Organization for Caries Research-European Federation of Conservative Dentistry Consensus Report on Clinical Recommendations for Caries Diagnosis Paper II: Caries Lesion Activity and Progression Assessment.

INTRODUCTION: This consensus paper provides recommendations for oral health professionals on why and how to assess caries activity and progression with special respect to the site of a lesion. METHODS: An expert panel was nominated by the executive councils of the European Organization for Caries Research (ORCA) and the European Federation of Conservative Dentistry (EFCD). The steering committee built three working groups that were asked to provide recommendations on (1) caries detection and diagnostic methods, (2) caries activity and progression assessment, and (3) obtain individualized caries diagnoses. The experts of work group 2 phrased and agreed on provisional general and specific recommendations on caries lesion activity and progression, based on a review of the current literature. These recommendations were then discussed and refined in a consensus workshop followed by an anonymous Delphi survey to determine the agreement on each recommendation. RESULTS: The expert panel agreed on general (n = 7) and specific recommendations (n = 6). The specific recommendations cover coronal caries on pits and fissures, smooth surfaces, proximal surfaces, as well as root caries and secondary caries/caries adjacent to restorations and sealants. 3/13 recommendations yielded perfect agreement. CONCLUSION: The most suitable method for lesion activity assessment is the visual-tactile method. No single clinical characteristic is indicative of lesion activity; instead, lesion activity assessment is based on assessing and weighing several clinical signs. The recall intervals for visual and radiographic examination need to be adjusted to the presence of active caries lesions and recent caries progression rates. Modifications should be based on individual patient characteristics.

ORCA-EFCD consensus report on clinical recommendation for caries diagnosis. Paper I: caries lesion detection and depth assessment.

OBJECTIVES: The aim of the present consensus paper was to provide recommendations for clinical practice considering the use of visual examination, dental radiography and adjunct methods for primary caries detection. MATERIALS AND METHODS: The executive councils of the European Organisation for Caries Research (ORCA) and the European Federation of Conservative Dentistry (EFCD) nominated ten experts each to join the expert panel. The steering committee formed three work groups that were asked to provide recommendations on (1) caries detection and diagnostic methods, (2) caries activity assessment and (3) forming individualised caries diagnoses. The experts responsible for "caries detection and diagnostic methods" searched and evaluated the relevant literature, drafted this manuscript and made provisional consensus recommendations. These recommendations were discussed and refined during the structured process in the whole work group. Finally, the agreement for each recommendation was determined using an anonymous Delphi survey. RESULTS: Recommendations (N = 8) were approved and agreed upon by the whole expert panel: visual examination (N = 3), dental radiography (N = 3) and additional diagnostic methods (N = 2). While the quality of evidence was found to be heterogeneous, all recommendations were agreed upon by the expert panel. CONCLUSION: Visual examination is recommended as the first-choice method for the detection and assessment of caries lesions on accessible surfaces. Intraoral radiography, preferably bitewing, is recommended as an additional method. Adjunct, non-ionising radiation methods might also be useful in certain clinical situations. CLINICAL RELEVANCE: The expert panel merged evidence from the scientific literature with practical considerations and provided recommendations for their use in daily dental practice.

Examining the effectiveness of different dental recall strategies on maintenance of optimum oral health: the INTERVAL dental recalls randomised controlled trial.

Objective To compare the clinical effectiveness of different frequencies of dental recall over a four-year period.Design A multi-centre, parallel-group, randomised controlled trial with blinded clinical outcome assessment. Participants were randomised to receive a dental check-up at six-monthly, 24-monthly or risk-based recall intervals. A two-strata trial design was used, with participants randomised within the 24-month stratum if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or six-month recall interval.Setting UK primary dental care.Participants Practices providing NHS care and adults who had received regular dental check-ups.Main outcome measures The percentage of sites with gingival bleeding on probing, oral health-related quality of life (OHRQoL), cost-effectiveness.Results In total, 2,372 participants were recruited from 51 dental practices. Of those, 648 were eligible for the 24-month recall stratum and 1,724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding on probing between intervention arms in any comparison. For those eligible for 24-month recall stratum: the 24-month versus six-month group had an adjusted mean difference of -0.91%, 95% CI (-5.02%, 3.20%); the 24-month group versus risk-based group had an adjusted mean difference of 0.07%, 95% CI (-3.99%, 4.12%). For the overall sample, the risk-based versus six-month adjusted mean difference was 0.78%, 95% CI (-1.17%, 2.72%). There was no evidence of a difference in OHRQoL (0-56 scale, higher score for poorer OHRQoL) between intervention arms in any comparison. For the overall sample, the risk-based versus six-month effect size was -0.35, 95% CI (-1.02, 0.32). There was no evidence of a clinically meaningful difference between the groups in any comparison in either eligibility stratum for any of the secondary clinical or patient-reported outcomes.Conclusion Over a four-year period, we found no evidence of a difference in oral health for participants allocated to a six-month or a risk-based recall interval, nor between a 24-month, six-month or risk-based recall interval for participants eligible for a 24-month recall. However, patients greatly value and are willing to pay for frequent dental check-ups.

