The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia.

BACKGROUND: Child anxiety before general anaesthesia and surgery is common. Midazolam is a commonly used premedication to address this. Melatonin is an alternative anxiolytic, however trials evaluating its efficacy in children have delivered conflicting results. METHODS: This multicentre, double-blind randomised trial was performed in 20 UK NHS Trusts. A sample size of 624 was required to declare noninferiority of melatonin. Anxious children, awaiting day case elective surgery under general anaesthesia, were randomly assigned 1:1 to midazolam or melatonin premedication (0.5 mg kg-1, maximum 20 mg) 30 min before transfer to the operating room. The primary outcome was the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). Secondary outcomes included safety. Results are presented as n (%) and adjusted mean differences with 95% confidence intervals. RESULTS: The trial was stopped prematurely (n=110; 55 per group) because of recruitment futility. Participants had a median age of 7 (6-10) yr, and 57 (52%) were female. Intention-to-treat and per-protocol modified Yale Preoperative Anxiety Scale-Short Form analyses showed adjusted mean differences of 13.1 (3.7-22.4) and 12.9 (3.1-22.6), respectively, in favour of midazolam. The upper 95% confidence interval limits exceeded the predefined margin of 4.3 in both cases, whereas the lower 95% confidence interval excluded zero, indicating that melatonin was inferior to midazolam, with a difference considered to be clinically relevant. No serious adverse events were seen in either arm. CONCLUSION: Melatonin was less effective than midazolam at reducing preoperative anxiety in children, although the early termination of the trial increases the likelihood of bias. CLINICAL TRIAL REGISTRATION: ISRCTN registry: ISRCTN18296119.

Parental acceptability of silver diamine fluoride: The UK and US experiences.

BACKGROUND: International data suggest that parents may have reservations about the use of silver diamine fluoride (SDF). AIM: The aims of this study were to: (1) examine the acceptance of parents/carers towards the use of SDF for the management of caries in children's primary teeth in secondary care dental settings in the UK and the United States and (2) determine which factors may affect the acceptance of the use of SDF. DESIGN: This was a cross-sectional questionnaire of SDF acceptability, completed by parents of young children. It was validated and adapted to local populations. Data were analysed with descriptive and inferential statistics. RESULTS: Of the 113 Sheffield parents, 73% reported that they would accept SDF treatment of children's posterior teeth, with 58% reporting this for anterior teeth. Parents having less concern about posterior aesthetics had a statistically significant effect on reported acceptance of SDF (p = .013). In the Colorado sample (n = 104), 72% reported that they would accept SDF on posterior teeth, and 58% reported that they would accept SDF on anterior teeth. Concerns about aesthetics had an effect on decreasing SDF acceptance overall (p = .0065) in anterior (p = .023) and posterior teeth (p = .108). CONCLUSION: The majority of parents in the two study populations accepted the treatment using SDF. However, concern about aesthetics had an influence on acceptability.

Dimensions of young children's toothbrushing resistance: A qualitative content analysis of discussions on the online parenting forum Mumsnet.

BACKGROUND: Young children's resistant behaviour is a barrier to parental-supervised brushing. Discussions on online parenting forums offer an insight into parental experiences, behaviour and attitudes. Analysing these discussions also demonstrates how dental advice is represented and potentially resisted. AIM: To analyse how young children's toothbrushing resistance is discussed on an online parenting forum. DESIGN: Qualitative content analysis of threads on toothbrushing resistance retrieved from the UK parenting forum Mumsnet. RESULTS: A search was carried out on Mumsnet in April 2022. Overall, 204 relevant threads were identified and analysed. A coding frame was developed. Posters interacted by discussing their experiences of resistance, asking for advice, making suggestions and being both supportive and critical. Thirty-seven strategies for addressing resistance were identified. Discussions reflected attitudes and concerns relating to young children and toothbrushing resistance, including the idea brushing should be 'non-negotiable'. A key issue was the acceptability of physical force or restraint to achieve adequate brushing. Posters invoked dental authority to support their views. CONCLUSION: Understanding how toothbrushing resistance is discussed on a parenting forum helps establish what information and advice is shared, and highlights attitudes and concerns that shape how this problem is approached.

