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.

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.

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.

Acceptability of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial intervention: a qualitative study of perspectives of young people and school staff.

BACKGROUND: The Brushing RemInder 4 Good oral HealTh (BRIGHT) trial is investigating the clinical and cost-effectiveness of a multi-component behaviour change intervention to reduce the prevalence of dental caries in young people from deprived areas aged 11-13 years. Mobile health has gained popularity in delivering behaviour change interventions for improving oral health. The intervention, based on behaviour change theory, consists of two components; a single classroom-based session embedded in the school curriculum and a series of follow-up text messages (SMS) delivered twice daily to participants. This element of the process evaluation aimed to explore the acceptability of the BRIGHT intervention for pupils and school staff. METHODS: Qualitative study, based on the concept of acceptability. Focus groups were conducted with 50 pupils, from six secondary schools across the UK, who had received the intervention. Semi-structured interviews were conducted with 12 members of staff. Purposive maximum variation sampling was used. Interviews were transcribed verbatim and analysed using a framework approach. RESULTS: In line with the theoretical framework of acceptability, affective attitude, perceived effectiveness, ethicality, burden and self-efficacy were identified as factors that affect the acceptability of the BRIGHT intervention. Pupil participants appreciated learning about the consequences of inadequate brushing particularly the photographs of carious teeth during the classroom-based session. More detailed information on brushing techniques and follow-up lessons on oral health were recommended by pupils. In terms of the SMS, the data suggest that pupil participants found them to be helpful reminders for brushing their teeth. To further improve acceptability, more choice over the timing of the messages and greater interactivity to reduce tedium were suggested. Staff participants recognised the value of the lesson and reported that in general the content was suitable for their pupils. Having the lesson material prepared for them, having the necessary support and whether it was included in the curriculum, were factors that improved acceptability. CONCLUSION: Overall, pupils and staff found the BRIGHT intervention acceptable and made some suggestions which could be adopted in any subsequent implementation of the intervention.

Multimorbid disease trajectories for people with periodontitis.

AIM: Periodontitis is a multifactorial condition linked to increased risk of systemic diseases. This study aimed to identify disease trajectories of people with periodontitis using the process mining technique as a heuristic approach. MATERIALS AND METHODS: A total of 188,863 participants from the UK Biobank cohort were included. Self-reported oral health indicators (bleeding gums, painful gums, loose teeth) were surrogates for periodontitis at baseline. Systemic disease diagnoses and dates formed the process mining event log. Relative risk (RR) of systemic diseases, disease trajectories, and Cox proportional hazard ratio models for mortality were compared to age- and sex-matched controls who did not report a history of periodontitis. RESULTS: Participants with loose teeth had shorter median time to most systemic diseases, and crude RR was increased for several diseases including cardiovascular disease (crude RR: 1.15, 95% CI: 1.03-1.28), hypertension (crude RR: 1.14, 95% CI: 1.05-1.24), and depression (crude RR: 1.33, 95% CI: 1.09-1.61). Participants with loose teeth had increased RR for 20 disease trajectories, though these were not significant after adjustments. Participants with bleeding/painful gums had similar disease trajectories as those of matched controls. CONCLUSIONS: Self-reported periodontitis may be associated with early and frequent multimorbidity development, though further evidence is required to confirm this hypothesis. People with periodontitis should be informed of the risks of disease progression and be targeted in prevention initiatives.

Outcome measures in facial prosthesis research: A systematic review.