Risk-based, 6-monthly and 24-monthly dental check-ups for adults: the INTERVAL three-arm RCT.

BACKGROUND: Traditionally, patients are encouraged to attend dental recall appointments at regular 6-month intervals, irrespective of their risk of developing dental disease. Stakeholders lack evidence of the relative effectiveness and cost-effectiveness of different recall strategies and the optimal recall interval for maintenance of oral health. OBJECTIVES: To test effectiveness and assess the cost-benefit of different dental recall intervals over a 4-year period. DESIGN: Multicentre, parallel-group, randomised controlled trial with blinded clinical outcome assessment at 4 years and a within-trial cost-benefit analysis. NHS and participant perspective costs were combined with benefits estimated from a general population discrete choice experiment. A two-stratum trial design was used, with participants randomised to the 24-month interval if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or 6-month recall interval. SETTING: UK primary care dental practices. PARTICIPANTS: Adult, dentate, NHS patients who had visited their dentist in the previous 2 years. INTERVENTIONS: Participants were randomised to attend for a dental check-up at one of three dental recall intervals: 6-month, risk-based or 24-month recall. MAIN OUTCOMES: Clinical - gingival bleeding on probing; patient - oral health-related quality of life; economic - three analysis frameworks: (1) incremental cost per quality-adjusted life-year gained, (2) incremental net (societal) benefit and (3) incremental net (dental health) benefit. RESULTS: A total of 2372 participants were recruited from 51 dental practices; 648 participants were eligible for the 24-month recall stratum and 1724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison. For the eligible for 24-month recall stratum: the 24-month (n = 138) versus 6-month group (n = 135) had an adjusted mean difference of -0.91 (95% confidence interval -5.02 to 3.20); the risk-based (n = 143) versus 6-month group had an adjusted mean difference of -0.98 (95% confidence interval -5.05 to 3.09); the 24-month versus risk-based group had an adjusted mean difference of 0.07 (95% confidence interval -3.99 to 4.12). For the overall sample, the risk-based (n = 749) versus 6-month (n = 737) adjusted mean difference was 0.78 (95% confidence interval -1.17 to 2.72). There was no evidence of a difference in oral health-related quality of life between intervention arms in any comparison. For the economic evaluation, under framework 1 (cost per quality-adjusted life-year) the results were highly uncertain, and it was not possible to identify the optimal recall strategy. Under framework 2 (net societal benefit), 6-month recalls were the most efficient strategy with a probability of positive net benefit ranging from 78% to 100% across the eligible and combined strata, with findings driven by the high value placed on more frequent recall services in the discrete choice experiment. Under framework 3 (net dental health benefit), 24-month recalls were the most likely strategy to deliver positive net (dental health) benefit among those eligible for 24-month recall, with a probability of positive net benefit ranging from 65% to 99%. For the combined group, the optimal strategy was less clear. Risk-based recalls were more likely to be the most efficient recall strategy in scenarios where the costing perspective was widened to include participant-incurred costs, and in the Scottish subgroup. LIMITATIONS: Information regarding factors considered by dentists to inform the risk-based interval and the interaction with patients to determine risk and agree the interval were not collected. CONCLUSIONS: Over a 4-year period, we found no evidence of a difference in oral health for participants allocated to a 6-month or a risk-based recall interval, nor between a 24-month, 6-month or risk-based recall interval for participants eligible for a 24-month recall. However, people greatly value and are willing to pay for frequent dental check-ups; therefore, the most efficient recall strategy depends on the scope of the cost and benefit valuation that decision-makers wish to consider. FUTURE WORK: Assessment of the impact of risk assessment tools in informing risk-based interval decision-making and techniques for communicating a variable recall interval to patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95933794. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme [project numbers 06/35/05 (Phase I) and 06/35/99 (Phase II)] and will be published in full in Health Technology Assessment; Vol. 24, No. 60. See the NIHR Journals Library website for further project information.

