Cost-effectiveness and cost-benefit analyses of fluoride varnish for caries prevention in Guangxi, China.

OBJECTIVES: The objectives of this study were to evaluate the cost-effectiveness and cost-benefit of fluoride varnish (FV) interventions for preventing caries in the first permanent molars (FPMs) among children in rural areas in Guangxi, China. METHODS: This study constituted a secondary analysis of data from a randomised controlled trial, analysed from a social perspective. A total of 1,335 children aged 6-8 years in remote rural areas of Guangxi were enrolled in this three-year follow-up controlled study. Children in the experimental group (EG) and the control group (CG) received oral health education and were provided with a toothbrush and toothpaste once every six months. Additionally, FV was applied in the EG. A decision tree model was developed, and single-factor and probabilistic sensitivity analyses were conducted. RESULTS: After three years of intervention, the prevalence of caries in the EG was 50.85%, with an average decayed, missing, and filled teeth (DMFT) index score of 1.12, and that in the CG was 59.04%, with a DMFT index score of 1.36. The total cost of caries intervention and postcaries treatment was 42,719.55 USD for the EG and 46,622.13 USD for the CG. The incremental cost-effectiveness ratio (ICER) of the EG was 25.36 USD per caries prevented, and the cost-benefit ratio (CBR) was 1.74 USD benefits per 1 USD cost. The results of the sensitivity analyses showed that the increase in the average DMFT index score was the largest variable affecting the ICER and CBR. CONCLUSIONS: Compared to oral health education alone, a comprehensive intervention combining FV application with oral health education is more cost-effective and beneficial for preventing caries in the FPMs of children living in economically disadvantaged rural areas. These findings could provide a basis for policy-making and clinical choices to improve children's oral health.

A cost-effectiveness analysis of fluoride varnish application in preventing Root caries in elderly persons: a Markov simulation study.

BACKGROUND: Root caries are prevalent issues that affect dental health, particularly among elderly individuals with exposed root surfaces. Fluoride therapy has shown effectiveness in preventing root caries, but limited studies have addressed its cost-effectiveness in elderly persons population. This study aimed to evaluate the cost-effectiveness of a fluoride treatment program for preventing root caries in elderly persons within the context of Chinese public healthcare. METHODS: A Markov simulation model was adopted for the cost-effectiveness analysis in a hypothetical scenario from a healthcare system perspective. A 60-year-old subject with 23 teeth was simulated for 20 years. A 5% sodium fluoride varnish treatment was compared with no preventive intervention in terms of effectiveness and cost. Tooth years free of root caries were set as the effect. Transition probabilities were estimated from the data of a community-based cohort and published studies, and costs were based on documents published by the government. The incremental cost-effectiveness ratio (ICER) was calculated to evaluate cost-effectiveness. Univariate and probabilistic sensitivity analyses were performed to evaluate the influence of data uncertainty. RESULTS: Fluoride treatment was more effective (with a difference of 10.20 root caries-free tooth years) but also more costly (with a difference of ¥1636.22). The ICER was ¥160.35 per root caries-free tooth year gained. One-way sensitivity analysis showed that the risk ratio of root caries in the fluoride treatment group influenced the result most. In the probabilistic sensitivity analysis, fluoride treatment was cost-effective in 70.5% of the simulated cases. CONCLUSIONS: Regular 5% sodium fluoride varnish application was cost-effective for preventing root caries in the elderly persons in most scenarios with the consideration of data uncertainty, but to a limited extent. Improved public dental health awareness may reduce the incremental cost and make the intervention more cost-effective. Overall, the study shed light on the economic viability and impact of such preventive interventions, providing a scientific basis for dental care policies and healthcare resource allocation.

Implementing Pediatric Fluoride Varnish Application in a Rural Primary Care Medical Office: A Feasibility Study.

