"Strong Teeth": an early-phase study to assess the feasibility of an oral health intervention delivered by dental teams to parents of young children.

BACKGROUND: Tooth decay (caries) is a significant health burden in young children. There is strong evidence for the benefits of establishing appropriate home-based oral health behaviours in early childhood. Dental teams are well placed to provide this information and there is clear advice on what oral health information should be given to parents. However, research has shown that there is limited guidance, training and resources on how dental teams should deliver this advice. "Strong Teeth" is a complex oral health intervention, using evidence-based resources and training underpinned by behaviour change psychology, to support behaviour change conversations in dental practice. This early phase evaluation aims to assess the feasibility of this intervention, prior to a full-scale trial. METHODS: The study recruited 15 parents of children aged 0-2-years-old and 21 parents of children aged 3-5 years old, from five NHS dental practices across West Yorkshire. Participant demographics, self-reported brushing behaviours, dietary habits, a dental examination and three objective measures of toothbrushing were collected in a home-setting at baseline, then at 2-weeks and 2-months post-intervention. Recruitment, retention and intervention delivery were analysed as key process outcomes. Brushing habits were compared to national toothbrushing guidelines - the Delivering Better Oral Health toolkit (Public Health England). RESULTS: Strong Teeth was feasible to deliver in a General Dental Practice setting in 94% of cases. Feasibility of recruitment (37%) exceeded progression criterion, however retention of participants (75%) was below the progression criterion for the 0-2 age group. More than half of children recruited aged 3-5-years had caries experience (52%). Total compliance to toothbrushing guidance at baseline was low (28%) and increased after the intervention (52%), an improvement that was statistically significant. Dietary habits remained largely unchanged. Plaque scores significantly decreased in the 3-5-year-olds and toothbrushing duration increased in all age groups. CONCLUSION: "Strong Teeth" intervention delivery and data collection in the home setting was feasible. There was a positive indication of impact on reported toothbrushing behaviours. Some amendments to study design, particularly relating to the inclusion of the 0-2-year-old group, should be considered before progression to a full trial. Trial registration ISRCTN Register: ISRCTN10709150. Registered retrospectively 24/7/2019.

Factors associated with antibiotic prescribing for adults with acute conditions: an umbrella review across primary care and a systematic review focusing on primary dental care.

INTRODUCTION: One way to slow the spread of resistant bacteria is by improved stewardship of antibiotics: using them more carefully and reducing the number of prescriptions. With an estimated 7%-10% of antibiotic prescriptions globally originating from dental practices and up to 80% prescribed unnecessarily, dentistry has an important role to play. To support the design of new stewardship interventions through knowledge transfer between contexts, this study aimed to identify factors associated with the decision to prescribe antibiotics to adults presenting with acute conditions across primary care (including dentistry). METHODS: Two reviews were undertaken: an umbrella review across primary healthcare and a systematic review in dentistry. Two authors independently selected and quality assessed the included studies. Factors were identified using an inductive thematic approach and mapped to the Theoretical Domains Framework (TDF). Comparisons between dental and other settings were explored. Registration number: PROSPERO_CRD42016037174. RESULTS: Searches identified 689 publications across primary care and 432 across dental care. Included studies (nine and seven, respectively) were assessed as of variable quality. They covered 46 countries, of which 12 were low and middle-income countries (LMICs). Across the two reviews, 30 factors were identified, with 'patient/condition characteristics', 'patient influence' and 'guidelines & information' the most frequent. Two factors were unique to dental studies: 'procedure possible' and 'treatment skills'. No factor related only to LMICs. CONCLUSIONS: A comprehensive list of factors associated with antibiotic prescribing to adults with acute conditions in primary care settings around the world has been collated and should assist theory-informed design of new context-specific stewardship interventions.

'Warning: allergic to penicillin': association between penicillin allergy status in 2.3 million NHS general practice electronic health records, antibiotic prescribing and health outcomes.

