Dental caries and school readiness in 5-year-olds: A birth cohort data linkage study.

OBJECTIVE: To describe the association between dental caries and school readiness in 5-year-old children taking part in the Born in Bradford (BiB) birth cohort, UK. METHODS: The Early Years Foundation Stage Profile (EYFSP) assesses the school readiness of young children and is strongly predictive of future academic attainment. Children are recorded as 'emerging' (below expected), 'expected', or 'exceeding' in five key learning areas. The Oral Health Survey of 5-year-olds (OHS5) is undertaken biennially in England, assessing caries experience at a dentine threshold (d3mft). EYFSP and OHS5 were available for a proportion of children participating in BiB. Odds ratios and confidence intervals for caries experience were established, and odds ratios adjusted for significant sociodemographic variables. RESULTS: EYFSP and OHS5 data were available for 2.5% (n = 346) BiB participants. Nearly half (45.2%) had caries. A measure of socio-economic status, receiving free school meals, was the only demographic variable strongly related to caries experience (OR: 2.8, 95% CI: 1.6-4.9). After adjustment, children 'emerging' in EYFSP learning areas had 1.6- to 2.2-fold (95% CI: 1.0-3.8) higher odds of experiencing caries. Children 'exceeding' EYFSP learning areas had 2.3- to 4-fold (95% CI: 0.1-0.9) lower odds of caries experience. CONCLUSION: This is the first study to explore the association between caries experience and school readiness using a holistic assessment tool. The association was found across different learning areas and was comparable to and independent of socio-economic status. The findings indicate oral health-related absenteeism is not a causative factor. EYFSP shows potential to enhance the targeting of preventive interventions at a child, class or school level.

Exposing the molecular heterogeneity of glycosylated biotherapeutics.

The heterogeneity inherent in today's biotherapeutics, especially as a result of heavy glycosylation, can affect a molecule's safety and efficacy. Characterizing this heterogeneity is crucial for drug development and quality assessment, but existing methods are limited in their ability to analyze intact glycoproteins or other heterogeneous biotherapeutics. Here, we present an approach to the molecular assessment of biotherapeutics that uses proton-transfer charge-reduction with gas-phase fractionation to analyze intact heterogeneous and/or glycosylated proteins by mass spectrometry. The method provides a detailed landscape of the intact molecular weights present in biotherapeutic protein preparations in a single experiment. For glycoproteins in particular, the method may offer insights into glycan composition when coupled with a suitable bioinformatic strategy. We tested the approach on various biotherapeutic molecules, including Fc-fusion, VHH-fusion, and peptide-bound MHC class II complexes to demonstrate efficacy in measuring the proteoform-level diversity of biotherapeutics. Notably, we inferred the glycoform distribution for hundreds of molecular weights for the eight-times glycosylated fusion drug IL22-Fc, enabling correlations between glycoform sub-populations and the drug's pharmacological properties. Our method is broadly applicable and provides a powerful tool to assess the molecular heterogeneity of emerging biotherapeutics.

Sialic Acid Mediated Endothelial and Hepatic Uptake: A Mechanism based Mathematic Model Elucidating the Complex Pharmacokinetics and Pharmacodynamics of Efmarodocokin Alfa, a Variably Glycosylated Fusion Protein.