INTRODUCTION: The objective of this study was to determine if the application of fluoride varnish (FV) to children 5 years and under was acceptable and practical for health care providers in a rural primary care office. METHODS: We employed a quasi-experimental study design comprised of providers who received education and training in FV application. Pre- and post-study surveys regarding barriers and facilitators were administered. Data was collected on the number of FV applications, time spent on procedure, perceived barriers, and overall cost. RESULTS: The total direct variable cost of providing FV was $4.35 per procedure, resulting in an $11.85 profit. FV application increased 9.57%. Potential barriers were lack of proper supplies, lack of adequate support staff, and lack of additional financial compensation for providers. DISCUSSION: FV application is a service that can be delivered in a rural practice with existing resources, but the initiative needs support from practice management.

Changes in Silver Diamine Fluoride Use and Dental Care Costs: A Longitudinal Study.

Purpose: This study evaluated the impact of silver diamine fluoride (SDF) by investigating coverage and reimbursement policies. Methods: We performed a population-level retrospective cohort analysis (N equals 117,599) using claims. We evaluated two policy events: (1) dental board approval permitting SDF use by expanded practice dental hygienists (EPDHs); (2) approval of SDF by Medicaid. Coincident with coverage, Advantage Dental Services instituted EPDH practice algorithms. To evaluate changes, we: estimated CDT code 1354 utilization and average quarterly costs; stratified the population into patients who initiated preventive care from an EPHD or dentist; estimated outcome differences with either policy in quarterly trends; and counted SDF use with claims by quarter and calculated utilization per 1,000 patients. Results: Average per-patient quarterly dental costs (June 2017) ranged from $384 to $423. SDF use grew associated with Medicaid policy: rates increased from $0.32 per 1,000 to $156 per 1,000 in six quarters. Care initiated by EPDHs had lower costs, with quarterly savings of $201 (P=0.011) per patient, without differences in SDF utilization. Conclusions: Policy makers can use our results to improve access and reduce costs. Clinical experts should address more clearly when SDF substitutes for or is used in conjunction with restorative treatment.

Economic evaluation of an expanded caries-preventive program targeting toddlers in high-risk areas in Sweden.

OBJECTIVE: To economically evaluate a caries-preventive program "Stop Caries Stockholm" (SCS) where a standard program is supplemented with biannual applications of fluoride varnish in toddlers and compared it with the standard preventive program. MATERIAL AND METHODS: Data from the cluster randomized controlled field trial SCS including 3403 children, conducted in multicultural areas with low socioeconomic status was used. The difference in mean caries increment between the examinations; when the toddlers were 1 and 3 years old, was outcome measure of the intervention. The program was evaluated from a societal as well as a dental health care perspective. The incremental cost-effectiveness ratio (ICER) was calculated as the incremental cost for each defs prevented. RESULTS: Average dental health care costs per child at age 3 years were EUR 95.77 for the supplemental intervention and EUR 70.52 for the standard intervention. The ICER was EUR 280.56 from a dental health care perspective and EUR 468.67 and considered high. CONCLUSIONS: The supplemental caries intervention program was not found to be cost-effective. The program raised costs without significantly reducing caries development. A better alternative use of the resources is recommended. TRIAL REGISTRATION: www.controlled-trials.com (ISRCTN35086887).

Cost-Effectiveness through the Dental-Health FRAMM Guideline for Caries Prevention among 12- to 15-Year-Olds in Sweden.

Since 2008, FRAMM has been a guideline for caries prevention for all 3- to 15-year-olds in the Västra Götaland Region in Sweden and a predominant part is school-based fluoride varnish applications for all 12- to 15-year-olds. The aims were to evaluate dental health-economic data among 12- to 15-year-olds, based on the approximal caries prevalence at the age of 12, and to evaluate cost-effectiveness. Caries data for 13,490 adolescents born in 1993 who did not take part and 11,321 adolescents born in 1998 who followed this guideline were extracted from dental records. Those with no dentin and/or enamel caries lesions and/or fillings on the approximal surfaces were pooled into the "low" subgroup, those with 1-3 into the "moderate" subgroup and those with ≥4 into the "high" subgroup. The results revealed that the low subgroup had a low approximal caries increment compared with the moderate and high subgroups during the 4-year study period. In all groups, there were statistically significant differences between those who took part in the guideline and those who did not. The analysis of cost-effectiveness revealed the lowest incremental cost-effectiveness ratio (ICER) for the high subgroup for decayed and/or filled approximal surfaces (DFSa) and approximal enamel lesions together and the highest ICER for the low subgroup for DFSa alone. To conclude, the FRAMM Guideline reduced the caries increment for adolescents with low, moderate and high approximal caries prevalence. The subgroup with the most favourable cost-effectiveness comprised those with a high caries prevalence at the age of 12.