Dental professionals' views on motivational interviewing for the prevention of dental caries with adolescents in central Norway.

BACKGROUND: Establishing positive oral health behaviours during adolescence should be a key priority to improve lifelong oral health. However, changing adolescent behaviours is known to be a challenge. Motivational interviewing (MI) is a method of working with patients to activate their motivation for change and has shown promising results within the dental setting. Yet, little is known about the actual experiences and perspectives of Norwegian dental health professionals in delivering motivational interviewing as part of routine care to their young patients. The overall aim of the present study was to explore the implementation of motivational interviewing by dentists and dental hygienists, employed by the Norwegian Public Dental Service, for their adolescent patients. METHODS: As part of the larger #Care4YoungTeeth <3 project, a Norwegian Research Council funded four-year Collaborative Project to Meet Societal and Industry-related Challenges, an online survey was developed and administered to dental personnel (n = 168) in one region of Central Norway. Data were analysed by descriptive statistics and two-sample tests of proportions at the 95% confidence level. RESULTS: A total of 98 dental personnel responded to the survey (response rate 58.3%), of which 37 were dental hygienists (response rate 72.5%) and 61 were dentists (response rate 52.1%). A greater proportion of hygienists reported implementing this intervention compared to dentists (78.4% versus 50.8%; p = 0.007). Similarly, a greater proportion of hygienists (83.8%) stated that they had received training in MI compared to dentists (65.6%; p = 0.051). About 80% of dentists and 90% of dental hygienists felt that they understood the principles of MI. However, only about 45% and 60%, respectively, felt confident in its use. Dental hygienists found MI more usable in their work (p = 0.052), to a greater extent want to use MI (p = 0.002) and found that using MI works well (p < 0.001), as compared to dentists. CONCLUSIONS: A high proportion of dental professionals working within a Norwegian public dental service have received training in MI. However, barriers to implementation for adolescent patients and differences in practice between dentists and hygienists warrant further enquiry.

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.

A qualitative study of barriers and facilitators to the implementation of a pilot school-based, toothbrushing programme.

BACKGROUND: While supervised toothbrushing programmes have been established in many countries of the world, little is known about different perspectives on their implementation. The aim of the study was to explore stakeholders' barriers and facilitators to implementation of a school-based toothbrushing programme in Taiwan. METHODS: Focus groups and interviews were used to explore the views of elementary school students, teachers, staff, and nurses in a piloted school-based toothbrushing programme. The topic guides were developed according to the Theoretical Domains Framework (TDF) to cover the behavioural factors systematically and comprehensively. Data were analysed with content analysis. RESULTS: Overall, 36 students, 29 teachers/staff, and five school nurses (N = 65) were included. The overarching theme was the importance of habit formation for both staff and children to ensure that toothbrushing as part of the programme was embedded into the school schedule and routine. While children did not necessarily appear to retain the dental knowledge which was taught in the programme, the provision of fluoride toothpaste and toothbrush for their use in schools allowing teachers and staff to choose the timing of the brushing and engaging classmates to supervise each other were found to be key factors. CONCLUSIONS: Implementing a school-based toothbrushing programme with the support of staff and active engagement of children can help children to develop a toothbrushing habit. Classmate-supervised toothbrushing may reduce the burden on teachers and staff to implement the programme.

Health visiting teams and children's oral health: a scoping review.