STATEMENT OF PROBLEM: Facial prosthesis research uses a wide variety of outcome measures, which results in challenges when comparing the effectiveness of interventions among studies. Consensus is lacking regarding the most appropriate and meaningful outcome measures to use in facial prosthesis research to capture important perspectives. PURPOSE: The purpose of the systematic review was to identify and synthesize outcome measures used in facial prosthesis research. MATERIAL AND METHODS: Electronic searches were performed in 11 databases (including nonpeer-reviewed literature). The citations were searched, and expert societies were contacted to identify additional studies. Inclusion criteria comprised studies of participants with facial defects who required or had received prosthetic rehabilitation with an external facial prosthesis. Exclusion criteria comprised participants with ocular prostheses, case reports, case series with fewer than 5 participants, laboratory-based studies, and studies published before 1980. Study selection was performed independently by 2 reviewers. Discrepancies were resolved through discussion or by a third reviewer. Outcome measures were synthesized with a categorization approach based on the perspective, theme, and subtheme of the outcome measures. Quality assessment was performed with an appraisal tool that enabled evaluation of studies with diverse designs. RESULTS: Database searching identified 13 058 records, and 7406 remained after duplications were removed. After initial screening, 189 potentially relevant records remained, and 186 full texts were located (98% retrieval rate). After full-text screening, 124 records were excluded. Citation searches and contact with expert societies identified 4 further records. In total, 69 articles (grouped into 65 studies) were included. Studies were categorized as per the perspective of their outcome measures, with the following findings: patient-reported (74% of studies), clinical indicators (34%), clinician-reported (8%), multiple viewpoints (6%), and independent observer-reported (3%). Patient-reported outcome measures included tools to assess satisfaction, quality of life, and psychologic health. Variability in the choice of outcome measures was evident among the studies, with many self-designed, unvalidated, condition-specific questionnaires reported. A greater number of outcome measure themes emerged over time; themes such as service delivery and health state utility have recently been evaluated. CONCLUSIONS: Over the past 40 years, facial prosthesis research has focused on patient-reported outcome measures. Outcome measures relating to other perspectives have been used less frequently, although new themes appear to be emerging in the literature. Future research should use outcome measures with appropriate measurement properties for use with facial prosthetics.

Development of a secondary school-based digital behaviour change intervention to improve tooth brushing.

BACKGROUND: Dental caries in adolescents remains a significant public health problem with few oral health promotion interventions aimed at reducing dental caries in secondary school-aged students. Previous oral health and mobile health (mHealth) research has suggested the need for the development of a school-based behaviour change intervention incorporating a digital component. This study aimed to describe the development process of a behaviour change intervention to improve the oral health of students aged 11-16 years attending secondary schools in the UK. METHODS: A six-step process was used to develop the complex intervention informed by behaviour change theory and involving students, young people, parents and teachers in the process. The steps were: (1) identifying the target behaviours, namely tooth brushing with a fluoride toothpaste (2) identifying the theoretical basis and developing the causal model (3) reviewing the relevant literature and developing the logic model (4) designing the intervention with young people, parents and school staff (5) specifying the intervention content and (6) translating this content into features of the intervention and piloting. RESULTS: The resultant intervention included a quality-assured classroom-based session (CBS) (guided by a lesson plan and teaching resources), delivered by school teachers which was embedded within the school curriculum. This CBS was followed by a series of (Short Message Service) SMS texts delivered twice daily to student's mobile telephones with the content, duration and timing of the messages informed by involvement of students and young people. CONCLUSIONS: An intervention to improve the oral health of secondary school students through improved tooth brushing was rigorously developed based on behaviour change theory and work with young people, parents and school staff. Further research is needed to evaluate the outcomes and processes involved following the delivery of this intervention. BRIGHT Trial Trial Registration ISRCTN12139369.