Cost-Benefit Analysis of Providing Fluoride Varnish in a Pediatric Primary Care Office.

INTRODUCTION: The American Academy of Pediatrics and the U.S. Preventive Services Task Force, among others, call for the provision of fluoride varnish in the pediatric primary care setting, but many barriers exist to the implementation of such a service in this setting. Knowledge of costs and benefits is one such barrier. METHODS: A cost-benefit analysis of the implementation of a fluoride varnish program in a pediatric primary care office located in Volusia County, Florida was conducted with the assistance of the office manager and a nurse practitioner using data retrieved from the electronic health record program. RESULTS: Microsoft Excel was used to calculate estimated mean reimbursement data from the top insurers in this office for this service, and the data show a positive annual net income of $4,498 to $26,775, with an average potential annual net income of $15,637. CONCLUSIONS: The data from this cost-benefit analysis show a positive financial benefit as an incentive to implement a fluoride varnish program in this primary care pediatric office and serve as a solid foundation for a future quality improvement project to implement such a program.

Costs and Resource Use Among Child Patients Receiving Silver Nitrate/Fluoride Varnish Caries Arrest.

PURPOSE: The purpose of this study was to assess the impact of silver nitrate/fluoride varnish (SN/FV) on care costs. METHODS: A retrospective matched cohort study, using Oregon Medicaid claims (January 1, 2012 to December 31, 2014) for patients younger than 21 years old, compared patients treated with SN/FV to matched patients not treated with SN/FV. The number of services and costs were compared using student's t test and generalized estimating equation (GEE) regression models. RESULTS: Patients treated with SN/FV (n equals 4,612) and matched patients treated conventionally (n equals 13,498) averaged 28±7 (SD) months of continuous eligibility based on initial treatment date. The number of first-year services and total services over an average of 28 months were higher for patients treated with SN/FV (10.6 versus 6.7 in year one; 19.3 versus 8.8 overall; P<0.0001). Excluding diagnostic/preventive services, costs were higher in patients treated conventionally than patients treated with SN/FV in the first year. Overall costs were similar ($698 versus $707; P=.52). The average number of services was 58 percent higher (95 percent confidence interval [CI] 1.54 to 1.63) for patients treated with SN/FV, but costs remained similar. CONCLUSION: Patients treated with silver nitrate/fluoride varnish accrued a greater number of services and higher total costs over approximately 28 months but lower treatment costs than patients treated conventionally.

Seal or Varnish? A randomised controlled trial to determine the relative cost and effectiveness of pit and fissure sealant and fluoride varnish in preventing dental decay.