Sialic acid (SA) is crucial for protecting glycoproteins from clearance. Efmarodocokin alfa (IL-22Fc), a fusion protein agonist that links IL-22 to the crystallizable fragment (Fc) of human IgG4, contains 8 N-glycosylation sites and exhibits heterogeneous and variable terminal sialylation biodistribution. This presents a unique challenge for Pharmacokinetic (PK) and Pharmacodynamic (PD) analysis and cross-species translation. In this study, we sought to understand how varying SA levels and heterogeneous distribution contribute to IL-22Fc's complex PKPD properties. We initially used homogenous drug material with varying SA levels to examine PKPD in mice. Population PKPD analysis based on mouse data revealed that SA was a critical covariate simultaneously accounting for the substantial between subject variability (BSV) in clearance (CL), distribution clearance (CLd), and volume of distribution (Vd). In addition to the well-established mechanism by which SA inhibits ASGPR activity, we hypothesized a novel mechanism by which decrease in SA increases the drug uptake by endothelial cells. This decrease in SA, leading to more endothelial uptake, was supported by the neonatal Fc receptor (FcRn) dependent cell-based transcytosis assay. The population analysis also suggested in vivo EC50 (IL-22Fc stimulating Reg3ß) was independent on SA, while the in-vitro assay indicated a contradictory finding of SA-in vitro potency relationship. We created a mechanism based mathematical (MBM) PKPD model incorporating the decrease in SA mediated endothelial and hepatic uptake, and successfully characterized the SA influence on IL-22Fc PK, as well as the increased PK exposure being responsible for increased PD. Thereby, the MBM model supported that SA has no direct impact on EC50, aligning with the population PKPD analysis. Subsequently, using the MBM PKPD model, we employed 5 subpopulation simulations to reconstitute the heterogeneity of drug material. The simulation accurately predicted the PKPD of heterogeneously and variably sialylated drug in mouse, monkey and human. The successful prospective validation confirmed the MBM's ability to predict IL-22Fc PK across variable SA levels, homogenous to heterogeneous material, and across species (R2=0.964 for clearance prediction). Our model prediction suggests an average of 1 mol/mol SA increase leads to a 50% increase in drug exposure. This underlines the significance of controlling sialic acid levels during lot-to-lot manufacturing.

An industry perspective approach and control strategy for implementation of ready-to-use cells in bioassays: survey outcome and recommendations.

The BioPhorum Development Group is an industry collaboration enabling the sharing of common practices for the development of biopharmaceuticals. Bioassays are an important part of an analytical control system. Utilization of ready-to-use cells can increase operational flexibility and improve efficiency by providing frozen cell banks uniform stock while removing challenges associated with maintaining cultured cells. The BioPhorum Development Group-Bioassay workstream conducted an intercompany benchmarking survey and group discussions around the use of ready-to-use cells for bioassays. The results of the collaboration provide alignment on nomenclature, production, qualification and implementation of ready-to-use cells to support the assay life cycle.

Behaviour change intervention for toothbrushing (lesson and text messages) to prevent dental caries in secondary school pupils: The BRIGHT randomized control trial.

OBJECTIVES: This multicentre, assessor-blinded, two-arm cluster randomized trial evaluated the clinical and cost-effectiveness of a behaviour change intervention promoting toothbrushing for preventing dental caries in UK secondary schools. METHODS: Pupils aged 11-13 years with their own mobile telephone attending secondary schools with above average free school meals eligibility were randomized (at year-group level) to receive a lesson and twice-daily text messages or to usual care. Year-groups (n = 84) from 42 schools including 4680 pupils (intervention, n = 2262; control, n = 2418) were randomized. RESULTS: In 2383 participants with valid data at baseline and 2.5 years, the primary outcome of presence of at least one treated or untreated carious lesion (D4-6 MFT [Decayed, Missing and Filled Teeth] in permanent teeth using International Caries Detection and Assessment System) was 44.6% in the intervention group and 43.0% in control (odds ratio [OR] 1.04, 95% CI 0.85-1.26, p = .72). There were no statistically significant differences in secondary outcomes of presence of at least one treated or untreated carious lesion (D1-6 MFT), number of D4-6 MFT and D1-6 MFT, plaque and bleeding scores or health-related- (Child Health Utility 9D) or oral health-related- quality of life (CARIES-QC). However, twice-daily toothbrushing, reported by 77.6% of pupils at baseline, increased at 6 months (intervention, 86.9%; control, 83.0%; OR 1.30, 95% CI 1.03-1.63, p = .03), but returned to no difference at 2.5 years (intervention, 81.0%; control, 79.9%; OR 1.05, 95% CI 0.84-1.30, p = .69). Estimated incremental costs and quality-adjusted life-years (QALYs) of the intervention, relative to control, were £1.02 (95% CI -1.29 to 3.23) and -0.003 (95% CI -0.009 to 0.002), respectively, with a 7% chance of being cost-effective (£20 000/QALY gained threshold). CONCLUSION: There was no evidence of statistically significant difference for caries prevalence at 2.5-years. The intervention's positive 6-month toothbrushing behaviour change did not translate into caries reduction. (ISRCTN 12139369). COVID-19 pandemic adversly affected follow-up.

Qualitative research in dental traumatology-A narrative review.