BACKGROUND: The prevalence of reported penicillin allergy (PenA) and the impact these records have on health outcomes in the UK general population are unknown. Without such data, justifying and planning enhanced allergy services is challenging. OBJECTIVES: To determine: (i) prevalence of PenA records; (ii) patient characteristics associated with PenA records; and (iii) impact of PenA records on antibiotic prescribing/health outcomes in primary care. METHODS: We carried out cross-sectional/retrospective cohort studies using patient-level data from electronic health records. Cohort study: exact matching across confounders identified as affecting PenA records. Setting: English NHS general practices between 1 April 2013 and 31 March 2014. Participants: 2.3 million adult patients. Outcome measures: prevalence of PenA, antibiotic prescribing, mortality, MRSA infection/colonization and Clostridioides difficile infection. RESULTS: PenA prevalence was 5.9% (IQR = 3.8%-8.2%). PenA records were more common in older people, females and those with a comorbidity, and were affected by GP practice. Antibiotic prescribing varied significantly: penicillins were prescribed less frequently in those with a PenA record [relative risk (RR)  = 0.15], and macrolides (RR = 4.03), tetracyclines (RR = 1.91) nitrofurantoin (RR = 1.09), trimethoprim (RR = 1.04), cephalosporins (RR = 2.05), quinolones (RR = 2.10), clindamycin (RR = 5.47) and total number of prescriptions were increased in patients with a PenA record. Risk of re-prescription of a new antibiotic class within 28 days (RR = 1.32), MRSA infection/colonization (RR = 1.90) and death during the year subsequent to 1 April 2013 (RR = 1.08) increased in those with PenA records. CONCLUSIONS: PenA records are common in the general population and associated with increased/altered antibiotic prescribing and worse health outcomes. We estimate that incorrect PenA records affect 2.7 million people in England. Establishing true PenA status (e.g. oral challenge testing) would allow more people to be prescribed first-line antibiotics, potentially improving health outcomes.

Assessing the perceived impact of post Minamata amalgam phase down on oral health inequalities: a mixed-methods investigation.

BACKGROUND: Data from countries that have implemented a complete phase out of dental amalgam following the Minamata agreement suggest increased costs and time related to the placement of alternatives with consumers absorbing the additional costs. This aim of this study was to investigate the impact of a complete phase out of dental amalgam on oral health inequalities in particular for countries dependent on state run oral health services. METHODS: A mixed methods component design quantitative and qualitative study in the United Kingdom. The quantitative study involved acquisition and analysis of datasets from NHS Scotland to compare trends in placement of dental amalgam and a survey of GDPs in Yorkshire, UK. The qualitative study involved analysis of the free text of the survey and a supplementary secondary analysis of semi-structured interviews and focus groups with GDPs (private and NHS), dental school teaching leads and NHS dental commissioners to understand the impact of amalgam phase down on oral health inequalities. RESULTS: Time-trends for amalgam placement showed that there was a significant (p < 0.05) reduction in amalgam use compared with composites and glass ionomers. However dental amalgam still represented a large proportion (42%) of the restorations (circa 1.8 million) placed in the 2016-2017 financial year. Survey respondents suggest that direct impacts of a phase down were related to increased costs and time to place alternative restorations and reduced quality of care. This in turn would lead to increased tooth extractions, reduced access to care and privatisation of dental services with the greatest impact on deprived populations. CONCLUSION: Amalgam is still a widely placed material in state run oral health services. The complete phase down of dental amalgam poses a threat to such services and threatens to widen oral health inequalities. Our data suggest that a complete phase out is not currently feasible unless appropriate measures are in place to ensure cheaper, long-lasting and easy to use alternatives are available and can be readily adopted by primary care oral health providers.

Systemic Multimorbidity Clusters in People with Periodontitis.