Traditionally, dentists have encouraged both patients at low risk and patients at high risk of developing dental disease to attend their dental practices for regular 6-month 'check-ups'. There is, however, little evidence available for either patients or dentists to use when deciding on the best dental recall interval (i.e. time between dental check-ups) for maintaining oral health. In this study, we wanted to find out, for adult patients who regularly attend the dentist, what interval of time between dental check-ups maintains optimum oral health and represents value for money. A total of 2372 adults who regularly attended 51 different dental practices across Scotland, Northern Ireland, England and Wales were involved. Patients aged 18 years or over who received all or part of their care as NHS patients were randomly allocated to groups to receive a check-up either every 6 months, at an individualised recall interval based on their own risk of oral disease (risk-based recall), or every 24 months (if considered at low risk by their dentist). The recruited adults completed questionnaires at their first trial appointment and then every year of the 4-year study. Their attendance at recall appointments was recorded and they received a clinical assessment taken by study staff at the end of their involvement at year 4. After 4 years, there was no evidence of a difference in the oral health of patients allocated to a 6-month or variable risk-based recall interval. For patients considered by their dentists to be suitable for a 24-month recall interval, there was no difference between those in the 24-month, 6-month or risk-based recall intervals. However, people greatly value and are willing to pay for frequent dental check-ups. The recall strategy that offers the best value for money to patients and the NHS, therefore, depends on what people and decision-makers wish to value within a health-care system.

Cost-effectiveness of child caries management: a randomised controlled trial (FiCTION trial).

BACKGROUND: A three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C + P), Biological with best practice prevention (B + P), or best practice Prevention Alone (PA). METHODS: Data on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%. RESULTS: A total of 1144 children were randomised with data on 1058 children (C + P n = 352, B + P n = 352, PA n = 354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B + P. In terms of effectiveness, on average, there were fewer incidences of, (- 0.06; 97.5% CI: - 0.14 to 0.02) and fewer episodes of dental pain and/or infection (- 0.14; 97.5% CI: - 0.29 to 0.71) in B + P compared to PA. C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P. CONCLUSIONS: The mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B + P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B + P being considered cost-effective never exceeded 75%. TRIAL REGISTRATION: The trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT.