BACKGROUND: Fissure sealant (FS) and fluoride varnish (FV) have been shown to be effective in preventing dental caries when tested against a no-treatment control. However, the relative clinical effectiveness and cost-effectiveness of these interventions is unknown. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of FS and FV in preventing dental caries in first permanent molars (FPMs) in 6- and 7-year-olds and to determine their acceptability. DESIGN: A randomised controlled allocation-blinded clinical trial with two parallel arms. SETTING: A targeted population programme using mobile dental clinics (MDCs) in schools located in areas of high social and economic deprivation in South Wales. PARTICIPANTS: In total, 1016 children were randomised, but one parent subsequently withdrew permission and so the analysis was based on 1015 children. The randomisation of participants was stratified by school and balanced for sex and primary dentition baseline caries levels using minimisation in a 1 : 1 ratio for treatments. A random component was added to the minimisation algorithm, such that it was not completely deterministic. Of the participants, 514 were randomised to receive FS and 502 were randomised to receive FV. INTERVENTIONS: Resin-based FS was applied to caries-free FPMs and maintained at 6-monthly intervals. FV was applied at baseline and at 6-month intervals over the course of 3 years. MAIN OUTCOME MEASURES: The proportion of children developing caries into dentine (decayed, missing, filled teeth in permanent dentition, i.e. D4-6MFT) on any one of up to four treated FPMs after 36 months. The assessors were blinded to treatment allocation; however, the presence or absence of FS at assessment would obviously indicate the probable treatment received. Economic measures established the costs and budget impact of FS and FV and the relative cost-effectiveness of these technologies. Qualitative interviews determined the acceptability of the interventions. RESULTS: At 36 months, 835 (82%) children remained in the trial: 417 in the FS arm and 418 in the FV arm. The proportion of children who developed caries into dentine on a least one FPM was lower in the FV arm (73; 17.5%) than in the FS arm (82, 19.6%) [odds ratio (OR) 0.84, 95% confidence interval (CI) 0.59 to 1.21; p = 0.35] but the difference was not statistically significant. The results were similar when the numbers of newly decayed teeth (OR 0.86, 95% CI 0.60 to 1.22) and tooth surfaces (OR 0.85, 95% CI 0.59 to 1.21) were examined. Trial fidelity was high: 95% of participants received five or six of the six scheduled treatments. Between 74% and 93% of sealants (upper and lower teeth) were intact at 36 months. The costs of the two technologies showed a small but statistically significant difference; the mean cost to the NHS (including intervention costs) per child was £500 for FS, compared with £432 for FV, a difference of £68.13 (95% CI £5.63 to £130.63; p = 0.033) in favour of FV. The budget impact analysis suggests that there is a cost saving of £68.13 (95% CI £5.63 to £130.63; p = 0.033) per child treated if using FV compared with the application of FS over this time period. An acceptability score completed by the children immediately after treatment and subsequent interviews demonstrated that both interventions were acceptable to the children. No adverse effects were reported. LIMITATIONS: There are no important limitations to this study. CONCLUSIONS: In a community oral health programme utilising MDCs and targeted at children with high caries risk, the twice-yearly application of FV resulted in caries prevention that is not significantly different from that obtained by applying and maintaining FSs after 36 months. FV proved less expensive. FUTURE WORK: The clinical effectiveness and cost-effectiveness of FS and FV following the cessation of active intervention merits investigation. TRIAL REGISTRATION: EudraCT number 2010-023476-23, Current Controlled Trials ISRCTN17029222 and UKCRN reference 9273. 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. 21, No. 21. See the NIHR Journals Library website for further project information.

Outcomes and costs of pre-school and school-based fluoride varnish pilots.

Objective Fluoride varnish (FV) applications reduce the risk of dental decay in research trials. These pilots were conducted to test the feasibility and costs of providing FV applications in schools. Changes in dental decay levels were also monitored.Methods Data were collected on the proportion of children with dental decay, mean number of teeth affected and whether the child had attended for dental care. The cost of delivering the intervention was calculated.Results More children were reported to be attending for dental care by the end of the pilot than at the start. The proportion of children with dental decay and the mean number of teeth affected increased, but more children seemed to have received treatment. The intervention cost about £88 per child per year, with most of the costs due to the intensive efforts needed to recruit and maintain participation in the pilots.Conclusions Establishing community FV programmes requires significant investment and the long-term benefits in practice are unclear. If dental decay levels are to be reduced, there is a need to improve diets, alongside fluoride strategies. This may be best achieved by integrating oral health improvement programmes into other health programmes, particularly sugar-reduction strategies.

Use of caries prevention tools and associated caries risk in a suburban population of children in Nigeria.