This study aimed to identify systemic multimorbidity clusters in people with periodontitis via a novel artificial intelligence-based network analysis and to explore the effect of associated factors. This study utilized cross-sectional data of 3,736 participants across 3 cycles of the National Health and Nutrition Examination Survey (2009 to 2014). Periodontal examination was carried out by trained dentists for participants aged ≥30 y. The extent of periodontitis was represented by the proportion of sites with clinical attachment loss (CAL)≥ 3 mm, split into 4 equal quartiles. A range of systemic diseases reported during the survey were also extracted. Hypergraph network analysis with eigenvector centralities was applied to identify systemic multimorbidity clusters and single-disease influence in the overall population and when stratified by CAL quartile. Individual factors that could affect the systemic multimorbidity clusters were also explored by CAL quartile. In the study population, the top 3 prevalent diseases were hypertension (63.9%), arthritis (47.6%), and obesity (45.9%). A total of 106 unique systemic multimorbidity clusters were identified across the study population. Hypertension was the most centralized disease in the overall population (centrality [C]: 0.50), followed closely by arthritis (C: 0.45) and obesity (C: 0.42). Diabetes had higher centrality in the highest CAL quartile (C: 0.31) than the lowest (C: 0.26). "Hypertension, obesity" was the largest weighted multimorbidity cluster across CAL quartiles. This study has revealed a range of common systemic multimorbidity clusters in people with periodontitis. People with periodontitis are more likely to present with hypertension and obesity together, and diabetes is more influential to multimorbidity clusters in people with severe periodontitis. Factors such as ethnicity, deprivation, and smoking status may also influence the pattern of multimorbidity clusters.

Adolescent and Parent Preferences for Hypodontia: Discrete Choice Experiment.

Choosing hypodontia treatment requires young people and parents to consider a large amount of information, identify what is important to them, and make trade-offs between options. This study aimed to examine young people and parents' preferences for hypodontia treatment using discrete choice experiment (DCE). This was a cross-sectional survey of young people (12-16 y) with hypodontia of any severity, at any stage of treatment, and their parents. Participants were recruited from NHS Hospitals in England and Wales. A bespoke DCE questionnaire was developed to measure preferences for 6 attributes of hypodontia treatment (waiting time, treatment time, problems during treatment, discomfort during treatment, bite, appearance). The questionnaire was completed 1) online by young people and parents, individually or together, and 2) by child-parent dyads under observation. Preferences were analyzed using regression models. In total, 204 participants (122 young people, 56 parents, 26 dyads) completed the online questionnaire and 15 child-parent dyads completed the questionnaire under observation. The most important attribute in hypodontia treatment was improvement in appearance, but significant heterogeneity was found in preferences. Four distinct groups of participants were found: group 1 (39%): severe discomfort and problems were most important; group 2 (31%): most concerned about improvement in appearance of teeth and improvement in bite; group 3 (22%): appearance 3 times more important than any other attribute; and group 4 (9%): preferences difficult to interpret. There was variation in how child-parent dyads approached decision-making, with some negotiating joint preferences, while for others, one individual dominated. Making trade-offs in DCE tasks helped some people think about treatment and identify their preferences. Appearance is an important outcome from hypodontia treatment, but preferences vary and potential risks and functional outcome are also important to some people. There is a notable level of uncertainty in decision-making, which suggests further shared decision support would be valuable.

Using process drama to explore the causes of dental anxiety in primary-school children.

BACKGROUND: Drama and role play can be unlisted as methods to allow children to view problems from a range of different perspectives that may differ from their own experience. Application of drama technique to assess the cause of dental fear and anxiety in a school setting is novel. AIM: The aim of this study was to engage primary school children in the core investigation via participatory arts methodologies, namely, process drama to gain understanding of the causes of dental anxiety. DESIGN: Sixty-three children, aged 7-10 years from three primary schools participated in this study. A 90-min drama workshop was carried in each school. The children were encouraged to identify the causes of dental anxiety using key concepts from process drama. The sessions were audio-recorded and transcribed. RESULTS: Four key concepts emerged: (1) fear of the unknown; (2) unpleasant sensory experience; (3) society's perception and portrayal of the dentist; and (4) learnt negative associations with the dentist. Within each four key concepts, two sub-themes were identified. CONCLUSIONS: Role-playing and use of drama are a novel application and can reveal a considerable amount of information from the child's perspective on the cause of dental fear and anxiety.

Additive Effect of Periodontal Disease and Obesity on COVID-19 Outcomes.