This review highlights the recent contributions of qualitative research in advancing understanding of dental trauma injury and the barriers and enablers to guide policy for improved patient-centred care including transitional care. It summarises the common approaches and methods used and outlines the key factors that guide the appraisal of qualitative studies. It highlights the importance of the application of qualitative research methods in dental research to generate rich and detailed data to provide explanations and insights into people's experiences, beliefs and attitudes and the complexity of human decision-making and behaviour. In the past decade while there have been a growing number of publications of qualitative studies in dental journals, qualitative studies remain a small percentage of the published dental traumatology research. This may be because of limited understanding about the background, methods and rigour of qualitative research.

The oral health of secondary school pupils: baseline data from the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial.

Background This paper describes the sociodemographics and oral health of UK secondary school pupils. They were participants of the BRIGHT trial, which was designed to evaluate the effectiveness of a toothbrushing intervention to reduce dental caries.Methods Overall, 4,680 pupils aged 11-13 years attending 42 secondary schools in England, Scotland and Wales with above average proportion of pupils eligible for free school meals, were recruited to the trial. Sociodemographic data were collected. Participants had a clinical assessment for caries, plaque and bleeding and completed measures of oral and general health-related quality of life and oral health behaviours (frequency of toothbrushing, dental attendance and cariogenic food/drinks consumed). Regression analyses were performed.Results Over one-third (34.7%) of participants had caries experience, with 44.5% reporting their oral health had an impact on their daily lives. Factors associated with a statistically significant increased likelihood of caries experience were older age, being female, eligibility for free school meals, worse oral health-related quality of life, higher cariogenic diet, less than twice-daily toothbrushing, living in a more deprived area and lower school attendance.Conclusions The prevalence and impact of dental caries on the lives of pupils remains high, with further oral health promotion activities needed in targeted secondary schools.

Special considerations in paediatric dental trauma.

Traumatic dental injuries (TDIs) in the paediatric population are common and frequently seen in general dental practice. The management of TDIs can be challenging and, in most cases, the General Dental Practitioner is tasked with the initial assessment and emergency treatment. Patients and their families typically attend with elevated levels of distress, which is complicated by the limited dental experience of some children. Behaviour management is essential and helps prepare patients for dental care at both their emergency and follow-up appointments. Early and accurate diagnosis in combination with appropriate treatment contributes to favourable outcomes for traumatised teeth. Early discussions with or referral to paediatric dental teams for management of complex TDIs is encouraged, however shared follow-up care is beneficial over the long-term. In specific cases, initial dental treatment can be delayed by a few days to a subsequent appointment, allowing the dental team to book sufficient time for the treatment and for the patient and their families to prepare. Education of the patients and adults with parental responsibility is essential to manage expectations, explain likely complications and encourage attendance for long-term follow-up visits. This paper discusses the management of paediatric patients to aid the primary care practitioner in providing effective immediate and long-term care.

A national survey of supervised toothbrushing programmes in England.

Introduction Supervised toothbrushing programmes (STPs) are a cost-effective public health intervention, reducing tooth decay and health inequalities in children. However, the uptake of STPs in England is unknown. This study aimed to establish the current provision of STPs across England and summarise the barriers and facilitators to their implementation.Methods An online survey was sent to dental public health consultants, local authority (LA) oral health leads, and public health practitioners across England. Quantitative data were analysed using descriptive statistics. Barriers and facilitators were analysed using the Consolidated Framework for Implementation Research.Results Information was received for 141 LAs across England. Approximately half implemented an STP (n = 68/141). Most STPs were commissioned by LAs (n = 44/68) and adopted a targeted approach (n = 54/68). Barriers to implementation were: 1) acquiring funding; 2) poor communication and engagement between LAs, oral health providers and settings; 3) oral health not a priority; 4) logistically challenging to implement; and 5) lack of capacity. Facilitators were: 1) an integrated and mandated public health approach; 2) collaboration and ongoing support between LAs, oral health providers, and settings; 3) clarity of guidance; 4) flexible approach to delivery; 5) adequate available resources; and 6) ownership and empowerment of setting staff.Conclusion The current provision of STPs is varied, and although there are challenges to their implementation, there are also areas of good practice where these challenges have been overcome.

