, non-small cell lung cancer; IPM, ipsilateral pulmonary metastasis

PMC10614355

Statistical analysis

Random division of patients, all analyses and figures were performed by R version 4.2.2 and R studio 2022.12.0 Build 353 (

PMC10614355

Results

PMC10614355

Construction and validation of nomogram for predicting OS

NSCLC, tumor

NON-SMALL CELL LUNG CANCER, TUMOR, PRIMARY TUMOR, NSCLC, REGRESSION

Based on the results of the multivariate Cox regression model, a nomogram was constructed using independent factors including age, sex, primary tumor size, tumor grade, N status, number of regional lymph nodes removed, and chemotherapy. The nomogram can predict the 1-year, 3-year, and 5-year OS rates by summing the points of each variable (Fig. Nomogram for predicting OS of NSCLC patients with IPM. OS, overall survival; NSCLC, non-small cell lung cancer; IPM, ipsilateral pulmonary metastasisThe C-index for OS prediction was 0.714 (95% CI, 0.692 to 0.773) in the training cohort and 0.695 (95% CI, 0.660 to 0.730) in the validation cohort, indicating good discrimination ability. The calibration plots for the probability of survival at 1, 3, and 5 years showed good agreement between nomogram-predicted OS and actual observation (Fig. The calibration curve to evaluate the accuracy of the nomogram at 1, 3 and 5 years, respectively. The ROC analysis assessed the accuracy of the nomogram, and the AUCs for predicting 1-year, 3-year, and 5-year OS rates in the training cohort were 0.755 (95% CI, 0.724 to 0.786), 0.756 (95% CI, 0.730 to 0.783), and 0.740 (95% CI, 0.710 to 0.770), respectively. In the validation cohort, the AUCs for predicting 1-year, 3-year, and 5-year OS rates were 0.709 (95% CI, 0.657 to 0.761), 0.723 (95% CI, 0.682 to 0.764), and 0.725 (95% CI, 0.676 to 0.774), respectively (Fig. The AUC values for the prediction of 1, 3, 5-year OS of NSCLC patients with IPM. The DCA demonstrated that the nomogram had a significant clinical value in both the training and validation cohorts. The area under the DCA curve for predicting 1-year, 3-year, and 5-year OS rates in the training cohort was 0.017, 0.078, and 0.142, respectively. In the validation cohort, the area under the DCA curve was 0.017, 0.084, and 0.148 (Fig. The DCA curve analysis to evaluate the clinical application ability of the nomogram at 1, 3 and 5 years, respectively. Based on the nomogram score for each patient, we classified patients into low-risk (≤ 96) and high-risk (> 96) groups. The Kaplan–Meier survival curves and log-rank tests showed that the high-risk group had a significantly lower survival rate than the low-risk group in both the training and validation sets (Kaplan–Meier curves of overall survival stratified by risk groups in the

PMC10614355

Discussion

NSCLC, tumor, Tumor, lung cancer, tumors

NON-SMALL CELL LUNG CANCER, TUMOR, METASTASIS, TUMOR, LYMPH NODE METASTASES, LUNG CANCER, NSCLC, PRIMARY TUMOR, TUMORS

IPM is a heterogeneous category in NSCLC and survival outcomes can be affected by various factors [Our data suggest that patients over 65 years old have a worse prognosis, which is consistent with other studies on lung cancer [Tumor size is a well-known prognostic factor for NSCLC, and larger tumors have a greater risk of invasion and distant metastasis. In our study, we subdivided primary tumor size into four categories to facilitate statistical analysis by nomogram. We found that primary tumor size was an independent prognostic factor for NSCLC with IPM, with patients having a primary tumor size of ≤ 3 cm having better overall survival (The status of lymph node metastases, as reflected by the N status, is a critical prognostic factor for NSCLC. Lee et al. [Pulmonary resection with lymph node removal is the standard treatment for NSCLC [Tumor histology, specifically the degree of differentiation of tumor tissue, is another important factor affecting prognosis. Sun et al. [In terms of treatment for surgically treated patients, chemotherapy is indicated for those with stage II and IIIa non-small cell lung cancer. Salazar et al. [In our study, we meticulously incorporated several independent prognostic factors, including age, sex, primary tumor size, N status, number of regional lymph nodes removed, tumor grade, and chemotherapy, into the construction of our nomogram. To assess its clinical utility, we rigorously evaluated the nomogram's performance using various metrics such as the C-index, calibration curves, ROC curves, and AUC. These comprehensive evaluations consistently demonstrated that our nomogram exhibits exceptional accuracy, discrimination, and practicality when it comes to predicting overall survival. It's worth noting that recent work by Wang et al. [Our study has several limitations worth noting. Firstly, due to the retrospective nature of our research, there is a potential for selection bias, and certain crucial variables, such as the size and number of separate tumor nodules, were lacking in the SEER database. It is important to highlight that these variables have not consistently demonstrated significant prognostic associations in the literature [