This study aims to examine the impact of periodontal disease in obesity on COVID-19 infection and associated outcomes. This retrospective longitudinal study included 58,897 UK Biobank participants tested for COVID-19 between March 2020 and February 2021. Self-reported oral health indicators (bleeding gums, painful gums, and loose teeth) were used as surrogates for periodontal disease. Body fat levels were quantified by body mass index (BMI) and categorized as normal weight (18.5 to 24.9 kg/m2), overweight (25 to 29.9 kg/m2), and obese (≥30 kg/m2). Multivariable logistic regression and Cox proportional hazard models were used to quantify risk of COVID-19 infection, hospital admission, and mortality, adjusted for participants' demographics and covariates. Of 58,897 participants, 14,466 (24.6%) tested positive for COVID-19 infection. COVID-19 infection was higher for participants who were overweight (odds ratio, 1.18; 95% CI, 1.12 to 1.24) and obese (odds ratio, 1.33; 95% CI, 1.26 to 1.41) as compared with those of normal weight, but infection was not affected by periodontal disease. The hospital admission rate was 57% higher (hazard ratio, 1.57; 95% CI, 1.25 to 1.97) in the obese group with periodontal disease than without periodontal disease, and admission rates increased with BMI category (normal weight, 4.4%; overweight, 6.8%; obese, 10.1%). Mortality rates also increased with BMI category (normal weight, 1.9%; overweight, 3.17%; obese, 4.5%). In addition, for participants with obesity, the mortality rate was much higher (hazard ratio, 3.11; 95% CI, 1.91 to 5.06) in participants with periodontal disease than those without. Obesity is associated with higher hospitalization and mortality rates, and periodontal disease may exacerbate this impact. The results could inform health providers, policy makers, and the general public of the importance to maintain good oral health through seamless provision of dental services and public oral health prevention initiatives.

Patient perspective on decisions to switch disease-modifying treatments in relapsing-remitting multiple sclerosis.

BACKGROUND: There are now large cohorts of people with relapsing-remitting multiple sclerosis (pwRRMS) who have taken several Disease-Modifying Treatments (DMTs). Studies about switching DMTs mostly focus on clinical outcomes rather than patients' decision-making. Neurologists are now required to support decisions at various times during the relapsing disease course and they do so with concerns about DMTs risks. This qualitative study investigates how pwRRMS weigh up the pros and cons of DMTs, focusing on perceptions of effectiveness and risks when new treatments are considered. OBJECTIVE: To increase understanding of people's experiences of decision-making when switching DMTs. METHODS: 30 semi-structured interviews were conducted with pwRRMS in England. 16 participants had switched DMT and their experiences were compared with those who had only taken one DMT. Interviews were analysed thematically to answer: what main factors influence people's decision-making to switch DMTs and why? RESULTS: Of the 16 participants with experience of switching DMT, eight had taken two or more DMTs; eight had taken three or more. Two was the DMT median. This study demonstrated that despite the term "switching" implying that similar treatments are inter-changeable, for pwRRMS taking new treatments involves different emotions, routines, risks, prognosis and communication experiences. Two meta themes identified were: 1) A distinctive, rapid and emotional decision-making process where old emotions related to MS prognosis are revisited. 2) Switching has a different impact on communication for escalation or de-escalation processes. CONCLUSION: Switching DMT involves different routines, risks, prognosis and communication experiences. These decisions are emotionally difficult because of the fear about transitioning to secondary progressive MS, and DMT effectiveness uncertainty. Patient centred decision aids should include information about first and consecutive treatment decisions.

Eliciting Preferences in Dentistry with Multiattribute Stated Preference Methods: A Systematic Review.

