The objective of this study is to analyse the relationship and psychosocial issues between working during the COVID-19 pandemic in primary healthcare (PHC) facilities located in the most vulnerable health region (HR) of the Federal District of Brazil (FDB) compared with a lesser region.

Mixed-method study data. The questionnaire was based on the World Health Survey and the Convid Behavioural Survey. Quantitative data were described in absolute and relative frequency. Pearson’s ² test verified differences according to the region (significance level

A representative sample of PHC professionals working at the Western HR and Central HR of the FDB.

111 women and 27 male PHC professionals, aged ≥ 18 years.

Psychosocial variables—personal emotions towards the clients, social relationships and use of psychoactive substances (PAS).

An online questionnaire (27 questions) and 1 open-ended question.

The sample comprised 138 PHC professionals; 80.40% were female aged between 40 and 49 years old (27.3%); declared themselves as black/pardo (58.7%); were married (53.60%), and worked in family healthcare teams (47.80%). No association between working in the most vulnerable HR compared with the least one and presenting psychosocial issues, except for anger towards clients (p=0.043). 55.10% worked much more than usual, 60.80% reported being depressed, 78.20% anxious, 76.80% stressed, 77.50% had no empathy and 78.30% felt isolated from family/friends. Towards the clients, 59.40% reported empathy and 72.5% no affection/care. The consume of psychotropic medications was reported by 34.80%, and 14.50% increased alcohol/PAS use. Qualitative data leverage quantitative findings: work overload, the indifference of the Federal Government and distance from family/friends.

Working in the most vulnerable region and in the least one affects the psychosocial aspects of the PHC professionals equally.

To outline current knowledge regarding workplace-based learning about health promotion in individual patient care.

Scoping review.

PubMed, ERIC, CINAHL and Web of Science from January 2000 to August 2023.

We included articles about learning (activities) for healthcare professionals (in training), about health promotion in individual patient care and in the context of workplace-based learning.

The studies were evaluated using a charting template and were analysed thematically using a template based on Designable Elements of Learning Environments model.

From 7159 studies, we included 31 that described evaluations of workplace-based learning about health promotion, around a variety of health promotion topics, for different health professions. In the articles, health promotion was operationalised as knowledge, skills or attitudes related to specific lifestyle factors or more broadly, with concepts such as health literacy, advocacy and social determinants of health. We assembled an overview of spatial and instrumental, social, epistemic and temporal elements of learning environments in which health promotion is learnt.

The studies included in our analysis varied greatly in their approach to health promotion topics and the evaluation of learning outcomes. Our findings suggest the importance of providing opportunities for health profession learners to engage in authentic practice situations and address potential challenges they may experience translating related theory into practice. Additionally, our results highlight the need for conscious and articulated integration of health promotion in curricula and assessment structures. We recommend the exploration of opportunities for health profession students, professionals and patients to learn about health promotion together. Additionally, we see potential in using participatory research methods to study future health promotion learning.

Open Science Framework, https://doi.org/10.17605/OSF.IO/6QPTV.

Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.

In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.

Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.

NCT03841669.

The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE.

REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial.

All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to – Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide.

NCT03374800.

‘Healthier Wealthier Families’ (HWF) seeks to reduce financial hardship in the early years by embedding a referral pathway between Australia’s universal child and family health (CFH) services and financial counselling. This pilot study investigated the feasibility and short-term impacts of HWF, adapted from a successful Scottish initiative.

Setting: CFH services in five sites across two states, coinciding with the COVID-19 pandemic. Participants: Caregivers of children aged 0–5 years experiencing financial hardship (study-designed screen). Design: Mixed methods. With limited progress using a randomised trial (RCT) design in sites 1–3 (March 2020–November 2021), qualitative interviews with service providers identified implementation barriers including stigma, lack of knowledge of financial counselling, low financial literacy, research burden and pandemic disruption. This informed a simplified RCT protocol (site 4) and direct referral model (no randomisation, pre–post evaluation, site 5) (June 2021–May 2022). Intervention: financial counselling; comparator: usual care (sites 1–4). Feasibility measures: proportions of caregivers screened, enrolled, followed up and who accessed financial counselling. Impact measures: finances (quantitative) and other (qualitative) to 6 months post-enrolment.