AIMS: To determine the association between use of recommended oral self-care (ROSC) caries prevention tools and presence of dental caries in children resident in suburban Nigeria. METHODOLOGY: Secondary analysis was conducted for a dataset generated for 1-12 years old children recruited through a household survey. Information on use of ROSC caries prevention tools (brushing more than once a day, use of fluoridated toothpaste always, and eating sugary snacks between main meals less than once a day), use of oral health adjuncts (dental floss, mouth rinses, other tooth cleansing agents) and presence of caries were extracted. The odds of having caries when ROSC caries prevention tools were used singly or in combination, were determined using multivariate logistic regression adjusted for age and sex. RESULTS: The single or combined use of ROSC caries prevention tools had no statistically significant association with presence of caries. Brushing more than once a day reduced the odds of having caries while consumption of sugar between meals once a day or more increased the odds of having caries after adjusting for age and gender. The use of two ROSC caries prevention tools reduced the risk for caries (AOR 0.28; 95 % CI 0.05-1.53) when adjusted for age. The converse was observed when adjusted for gender (AOR 1.15; 95 % CI 0.38-3.45). The largest effect size was observed when sugary snacks were taken once a day or more between meals after adjusting for age (AOR 5.74; 95 % CI 0.34-96.11). CONCLUSION: The use of a combination of fluoridated toothpaste and twice-daily tooth brushing had the largest effect on reducing the chance for caries in children resident in Ile-Ife, Nigeria.

Effectiveness, cost-effectiveness and cost-benefit of a single annual professional intervention for the prevention of childhood dental caries in a remote rural Indigenous community.

BACKGROUND: The aim of the study is to reduce the high prevalence of tooth decay in children in a remote, rural Indigenous community in Australia, by application of a single annual dental preventive intervention. The study seeks to (1) assess the effectiveness of an annual oral health preventive intervention in slowing the incidence of dental caries in children in this community, (2) identify the mediating role of known risk factors for dental caries and (3) assess the cost-effectiveness and cost-benefit of the intervention. METHODS/DESIGN: The intervention is novel in that most dental preventive interventions require regular re-application, which is not possible in resource constrained communities. While tooth decay is preventable, self-care and healthy habits are lacking in these communities, placing more emphasis on health services to deliver an effective dental preventive intervention. Importantly, the study will assess cost-benefit and cost-effectiveness for broader implementation across similar communities in Australia and internationally. DISCUSSION: There is an urgent need to reduce the burden of dental decay in these communities, by implementing effective, cost-effective, feasible and sustainable dental prevention programs. Expected outcomes of this study include improved oral and general health of children within the community; an understanding of the costs associated with the intervention provided, and its comparison with the costs of allowing new lesions to develop, with associated treatment costs. Findings should be generalisable to similar communities around the world. The research is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), registration number ACTRN12615000693527; date of registration: 3rd July 2015.

[The cost-effectiveness evaluation of 2 caries prevention strategies compared with the standard approach]. / Een economische evaluatie van 2 cariëspreventieve strategieën vergeleken met standaardzorg.

A cost-effectiveness evaluation was conducted with a randomised controlled clinical trial of caries prevention measures among 6-year-old children who were assigned to either a control group or 1 of 2 experimental groups (IPFA: 2 extra professionally-delivered fluoride applications per year, or NOCTP: a non-operative caries treatment programme, like the one that was previously carried out in Nexø, Denmark. In order to determine the cost of the prevention of 1 DMFS in comparison with the control practice information on expenses incurred was collected for 3 years. The prevention of a single DMFS - depending on whether costs of dental treatment only were taken into consideration or also other social costs - were, in the IPFA programme, 269 and 1,369 euro respectively and, in the NOCTP programme, 30 and 100 euro respectively. On the basis of these results, it can be concluded that from both a dental and cost-effective perspective the NOCTP programme produces the most favourable results. Following the NOCTP strategy - during the 3-year period - just like following the IPFA approach was, however, more expensive than the standard approach.

Design of an innovative paediatric capitation payment approach for public sector dentistry: an Australian experience.