BACKGROUND: Historically, lack of evidence for effective management of decay in primary teeth has caused uncertainty, but there is emerging evidence to support alternative strategies to conventional fillings, which are minimally invasive and prevention orientated. OBJECTIVES: The objectives were (1) to assess the clinical effectiveness and cost-effectiveness of three strategies for managing caries in primary teeth and (2) to assess quality of life, dental anxiety, the acceptability and experiences of children, parents and dental professionals, and caries development and/or progression. DESIGN: This was a multicentre, three-arm parallel-group, participant-randomised controlled trial. Allocation concealment was achieved by use of a centralised web-based randomisation facility hosted by Newcastle Clinical Trials Unit. SETTING: This trial was set in primary dental care in Scotland, England and Wales. PARTICIPANTS: Participants were NHS patients aged 3-7 years who were at a high risk of tooth decay and had at least one primary molar tooth with decay into dentine, but no pain/sepsis. INTERVENTIONS: Three interventions were employed: (1) conventional with best-practice prevention (local anaesthetic, carious tissue removal, filling placement), (2) biological with best-practice prevention (sealing-in decay, selective carious tissue removal and fissure sealants) and (3) best-practice prevention alone (dietary and toothbrushing advice, topical fluoride and fissure sealing of permanent teeth). MAIN OUTCOME MEASURES: The clinical effectiveness outcomes were the proportion of children with at least one episode (incidence) and the number of episodes, for each child, of dental pain or dental sepsis or both over the follow-up period. The cost-effectiveness outcomes were the cost per incidence of, and cost per episode of, dental pain and/or dental sepsis avoided over the follow-up period. RESULTS: A total of 72 dental practices were recruited and 1144 participants were randomised (conventional arm, n = 386; biological arm, n = 381; prevention alone arm, n = 377). Of these, 1058 were included in an intention-to-treat analysis (conventional arm, n = 352; biological arm, n = 352; prevention alone arm, n = 354). The median follow-up time was 33.8 months (interquartile range 23.8-36.7 months). The proportion of children with at least one episode of pain or sepsis or both was 42% (conventional arm), 40% (biological arm) and 45% (prevention alone arm). There was no evidence of a difference in incidence or episodes of pain/sepsis between arms. When comparing the biological arm with the conventional arm, the risk difference was -0.02 (97.5% confidence interval -0.10 to 0.06), which indicates, on average, a 2% reduced risk of dental pain and/or dental sepsis in the biological arm compared with the conventional arm. Comparing the prevention alone arm with the conventional arm, the risk difference was 0.04 (97.5% confidence interval -0.04 to 0.12), which indicates, on average, a 4% increased risk of dental pain and/or dental sepsis in the prevention alone arm compared with the conventional arm. Compared with the conventional arm, there was no evidence of a difference in episodes of pain/sepsis among children in the biological arm (incident rate ratio 0.95, 97.5% confidence interval 0.75 to 1.21, which indicates that there were slightly fewer episodes, on average, in the biological arm than the conventional arm) or in the prevention alone arm (incident rate ratio 1.18, 97.5% confidence interval 0.94 to 1.48, which indicates that there were slightly more episodes in the prevention alone arm than the conventional arm). Over the willingness-to-pay values considered, the probability of the biological treatment approach being considered cost-effective was approximately no higher than 60% to avoid an incidence of dental pain and/or dental sepsis and no higher than 70% to avoid an episode of pain/sepsis. CONCLUSIONS: There was no evidence of an overall difference between the three treatment approaches for experience of, or number of episodes of, dental pain or dental sepsis or both over the follow-up period. FUTURE WORK: Recommendations for future work include exploring barriers to the use of conventional techniques for carious lesion detection and diagnosis (e.g. radiographs) and developing and evaluating suitable techniques and strategies for use in young children in primary care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77044005. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 1. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: Tooth decay is common; it can lead to pain, days off school for children and days off work for parents and is a financial burden to the NHS. There is uncertainty about the best way of managing decay in young children. This trial aimed to find out whether or not there was a difference in the amount of pain and/or infection suffered by children having their decay treated with one of the following: fillings, having decay sealed in or using preventative treatment alone. Which method represented the best value was also explored. WHAT DID WE DO?: For young children with decay, the Filling Children's Teeth: Indicated Or Not? (FiCTION) trial compared the difference between fillings, sealing in the decay and using preventative treatment alone over 3 years in NHS dental practices in Scotland, England and Wales. We recruited 1144 children aged 3­7 years with one or more holes in their baby back teeth (molars), but without pain/infection, and placed them at random into one of three groups: (1) tooth numbing, removing decay and filling(s) with preventative treatment; (2) sealing in decay with fillings or caps and preventative treatment but no numbing; or (3) preventative treatment alone. WHAT DID WE FIND?: Recruitment was challenging but was achieved. There was no evidence of a difference in children's experience of pain or infection, quality of life or dental anxiety between groups. All three ways of treating decay were acceptable to children, parents and dental professionals. Sealing in with preventative treatment was most likely to be considered the best way of managing children's decay if we are willing to pay a minimum of £130 to avoid an episode of pain or infection. WHAT DOES THIS MEAN?: As there was no evidence of a difference between the three treatment groups in pain/infection experienced, treatment choice should continue to be based on shared decision-making between the child, parent and clinician to agree the best option for the individual child.

The views and experiences of general dental practitioners (GDP's) in West Yorkshire who used the International Caries Detection and Assessment System (ICDAS) in research.

OBJECTIVE: To explore, through face to face interviews with a selection of General Dental Practitioners (GDPs), their views and experiences of having used the International Caries Detection and Assessment System (ICDAS) within primary care research studies for recording caries. METHODS: This qualitative study involved one on one interviews with eight GDP's who had previously used ICDAS on patients in their dental practices as part of a research study. The participants were selected from among those who had taken part in two clinical studies in the UK using convenient, but purposive sampling. The interviews were tape-recorded and transcribed; the data analysis was conducted by thematic analysis. RESULTS: GDP's indicated their beliefs that ICDAS had an important role in caries prevention but reported four main barriers while using the full (6 caries stages) ICDAS coding system in their practices: lack of simplicity of coding, financial implications and time consumption (in both training and use of ICDAS) and inadequate undergraduate training. An overarching theme identified from the GDPS was the willingness to offer potential solutions to their barriers which might improve the utilisation of the system in primary care. CONCLUSION: The GDPs experienced common obstacles in using ICDAS in the primary care setting, many of which have relatively straight-forward solutions which they put forward themselves such as: incentivisation, undergraduate-level training in ICDAS for both dentists and nurses and computerized data entry. Further qualitative and quantitative research is needed on how to facilitate the utilisation of the system in dental practice. It is also recommended to explore the influences of wider agencies on influencing primary dental care professionals' caries management, including appropriate recording of diagnosis and risk assessment.

