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.

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.

Development of the Orthodontic Treatment Impact Questionnaire: Cross-sectional validation.

INTRODUCTION: The need to involve patients in developing and evaluating health care interventions is now well-recognized. This study assesses and refines the Orthodontic Treatment Impact Questionnaire for use as a patient-reported outcome in an interventional clinical trial to evaluate and compare any orthodontic interventions. METHODS: The face and content validity of a previously developed questionnaire were tested in 2 focus groups involving adolescents aged 11-17 years. They were wearing a range of orthodontic appliances and at different treatment stages. A similar cross-sectional convenience sample completed the questionnaire during routine appliance adjustment appointments. A Rasch model, using item response theory, was used for item reduction, assessment of the response format, and differential item functioning. Spearman's rank correlation was used to assess construct validity, Cronbach α for internal consistency and reliability, and intraclass correlation coefficient for test-retest reliability. RESULTS: Seven adolescents (4 females, 3 males) were involved in the initial testing; 181 (117 females, 64 males; mean age, 14.7 ± 1.5 years) completed the questionnaire once and 41 twice. The initial measure demonstrated a misfit to the Rasch model. Ten of the original 31 items had disordered thresholds and were removed. The 5-point scale was changed to a 3-point scale. None of the participants demonstrated a misfit to the model. Construct validity (P = 0.480), internal consistency (Cronbach α = 0.827) and test-retest reliability (intraclass correlation coefficient = 0.85; 95% confidence interval, 0.73-0.92) were good. CONCLUSIONS: The initial Orthodontic Treatment Impact Questionnaire was tested and modified using item response theory. The modified questionnaire demonstrated good construct validity, reliability, and internal consistency. Further testing to assess generalizability and longitudinal responsiveness is required.

Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP): a feasibility study.

BACKGROUND: Progression of dental caries can result in irreversible pulpal damage. Partial irreversible pulpitis is the initial stage of this damage, confined to the coronal pulp whilst the radicular pulp shows little or no sign of infection. Preserving the pulp with sustained vitality and developing minimally invasive biologically based therapies are key themes within contemporary clinical practice. However, root canal treatment involving complete removal of the pulp is often the only option (other than extraction) given to patients with irreversible pulpitis, with substantial NHS and patient incurred costs. The European Society of Endodontology's (ESE 2019) recent consensus statement recommends full pulpotomy, where the inflamed coronal pulp is removed with the goal of keeping the radicular pulp vital, as a more minimally invasive technique, potentially avoiding complex root canal treatment. Although this technique may be provided in secondary care, it has not been routinely implemented or evaluated in UK General Dental Practice. METHOD: This feasibility study aims to identify and assess in a primary care setting the training needs of general dental practitioners and clinical fidelity of the full pulpotomy intervention, estimate likely eligible patient pool and develop recruitment materials ahead of the main randomised controlled trial comparing the clinical and cost-effectiveness of full pulpotomy compared to root canal treatment in pre/molar teeth of adults 16 years and older showing signs indicative of irreversible pulpitis. The feasibility study will recruit and train 10 primary care dentists in the full pulpotomy technique. Dentists will recruit and provide full pulpotomy to 40 participants (four per practice) with indications of partial irreversible pulpitis. DISCUSSION: The Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP) study will address the lack of high-quality evidence in the treatment of irreversible pulpitis, to aid dental practitioners, patients and policymakers in their decision-making. The PIP feasibility study will inform the main study on the practicality of providing both training and provision of the full pulpotomy technique in general dental practice. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN17973604 . Registered on 28 January 2021. Protocol version Protocol version: 1; date: 03.02.2021.

Stakeholder perspectives on barriers and enablers to recruiting anxious children undergoing day surgery under general anaesthetic: a qualitative internal pilot study of the MAGIC randomised controlled trial.