AIM: The aim of this study was to trial the methodology and administration processes of a public paediatric capitation programme provided in the period 1 July 2011 to 31 December 2011 through a Bachelor of Oral Health programme in rural New South Wales (NSW), Australia, where access to public dental services is limited. BASIC RESEARCH DESIGN: The principal structure of the programme was the development of three diagnostic pathways: active caries and pain (Pathway A); active caries and no pain (Pathway B); and no active caries and no pain (Pathway C). In 2011, de-identified treatment data for NSW public dental services' patients under 18 years of age were analysed to identify the top 10 dental treatment items. These items were clustered according to the mean decayed and/or filled surface of patients under 18 years of age who had decayed, filled or missing teeth. Each treatment item was allocated 60% of the 2011 Australian Government Department of Veteran Affairs Schedule of Fees. CLINICAL SETTING: The programme was trialled in Charles Sturt University dental facility in Wagga Wagga, NSW. PARTICIPANTS: The programme targeted patients in the following age groups: 0-5 years; 6-11 years; and 12-17 years. RESULT: The 6-month trial provided 361 patients with a capitation pathway, at a total cost of $47,567.90, averaging $131.76 per capitation pathway. The total number of items provided (n=2,070) equated to an average of 5.7 items per capitation diagnostic pathway. CONCLUSION: This model offered an early entry point for paediatric patients to access dental care that addressed their needs, whilst being flexible enough to be fiscally attractive.

Detecting and treating occlusal caries lesions: a cost-effectiveness analysis.

The health gains and costs resulting from using different caries detection strategies might not only depend on the accuracy of the used method but also the treatment emanating from its use in different populations. We compared combinations of visual-tactile, radiographic, or laser-fluorescence-based detection methods with 1 of 3 treatments (non-, micro-, and invasive treatment) initiated at different cutoffs (treating all or only dentinal lesions) in populations with low or high caries prevalence. A Markov model was constructed to follow an occlusal surface in a permanent molar in an initially 12-y-old male German patient over his lifetime. Prevalence data and transition probabilities were extracted from the literature, while validity parameters of different methods were synthesized or obtained from systematic reviews. Microsimulations were performed to analyze the model, assuming a German health care setting and a mixed public-private payer perspective. Radiographic and fluorescence-based methods led to more overtreatments, especially in populations with low prevalence. For the latter, combining visual-tactile or radiographic detection with microinvasive treatment retained teeth longest (mean 66 y) at lowest costs (329 and 332 Euro, respectively), while combining radiographic or fluorescence-based detections with invasive treatment was the least cost-effective (<60 y, >700 Euro). In populations with high prevalence, combining radiographic detection with microinvasive treatment was most cost-effective (63 y, 528 Euro), while sensitive detection methods combined with invasive treatments were again the least cost-effective (<59 y, >690 Euro). The suitability of detection methods differed significantly between populations, and the cost-effectiveness was greatly influenced by the treatment initiated after lesion detection. The accuracy of a detection method relative to a "gold standard" did not automatically convey into better health or reduced costs. Detection methods should be evaluated not only against their criterion validity but also the long-term effects resulting from their use in different populations.

A retrospective analysis of caries treatment and development in relation to assessed caries risk in an adult population in Sweden.

BACKGROUND: The Public Dental Service of Västerbotten County (Sweden) recommends using population-based prevention strategies combined with an individual strategy for high-risk patients to manage caries. To facilitate this management strategy, all patients are evaluated for their risk of developing caries in the coming year using defined criteria. Using caries risk scoring over a seven-year period, the present study evaluates prophylactic measures, caries development, and non-operative treatments in adult patients. METHODS: From all adult patients (25-65 years; n = 76 320) scored with a high caries risk in 2005 (baseline) and with a dental visit in 2011, 200 subjects were randomly selected. In addition, an equally sized control group with a no/low caries risk was selected. Information concerning dental status, counselling, treatments, visits, and costs were retrieved from dental records. RESULTS: Over the seven-year study period, subjects with high caries risk had significantly higher caries incidence in spite of shorter recall intervals, more dental appointments, and higher costs for dental care than subjects with no/low caries risk. Non-operative measures, such as additional fluoride and individual counselling on diet at baseline (2005), was higher in the high caries risk group, whereas information about basic prophylaxis and counselling on oral hygiene showed only small differences. The frequency of non-operative measures given during the seven-year study period to patients in the high caries risk group is considered to be remarkably low and improvement, determined as reclassification from high to no/low caries risk from 2005 to 2011, was seen in only 13% of the participants. CONCLUSIONS: This study formulated two major conclusions. First, adult patients with high or no/low caries represent different populations, that each contain distinct subpopulations, those who improve/impair or maintained their caries risk and disease progression. These groups need different strategies in disease treatment. Second, preventive measures and non-operative treatments were associated with improvements in caries risk and maintenance, but the extent to which such treatments were given to high caries risk subjects was unacceptably low. Improved adherence to the guidelines for caries treatment may reduce caries risk, visits to dental clinics, and costs for the patients.