BACKGROUND: Preference experiments are used to understand how patients and stakeholders value aspects of health care. These methods are gaining popularity in dentistry, but quality and breadth of use have not been evaluated. OBJECTIVES: To describe multiattribute stated preference experiment use in dentistry through illustration and critique of existing studies. DATA SOURCES: Systematic literature search of PubMed, Econlit and Ovid for Medline, Embase, PsychINFO, PsychARTICLES, and All EBM Reviews, as well as gray literature. STUDY ELIGIBILITY: Multiattribute stated preference experiments eliciting preferences for dental service delivery, treatments, and oral health states from the perspective of patients, the public, and dental professionals. Outcomes of interest were preference weights and marginal rates of substitution. Study selection was independently performed by 2 reviewers. APPRAISAL: Ten-point checklist published by the International Society of Pharmacoeconomics and Outcomes Research was used for quality assessment. SYNTHESIS: Descriptive analysis. RESULTS: Searches identified 12 records published between 1999 and 2015, mostly in nondental academic journals. Studies were undertaken in high-income countries in Europe and the United States. The studies aimed to elicit preference for service delivery, treatment, or oral health states from the perspective of the patients, dentists, or the public via discrete choice experiment methods. The quality scores for the studies ranged from 53% to 100%. LIMITATIONS: A detailed description and critique of stated preference methods are provided, but it was not possible to provide synthesized preference data. CONCLUSIONS: Multiattribute stated preference experiments are increasingly popular, but understanding the methods and outputs is essential for designing and interpreting preference studies to improve patient care. Patient preferences highlight important considerations for decision making during treatment planning. Valuation of health states and estimation of willingness-to-pay are important for resource planning and allocation and economic evaluation. Preference estimates and relative value of attributes for interventions and service delivery inform development and selection of treatments and services (PROSPERO 21.3.17: CRD42017059859). KNOWLEDGE TRANSFER STATEMENT: Understanding patient, professional, and public preferences is fundamental for evidence-based decision making and treatment delivery. Preference elicitation methods can be used to estimate the value given to health states, service delivery, individual treatments, and health outcomes. By describing and appraising the methodology and application of multiattribute stated preference experiments in dentistry, this review provides an essential first step to wider use of well-designed, high-quality preference elicitation methods.

Brain Diffusion Abnormalities in Children with Tension-Type and Migraine-Type Headaches.

BACKGROUND AND PURPOSE: Tension-type and migraine-type headaches are the most common chronic paroxysmal disorders of childhood. The goal of this study was to compare regional cerebral volumes and diffusion in tension-type and migraine-type headaches against published controls. MATERIALS AND METHODS: Patients evaluated for tension-type or migraine-type headache without aura from May 2014 to July 2016 in a single center were retrospectively reviewed. Thirty-two patients with tension-type headache and 23 with migraine-type headache at an average of 4 months after diagnosis were enrolled. All patients underwent DWI at 3T before the start of pharmacotherapy. Using atlas-based DWI analysis, we determined regional volumetric and diffusion properties in the cerebral cortex, thalamus, caudate, putamen, globus pallidus, hippocampus, amygdala, nucleus accumbens, brain stem, and cerebral white matter. Multivariate analysis of covariance was used to test for differences between controls and patients with tension-type and migraine-type headaches. RESULTS: There were no significant differences in regional brain volumes between the groups. Patients with tension-type and migraine-type headaches showed significantly increased ADC in the hippocampus and brain stem compared with controls. Additionally, only patients with migraine-type headache showed significantly increased ADC in the thalamus and a trend toward increased ADC in the amygdala compared with controls. CONCLUSIONS: This study identifies early cerebral diffusion changes in patients with tension-type and migraine-type headaches compared with controls. The hypothesized mechanisms of nociception in migraine-type and tension-type headaches may explain the findings as a precursor to structural changes seen in adult patients with chronic headache.

Automated osteoporosis risk assessment by dentists: a new pathway to diagnosis.

General dental practitioners use a vast amount of panoramic radiography in their routine clinical work, but valuable information about patients' osteoporotic status is not collected. There are many reasons for this, but one of the prime reasons must be the disruption involved in clinical routine with lengthy manual radiographic assessment. We have developed computer software, based on active shape modeling that will automatically detect the mandibular cortex on panoramic radiographs, and then measure its width. Automatic or semi-automatic measurement of the cortical width will indicate the osteoporotic risk of the patient. The aim of our work was to assess the computer search technique's ability to measure the mandibular cortical width and to assess its potential for detection of osteoporosis of the hip, spine and femoral neck. Mandibular cortical width was measured using the manually initialized (semi-automatic) method and, when assessed for diagnosing osteoporosis at one of the three measurement sites, gave an area under the ROC curve (A(z))=0.816 (95% CI=0.784 to 0.845) and for the automatically initialized searches, A(z)=0.759 (95% CI=0.724 to 0.791). The difference between areas=0.057 (95% Confidence interval=0.025 to 0.089), p<0.0001. For diagnosing osteoporosis at the femoral neck, mandibular cortical width derived from the manually initialized fit gave an area under the ROC curve (A(z))=0.835 (95% CI=0.805 to 0.863) and for the automatically initialized searches A(z)=0.805 (95% CI=0.773 to 0.835). The difference in A(z) values between active shape modeling search methods=0.030 (95% CI=-0.010 to 0.070), and this was not significant, p=0.138. We concluded that measurement of mandibular cortical width using active shape modeling is capable of diagnosing skeletal osteoporosis with good diagnostic ability and repeatability.