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

BACKGROUND: Dental caries (tooth decay) in children is a worldwide public health problem. The leading cause of caries is poor oral hygiene behaviours and the frequent consumption of sugary foods and drinks. Changing oral health habits requires effective behaviour change conversations. The dental practice provides an opportunity for dental teams to explore with parents the oral health behaviours they undertake for their young children (0-5 years old). However, evidence suggests that dental teams need further support, training and resources. Therefore, "Strong Teeth" (an oral health intervention) was co-developed to help dental teams undertake these behaviour change conversations. The current paper will explore the acceptability of the "Strong Teeth" intervention with dental teams and parents of children aged 0-5 years old using multiple datasets (interviews, focus groups and dental team member diaries) METHODS: Following the delivery of the "Strong Teeth" intervention, qualitative interviews with parents and focus groups with dental team members were undertaken. Interviews were audio-recorded, transcribed and analysed using a theoretical framework of acceptability. The self-reported dental team diaries supplemented the interviews and focus groups and were analysed using framework analysis. RESULTS: Four themes were developed: (1) integration within the dental practice; (2) incorporating the Oral-B electric toothbrush; (3) facilitating discussions and demonstrations; and (4) the practicality of the Disney Magic Timer app. Overall, the "Strong Teeth" intervention was acceptable to parents and dental teams. Parents felt the Oral-B electric toothbrush was a good motivator; however, the Disney Magic Timer app received mixed feedback on how well it could be used effectively in the home setting. Findings suggest that the intervention was more acceptable as a "whole team approach" when all members of the dental practice willingly participated. CONCLUSIONS: There are limited studies that use a robust process evaluation to measure the acceptability of an intervention. The use of the theoretical framework of acceptability helped identify aspects of the intervention that were positive and helped identify the interventions areas for enhancement moving forwards. Future modifications include enhanced whole team approach training to optimise acceptability to all those involved. TRIAL REGISTRATION: ISRCTN Register, (ISRCTN10709150).

A study of the reporting of patient and public involvement and engagement (PPIE) in orthodontic research.

INTRODUCTION: Patient and public involvement and engagement (PPIE) in research is an essential component of high-quality research. Patients and the public can identify which research topics are most relevant to them, contribute to study design, and interpretation and dissemination of findings. While inclusion of PPIE is widely adopted in medical research, awareness within the dental research community is more limited. AIM: To examine patient and public involvement and engagement in orthodontic research activity. DESIGN: Identification and appraisal of use of PPIE in orthodontic research reporting and funding applications using a systematic approach. METHODS: Three sources of information were examined: (1) research articles published between September 2018 and September 2019 in four major orthodontic journals. Articles were examined for reported PPIE; (2) common funding bodies for orthodontic research were assessed to establish whether PPIE was mandated (National Institute for Health Research, Medical Research Council, Wellcome Trust, Chief Scientist Office (Scotland), Health and Care Research Wales, British Orthodontic Society Foundation, Royal College of Surgeons and CLEFT); and (3) publication guidance for authors in these journals was examined to identify whether reporting of PPIE was included. RESULTS: Of the 363 research articles, 2 (0.6%) mention patient/public involvement. None of the 363 research articles mention patient/public engagement. Of nine funding bodies, 2 (22%) request evidence of patient/public involvement as a condition of receiving funding with one (11%) expecting evidence of public engagement to be provided as a condition of receiving funding. None of the four major orthodontic journals include patient/public involvement and/or engagement in their guidance for authors. CONCLUSION: There is currently: (1) a notable lack of reporting of PPIE in orthodontic research; (2) variability in the requirements of funding bodies for researchers to include PPIE in funding applications and throughout the research process; and (3) no stipulation in journals' instructions for authors.

Bidirectional relations between cognitive function and oral health in ageing persons: a longitudinal cohort study.