Timing Differences in Stride Cycle Phases in Retired Racehorses Ridden in Rising and Two-Point Seat Positions at Trot on Turf, Artificial and Tarmac Surfaces.

Injuries to racehorses and their jockeys are not limited to the racetrack and high-speed work. To optimise racehorse-jockey dyads' health, well-being, and safety, it is important to understand their kinematics under the various exercise conditions they are exposed to. This includes trot work on roads, turf and artificial surfaces when accessing gallop tracks and warming up. This study quantified the forelimb hoof kinematics of racehorses trotting over tarmac, turf and artificial surfaces as their jockey adopted rising and two-point seat positions. A convenience sample of six horses was recruited from the British Racing School, Newmarket, and the horses were all ridden by the same jockey. Inertial measurement units (HoofBeat) were secured to the forelimb hooves of the horses and enabled landing, mid-stance, breakover, swing and stride durations, plus stride length, to be quantified via an in-built algorithm. Data were collected at a frequency of 1140 Hz. Linear Mixed Models were used to test for significant differences in the timing of these stride phases and stride length amongst the different surface and jockey positions. Speed was included as a covariate. Significance was set at p < 0.05. Hoof landing and mid-stance durations were negatively correlated, with approximately a 0.5 ms decrease in mid-stance duration for every 1 ms increase in landing duration (r2 = 0.5, p < 0.001). Hoof landing duration was significantly affected by surface (p < 0.001) and an interaction between jockey position and surface (p = 0.035). Landing duration was approximately 4.4 times shorter on tarmac compared to grass and artificial surfaces. Mid-stance duration was significantly affected by jockey position (p < 0.001) and surface (p = 0.001), speed (p < 0.001) and jockey position*speed (p < 0.001). Mean values for mid-stance increased by 13 ms with the jockey in the two-point seat position, and mid-stance was 19 ms longer on the tarmac than on the artificial surface. There was no significant difference in the breakover duration amongst surfaces or jockey positions (p ≥ 0.076) for the ridden dataset. However, the mean breakover duration on tarmac in the presence of a rider decreased by 21 ms compared to the in-hand dataset. Swing was significantly affected by surface (p = 0.039) and speed (p = 0.001), with a mean swing phase 20 ms longer on turf than on the artificial surface. Total stride duration was affected by surface only (p = 0.011). Tarmac was associated with a mean stride time that was significantly reduced, by 49 ms, compared to the turf, and this effect may be related to the shorter landing times on turf. Mean stride length was 14 cm shorter on tarmac than on grass, and stride length showed a strong positive correlation with speed, with a 71 cm increase in stride length for every 1 m s-1 increase in speed (r2 = 0.8, p < 0.001). In summary, this study demonstrated that the durations of the different stride cycle phases and stride length can be sensitive to surface type and jockey riding position. Further work is required to establish links between altered stride time variables and the risk of musculoskeletal injury.

Improving data quality from routine clinical appointments-Development of a minimum dataset for traumatic dental injuries in children and adolescents.

BACKGROUND/AIMS: It is currently difficult to evaluate the success or not of treatment for dental injuries due to poor recording of diagnostic and treatment codes in clinical dentistry. A minimum dataset comprises a standardised minimum set of outcomes along with a specified outcome measurement instrument, to allow aggregated use of data from routine clinical care appointments. This study aimed to determine which outcomes should be included in a minimum dataset for traumatic dental injuries (TDI). MATERIALS AND METHODS: This is a three-stage sequential, mixed-methods study, using evidence-based best practice for dataset development. Normalisation process theory informed the development of the study protocols. In Stage 1, semi-structured interviews with patients and their parent or guardian were undertaken to identify outcomes of importance to patients. In Stage 2, an online Delphi survey was undertaken to identify outcomes of importance to clinicians. In Stage 3, a National Consensus Meeting was undertaken involving patient representatives, clinicians and other stakeholders, to agree which outcomes should be included in the minimum dataset. RESULTS: Stage 1: Eleven participants were recruited, five children and six parents. Two key themes emerged from the analysis-communication and aesthetics. In Stage 2, 34 dentists were recruited, and 32 completed both rounds of the survey (97% retention). Most outcomes were deemed by participants to be of 'critical importance', with three outcomes deemed 'important' and none to be 'of limited importance'. In Stage 3, 15 participants took part in the consensus meeting. Participants agreed that the dataset should comprise a list of clinician-important outcomes (pulp healing, periodontal healing, discolouration, tooth loss) and a list of patient-important outcomes (communication, aesthetics, pain, quality of life). CONCLUSION: A Minimum Dataset for TDI has been developed using a robust and transparent methodology.

Experiences of newly qualified dentists in delivering oral health advice to parents/caregivers of young children-challenges and solutions.

Introduction: A key skill for dental professionals to master is their ability to have effective preventive oral health conversations. On qualifying, UK dentists undertake a one-year foundation training programme in general practice. This study explored with Foundation Dentists, the barriers and facilitators to undertaking oral health conversations with parents/caregivers and their children, aged 0-11 years old. Materials and methods: Approximately 100 Foundation Dentists from the Yorkshire and Humber region attended a series of focus groups. They discussed how they and their wider dental team undertake oral health conversations with parents/caregivers of young children, aged 0-11 years old. The data was analysed using thematic analysis. Results: Five themes were identified as barriers and facilitators to providing oral health advice: (1) Lack of knowledge around parenting skills and child development; (2) Parental receptivity; (3) Motivation for changing behaviours; (4) Information content and inconsistency; and (5) Current National Health Service (NHS) structures of general dental practice. Discussion: A multi-faceted approach is needed to develop the training of Foundation Dentists to undertake preventive oral health conversations with parents/caregivers and children. Such an approach has the potential to improve the patient-practitioner relationship and increase effective behaviour change conversations taking place in general dental care, thus improving children's oral health.

Identifying important prognostic factors and outcomes for autotransplantation of developing teeth: Clinicians' perspectives.

BACKGROUND/AIM: Variability in the outcome measures used to assess the success of tooth autotransplantation presents challenges for combining data to examine the success of the technique. Reaching agreement on the most important outcomes will enable routine procedural and follow-up data to be collected in a standardised way. In turn this will promote greater data synthesis to evaluate outcomes and examine which procedural techniques influence outcome. The aim of this study was to identify which prognostic factors and outcomes are most important to clinicians with experience in autotransplantation of developing teeth. METHODS: The Delphi method was used to build consensus on the most important prognostic factors and outcomes. Item identification involved a systematic literature review and review of current clinical datasets in use. A two-round Delphi questionnaire was undertaken with clinicians providing tooth autotransplantation, followed by a consensus meeting to finalise the most important items. RESULTS: Outcomes and prognostic factors were identified from the systematic review (82 studies and eight reviews), one guideline and three existing clinical datasets. Patient interviews and a clinician survey added a number of items that would not have been identified from the literature only. A total of 56 outcomes and 93 prognostic factors were included for rating in the Delphi questionnaire. The Delphi questionnaire was completed by 15 respondents in round one and 13 respondents in round two. The consensus meeting was attended by nine participants. The final items that were judged to be most important included 29 outcomes (25 clinical, three patient-reported and one service delivery) and 49 prognostic factors (18 patient characteristics, four presurgical, 17 surgical and 10 postsurgical). Clinical outcomes were consistently rated higher than patient-reported outcomes. CONCLUSIONS: The clinical outcomes rated as the most important were transplant survival and reason for failure, outcomes relating to pulp health, different types of resorption and evidence of infection (suppuration). Important patient-reported outcomes were satisfaction with overall treatment experience, and outcome and quality of life related to function of the transplanted tooth. Procedural information rated as being the most important related to the donor tooth: stage of root development, method for surgical removal and storage and condition of the donor tooth root surface following removal.

The outcomes of auto-transplanted premolars in the anterior maxilla following traumatic dental injuries.