Accuracy in osteoporosis diagnosis of a combination of mandibular cortical width measurement on dental panoramic radiographs and a clinical risk index (OSIRIS): the OSTEODENT project.

Clinical questionnaires and dental radiographic findings have both been suggested as methods of identifying women at risk of having osteoporosis and who might benefit from bone densitometry. The aim of this study was to measure the diagnostic accuracy of a combination of mandibular cortical width (MCW) measured from dental panoramic radiographs (DPRs) and the osteoporosis index of risk (OSIRIS) in the diagnosis of osteoporosis. 653 women (age range 45-70 years, mean age 54.95 years) in four European centres underwent standardised dual X-ray energy absorptiometry (DXA) to provide reference data on osteoporosis status. Each subject was interviewed to derive OSIRIS scores and underwent DPR examination. MCW was measured directly by five observers. Receiver Operating Characteristic (ROC) curve analysis was used to calculate sensitivities and specificities of the clinical and radiographic tests for the diagnosis of osteoporosis. 512 (78.4%) of the study population were classified as having normal BMD and 141 (21.6%) as having osteoporosis. Using ROC analysis, OSIRIS gave a ROC curve area (A(z)) of 0.838, with a sensitivity of 70.9% and a specificity of 79.5% at a diagnostic threshold of

Interventions for the treatment of oral and oropharyngeal cancers: surgical treatment.

BACKGROUND: Oral and oropharyngeal cancers can be managed by surgery alone or with any combination of radiotherapy, chemotherapy and immunotherapy/biotherapy. Opinions on the surgical treatment, the optimal combinational therapy and the sequence of treatments in combinational therapy varies enormously. OBJECTIVES: To determine which surgical treatment modalities for oral and oropharyngeal cancers lead to the best outcomes compared with other surgical, radiotherapy, chemotherapy or immunotherapy/biotherapy combinations. SEARCH STRATEGY: Electronic search of the Cochrane Oral Health Group Trials Register, CENTRAL, MEDLINE, OLDMEDLINE, EMBASE, AMED and the National Cancer Trials Database. Reference lists from relevant articles were searched and the authors of eligible trials were contacted. Date of the most recent searches: July 2007. SELECTION CRITERIA: Randomised controlled trials of surgery alone or in combination with chemotherapy, radiotherapy or immunotherapy/biotherapy for the treatment of primary oral or oropharyngeal cancer or both. DATA COLLECTION AND ANALYSIS: A minimum of two review authors conducted data extraction. Risk ratios were calculated for dichotomous outcomes at different time intervals, and hazard ratios were extracted or calculated for disease-free survival, total mortality, and disease-related mortality. Additional information from trial authors was sought. Data on adverse events were collected from the trial reports. MAIN RESULTS: Thirty-one trials satisfied the inclusion criteria, only 13 of which were assessed as low risk of bias. Trials were grouped into 12 main comparisons. There were no trials that compared different surgical modalities of the primary tumour itself. However, there were a number of trials comparing different approaches to managing the cervical lymph nodes. The majority of treatment regimens under evaluation were surgery in combination with other modalities. As individual treatment regimens within each comparison varied, meta-analysis was inappropriate in most instances. Only two trials could be pooled, comparing concomitant radio/chemotherapy (with surgery) versus radiotherapy (with surgery). A statistically significant difference was shown for disease-free survival (hazard ratio 0.77, 95% confidence interval (CI): 0.64 to 0.92) and total mortality (hazard ratio 0.78, 95% CI: 0.64 to 0.95) in favour of the concomitant chemotherapy and radiotherapy (with surgery) arm. No other treatment regimens showed consistent statistically significant results across the outcomes measured. AUTHORS' CONCLUSIONS: There is some evidence that concomitant radio/chemotherapy (with surgery) is more effective than radiotherapy (with surgery) and may benefit outcomes in patients with more advanced oral and oropharyngeal cancers. As these trials were based on head and neck studies, future studies should evaluate this treatment regimen specifically in oral and oropharyngeal cancers separately and also address tumour staging and its impact on outcomes. In general, future studies are encouraged to evaluate site-specific and stage-specific data for oral and oropharyngeal cancers. Future trials should include health-related quality of life assessment as an outcome measure. There is a need for a consolidated standardised approach to reporting adverse events.