BACKGROUND: Recent policies have recommended early-life interventions to prevent caries. The four nations of the UK each have a national universal children's health programme, through which health visitors and their wider team (HVTs) promote health in the early years. HVT visits offer an opportunity to support parents to improve their child's oral health. A scoping review was conducted to provide a descriptive synthesis of the current literature related to the role of HVTs in improving the oral health of children 0-5 years old and to identify significant gaps for future research. This review informed the feasibility study of the First Dental Steps Intervention, a targeted health visitor-led infant oral health intervention in England. METHODS: Electronic database searches for peer-reviewed literature were performed using Medline via Ovid and Web of Science (1946-2021). The quality of included intervention studies was assessed using the Effective Public Health Practice Project tool. Additionally, a grey literature search was conducted (key organisations, bibliographic and thesis databases, forwards and backwards citation, Google). RESULTS: Thirty-nine publications, published between 1980 and 2021, were included. The majority of included papers were from the UK. The quality of intervention studies (n = 7) ranged from weak to strong. Thematic analysis identified the following themes: (1) professional knowledge, education, and training; (2) involvement of HVs in the delivery of oral health interventions; (3) effectiveness of interventions; (4) perspectives of HVs providing oral health advice and acceptability; and (5) barriers and facilitators to promoting oral health. The grey literature search identified 125 sources. HVT involvement was reported in a variety of source types: reports, guidance documents, evaluations, reviews, and training resources. HVTs were involved in oral health by providing oral health packs, brushing and oral health advice, registration and attendance, oral health training, risk assessment, and referral to dental services. CONCLUSION: The current literature suggests that HVTs are well placed to improve children's oral health. Facilitators and barriers are encountered by HVTs in promoting oral health which should be considered by commissioners. There is a need for future high-quality studies that address the inadequacies found and provide further evidence of the effectiveness of HVT's oral health interventions.

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.

Does dental caries lead to stunting and wasting in children?

Design This was a systematic review of the evidence on the impact of dental caries severity and prevalence on undernutrition (wasting and stunting) in children.Study selection The systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered with PROSPERO (registration number CRD42018091581). A database search of Medline and Embase was conducted in March 2018 with an updated search in July 2019. Participants were children aged 0-18 years from countries of different income groups. The exposure variable was dental caries reported as prevalence, incidence and/or severity, or changes in those variables. The outcome variable was undernutrition; specifically, wasting (low weight-for-height) and stunting (low height-for-age) in children.Data analysis Evidence was grouped into caries of the permanent dentition, primary dentition, early childhood caries and severe early childhood caries as a risk factor for undernutrition. A best-available-evidence approach was applied to narrative synthesis. Evidence synthesis by vote counting was depicted using harvest plots. The heterogeneous nature of the data prevented a meta-analysis from being appropriate.Results Of the 2,690 studies identified, 117 underwent quality assessment, resulting in 46 studies for narrative synthesis and 38 pertaining to wasting or stunting included in vote counting. The majority of studies were cross-sectional (33 studies).For the permanent dentition, the balance of evidence showed generally no association between caries prevalence or severity with wasting. For the primary dentition, positive associations between dental caries prevalence and severity with wasting, as well as between dental caries prevalence and severity with stunting, were reported. Conclusions Overall, the authors concluded that the balance of evidence favoured an association between dental caries in the primary dentition and undernutrition in children but highlighted the complexity of synthesising dental and nutritional data along with dentition type, age of child participants and income status of countries.

Does the use of miswak reduce plaque and gingivitis among adults?

Data sources Searches were performed using broad search terms and suitable Boolean operators and Medical Subject Headings terms on the electronic databases PubMed (US National Library archive), EBSCOHost (Dentistry and Oral Sciences) (US Corporate Research Database), Scopus (Elsevier Archive) and the Cochrane Database for Systematic Reviews with no relevant time limit.Study selection Randomised control trials were included where adults were participants and using miswak sticks to brush was the independent variable. The primary outcome reviewed was the effect on periodontal health, with secondary outcomes including oral health practices. Exclusion criteria were applied to studies including patients with orthodontic appliances.Data extraction and synthesis Data extraction was led by a single author, with further authors (where necessary) assessing accuracy and appropriateness. Data extracted included first author, publication year, study design and setting, sample size, description of the participant, the intervention and comparison, clinical measurements, assessment interval and wash-out period. An I2 test with confidence intervals was performed, showing the included studies to display heterogeneity in methodology and outcome measures. As such, a random effects model was used for the meta-analysis of effect size. Further subgroup analysis of the included papers was completed and presented in a forest plot format. The Cochrane risk of bias tool was employed.Results In total, 150 abstracts were screened, with ten RCTs included and nine utilised in a descriptive meta-analysis. The findings claimed that miswak offered similar outcomes to toothbrushing when considering mean plaque score (p = 0.08; SMD: 0.39 and 95% CI: 0.05-0.83) and mean gingivitis score (p = 0.37; SMD: 0.13, and 95% CI: 0.16-0.43). A further significant secondary outcome was noted, showing reduced mean plaque scores (p = 0.01; SMD: 0.68, and 95% CI: 0.14-1.22) and reduced gingivitis score (p = 0.04; SMD: 0.66, and 95% CI: 0.03-1.29) when miswak was used in addition to toothbrushing.Conclusions Miswak sticks may offer similar plaque reduction to brushing and may reduce plaque-induced gingivitis when used as an adjunct to toothbrushing. However, more evidence is required in this area.