PMC10614355

Conclusion

NSCLC, tumor

PRIMARY TUMOR, TUMOR, NSCLC

In conclusion, age, sex, primary tumor size, N status, number of regional lymph nodes removed, tumor grade, and chemotherapy of patients were the independent prognostic factors for NSCLC patients with IPM. We constructed and internally validated a nomogram to predict 1-year, 3-year, and 5-year OS for NSCLC patients with IPM according to independent prognostic factors. After internal validation, this novel nomogram demonstrated good calibration, discrimination, clinical utility, and practical decision-making effects for the prognosis of NSCLC patients with IPM.

PMC10614355

Acknowledgements

We thank the Surveillance, Epidemiology, and End Results database (

PMC10614355

Authors’ contributions

Jiajun Zhang: conception and design, preparation of the manuscript, and analysis of the data. Jin Zhang: design and review.

PMC10614355

Funding

No funding.

PMC10614355

Availability of data and materials

All data and documents needed will be provided upon request through email: 361532004@qq.com.

PMC10614355

Declarations

PMC10614355

Ethics approval and consent to participate

cancer, Cancer

CANCER, CANCER

We promise that our research was performed in accordance with the Declaration of Helsinki and all methods were carried out in accordance with relevant guidelines and regulations. All experimental protocols were approved by the ethics committee of National Cancer Institute (USA) to obtain research data on cancer patients (reference number 15156-Nov2021). Informed consent was waived by Committee for the Conduct of Human Research at the General Hospital of Ningxia Medical University because the patient information in the SEER database is deidentified and publicly available.

PMC10614355

Consent to publication

Not applicable.

PMC10614355

Competing interests

The authors declare no competing interests.

PMC10614355

References

PMC10614355

Background:

coronavirus disease

CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME

In individuals with coronavirus disease (COVID-19), the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load (VL) plays an important role in infectivity.

PMC10326526

Objectives:

This study aimed to evaluate the reduction in the VL and infectivity induced by phthalocyanine mouthwash and nasal spray in patients with COVID-19.

PMC10326526

Methods:

Patients with mild COVID-19 were recruited to participate in a triple-blinded randomized controlled trial. Participants were assigned to one of three groups: Group 1, non-active mouthwash and saline nasal spray (SNS); Group 2, phthalocyanine mouthwash and SNS; and Group 3 phthalocyanine mouthwash and phthalocyanine nasal spray. VL was assessed in nasopharyngeal and oropharyngeal swabs collected at the time of clinical diagnosis at baseline as well as 24 and 72 hours after starting the rinsing protocols.

PMC10326526

Findings:

Forty-six participants were included in the analysis: 15, 16, and 15 in Groups 1, 2, and 3, respectively. After 72 hours, the reduction in VL was significantly higher in Group 3 (mean cycle threshold (Ct) decrease: 11.21) than in Group 1 (mean Ct decrease: 5.53). Additionally, only the mean VL in Group 3 was reduced to a non-contagious level after 72 hours.

PMC10326526

Main conclusions:

Use of phthalocyanine mouthwash and nasal spray is effective at reducing SARS-CoV-2 infectivity.

PMC10326526

Zusammenfassung

PMC10326526

Hintergrund:

CORONAVIRUS

Bei Personen mit Coronavirus-Erkrankung (COVID-19) spielt die Viruslast (VL) des schweren akuten respiratorischen Syndroms Coronavirus 2 (SARS-CoV-2) eine wichtige Rolle für die Infektiosität.

PMC10326526