The Body Composition Monitor: a flexible tool for routine fluid management across the haemodialysis population.

Bioimpedance measurements with the Body Composition Monitor (BCM) have been shown to improve fluid management in haemodialysis. However, there is a lack of a sufficiently robust evidence-base for use of the BCM outside of standard protocols. This study aims to characterise BCM measurement variation to allow users to make measurements and interpret the results with confidence in a range of clinical scenarios. BCM measurements were made in 48 healthy controls and in 48 stable haemodialysis patients before and immediately after dialysis. The effect of utilising alternative measurement paths was assessed using mixed effects models and the effect of measuring post-dialysis was assessed by comparing changes in BCM-measured overhydration (OH) with weight changes over dialysis. The data from healthy controls suggest that there is no difference in BCM-measured OH between all the whole-body paths other than the foot-to-foot measurement. Dialysis patients showed similar results other than having higher BCM-measured OH when measured across the site of a vascular access. There was good agreement between BCM-measured OH and change in weight, suggesting post-dialysis measurements can be utilised. These results suggest BCM protocols can be flexible regarding measurement paths and timing of measurement to ensure as many patients as possible can benefit from the technology.

Shaping dental contract reform: a clinical and cost-effective analysis of incentive-driven commissioning for improved oral health in primary dental care.

OBJECTIVE: To evaluate the clinical and cost-effectiveness of a new blended dental contract incentivising improved oral health compared with a traditional dental contract based on units of dental activity (UDAs). DESIGN: Non-randomised controlled study. SETTING: Six UK primary care dental practices, three working under a new blended dental contract; three matched practices under a traditional contract. PARTICIPANTS: 550 new adult patients. INTERVENTIONS: A new blended/incentive-driven primary care dentistry contract and service delivery model versus the traditional contract based on UDAs. MAIN OUTCOME MEASURES: Primary outcome was as follows: percentage of sites with gingival bleeding on probing. Secondary outcomes were as follows: extracted and filled teeth (%), caries (International Caries Detection and Assessment System (ICDAS)), oral health-related quality of life (Oral Health Impact Profile-14 (OHIP-14)). Incremental cost-effective ratios used OHIP-14 and quality adjusted life years (QALYs) derived from the EQ-5D-3L. RESULTS: At 24 months, 291/550 (53%) patients returned for final assessment; those lost to follow-up attended 6.46 appointments on average (SD 4.80). The primary outcome favoured patients in the blended contract group. Extractions and fillings were more frequent in this group. Blended contracts were financially attractive for the dental provider but carried a higher cost for the service commissioner. Differences in generic health-related quality of life were negligible. Positive changes over time in oral health-related quality of life in both groups were statistically significant. CONCLUSIONS: This is the first UK study to assess the clinical and cost-effectiveness of a blended contract in primary care dentistry. Although the primary outcome favoured the blended contract, the results are limited because 47% patients did not attend at 24 months. This is consistent with 39% of adults not being regular attenders and 27% only visiting their dentist when they have a problem. Promotion of appropriate attendance, especially among those with high need, necessitates being factored into recruitment strategies of future studies.

Hyaluronic Acid Binding Sperm Selection for assisted reproduction treatment (HABSelect): study protocol for a multicentre randomised controlled trial.