BACKGROUND: The 'Melatonin for Anxiety prior to General anaesthesia In Children' (MAGIC) trial was designed to compare midazolam and melatonin as pre-medications for anxious children (aged five to fourteen), undergoing day-case surgical procedures under general anaesthesia. Low recruitment is a challenge for many trials, particularly paediatric trials and those in 'emergency' settings. A qualitative study as part of MAGIC aimed to gather stakeholder perspectives on barriers and enablers to recruitment. METHODS: Sixteen stakeholders from six sites participated in semi-structured interviews about their experiences of setting up the MAGIC trial and recruiting patients as part of the internal pilot. Data was analysed using framework analysis. RESULTS: Participants identified barriers and enablers to recruitment. Barriers and enablers related to the study, participants, the population of anxious children, practitioners, collaboration with other health professionals, ethics, specific settings and the context of surgical day units and the wider health system. Attempting to recruit anxious children from a surgical day unit is particularly challenging for several reasons. Issues include the practicalities of dealing with a child experiencing anxiety for parents/guardians; professional unwillingness to make things more difficult for families and clinicians and nurses valuing predictability within a busy and time-sensitive setting. CONCLUSIONS: Multi-site RCTs face recruitment barriers relating to study-wide and site-specific factors. There are multiple barriers to recruiting anxious children due to undergo day-case surgery. Barriers across domains can interrelate and reinforce each other, reflecting challenges relating to populations and settings. For example, in the case of anxious children, parents and other health professionals are concerned about exacerbating children's anxiety prior to surgery. They may look for ways to keep things predictable and avoid the uncertainty of an RCT. Pre-trial engagement work could help address concerns among collaborating health professionals. Using rapid ethnography during set-up or an internal pilot to focus on how the protocol will be or has been operationalised in practice may help identify issues. Allowing time to reflect on the findings of internal pilots and implement necessary changes could facilitate higher recruitment during the main phase of a trial. TRIAL REGISTRATION: NIHR Trial Registration Number: ISRCTN18296119 . Registered on October 01, 2019.

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 .

'I Would Rather Be Having My Leg Cut off Than a Little Needle': A Supplementary Qualitative Analysis of Dentally Anxious Children's Experiences of Needle Fear.

Fear of needles is common in childhood, with up to 50% being affected to some degree. In individuals who are dentally anxious, the prevalence may be as high as 91%. Fear of needles, and therefore intra-oral injections can have negative impacts on children's quality of life and healthcare experiences, including a requirement for pharmacological methods to facilitate dental treatment. The aim of this study is to identify whether dentally anxious children report fear of injections and explore how these children experience a fear of needles in a dental setting. A supplementary analysis of interviews collected as part of two previous studies relating to children with dental anxiety. Five main themes were identified: feelings about needles; the nature of needle fear; the context of the fear, its consequences and how children tried to control the process. Children showed a desire to have control of their healthcare interventions, and wanted to trust the healthcare professionals giving the injections. There is evidence that children with dental anxiety also experience fear of needles, including intra-oral injections. Further primary qualitative research is needed to explore this topic in more depth and to design appropriate child centred interventions to reduce needle fear.

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.

Managing orthodontic appliances in everyday life: A qualitative study of young people's experiences with removable functional appliances, fixed appliances and retainers.

OBJECTIVE: To compare young people's experiences of wearing a range of orthodontic appliances. DESIGN: A cross-sectional, qualitative study with purposive sampling. SETTING: UK dental teaching hospital. PARTICIPANTS: Twenty-six orthodontic patients aged 11-17 years. METHODS: Patients participated in in-depth semi-structured interviews. All interviews were transcribed verbatim and analysed thematically. RESULTS: Young people reported physical, practical and emotional impacts from their appliances. Despite these reported impacts, participants described 'getting used' to and, therefore, not being bothered by their appliance. Framework analysis of the data identified a multi-dimensional social process of managing everyday life with an appliance. This involves addressing the 'dys-appearance' of the body through physically adapting to an appliance. This process also includes psychological approaches, drawing on social networks, developing strategies and situating experiences in a longer-term context. Engaging in this process allowed young people to address the physical, practical and emotional impacts of their appliances. CONCLUSION: This qualitative research has identified how young people manage everyday life with an appliance. Understanding this process will help orthodontists to support their patients.