BACKGROUND: evidence suggests a reciprocal relationship between cognitive function (CF) and oral health (OH), but no study has demonstrated this inter-relationship in a longitudinal population. OBJECTIVE: to investigate the bidirectional relationship between CF and OH in an ageing cohort. DESIGN: cohort study. SETTING: general community. SUBJECTS: participants from the English Longitudinal Study of Ageing. METHODS: OH, measured by teeth status, self-reported OH and OH-related quality of life (OHRQoL), and CFs were collected at three time points in 2006/07, 2010/11 and 2014/15. Cross-lagged structural equation models were used to investigate the association between CF and OH, adjusted for potential confounding factors. RESULTS: 5477 individuals (56.4% women) were included (mean age = 63.1 years at 2006/07, 67.2 at 2010/11 and 70.4 at 2014/15, SD = 8.9) in analyses. The average CF score was 46.5(SD = 12.3) at baseline and 41.2 (SD = 13.4) at follow-up. 3350 (61.2%) participants had natural teeth only and 622 (11.2%) were edentulous. In the fully adjusted model, better cognition at baseline was associated with better OH at follow-up (beta coefficient = 0.02, 95% CI: 0.01-0.03); conversely better OH at baseline predicted better cognition (beta coefficient = 0.12, 95% CI: 0.06-0.18). Similar magnitude and direction of the reciprocal association was evident between cognition and OHRQoL. CONCLUSIONS: This is the first longitudinal study to demonstrate the positive reciprocal association between CF and OH. The findings suggest the importance of maintaining both good CF and OH in old age.

Evaluation on the effectiveness of a peer led video on oral hygiene education in young children.

This study evaluated the effectiveness of a peer-led oral hygiene education video in improving oral hygiene knowledge and behaviour in year 2 (6- to 7-year-old) and year 3 (7- to 8-year-old) children. A novel peer-led oral hygiene education video was created, in which a group of 6- to 10-year-old children delivered key oral hygiene messages. The video was then shown to children of the same age group, whom oral hygiene knowledge and behaviours were assessed before and after the video. Results found that the video was an effective method of improving overall oral hygiene knowledge. It was effective in improving specific aspects of oral hygiene such as knowledge of the frequency of brushing and toothpaste amount, and in the behaviour of using the toothbrush in a circular motion. It was not an effective method in improving the overall oral hygiene knowledge and behaviour of Year Two children, demonstrating children may develop significantly in just 1 year.

Can the current hypodontia care pathway promote shared decision-making?

OBJECTIVE: To determine the extent to which the current care pathway in hypodontia promotes shared decision-making (SDM). DESIGN: Exploratory cross-sectional study using qualitative methods. SETTING: Orthodontic department of two NHS teaching hospitals in Yorkshire. PARTICIPANTS: Young people aged 12-16 years with hypodontia of any severity and at any stage of treatment, and their parents and guardians. METHODS: (1) Observation and audio-recording of interdisciplinary consultation in hypodontia clinics (n = 5) without any researcher interference; (2) short, structured interviews with young people with hypodontia (n = 8) and their parent (n = 8) using a topic guide to explore themes around decision-making. Audio-recordings were transcribed and analysed using a thematic framework. RESULTS: Consultations were used as an opportunity for interdisciplinary discussion, information provision and treatment planning. Evidence of good communication was observed but patient engagement was low. The decision to be made was usually stated and treatment options discussed, but time constraints limited the scope for adequate information exchange and assessment of understanding. No methods were used to establish patient and family preferences or values. Interviews suggested parents expect the dental team to make decisions and young people rely on parental advocacy. Despite little evidence of SDM, participants reported satisfaction with their treatment. CONCLUSIONS: The current care pathway for hypodontia does not support clinicians in the steps of SDM. Recommendations for improving SDM processes include support to identify preference-based decisions, greater access to comprehensive and accessible patient information to enable preparation for consultation, alternative methods for effective communication of complex information and use of preference elicitation tools to aid value-driven decision-making.

Identification and appraisal of outcome measures used to evaluate hypodontia care: A systematic review.