INTRODUCTION: The selection of a sperm with good genomic integrity is an important consideration for improving intracytoplasmic sperm injection (ICSI) outcome. Current convention selects sperm by vigour and morphology, but preliminary evidence suggests selection based on hyaluronic acid binding may be beneficial. The aim of the Hyaluronic Acid Binding Sperm Selection (HABSelect) trial is to determine the efficacy of hyaluronic acid (HA)-selection of sperm versus conventionally selected sperm prior to ICSI on live birth rate (LBR). The mechanistic aim is to assess whether and how the chromatin state of HA-selected sperm corresponds with clinical outcomes-clinical pregnancy rate (CPR), LBR and pregnancy loss (PL). METHODS AND ANALYSIS: Couples attending UK Centres will be approached, eligibility screening performed and informed consent sought. Randomisation will occur within 24 hours prior to ICSI treatment. Participants will be randomly allocated 1:1 to the intervention arm (physiological intracytoplasmic sperm injection, PICSI) versus the control arm using conventional methods (ICSI). The primary clinical outcome is LBR ≥37 weeks' gestation with the mechanistic study determining LBR's relationship with sperm DNA integrity. Secondary outcomes will determine this for CPR and PL. Only embryologists performing the procedure will be aware of the treatment allocation. Steps will be taken to militate against biases arising from embryologists being non-blinded. Randomisation will use a minimisation algorithm to balance for key prognostic variables. The trial is powered to detect a 5% difference (24-29%: p=0.05) in LBR ≥37 weeks' gestation. Selected residual sperm samples will be tested by one or more assays of DNA integrity. ETHICS AND DISSEMINATION: HABSelect is a UK NIHR-EME funded study (reg no 11/14/34; IRAS REF. 13/YH/0162). The trial was designed in partnership with patient and public involvement to help maximise patient benefits. Trial findings will be reported as per CONSORT guidelines and will be made available in lay language via the trial web site (http://www.habselect.org.uk/). TRIAL REGISTRATION NUMBER: ISRCTN99214271; Pre-results.

Cost-effectiveness of silicone and alginate impressions for complete dentures.

OBJECTIVE: The aim of this study was to assess the cost effectiveness of silicone and alginate impressions for complete dentures. METHODS: Cost effectiveness analyses were undertaken alongside a UK single centre, double blind, controlled, crossover clinical trial. Taking the perspective of the healthcare sector, effectiveness is measured using the EuroQol (EQ-5D-3L) which provides a single index value for health status that may be combined with time to produce quality adjusted life years (QALYs); and Oral Health Impact Profile (OHIP-EDENT). Incremental cost effectiveness ratios are presented representing the additional cost per one unit gained. RESULTS: Mean cost was higher in the silicone impression group (£388.57 vs. £363.18). Negligible between-group differences were observed in QALY gains; the silicone group had greater mean OHIP-EDENT gains. The additional cost using silicone was £3.41 per change of one point in the OHIP-EDENT. CONCLUSIONS: The silicone group was more costly, driven by the cost of materials. Changes in the EQ-5D and QALY gains over time and between arms were not statistically significant. Change in OHIP-EDENT score showed greater improvement in the silicone group and the difference between arms was statistically significant. Given negligible QALY gains and low level of resource use, results must be treated with caution. It is difficult to make robust claims about the comparative cost-effectiveness. CLINICAL SIGNIFICANCE: Silicone impressions for complete dentures improve patients' quality of life (OHIP-EDENT score). The extra cost of silicone impressions is £30 per patient. Dentists, patients and health care funders need to consider the clinical and financial value of silicone impressions. Different patients, different dentists, different health funders will have individual perceptions and judgements. ISRCTN01528038. NIHR-RfPB grant PB-PG-0408-16300. This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014.

A randomised controlled trial of complete denture impression materials.

OBJECTIVES: There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. METHODS: Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. RESULTS: Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, p<0.0001). CONCLUSION: There is significant evidence that dentures made from silicone impressions were preferred by patients. CLINICAL SIGNIFICANCE: Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures. TRIAL REGISTRATION: ISRCTN 01528038. This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014.