Oral care as a life course project: A qualitative grounded theory study.

OBJECTIVE: To report on a theory to explain the oral health of older people over the life course. BACKGROUND: The study of ageing has burgeoned into a complex interdisciplinary field of research, yet there are few studies in oral health from the perspective of older people that bridge the gap between sociology and oral health related research. METHODS: A grounded theory study involving a convenience sample of 15 men and 28 women aged between 65 and 91 years across different levels of education. Data were subjected to grounded theory analysis using QSR NVivo 11.0 and where relevant phenomenological theory. RESULTS: Participants conceived of oral care as a life course project that resulted from an active plan to keep one's teeth into older age. This involved accessing the social world of dentistry, holding appropriate values, understanding the associated personality types, social practices, goals and outcomes. The life course project is a social project supported by social institutions. It involves ideas about appropriate ageing including how oral health is to be managed at different stages in the life course. The degree to which individuals are able to participate in this project is determined by both individual and social factors. CONCLUSIONS: The theory explains why the loss of a single tooth might be experienced as traumatic but also why older people adapt to their changing oral health. Oral health in older age represented a lifetime's investment in oral care. Future health policies should consider this lifetime investment when considering care for older people.

'I didn't want to pass that on to my child, being afraid to go to the dentist': making sense of oral health through narratives of connectedness over the life course.

While previous sociological research on oral health has identified the relevance of personal relationships, there is more scope to analyse the mouth through a lens of connectedness. Recent qualitative interviews with 43 older people (65+) in England and Scotland found that participants constructed relational narratives to make sense of their oral health practices. By drawing on ideas of family practices, family display and personal life, we illustrate how the mouth can be understood relationally. Participants presented their own embodied experiences as connected to the actions of their parents. Narratives also reflected how, as parents and grandparents themselves, participants tried to shape the experiences of others. In this way, oral health practices were conceptualised as being about family. This can be seen in self-narratives that demonstrated how participants located themselves as embedded in webs of ongoing relationships. We highlight the importance of narrated practices of thinking and feeling, whereby participants imagined doing oral health, and indeed family, in different ways. We thereby demonstrate how oral health practices are constituted through family connectedness and at the same time how these practices contribute to the constitution of family. Policy should therefore pay attention to family relations when promoting improvements in oral health practices.

How do patients perceive the British orthodontic society online information resource about orthognathic treatment? A qualitative study.

OBJECTIVES: To explore the accessibility, usability and relevance of the British Orthodontic Society (BOS) online information resource (OIR), Your Jaw Surgery. DESIGN: Qualitative, cross-sectional study. SETTING: 5 UK sites. PARTICIPANTS: Patients before, during and after treatment for non-cleft skeletal discrepancy. METHODS: Patients were identified at joint clinics and recruited after having time to view the OIR. Semi-structured interviews were conducted with 17 patients (aged 16-46 years). The interviews were transcribed and thematic analysis was undertaken using a framework approach. RESULTS: The main themes identified were the overall usefulness, personal relevance and positive perceptions of the OIR. The OIR was seen to be useful for patients considering treatment, and potentially useful for patients undergoing treatment. Participants were looking for a personally relevant resource that would give them the best possible idea of how they would look and feel after surgery. The OIR was perceived as trusted, positive and reassuring. CONCLUSIONS: Patients at different stages of treatment found the OIR helpful and reassuring. Clinicians may find it useful to direct patients to the OIR to complement a professional consultation, but should be aware that patients may perceive it as presenting a positive image of the long-term benefits of orthognathic surgery.