INTRODUCTION: Identification and appraisal of the outcome measures that have been used to evaluate hypodontia treatment and deliver services are essential for improving care. A lack of alignment between outcomes and patient values can limit the scope for patient-centered care. Our objectives were to identify and appraise the outcomes selected to evaluate hypodontia care. METHODS: Data sources included 10 electronic databases and grey literature, searched using terms for hypodontia and its treatment methods. Study eligibility included mixed study designs to ensure comprehensive identification of outcomes, excluding case reports and case series with fewer than 10 participants and nonsystematic reviews. Participants and interventions involved people with hypodontia receiving any dental treatment to manage their hypodontia. Simulated treatment, purely laboratory-based interventions, and future treatments still in development were excluded. Research outcomes were identified and synthesised into 4 categories: clinical indicators, and patient-reported, clinician-reported, and lay-reported outcomes. No synthesis of efficacy data was planned, and consequently no methodologic quality appraisal of the studies was undertaken. RESULTS: The search identified 497 abstracts, from which 106 eligible articles were retrieved in full. Fifty-six studies and 8 quality-improvement reports were included. Clinical indicators were reported in 49 studies (88%) including appearance, function, dental health, treatment longevity, treatment success and service delivery. Patient-reported outcomes were given in 22 studies (39%) including oral health-related quality of life, appearance, function, symptoms of temporomandibular dysfunction, and patient experience. Clinician-reported outcomes were limited to appearance. Variability was seen in the tools used for measuring outcomes. CONCLUSIONS: There is a lack of rationale and consistency in the selection of outcome measures used to evaluate hypodontia care. Outcomes are largely clinician and researcher-driven with little evidence of their relevance to patients. There was a paucity of outcomes measuring access to care, quality of care, and cost. Evidence from hypodontia research is clinician-focused and likely to have limited value to support patients during decision making. Attempts to synthesise the evidence base for translation into practice will be challenging. There is a need for a core outcomes set with a patient-centric approach to drive improvements in health services.

Removable partial dentures: The clinical need for innovation.

STATEMENT OF PROBLEM: The number of partially dentate adults is increasing, and many patients will require replacement of missing teeth. Although current treatment options also include fixed partial dentures and implants, removable partial dentures (RPDs) can have advantages and are widely used in clinical practice. However, a significant need exists to advance materials and fabrication technologies because of the unwanted health consequences associated with current RPDs. PURPOSE: The purpose of this review was to assess the current state of and future need for prosthetics such as RPDs for patients with partial edentulism, highlight areas of weakness, and outline possible solutions to issues that affect patient satisfaction and the use of RPDs. MATERIAL AND METHODS: The data on treatment for partial edentulism were reviewed and summarized with a focus on currently available and future RPD designs, materials, means of production, and impact on oral health. Data on patient satisfaction and compliance with RPD treatment were also reviewed to assess patient-centered care. RESULTS: Design, materials, ease of repair, patient education, and follow-up for RPD treatment all had a significant impact on treatment success. Almost 40% of patients no longer use their RPD within 5 years because of factors such as sociodemographics, pain, and esthetics. Research on RPD-based treatment for partial edentulism for both disease-oriented and patient-centered outcomes is lacking. CONCLUSIONS: Future trials should evaluate new RPD materials and design technologies and include both long-term follow-up and health-related and patient-reported outcomes. Advances in materials and digital design/production along with patient education promise to further the application of RPDs and improve the quality of life for patients requiring RPDs.

Legacy lessons from the COVID-19 era to improve trial participation and retention: Views from trial participants, PPIE contributors and trial staff across the NIHR portfolio.