BACKGROUND/AIMS: Tooth auto-transplantation is a treatment option, which is often not considered to replace anterior maxillary incisors in children and adolescents. There are multiple prognostic factors that may influence the outcomes of premolar auto-transplantation, but there is limited evidence from human studies. The aim of this study was to report the outcomes of auto-transplanted premolars in the anterior maxilla following traumatic dental injuries (TDIs) and to identify their prognostic factors. MATERIALS AND METHODS: The clinical records of patients who had premolars transplanted in the anterior maxilla following TDI, with appropriate radiographs and a minimal of 1-year follow-up, were reviewed retrospectively. A specific data extraction form was developed, tested and used to collect information for the prognostic factors and outcomes. RESULTS: The cohort included 120 patients with 144 auto-transplanted premolars. The mean age was 12.2 years (±2.0), and the mean observation period was 3.7 years (±1.8). The success rate was 80%, and the survival rate was 93%. Unfavourable outcomes included external replacement resorption in 12.5%, uncontrolled external inflammatory resorption in 2.7%, and both resorption types in 4.9% of teeth. Periodontal healing was significantly associated with donor tooth root maturity, graft handling at the time of surgery including ease of donor tooth extraction and placement at the recipient sites, recipient site alveolar bone status, and post-operative transplant mobility. Seventy-four teeth (53.4%) were immature at the time of transplantation where pulp revascularisation was anticipated, and 52 (70%) of those had radiographic and clinical signs of pulp healing. Pulp healing was significantly related to donor tooth eruption stage, ease of extraction of donor tooth, and ease of placement in the recipient site. CONCLUSIONS: Good outcomes were observed for premolar teeth auto-transplanted in the anterior maxilla. The main prognostic factors were ease of extraction of donor tooth and ease of placement in the recipient sites and donor tooth root maturity.

The CALM trial protocol: a randomised controlled trial of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children.

BACKGROUND: Globally, around 13% of children experience dental anxiety (DA). This group of patients frequently miss dental appointments, have greater reliance on treatment under general anaesthesia (GA) and have poorer oral health-related quality of life (OHRQoL) than their non-dentally anxious peers. Recently, a low-intensity cognitive behavioural therapy (CBT)-based, self-help approach has been recommended for management of childhood anxiety disorders. A feasibility study conducted in secondary care found this guided self-help CBT resource reduced DA and a randomised controlled trial was recommended. The present study aims to establish the clinical and cost-effectiveness of a guided self-help CBT intervention to reduce DA in children attending primary dental care sites compared to usual care. METHODS: This 4-year randomised controlled trial will involve 600 children (aged 9-16 years) and their parent/carers in 30 UK primary dental care sites. At least two dental professionals will participate in each site. They will be assigned, using random allocation, to receive the CBT training and deliver the intervention or to deliver usual care. Children with DA attending these sites, in need of treatment, will be randomly allocated to be treated either by the intervention (CBT) or control (usual care) dental professional. Children will complete questionnaires relating to DA, OHRQoL and HRQoL before treatment, immediately after treatment completion and 12 months post-randomisation. Attendance, need for sedation/GA and costs of the two different approaches will be compared. The primary outcome, DA, will be measured using the Modified Child Dental Anxiety Scale. Scores will be compared between groups using a linear mixed model. DISCUSSION: Treating dentally anxious patients can be challenging and costly. Consequently, these children are frequently referred to specialist services for pharmacological interventions. Longer waiting times and greater travel distances may then compound existing healthcare inequalities. This research will investigate whether the intervention has the potential to reduce DA and improve oral health outcomes in children over their life-course, as well as upskilling primary dental healthcare professionals to better manage this patient group. TRIAL REGISTRATION: This clinical trial has been registered with an international registry and has been allocated an International Standard Randomised Controlled Trial Number (ISRCTN27579420).

Set up and assessment of progression criteria for internal pilots: the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial example.