355/434 caregivers completed the screen (60%–100% across sites). In RCT sites (1–4), 79/365 (19%–41%) reported hardship but less than one-quarter enrolled. In site 5, n=66/69 (96%) caregivers reported hardship and 44/66 (67%) engaged with financial counselling; common issues were utility debts (73%), and obtaining entitlements (43%) or material aid/emergency relief (27%). Per family, financial counselling increased income from government entitlements by an average $A6504 annually plus $A784 from concessions, grants, brokerage and debt waivers. Caregivers described benefits (qualitative) including reduced stress, practical help, increased knowledge and empowerment.

Financial hardship screening via CFH was acceptable to caregivers, direct referral was feasible, but individual randomisation was infeasible. Larger-scale implementation will require careful, staged adaptations where CFH populations and the intervention are well matched and low burden evaluation.

ACTRN12620000154909.

This study was designed to assess the level of uptake of human papillomavirus (HPV) vaccination and its associated factors among school-age adolescent girls.

School-based cross-sectional study.

High schools in Mettu town, southwest Ethiopia, from 5 February to 10 March 2022.

Data were collected using a pretested and structured questionnaire through face-to-face interviews with 667 adolescent girls selected via multistage random sampling. Data were entered into EpiData V.3.1 and exported to SPSS V.26 for analysis. Simple binary logistic regression was done, and variables with a p value less than 0.25 were entered into a multivariable logistic regression model; variables with a p value

About half (48.6%) of adolescent girls aged 14–18 years had received the HPV vaccine. Being in the 16–18 years age group (adjusted OR 2.7, 95% CI 1.50 to 4.80), having good knowledge (2.14, 95% CI 1.29 to 3.52), having a positive attitude (5.86, 95% CI 3.51 to 9.76), and getting encouragement from healthcare workers (3.04, 95% CI 1.36 to 6.79), teachers (2.14, 95% CI 1.05 to 4.34) and parents (2.39, 95% CI 1.02 to 5.64) were significantly associated with vaccine uptake.

The uptake of HPV vaccination was low. Having good knowledge and positive attitude as well as encouragement from parents, healthcare workers and teachers were identified as factors associated with HPV vaccine uptake. Improving knowledge about HPV and involving teachers and parents in the immunisation campaign might help promote HPV vaccine uptake.

Circulatory system disease (CSD) patterns vary over time and between countries, related to lifestyle risk factors, associated in turn with socioeconomic circumstances. Current global CSD epidemics in developing economies are similar in scale to those observed previously in the USA and Australasia. Australia exhibits an important macroeconomic phenomenon as a rapidly transitioning economy with high immigration throughout the nineteenth and twentieth centuries. We wished to examine how that historical immigration related to CSD patterns subsequently.

We provide a novel empirical analysis employing census-derived place of birth by age bracket and sex from 1891 to 1986, in order to map patterns of immigration against CSD mortality rates from 1907 onwards. Age-specific generalised additive models for both CSD mortality in the general population, and all-cause mortality for the foreign-born (FB) only, from 1910 to 1980 were also devised for both males and females.

The percentage of FB fell from 32% in 1891 to 9.8% in 1947. Rates of CSD rose consistently, particularly from the 1940s onwards, peaked in the 1960s, then declined sharply in the 1980s and showed a strong period effect across age groups and genders. The main effects of age and census year and their interaction were highly statistically significant for CSD mortality for males (p

We argue our empirical calculations, supported by historical and socioepidemiological evidence, employing immigration patterns as a proxy for epidemiological transition, affirm the life course hypothesis that both early life circumstances and later life lifestyle drive CSD patterns.

Current formulations of ready-to-use therapeutic foods (RUTFs) to treat severe acute malnutrition (SAM) in children focus on nutrient density and quantity. Less attention is given to foods targeting gut microbiota metabolism and mucosal barrier functions. Heat-stabilised rice bran contains essential nutrients, prebiotics, vitamins and unique phytochemicals that have demonstrated favourable bioactivity to modulate gut microbiota composition and mucosal immunity. This study seeks to examine the impact of RUTF with rice bran on the microbiota during SAM treatment, recovery and post-treatment growth outcomes in Jember, Indonesia. Findings are expected to provide insights into rice bran as a novel food ingredient to improve SAM treatment outcomes.