Can motivational interviewing help prevent dental caries in secondary school children?

Design This study was a randomised controlled trial (RCT) designed to evaluate the effectiveness of three school-based interventions to improve the oral health behaviours of adolescents and prevent dental caries. Participants were assigned to one of three groups: Group I - oral health education (which was considered as usual care); Group II - motivational interviewing (MI); and Group III - MI aided by the interactive patient communication tool, the Cariogram. Cluster randomisation was applied and schools were stratified by district. The interventions were delivered at school by trained hygienists. The main outcome measures were psychological (self-efficacy) and behavioural measures about snacking and toothbrushing with clinical measures of plaque and caries.Case selection Participants were selected from 15 secondary schools located in three main districts in Hong Kong in 2015-16. Inclusion criteria were: full-time students enrolled in participating schools; 12 or 13 years old; and having unfavourable oral health behaviour, defined as 'toothbrushing less often than twice a day' and/or 'snacking three times or more a day'. Eligible participants were identified through a screening questionnaire.Results In total, 512 participants were recruited (161, 162 and 188 in Groups I-III, respectively) and of those, 460 (89.9%) were followed-up 24 months post intervention. When compared with Group I, restriction of frequent snacking was more likely in Group II (odds ratio [OR] [95% confidence interval (CI)]: 3.91 [1.48-10.33]) and Group III (OR [95% CI]: 6.33 [2.46-16.27]). Participants in Group III had a higher likelihood to start performing adequate toothbrushing (OR [95% CI]: 4.80 [1.79-12.85]). No significant reduction in plaque score reduction was found among the three groups (p >0.05). Groups II and III developed fewer teeth with caries into dentine (ß [95% CI]: -0.19 [-0.37, -0.01] and -0.20 [-0.38, -0.02], respectively), whereas the increment of total carious lesions (enamel and dentine) was lower in Group III (ß [95% CI]: -0.63 [-1.24, -0.02]).Conclusions The findings of this RCT suggest school-based MI interventions were more effective than traditional oral health education in improving adolescents' oral health self-efficacy, behaviours and preventing dental caries. The authors suggest the benefits of this intervention may potentially extend beyond caries prevention to other oral and systemic diseases.

Facilitators and barriers to home-based toothbrushing practices by parents of young children to reduce tooth decay: a systematic review.

OBJECTIVES: Parental supervised toothbrushing (PSB) is a collection of behaviours recommended by national guidance to improve oral health. This systematic review aimed to identify the barriers and facilitators to PSB. MATERIALS AND METHODS: Studies investigating parental involvement in home-based toothbrushing in children under 8 years old and the impact on tooth decay were included. Electronic databases, references and unpublished literature databases were searched. The Theoretical Domains Framework (TDF) was used to code barriers/facilitators to PSB. RESULTS: Of the 10,176 articles retrieved, 68 articles were included. Barriers and facilitators were found across all 12 TDF domains. Barriers included an inadequate toothbrushing environment and resources, knowledge of what PSB entails and child behaviour management. Facilitators were increased oral health knowledge, the adaption of the social environment to facilitate PSB and positive attitudes towards oral health. When only high-quality articles were synthesized, knowledge was not a common barrier/facilitator. CONCLUSIONS: There are a comprehensive range of barriers/facilitators to PSB acting across all domains and at multiple levels of influence. This review identifies the most popular domains, thus informing the focus for supporting resources to supplement oral health conversations. CLINICAL RELEVANCE: PSB is a complex behaviour. Practitioners need to understand and be able to explore the wide range of potential barriers and have practical suggestions to enable PSB. This review provides pragmatic examples of different barriers and facilitators and emphasises the importance of listening to parents and exploring their story to identify the barriers and solutions that are relevant to each family.