Remuneration of primary dental care in England: a qualitative framework analysis of perspectives of a new service delivery model incorporating incentives for improved access, quality and health outcomes.

OBJECTIVE: This study aimed to describe stakeholder perspectives of a new service delivery model in primary care dentistry incorporating incentives for access, quality and health outcomes. DESIGN: Data were collected through observations, interviews and focus groups. SETTING: This was conducted under six UK primary dental care practices, three working under the incentive-driven contract and three working under the traditional activity-based contract. PARTICIPANTS: Observations were made of 30 dental appointments. Eighteen lay people, 15 dental team staff and a member of a commissioning team took part in the interviews and focus groups. RESULTS: Using a qualitative framework analysis informed by Andersen's model of access, we found oral health assessments influenced patients' perceptions of need, which led to changes in preventive behaviour. Dentists responded to the contract, with greater emphasis on prevention, use of the disease risk ratings in treatment planning, adherence to the pathways and the utilisation of skill-mix. Participants identified increases in the capacity of practices to deliver more care as a result. These changes were seen to improve evaluated and perceived health and patient satisfaction. These outcomes fed back to shape people's predispositions to visit the dentist. CONCLUSION: The incentive-driven contract was perceived to increase access to dental care, determine dentists' and patients' perceptions of need, their behaviours, health outcomes and patient satisfaction. Dentists face challenges in refocusing care, perceptions of preventive dentistry, deployment of skill mix and use of the risk assessments and care pathways. Dentists may need support in these areas and to recognise the differences between caring for individual patients and the patient-base of a practice.

Variations in the provision and cost of oral healthcare in 11 European countries: a case study.

AIM: To compare the provision and costs at the point of delivery of dental treatments in a sample of European Union (EU) Member States. MATERIALS AND METHODS: A questionnaire with open-ended questions was sent to oral health policy-makers in Denmark, England, France, Germany, Hungary, Ireland, Italy, the Netherlands, Poland, Romania, Scotland and Spain. They were asked to answer questions on the probable costs and provision of treatment in their country for a vignette presented as a pre-defined case. RESULTS: All respondents returned answers to all questions. Wide variations were reported in: who would deliver care, cost of items of care and total cost. For example, in France, only a dentist would provide the treatment. In Denmark, England, Germany, Ireland, Italy, the Netherlands and Scotland, it was likely that the treatment would be provided by a combination of dentist, dental hygienist and dental nurse. Fees ranged from €72 in England (if treated within the NHS) to €603 in Denmark. In Italy, Spain and for most patients in Romania, all treatment costs were paid by the patient. In the other nine countries, some subsidy from public funds was available. In terms of percentage of per capita Gross National Income, the cost to the patient ranged from 0.12% in France to 1.57% in Spain. CONCLUSIONS: It was apparent that there are wide variations between EU Member States in the manner in which oral healthcare is delivered, its cost and the extent to which the cost of treatment is subsidised from state funds or through private insurance.

Knowledge, attitude and practice among Health Visitors in the United Kingdom toward children's oral health.

OBJECTIVES: The purpose of this study was to determine knowledge, attitude, and practical behavior of health visitors regarding children's oral health in the United Kingdom (UK). METHODS: A web-based self-administered survey with 18 closed and 2 open ended questions was distributed to a convenience sample of approximately 9,000 health visitors who were currently employed in the United Kingdom and a member of the Institute of Health Visiting. RESULTS: A total of 1,088 health visitors completed the survey, resulting in a response rate of 12%. One-third of the health visitors reported that they had not received oral health training previously. Almost all agreed that oral health advice/promotion should be included in their routine health visiting contacts. Previous oral health training/education was associated with an increase in oral health knowledge; confidence in entering a discussion with parents/caregivers and willingness to be involved in dental referral process. CONCLUSIONS: The results of our study support the need for health visitors to receive oral health training in oral health promotion including oral health risk assessment, guidance on evidence based up-to-date prevention measures, increasing the dental attendance prevalence at early stages and awareness of including specific oral health guidelines/fact sheets into their regular practice.