A total of 200 children aged 6–59 months with uncomplicated SAM (weight-for-height z-scores (WHZ)

The findings of this trial will be submitted to peer-reviewed journals and will be presented at relevant conferences. Ethics approval obtained from the Medical and Health Research Ethical Committee at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Madain Yogyakarta Ref. No.: KE/FK/0546/EC/2022 and KE/FK/0703/EC/2023 and from Colorado State University IRB#1823, OHRP FWA00000647.

NCT05319717.

During the last two decades, researchers and funders increasingly recognised the value of engaging patients and communities in research. Despite progress, community engagement remains challenging. There are few examples of successful participant engagement in governance of large-scale research programmes. Here we describe efforts to engage participants as partners in new governance roles in the All of Us Research Program, a precision medicine research initiative which intends to enrol at least one million participants. Using intentional, participant-centric engagement strategies, the All of Us Engagement Core recruited and integrated a diverse group of participants into governance roles including Steering and Executive Committees. Evaluation measures included a survey to assess Consortium Members’ readiness for participant engagement.

Over a 3-year period, all items on the survey increased (higher readiness). Of the 291 respondents to the 2021 survey, respondents most frequently agreed that participant perspectives are essential (100%), participants understand enough to contribute meaningfully (94%) and participants should be involved in setting goals (96%). Respondents least frequently agreed that participants should have an equal voice in Working Groups (75%), Steering Committee (69%) and Executive Committee (63%).

In conclusion, participants can be effectively integrated into large-scale research governance, which is associated with increased researcher readiness for engagement.

Current interventions for children with attention-deficit/hyperactivity disorder (ADHD) are primarily medication, behavioural therapy and parent training. However, research suggests dietary manipulations may provide therapeutic benefit for some. There is accumulating evidence that the gut microbiome may be atypical in ADHD, and therefore, manipulating gut bacteria in such individuals may help alleviate some of the symptoms of this condition. The aim of this study is to explore the effects of supplementation with kefir (a fermented dairy drink) on ADHD symptomatology, sleep, attention and the gut microbiome in children diagnosed with ADHD.

A 6-week randomised, double-blind, placebo-controlled trial in 70 children aged 8–13 years diagnosed with ADHD. Participants will be recruited throughout the UK, through support groups, community groups, schools, social media and word of mouth. Children will be randomised to consume daily either dairy kefir or a placebo dairy drink for 6 weeks. The primary outcome, ADHD symptomatology, will be measured by The Strengths and Weakness of ADHD-symptoms and Normal-behaviour scale. Secondary outcomes will include gut microbiota composition (using shotgun metagenomic microbiome sequencing), gut symptomatology (The Gastrointestinal Severity Index questionnaire), sleep (using 7-day actigraphy recordings, The Child’s Sleep Habits Questionnaire and Sleep Self Report questionnaire), inattention and impulsivity (with a computerised Go/NoGo test). Assessments will be conducted prior to the intervention and at the end of the intervention. Interaction between time (preintervention/postintervention) and group (probiotic/placebo) is to be analysed using a Mixed Model Analysis of Variances.

Ethical approval for the study was granted by St Mary’s University Ethics Committee. Results will be disseminated through peer-reviewed publications, presentations to the scientific community and support groups.

NCT05155696.

Worldwide, the prevalence of degenerative diseases such as dementia and mild cognitive impairment (MCI) is increasing with population ageing and increasing life expectancy. Both conditions share modifiable risk factors. Physical inactivity is one of these modifiable risk factors, and research points to the protective effect of physical activity on the incidence of dementia and MCI. However, this association tends to change according to type, intensity, frequency, duration and volume of physical activity. Furthermore, it remains unclear which of these characteristics offers the greatest protective effect. Therefore, this study aims to evaluate the impacts of different types, intensities, frequencies, duration and volume of physical activity on dementia and cognitive decline in older adults.