BACKGROUND: Dental caries is common in young people and has wide-ranging ramifications for health and quality of life. Text messaging interventions show promise as a means to promote oral health behaviour change among young people. This paper reports the internal pilot of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial, which is evaluating an intervention comprising an oral health classroom lesson and text messages about toothbrushing, on caries in young people. Pilot trial objectives were to evaluate the feasibility and appropriateness of recruitment and data collection methods, the randomisation strategy, and intervention delivery against progression criteria for the main trial. METHODS: This is an internal pilot trial embedded within an assessor-blinded, two-arm, cluster randomised controlled trial. Participants were pupils aged 11-13 years (in year 7/S1 or year 8/S2) in secondary schools in England, Scotland, and Wales with above average pupil eligibility for free school meals. Following completion of pupil baseline questionnaires and dental assessments, year groups within schools were randomised to the intervention or control arm. Approximately 12 weeks later, participants completed a follow-up questionnaire, which included questions about sources of oral health advice to assess intervention contamination between year groups. At the end of the pilot phase, trial conduct was reviewed against pre-specified progression criteria. RESULTS: Ten schools were recruited for the pilot, with 20 year groups and 1073 pupils randomised (average of 54 pupils per year group). Data collection methods and intervention delivery were considered feasible, the response rate to the follow-up questionnaire was over 80%, there was an indication of a positive effect on self-reported toothbrushing, and interest was obtained from 80% of the schools required for the main trial. Despite partial intervention contamination between year groups, within-school randomisation at the level of the year-group was considered appropriate for the main trial, and the sample size was revised to account for partial contamination. Facilitators and barriers to recruitment and data collection were identified and strategies refined for the main trial. CONCLUSIONS: Progression to the main trial of BRIGHT, with some design refinements, was concluded. The internal pilot was an efficient way to determine trial feasibility and optimise trial processes. TRIAL REGISTRATION: ISRCTN registry, ISRCTN12139369 , registered 10/05/2017.

An exploration of the use of photobiomodulation for management of oral mucositis in children and young people undergoing cancer treatment in the UK.

PURPOSE: Oral mucositis affects up to 80% of children and young people (CYP) receiving chemotherapy. This can result in pain, reduced oral intake and, in severe cases, hospitalisation for parental nutrition and pain relief. Photobiomodulation is recommended by multiple bodies for mucositis management for those undergoing cancer treatments. The current use of photobiomodulation within the UK, and the barriers and facilitators to implementation is unknown. METHOD: An online mixed-methods survey was administered to representatives from the Children's Cancer and Leukaemia Group (CCLG) between October 2021 and March 2022. This explored: use of photobiomodulation, planned future use, barriers and facilitators to implementation and dental assessment. Quantitative data underwent descriptive statistics. Barriers and facilitators to the implementation of photobiomodulation were analysed using the Theoretical Domains Framework (TDF). RESULTS: All UK CCLG centres responded (n = 20, a response rate of 100%). Two units in Scotland were delivering photobiomodulation. A further four units were planning to implement a service. Most units, 65% (n = 13) utilised specialist Paediatric Dentistry services for dental assessment. In the TDF analysis, five domains were most frequently populated: knowledge, skills, environmental context and resources, social influences, and social/professional role and identity. CONCLUSION: Photobiomodulation was only available in Scotland in two children's cancer units. Lack of knowledge and skills, and insufficient environmental resources were identified as barriers. Collaboration with paediatric dental services was identified as a facilitator. The establishment of a national network of Paediatric Dentists and Oncologists would promote collaboration to standardise protocols and to address the identified barriers to wider implementation of photobiomodulation.

Diagnosis Code and Health Care Utilization Patterns Associated With Diagnostic Uncertainty.

BACKGROUND AND OBJECTIVES: Diagnostic uncertainty is challenging to identify and study in clinical practice. This study compares differences in diagnosis code and health care utilization between a unique cohort of hospitalized children with uncertain diagnoses (UD) and matched controls. PATIENTS AND METHODS: This case-control study was conducted at Cincinnati Children's Hospital Medical Center. Cases were defined as patients admitted to the pediatric hospital medicine service and having UDs during their hospitalization. Control patients were matched on age strata, biological sex, and time of year. Outcomes included type of diagnosis codes used (ie, disease- or nondisease-based) and change in code from admission to discharge. Differences in diagnosis codes were evaluated using conditional logistic regression. Health care utilization outcomes included hospital length of stay (LOS), hospital transfer, consulting service utilization, rapid response team activations, escalation to intensive care, and 30-day health care reutilization. Differences in health care utilization were assessed using bivariate statistics. RESULTS: Our final cohort included 240 UD cases and 911 matched controls. Compared with matched controls, UD cases were 8 times more likely to receive a nondisease-based diagnosis code (odds ratio [OR], 8.0; 95% confidence interval [CI], 5.7-11.2) and 2.5 times more likely to have a change in their primary International Classification of Disease, 10th revision, diagnosis code between admission and discharge (OR, 2.5; 95% CI, 1.9-3.4). UD cases had a longer average LOS and higher transfer rates to our main hospital campus, consulting service use, and 30-day readmission rates. CONCLUSIONS: Hospitalized children with UDs have meaningfully different patterns of diagnosis code use and increased health care utilization compared with matched controls.