Home-based toothbrushing interventions for parents of young children to reduce dental caries: A systematic review.

BACKGROUND: Dental caries is the most prevalent preventable condition in children. A key preventive home-based oral health behaviour is the adoption and maintenance of parental supervised toothbrushing until 8 years of age. AIM: To examine interventions promoting parental supervised toothbrushing practices to reduce dental caries in young children (<8 years old). DESIGN: Interventions promoting parental involvement in home-based toothbrushing in children under 8 years old and their impact on caries were subjected to review. Electronic databases (MEDLINE, EMBASE, PubMed, Web of Science, PsycINFO, Scopus, and the Cochrane Library), references, and unpublished literature databases were searched for relevant literature. RESULTS: Of the 10 176 articles retrieved, forty-two articles were included. The Theoretical Domains Framework was used to code intervention content, with the main domains addressed being knowledge (41/42), skills (35/42), and environmental context and resources (22/42). Sufficient descriptions of the intervention development, delivery, and evaluation were lacking, with only 18 studies being underpinned by theory. Twenty-nine studies explored the impact on caries yielding mixed results. CONCLUSIONS: There are few interventions targeting home-based oral health behaviours underpinned by theory and methodological rigour in their development and evaluation. This demonstrates a clear need for future interventions to be guided by complex intervention methodology.

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).

Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care.

BACKGROUND: Dental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth. METHOD: This is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes. DISCUSSION: SCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN. TRIAL REGISTRATION NUMBER: ISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search .

Patient-reported Outcomes (PROs) in clinical trials in paediatric dentistry.

Patient-reported outcomes (PROs) are reports directly from patients without interpretation by clinicians or others and captured using validated patient-reported outcome measures (PROMs). These measures are increasingly employed in clinical practice and can be incorporated into clinical trials. Benefits of using PROs include reducing observer bias; eliciting unique views on aspects important to patients and increasing public accountability. Despite inclusion in clinical trials PRO data is often under-reported and the results may not be adopted into clinical practice due to concerns about the data generated. This review discusses what PROs are and how to measure them; the benefits of using PROs; how to choose an appropriate PROM to answer the research question; considerations for using PROs in paediatric dentistry and reporting guidelines. Finally, some examples of how PROs have been included in paediatric dentistry trials are given along with discussion of the development of core outcome sets and how these may improve reporting of PROs in the future.

Development of a core outcome set for use in routine orthodontic clinical trials.

INTRODUCTION: A diverse range of outcomes is used in orthodontic research with a focus on measuring outcomes important to clinicians and little consistency in outcome selection and measurement. We aimed to develop a core outcome set for use in clinical trials of orthodontic treatment not involving cleft or orthognathic patient groups. METHODS: A list of outcomes measured in previous orthodontic research was identified through a scoping literature review. Additional outcomes of importance to patients were obtained using qualitative interviews and focus groups with adolescents aged 10-16 years. Rating of outcomes was carried out in a 2-round electronic Delphi process involving health care professionals and patients using a 9-point scale. A face-to-face meeting was subsequently held with stakeholders to discuss the results before refining the core outcome set. RESULTS: After triangulation, a final list of 34 outcomes grouped under 10 domains was obtained for rating in the e-Delphi surveys. Fifteen outcomes were voted "in" after the second Delphi round involving 274 participants with a further outcome being included after the consensus meeting. These were subsequently refined into a final set of 7 core outcomes, including the impact of self-perceived esthetics, alignment and/or occlusion, skeletal relationship, stability, patient-related adherence, breakages, and adverse effects on teeth or teeth-supporting structures. CONCLUSIONS: A bespoke orthodontic core outcome set encompassing both clinician- and patient-focused outcomes was developed. Incorporating this is the first step into providing a more holistic assessment of the impact of treatment while allowing for meaningful comparisons and synthesis of results from individual trials.