The cost-effectiveness of smoking cessation services provided by general dental practice, general medical practice, pharmacy and NHS Stop Smoking Services in the North of England.

OBJECTIVES: To compare the cost-effectiveness of smoking cessation services in general dental practice (dental), general medical practice (GMP), pharmacy and NHS Stop Smoking Services (NHS SSS) from the perspective of the provider and the perspective of the NHS. METHODS: Retrospective monitoring data from NHS Bradford were accessed for any client attending a smoking cessation advisor within one of four commissioned smoking cessation services delivered by and within dental, GMP, pharmacy and NHS SSS (July 2011-December 2011). The treatment outcome of interest was 'quits' (effectiveness), and costs were assessed using incremental cost-effectiveness ratios (ICER) which compared each service setting against usual care (NHS SSS). All data were analysed using SPSS 19. RESULTS: For verified quits, only pharmacy services showed a lower mean cost per client and a higher proportion of CO verified quits than the other services. For both verified and self-reported quits dental services showed a slightly higher proportion of quits than NHS SSS; however, the mean cost per client was higher (£278.38 for an increase in quits of 1%). The GMP services were dominated by the NHS SSS, in as much as they were both less effective (a smaller proportion of quits and more expensive). This finding also holds true when we compared GMP services and pharmacy services. CONCLUSIONS: From the perspective of the service provider and the NHS, the service considered to be 'cost-effective' when compared with 'usual care' (NHS SSS) was pharmacy services. This research has identified variations in service costs and effectiveness of services through the analysis of a pragmatic data set. Given the exploratory nature of this research, further research should explore the impact of service/location selection on uptake and cessation rates.

INVESTIGATING THE MANAGEMENT OF CARIOUS PRIMARY TEETH IN GENERAL DENTAL PRACTICE: AN OVERVIEW OF THE DEVELOPMENT AND CONDUCT OF THE FICTION TRIAL.

The management of carious primary teeth is a challenge for patients, parents and clinicians. Most evidence supporting different management strategies originates from a specialist setting and therefore its relevance to the primary care setting is questionable. The UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) has commissioned the FiCTION (Filling Children's Teeth: Indicated Or Not?) trial; a multi-centre primary dental care randomised controlled trial (RCT) to determine the most clinically and cost- effective approach to managing caries in the primary dentition in the UK. This large trial began in 2012, is due to be completed in late 2017 and involves 72 practices and 1,124 children initially aged three to seven years with dentine caries, following randomisation to one of three caries management strategies. Clinical, radiographic, quality of life, treatment acceptability and health economics data are collected during the three-year follow up period. This article provides an overview of the development and conduct of FiCTION and discusses some approaches adopted to manage challenges and achieve the patient recruitment target.

The INCENTIVE protocol: an evaluation of the organisation and delivery of NHS dental healthcare to patients-innovation in the commissioning of primary dental care service delivery and organisation in the UK.

INTRODUCTION: In England, in 2006, new dental contracts devolved commissioning of dental services locally to Primary Care Trusts to meet the needs of their local population. The new national General Dental Services contracts (nGDS) were based on payment for Units of Dental Activity (UDAs) awarded in three treatment bands based on complexity of care. Recently, contract currency in UK dentistry is evolving from UDAs based on volume and case complexity towards 'blended contracts' that include incentives linked with key performance indicators such as quality and improved health outcome. Overall, evidence of the effectiveness of incentive-driven contracting of health providers is still emerging. The INCENTIVE Study aims to evaluate a blended contract model (incentive-driven) compared to traditional nGDS contracts on dental service delivery in practices in West Yorkshire, England. METHODS AND ANALYSIS: The INCENTIVE model uses a mixed methods approach to comprehensively evaluate a new incentive-driven model of NHS dental service delivery. The study includes 6 dental surgeries located across three newly commissioned dental practices (blended contract) and three existing traditional practices (nGDS contracts). The newly commissioned practices have been matched to traditional practices by deprivation index, age profile, ethnicity, size of practice and taking on new patients. The study consists of three interlinked work packages: a qualitative study to explore stakeholder perspectives of the new service delivery model; an effectiveness study to assess the INCENTIVE model in reducing the risk of and amount of dental disease and enhance oral health-related quality of life in patients; and an economic study to assess cost-effectiveness of the INCENTIVE model in relation to clinical status and oral health-related quality of life. ETHICS AND DISSEMINATION: The study has been approved by NRES Committee London, Bromley. The results of this study will be disseminated at national and international conferences and in international journals.

The FiCTION dental trial protocol - filling children's teeth: indicated or not?

BACKGROUND: There is a lack of evidence for effective management of dental caries (decay) in children's primary (baby) teeth and an apparent failure of conventional dental restorations (fillings) to prevent dental pain and infection for UK children in Primary Care. UK dental schools' teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed. However, the evidence base for this is limited in volume and quality, and comes from studies conducted in either secondary care or specialist practices. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned. The FiCTION trial addresses the Health Technology Assessment (HTA) Programme's commissioning brief and research question "What is the clinical and cost effectiveness of restoration caries in primary teeth, compared to no treatment?" It compares conventional restorations with an intermediate treatment strategy based on the biological (sealing-in) management of caries and with no restorations. METHODS/DESIGN: This is a Primary Care-based multi-centre, three-arm, parallel group, patient-randomised controlled trial. Practitioners are recruiting 1461 children, (3-7 years) with at least one primary molar tooth where caries extends into dentine. Children are randomized and treated according to one of three treatment approaches; conventional caries management with best practice prevention, biological management of caries with best practice prevention or best practice prevention alone. Baseline measures and outcome data (at review/treatment during three year follow-up) are assessed through direct reporting, clinical examination including blinded radiograph assessment, and child/parent questionnaires. The primary outcome measure is the incidence of either pain or infection related to dental caries. Secondary outcomes are; incidence of caries in primary and permanent teeth, patient quality of life, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists' preferences. DISCUSSION: FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children's primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth. The trial is currently recruiting patients. TRIAL REGISTRATION: Protocol ID: NCTU: ISRCTN77044005.

The management of dental caries in primary teeth - involving service providers and users in the design of a trial.

BACKGROUND: There is a lack of evidence for the effective management of dental caries in children's primary teeth. The trial entitled 'Filling Children's Teeth: Indicated Or Not?' (FiCTION) was designed to examine the clinical and cost effectiveness, in primary dental care, of three different approaches to the management of caries in primary teeth. However, before the FiCTION main trial commenced, a pilot trial was designed. Service provider (dentists and other members of the team including dental nurses and practice managers) and participant (child participants and their parents) involvement was incorporated into the pilot trial. The aim of this study is to describe service providers' and users' perspectives on the pilot trial to identify improvements to the conduct and design of the FiCTION main trial. METHODS: Qualitative interviews (individual and group) were held with dentists, dental team members, children and parents involved in the FiCTION pilot trial. Individual interviews were held with four dentists and a group interview was held with 17 dental team members. Face-to-face interviews were held with four parents and children (four- to eight-years old) representing the three arms of the trial and five telephone interviews were conducted with parents. All interviews were transcribed verbatim. Framework analysis was used. RESULTS: Overall, service providers, children and parents found the pilot trial to be well conducted and an interesting experience. Service providers highlighted the challenges of adhering to research protocols, especially managing the documentation and undertaking new clinical techniques. They indicated that the time and financial commitments were greater than they had anticipated. Particular difficulties were found recruiting suitable patients within the timeframe. For parents recruitment was apparently more related to trusting their dentist than the content of information packs. While some of the older children understood what a study was, others did not understand or were not aware they were enrolled. CONCLUSIONS: The findings provided valuable recommendations to improve the method of recruitment of dental practices and patients, the timing and content of the training, the type of support dentists would value and ways to further engage children and parents in the FiCTION main trial. TRIAL REGISTRATION: ISRCTN77044005.

The feasibility of data collection in dental practices, using codes for the International Caries Detection and Assessment System (ICDAS), to allow European general dental practitioners to monitor dental caries at local, national, and international levels.