The search will be carried out from October 2023, using the following databases: PubMed, Embase, Scopus, CINAHL and Web of Science. Cohort studies with a follow-up time of 1 year or longer that have investigated the incidence of dementia and/or MCI in older adults exposed to physical activity will be included. There will be no limitations on the date of publication of the studies. Studies published in English, Spanish or Portuguese will be analysed. Two researchers will independently screen the articles and extract the data. Any discrepancies will be resolved by a third reviewer. Association measures will be quantified, including OR, HR, relative risk and incidence ratio, with a 95% CI. If the data allow, a meta-analysis will be performed. To assess the methodological quality of the selected studies, the Grading of Recommendations, Assessment, Development and Evaluations instrument, and the Downs and Black instrument to assess the risk of bias, will be used.

Ethical approval is not required. The results will be submitted for publication in a peer-reviewed journal.

CRD42023400411.

The primary objective of the present systematic review is to: (1) identify the current vocal tasks being used for acoustic and/or auditory perceptual analysis to differentiate between individuals with and without voice disorders. The secondary objectives are to: (2) evaluate the evidence of the sensitivity, specificity and accuracy of those vocal tasks for acoustic and/or auditory perceptual analysis in discriminating the individuals with voice disorders from those without; and (3) compare the values between the vocal tasks in discriminating individuals with voice disorders from those without.

We search the following electronic databases: MEDLINE, EMBASE, CINAHL, Scopus, Web of Science Core Collection, PubMed Central and Google Scholar. Grey literature searches will include ProQuest Dissertations and Theses, ClinicalTrials.gov and the Cochrane Register of Controlled Trials. Websites of professional organisations and textbooks will be hand searched for relevant information related to the research question. Study screening, selection and data extraction will be conducted independently by two reviewers. Any disagreements will be resolved by discussion or by involving a third reviewer.

The methodological quality of the included studies will be appraised using the relevant Critical Appraisal Tools by JBI. The clinical guidelines and recommendations for voice assessment by professional bodies will be appraised using the Reporting Items for practice Guidelines in HealThcare (RIGHT) checklist. The findings will be presented in the form of an information matrix with the tasks identified tabulated against the nature of the task, dimensions being tested, and their accuracy, sensitivity, and specificity in identifying individuals with voice problems.

Formal ethics approval is not required. The findings will be presented at national and international conferences and published in a peer-reviewed journal.

CRD42023431634.

To examine the associations of cardiorespiratory fitness (VO₂ max) and muscular strength with indicators related to the risk scale, such as perceived competence, sensation seeking, competitiveness, risk taking and risk perception in sports.

Cross-sectional study.

High schools from the Region of Murcia (Spain).

Three-hundred-and-seventeen adolescents participated (mean age: 13.69±1.2 years old).

Body mass, body height, Course-Navette test, upper limb strength and psychoeducational factors that determine the propensity towards sports accidents in school children, the Sports Accident Propensity Scale were evaluated. It was performance t-test for independent samples, stepwise multiple linear regression models and a multiple mediation analysis.

The analysis showed significant differences with respect to sex in height, VO₂ max, handgrip strength and in all factors of the questionnaire (p=0.02-2 max, strength in the handgrip test and age showed a higher score in factors 1 and 3. Higher scores in factor 2 were associated with better VO₂ max and strength in handgrip test. Youngers and better values of strength in the handgrip showed higher score in factors 4 and 5. The mediation analysis with two mediating variables (handgrip strength and VO₂ max) showed a significant indirect effect. When handgrip strength and VO₂ max were included in the equations, the association between sex and each factor ceased to be significant.

This study highlights the potential benefits of muscular strength (handgrip) and VO₂ max in the perceived risk scale, and the variable of age on this.

Clinical trial: NCT05544370 (pre-results).

This study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks.

Economic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial.

Primary and secondary healthcare, community and social media advertising.

Women ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment.

Participants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment.

Cost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator’s global assessment, IGA

Spironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence’s threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis).

The results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis.

ISRCTN registry (ISRCTN12892056).