BACKGROUND: The Covid-19 pandemic had a profound effect on the delivery of healthcare research. Covid-19 research was prioritised and many non-essential trials were paused. This study explores the engagement experiences of trial participants', PPIE contributors' and trial staff during the Covid-19 pandemic and towards recovery and restoring a diverse and balanced UK clinical trials portfolio. METHODS: Interviews and focus groups were undertaken with PPIE contributors, trial participants and trial staff members from NIHR research trials across the UK (November 2020-June 2021) across portfolio specialities: Cancer, Oral and Dental Health, Musculoskeletal Disorders, Cardiovascular Disease, Neurological Disorders, Primary Care, and Conditions associated with susceptibility to Covid-19 (Diabetes, Stroke, Respiratory Disorders). Topic guides were developed for each participant group and interviews were conducted over Zoom. The transcripts were analysed using codebook thematic analysis in NVivo (V.12). RESULTS: 106 participants comprising, 45 PPIE contributors, 27 trial participants and 34 trial staff members were recruited. Three themes to engagement with trials during Covid-19 were developed. 1) Ensuring continued contact. Continued and tailored communication, having a trial point of contact and regular updates all enhanced trial engagement and retention. Patients' unfamiliarity with materials being sent electronically reduced engagement and trust. 2) A balanced move to remote consultations. Remote follow-up and monitoring were convenient and allowed for wider recruitment across the UK. Participants were more likely to discuss personal subjects in their own homes. Remote visits lacked a personal touch, some concerns over missed diagnoses or being unable to appreciate the situation, technical abilities or equipment failures were seen as barriers, especially for disadvantaged or older people. 3) The importance of feeling fully informed. Factors that supported attendance were knowledge about trial conduct adherence to Covid-19 regulations, social distancing, clear signage at the site and opportunities to ask questions. Barriers included not knowing what to expect and not feeling safe with rules and regulations. CONCLUSIONS: Our findings highlight a number of ways to future proof trial delivery against future pandemics or disruptions such as offering online options to participate in research, ensuring consistent communication between participants and the research team, making sure participants feel fully informed and the continued reassurance of safety in the clinical setting.

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.

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.

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.

IMPROVDENT: improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures.

BACKGROUND: According to the UK Adult Dental Health Survey (2009) 15% of adults aged 65-74, 30% aged 75-84 and 47% aged >85 years are edentulous and require complete dentures. Patients' quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. METHODS/DESIGN: IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone). Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period). Patients will then wear each set of dentures for a period of 8 weeks (in random order) during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period).Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference) and confirmation period (adjusted denture preference). A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. FUNDING: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300). DISCUSSION: This trial aims to provide evidence on the costs and quality of dentures cast from two different commonly used impression materials; the intention is to significantly impact on the quality of denture production within NHS dentistry. TRIAL REGISTRATION: ISRCTN Register: ISRCTN01528038 UKCRN Portfolio ID: 8305.

The additive effect of periodontitis with hypertension on risk of systemic disease and mortality.

BACKGROUND: Recent evidence suggests that periodontitis (PD) causes hypertension, which is a precursor to development of other systemic diseases. The aim of this study was to examine the effect of hypertension and PD on the risk of subsequent systemic disease. METHODS: This longitudinal cohort study included 244,393 UK Biobank participants who were free of systemic disease other than hypertension at baseline. Self-reported responses of painful gums or loose teeth were surrogates for PD. Hypertensives were identified by clinical diagnosis, or elevated blood pressure (≥140/90 mmHg). Systemic diseases including cancer, cardiovascular disease (CVD), and diabetes were identified from linked diagnostic codes. Multivariable Cox proportional hazard models were used to quantify the risk of systemic diseases and all-cause mortality, stratified by hypertensive and PD status. RESULTS: The average age of the study population was 55.4 years (standard deviation [SD:] 8.1 years), and 130,220 (53.3%) participants were female. At baseline, 131,566 (53.8%) participants were hypertensive and 4.5% reported PD. The incidence rates of all systemic diseases were higher in hypertensive than non-hypertensive participants of the same PD status. In hypertensives, an additive effect was observed for PD on the risks of CVD (adjusted hazard ratio [HR]: 1.35, 95% confidence interval [CI]: 1.21-1.53) and respiratory disease (HR: 1.11, 95% CI: 0.95-1.30) compared to hypertensive healthy controls. CONCLUSIONS: Hypertensives with PD have exacerbated risks of several systemic diseases. Future interventional studies should consider the effect of periodontal treatment on systemic outcomes in targeted hypertensive populations.