AIM: To determine whether or not European general dental practitioners can carry out comprehensive dental caries assessments of the teeth of selected quotas of their patients during routine dental check-ups, as an alternative or complement to the work of specialised, salaried, dental epidemiologists. METHODS: Dentists from several European countries were invited by local coordinators to be trained to carry out dental disease assessments. For caries, they used the International Caries Detection and Assessment System (ICDAS), as part of a wider oral health indicators project with a European perspective. They attended training events and recruited and examined patients in their own practices before completing questionnaires, which they returned to a central data-processing facility. RESULTS: Ninety-six dentists returned questionnaires giving their opinions of the data-collection system after performing ICDAS assessments on 1216 patients. Mean times for assessments varied between countries from 7.8 to 14.06 minutes and were dependent on the age of the patient and the number and general condition of the teeth present. Given a choice of six difficulty/ease options for both understanding and applying the system, 89% of the dental examiners chose one of the two categories indicating the least difficulty for understanding and 73% chose one of these two categories for applying. CONCLUSION: Volunteer general dental practitioners (GDPs) from six European countries were able successfully to perform data collection for survey work in addition to their routine practice. If larger numbers of GDPs across Europe are prepared to undertake this type of work for selected quota samples, it should be possible to collect data to monitor caries levels among patients who attend dental practices at local, national, and international levels, provided that the time taken is considered and remunerated appropriately.

Urban-rural differences in dental caries of 5-year old children in Scotland.

Previous research suggests there are significant differences between urban and rural areas in Scotland for health outcomes including heart disease, cancer and self reported health. The aim of this study was to describe the contemporary urban/rural variation in obvious decay experience amongst 5-year-olds in Scotland. Scotland was split into 6 geographies, ranging from 'The 4 Cities' (Glasgow, Edinburgh, Dundee and Aberdeen) to 'Remote Rural' areas. Data derived from the 2007/08 National Dental Inspection Programme, representative of the whole of Scotland, were modelled using Bayesian multilevel zero-inflated Negative Binomial and multilevel Poisson modelling, adjusting for age, sex and deprivation. The outcome variables modelled were d(3)mft (carious, extracted or filled deciduous teeth), d(3)t (carious teeth), mt (missing teeth, extracted due to caries) and ft (filled teeth). The proportion of 5-year old children in Scotland with d(3)mft = 0 was 58% in 2008. Adjusting for age and sex, the odds of a child in a Remote Rural area having d(3)mft>0 was 0.52 that of a city dweller. However, when deprivation was included in the model, the odds of having d(3)mft >0 rose to 0.74. The odds of d(3)mft>0 in 'Accessible Rural' areas also remained significantly lower than in the 4 Cities after adjustment for deprivation. For those with d(3)mft>0, the relative risk of additional d(3)mft was also significantly lower in Remote Rural areas, however this was explained by deprivation, while in Accessible Rural areas this remained significant even after adjustment for deprivation. The odds of having any extractions was lower in Rural areas, even after adjustment for deprivation, while the Care Index (ft/d(3)mft) was higher in Remote Towns. Deprivation, therefore, accounted for much but not all of the geographical difference in d(3)mft which exist in Scotland. Children in Remote and Rural areas appear to have better dental health and a higher proportion of filled teeth when compared with those living in Cities. Possible reasons for these differences and recommendations for future research are discussed.

The use of the International Caries Detection and Assessment System (ICDAS) in a National Health Service general dental practice as part of an oral health assessment.

INTRODUCTION: The Scottish Dental Clinical Effectiveness Programme (SDCEP) is developing guidance for oral health assessment and review that is intended for use in National Health Service (NHS) general dental practice. One section of this guidance is assessment of the teeth, including their caries status. The detailed caries assessment method identified by the guidance group is the International Caries Detection and Assessment System (ICDAS). AIM: The aim of this study was to investigate the implications of using the ICDAS in an NHS general practice and, in particular, the time taken to use the system. METHOD: After online and in-practice training and calibration, 50 adult and 50 child patients were randomly allocated for assessment using the ICDAS detection codes. The ICDAS protocol states that the teeth should be clean and dry. For this study, all patients had their teeth brushed by the dentist before the assessment and the results were recorded on draft ICDAS clinical pro forma sheets. The time taken for the assessment was assessed with a stopwatch and recorded in a spreadsheet program. RESULTS: The results showed that the mean time for the assessment of an adult was 3.80 minutes, or 4.99 minutes if the time for pre-examination cleaning and drying was included. For a child, the mean time was 2.53 minutes, or 3.99 minutes if pre-examination brushing time was included. CONCLUSIONS: These results indicate that with training and experience, it is possible to carry out an ICDAS assessment in a time that is practical in general dental practice.