HABIT: Health visitors delivering Advice in Britain on Infant Toothbrushing - an early-phase feasibility study of a complex oral health intervention.

OBJECTIVES: To conduct an early-phase feasibility study of an oral health intervention, Health visitors delivering Advice on Britain on Infant Toothbrushing (HABIT), delivered by Health Visitors to parents of children aged 9-12 months old. DESIGN: A mixed-methods, early-phase, non-controlled, feasibility study. PARTICIPANTS: Recruitment consisted of Group A-HABIT-trained Health Visitors (n=11) and Group B-parents of children aged 9-12 months old about to receive their universal health check (n=35). SETTING: Bradford, West Yorkshire, UK. INTERVENTION: A multidisciplinary team co-developed digital and paper-based training resources with health visitors and parents of young children. The intervention comprised of two components: (A) training for health visitors to deliver the HABIT intervention and (B) HABIT resources for parents, including a website, videos, toothbrushing demonstration and a paper-based leaflet with an oral health action plan. PRIMARY AND SECONDARY OUTCOME MEASURES: Recruitment, retention and intervention delivery were analysed as key process outcomes for Groups A and B. Group B demographics, self-reported toothbrushing behaviours, dietary habits and three objective measures of toothbrushing including plaque scores were collected at baseline, 2 weeks and 3 months post intervention. RESULTS: HABIT intervention delivery was feasible. Although the intended sample size was recruited (Group A=11 and Group B=35) it was more challenging than anticipated. Retention of Group B participants to final data collection was satisfactory (n=26). Total compliance with toothbrushing guidelines at baseline was low (30%), but significantly improved and was maintained 3 months after the intervention (68%). Plaque scores improved post intervention and participants found video recording of toothbrushing acceptable. Dietary habits remained largely unchanged. CONCLUSION: This feasibility study has demonstrated that HABIT is an appropriate oral health intervention. Adaptions to the study design are recommended to maximise recruitment and data collection in a definitive study. These quantitative findings have demonstrated an early signal of impact for improved oral health behaviours for young children at high risk of decay. TRIAL REGISTRATION NUMBER: ISRCTN55332414.

Co-design of an oral health intervention (HABIT) delivered by health visitors for parents of children aged 9-12 months.

BACKGROUND: Dental caries (tooth decay) in children is a national public health problem with impacts on the child, their family and wider society. Toothbrushing should commence from the eruption of the first primary tooth. Health visitors are a key provider of advice for parents in infancy and are ideally placed to support families to adopt optimal oral health habits. HABIT is a co-designed complex behaviour change intervention to support health visitors' oral health conversations with parents during the 9-12-month universal developmental home visit. METHODS: A seven stage co-design process was undertaken: (1) Preparatory meetings with healthcare professionals and collation of examples of good practice, (2) Co-design workshops with parents and health visitors, (3) Resource development and expert/peer review, (4) Development of an intervention protocol for health visitors, (5) Early-phase testing of the resources to explore acceptability, feasibility, impact and mechanism of action, (6) Engagement with wider stakeholders and refinement of the HABIT intervention for wider use, (7) Verification, Review and Reflection of Resources. RESULTS: Following preparatory meetings with stakeholders, interviews and co-design workshops with parents and health visitors, topic areas and messages were developed covering six key themes. The topic areas provided a structure for the oral health conversation and supportive resources in paper-based and digital formats. A five-step protocol was developed with health visitors to guide the oral health conversation during the 9-12 month visit. Following training of health visitors, an early-phase feasibility study was undertaken with preliminary results presented at a dissemination event where feedback for further refinement of the resources and training was gathered. The findings, feedback and verification have led to further refinements to optimise quality, accessibility, fidelity and behaviour change theory. CONCLUSION: The co-design methods ensured the oral health conversation and supporting resources used during the 9-12 month visit incorporated the opinions of families and Health Visitors as well as other key stakeholders throughout the development process. This paper provides key learning and a framework that can be applied to other healthcare settings. The structured pragmatic approach ensured that the intervention was evidence-based, acceptable and feasible for the required context. TRIAL REGISTRATION: ISRCTN55332414, Registration Date 11/11/2021.