Child maltreatment (CM) is a complex global public health issue with potentially devastating effects on individuals’ physical and mental health and well-being throughout the life course. A lack of uniform definitions hinders attempts to identify, measure, respond to, and prevent CM. The aim of this electronic Delphi (e-Delphi) study is to build consensus on definitions and types of CM for use in surveillance and multi-sectoral research in the 34 countries in the Euro-CAN (Multi-Sectoral Responses to Child Abuse and Neglect in Europe) project (COST Action CA19106).

The e-Delphi study will consist of a maximum of three rounds conducted using an online data collection platform. A multi-disciplinary expert panel consisting of researchers, child protection professionals (health and social care), police, legal professionals and adult survivors of CM will be purposefully recruited. We will approach approximately 100 experts, with between 50 and 60 of these anticipated to take part. Participants will rate their agreement with a range of statements relating to operational definitions and types of CM, and free-text comments on each of the statements to give further detail about their responses and areas of uncertainty. Consensus has been defined a priori as ≥70% of the panel agreeing or disagreeing with the statement after the final round. The responses to the open-ended questions will be analysed using a ‘codebook’ approach to thematic analysis, and used to refine the statements between rounds where no consensus is reached.

Ethical approval has been granted from the Cardiff University School of Medicine ethics committee (reference number SMREC22/96). Results will be submitted for publication in a peer-reviewed journal and presented at workshops (including for the participants) and international academic conferences. The Euro-CAN network will also be used to disseminate the results, with results briefings and presentations to key public health and other relevant organisations in the field.

Poor interdisciplinary care team communication has been associated with increased mortality. The study aimed to define conditions for effective interdisciplinary care team communication.

An observational cross-sectional qualitative study.

A surgical intensive care unit in a large, urban, academic referral medical centre.

A total 6 interviews and 10 focus groups from February to June 2021 (N=33) were performed. Interdisciplinary clinicians who cared for critically ill patients were interviewed. Participants included intensivist, transplant, colorectal, vascular, surgical oncology, trauma faculty surgeons (n=10); emergency medicine, surgery, gynaecology, radiology physicians-in-training (n=6), advanced practice providers (n=5), nurses (n=7), fellows (n=1) and subspecialist clinicians such as respiratory therapists, pharmacists and dieticians (n=4). Audiorecorded content of interviews and focus groups were deidentified and transcribed verbatim. The study team iteratively generated the codebook. All transcripts were independently coded by two team members.

Conditions for effective interdisciplinary care team communication.

We identified five themes relating to conditions for effective interdisciplinary care team communication in our surgical intensive care unit setting: role definition, formal processes, informal communication pathways, hierarchical influences and psychological safety. Participants reported that clear role definition and standardised formal communication processes empowered clinicians to engage in discussions that mitigated hierarchy and facilitated psychological safety.

Standardising communication and creating defined roles in formal processes can promote effective interdisciplinary care team communication by fostering psychological safety.

Healthcare systems are currently facing challenges in enhancing access and improving the quality of healthcare services around the world, and one of the innovative strategies that have been used to address such challenges is the positive deviance (PD) approach. The approach assumes that identifying, examining, understanding and disseminating solutions to problems that are already available within the community and organisations including the healthcare system can help in bringing improvements at scale. However, to the best of the researcher’s knowledge, there is no scoping review, that is, conducted to map and synthesise the available evidence on the use of the PD approach for healthcare system service improvements. Hence, this scoping review aims to map and synthesise resources on the methodologies and reported outcomes and identify gaps and potentials regarding the use of the PD approach in the healthcare system.

Articles will be searched and retrieved in research databases such as PubMed, Embase and Scopus. Retrieved articles will be screened independently for inclusion through a title and, or abstract review. Then, articles that passed the title and abstract review will be screened by reading the full texts. A descriptive mapping and synthesis of the literature will be employed to present data using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews checklist and data will be presented in text, figure and table formats.

The results of this scoping review will be published in peer-reviewed reputable international journals. Furthermore, it will also be disseminated through conference presentations, and popular press to the wider community. However, formal ethical approval is not required as primary data will not be collected.

Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.

Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the ² test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.

NCT05443035.