Dental professionals' experiences of managing children with carious lesions in their primary teeth - a qualitative study within the FiCTION randomised controlled trial.

BACKGROUND: The lack of evidence for the effective management of carious lesions in children's primary teeth has caused uncertainty for the dental profession and patients. Possible approaches include conventional and biological management alongside best practice prevention, and best practice prevention alone. The FiCTION trial assessed the effectiveness of these options, and included a qualitative study exploring dental professionals' (DPs) experiences of delivering the different treatment arms. This paper reports on how DPs managed children with carious lesions within FiCTION and how this related to their everyday experiences of doing dentistry. METHODS: Overall, 31 DPs from FiCTION-trained dental surgeries in four regions of the UK participated in semi-structured interviews about their experiences of the three treatment arms (conventional management of carious lesions and prevention (C + P), biological management of carious lesions and prevention (B + P) or prevention alone (PA)). A theoretical framework, drawing on social practice theory (SPT), was developed for analysis. RESULTS: Participants discussed perceived effectiveness of, and familiarity with, the three techniques. The C + P arm was familiar, but some participants questioned the effectiveness of conventional restorations. Attitudes towards the B + P arm varied in terms of familiarity, but once DPs were introduced to the techniques, this was seen as effective. While prevention was familiar, PA was described as ineffective. DPs manage children with carious lesions day-to-day, drawing on previous experience and knowledge of the child to provide what they view as the most appropriate treatment in the best interests of each child. Randomisation undermined these normal choices. Several DPs reported deviating from the trial arms in order to treat a patient in a particular way. Participants valued evidence-based dentistry, and expect to use the results of FiCTION to inform future practice. They anticipate continuing to use the full range of treatment options, and to personally select appropriate strategies for individual children. CONCLUSIONS: RCTs take place in the context of day-to-day practices of doing dentistry. DPs employ experiential and interpersonal knowledge to act in the best interests of their patients. Randomisation within a clinical trial can present a source of tension for DPs, which has implications for assuring individual equipoise in future trials.

Children and parents' perspectives on the acceptability of three management strategies for dental caries in primary teeth within the 'Filling Children's Teeth: Indicated or Not' (FiCTION) randomised controlled trial - a qualitative study.

BACKGROUND: The Filling Children's Teeth: Indicated Or Not? (FiCTION) randomised controlled trial (RCT) aimed to explore the clinical- and cost-effectiveness of managing dental caries in children's primary teeth. The trial compared three management strategies: conventional caries management with best practice prevention (C + P), biological management with best practice prevention (B + P) and best practice prevention alone (PA)-based approaches. Recently, the concept of treatment acceptability has gained attention and attempts have been made to provide a conceptual definition, however this has mainly focused on adults. Recognising the importance of evaluating the acceptability of interventions in addition to their effectiveness, particularly for multi-component complex interventions, the trial design included a qualitative component. The aim of this component was to explore the acceptability of the three strategies from the perspectives of the child participants and their parents. METHODS: Qualitative exploration, based on the concept of acceptability. Participants were children already taking part in the FiCTION trial and their parents. Children were identified through purposive maximum variation sampling. The sample included children from the three management strategy arms who had been treated and followed up; median (IQR) follow-up was at 33.8 (23.8, 36.7) months. Semi-structured interviews with thirteen child-parent dyads. Interviews were transcribed verbatim and analysed using a framework approach. RESULTS: Data saturation was reached after thirteen interviews. Each child-parent dyad took part in one interview together. The participants were eight girls and five boys aged 5-11 years and their parents. The children's distribution across the trial arms was: C + P n = 4; B + P n = 5; PA n = 4. Three key factors influenced the acceptability of caries management in primary teeth to children and parents: i) experiences of specific procedures within management strategies; ii) experiences of anticipatory dental anxiety and; iii) perceptions of effectiveness (particularly whether pain was reduced). These factors were underpinned by a fourth key factor: the notion of trust in the dental professionals - this was pervasive across all arms. CONCLUSIONS: Overall children and parents found each of the three strategies for the management of dental caries in primary teeth acceptable, with trust in the dental professional playing an important role.