Value for money: economic evaluation of two different caries prevention programmes compared with standard care in a randomized controlled trial.

A cost-effectiveness analysis was conducted during a 3-year randomized controlled clinical trial in a general dental practice in the Netherlands in which 230 6-year-old children (± 3 months) were assigned to either regular dental care, an increased professional fluoride application (IPFA) programme or a non-operative caries treatment and prevention (NOCTP) programme. Information on resource use during the 3-year period was documented by the dental nurse at every patient visit, such as treatment time, travel time and travel distance. Caries increment scores (at D3MFS level) were used to assess effectiveness. Cost calculations were performed using bottom-up micro-costing. Incremental cost-effectiveness ratios (ICERs) were expressed as additional average costs per prevented DMFS. The ICERs compared with regular dental care from a health care system perspective and societal perspective were, respectively, EUR 269 and EUR 1,369 per prevented DMFS in the IPFA programme, and EUR 30 and EUR 100 in the NOCTP programme. The largest investments for the NOCTP group were made in the first year of the study; they decreased in the second and equalled the costs of control group in third year of the study. From both medical and economic points of view, the NOCTP strategy may be considered the preferred strategy for caries prevention.

Protocol for "Seal or Varnish?" (SoV) trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay.

BACKGROUND: Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting. METHODS/DESIGN: The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6-7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and acceptability through acceptability scales, a schools questionnaire and interviews with children, parents, dentists, dental nurses and school staff. The primary outcome measure will be the proportion of children developing new caries on any one of up to four treated first permanent molars. DISCUSSION: The objectives of this study have been identified by the National Institute for Health Research as one of importance to the National Health Service in the UK. The results of this trial will provide guidance on which of these technologies should be adopted for the prevention of dental decay in the most susceptible tooth-surface in the most at risk children. TRIAL REGISTRATIONS: ISRCTN ref: ISRCTN17029222 EudraCT: 2010-023476-23 UKCRN ref: 9273.

Topical fluoride for preventing dental caries in children and adolescents.

The use of topically applied fluoride has been widely researched as a means to reduce the risk of dental caries in conjunction with other treatment modalities (mechanical oral hygiene, dietary control, antimicrobial intervention, pit and fissure sealants). There is overwhelming evidence that reports not only the significance and importance of the use of fluoride as a caries-preventive agent, but also how safe fluoride application is when used appropriately, particularly in higher risk individuals and populations. This paper reviews the caries-protective benefits of topical fluoride application in children and adolescents, with an emphasis on the clinical efficacy and safety of the vehicles by which fluoride is topically delivered. Fluoride toothpaste represents today the most cost-effective fluoride-delivery system in the oral cavity and its use should be the centerpiece in all caries-preventive strategies. On the other hand, mouthrinses, gels and varnishes currently represent adjuncts to toothpaste use and should be targeted towards individuals and groups at high risk of caries.

Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services.

BACKGROUND: Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. METHODS/DESIGN: A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group.The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will be obtained from parental questionnaires. DISCUSSION: This is a pragmatic trial conducted in general dental practice. It tests a composite caries prevention intervention, which represents an evidence based approach advocated by current guidance from the English Department of Health which is feasible to deliver to all low risk (caries free) children in general dental practice. The trial will provide valuable information to policy makers and clinicians on the costs and effects of caries prevention delivered to young children in general dental practice. TRIAL REGISTRATION: EudraCT No: 2009 - 010725 - 39 ISRCTN: ISRCTN36180119 Ethics Reference No: 09/H1008/93: