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.

Economic Evaluations of Preventive Interventions for Dental Caries and Periodontitis: A Systematic Review.

OBJECTIVES: To critically examine the methods used for full economic evaluations of preventive interventions for dental caries and periodontitis. METHODS: Published literature post-2000 was searched to April 2021. Based on a developed intervention classification framework for dental caries and periodontitis, only universal, selective or indicated interventions were included in this review. The Drummond 10-point checklist was used for quality appraisal. RESULTS: Of 3,007 unique records screened for relevance, 73 studies were reviewed. Most model-based studies (61/73) used cost-effectiveness analysis (49%) or cost-benefit analysis (28%). Trial-based studies (16/73) commonly used cost-effectiveness analysis (59%). Four studies used both economic evaluation methods. Sixty-four papers (88%) were on dental caries, eight papers (11%) focused on periodontitis, and one paper (1%) included both oral diseases; 72% of model-based and 82% of trial-based studies were of good quality. The most frequently investigated dental caries preventive interventions were water fluoridation (universal intervention; cost-saving or cost-effective), fissure sealant and fluoride varnish (selective and indicated interventions; cost-effectiveness outcomes were inconsistent). Supportive periodontal therapy with oral health education (indicated intervention; cost-effective) was the most frequently evaluated preventive intervention for periodontitis. Thirty percent of studies with a time horizon > 1 year did not apply an appropriate discount rate and 26% did not comprehensively discuss other important considerations beyond the technical analysis. CONCLUSIONS: Generic health outcome measures should be incorporated for economic evaluations on preventive interventions for dental caries and periodontitis, and an increased focus to prevent periodontitis using economic evaluation methods is needed to inform resource allocation and policy decision-making.

System dynamics modeling for tooth decay treatment in Brazilian children.

Prevention and health promotion are considered important strategies to control oral diseases. Dental caries is preventable disease and remains the most common chronic disease that affects mainly low income children and still considered the main cause of tooth loss in adulthood in Brazil. The aim of this study is to present a System Dynamics model (SDM) specifically developed with the Stella Architect software to estimate the cost and clinical hours required to control the evolution of dental caries in preschool children in Maringá, Brazil. Two main strategies to control caries were considered in the model: the application of fluoride varnish on teeth presenting white spots, and the use of Atraumatic Restorative Treatment (ART) in cavitated carious lesions without pulp involvement. The parameters used in the model were: number of people covered by a local oral health team = 4,000; number of children up to 5 years = 7% of the population; children's decayed, missing, filled teeth (dmft) index = 2.4; time/cost of 4 applications of fluoride varnish = 5 minutes/US$ 0.716; and time/cost of each ART restoration = 15 minutes/US$ 1.475. The SDM generated an estimated total cost of US$698.00, and a total of 112 clinical hours to treat the population in question. The use of the SDM presented here has the potential to assist decision making by measuring the material and human resources required to prevent and control dental caries at an early age.

A Markov cost-effective analysis of biannual fluoride varnish for preventing dental caries in permanent teeth over a 70-year time horizon.

ISSUE ADDRESSED: Biannual application of fluoride varnish is effective for dental caries prevention, but its cost-effectiveness using quality-adjusted life years (QALY) is unknown. This study performed a cost-effectiveness analysis, from the Australian health care system perspective of biannual application of fluoride varnish versus current practice (non-routine application) for an individual aged 15 years and older over a 70-year time horizon. METHODS: Health outcomes measured were the number of prevented decayed, missing, and filled teeth (prevented-DMFT) and QALY gained. The calculated incremental cost-effectiveness ratio (ICER) was compared against the reference cost-effectiveness ICER threshold of AUD$28 033 per QALY gained. A published Markov model capturing dental caries progression of eight permanent molars was used. This 6-monthly cycle model represented ten possible health states for an individual tooth. A 5% discount rate was applied with relevant sensitivity analysis. RESULTS: In the base-case scenario, the net cost for the intervention was $3600 compared to $2303 in the current practice arm. The intervention arm yielded 13.99 DMFT and 15.44 QALY gained, whereas the current practice arm yielded 15.52 DMFT and 14.74 QALY gained. The estimated ICER was $849 per prevented-DMFT and $1851 per QALY gained. Sensitivity analysis shows the ICER ranged from $424-$1807 per prevented-DMFT and $1851-$3941 per QALY gained. CONCLUSION: Biannual professional application of fluoride varnish appears to be a highly cost-effective strategy and should be considered for universal funding in Australia's health care system.

System dynamics modeling for tooth decay treatment in Brazilian children

Abstract Prevention and health promotion are considered important strategies to control oral diseases. Dental caries is preventable disease and remains the most common chronic disease that affects mainly low income children and still considered the main cause of tooth loss in adulthood in Brazil. The aim of this study is to present a System Dynamics model (SDM) specifically developed with the Stella Architect software to estimate the cost and clinical hours required to control the evolution of dental caries in preschool children in Maringá, Brazil. Two main strategies to control caries were considered in the model: the application of fluoride varnish on teeth presenting white spots, and the use of Atraumatic Restorative Treatment (ART) in cavitated carious lesions without pulp involvement. The parameters used in the model were: number of people covered by a local oral health team = 4,000; number of children up to 5 years = 7% of the population; children's decayed, missing, filled teeth (dmft) index = 2.4; time/cost of 4 applications of fluoride varnish = 5 minutes/US$ 0.716; and time/cost of each ART restoration = 15 minutes/US$ 1.475. The SDM generated an estimated total cost of US$698.00, and a total of 112 clinical hours to treat the population in question. The use of the SDM presented here has the potential to assist decision making by measuring the material and human resources required to prevent and control dental caries at an early age.

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.

Study protocol of the cost-effectiveness comparison of two preventive methods in the incidence of caries: A randomized, controlled clinical trial.

INTRODUCTION: Dental caries is the most frequent oral disease worldwide and the main cause of tooth loss in children and young adults. One of the most frequently affected areas is the occlusal surfaces of the first permanent molars (FPM) due to their morphological complexity. At present, several preventive treatments can reduce the incidence of this disease in school populations. In Mexico, the most commonly used technologies are those derived from some presentation of fluoride; on the other hand, research on this topic has been limited. OBJECTIVE: To determine the cost-effectiveness of two different methods for preventing the incidence of caries on the FPM of schoolchildren (6-8 years of age) from public primary schools. MATERIAL AND METHODS: This is a randomized experimental design. Participants will be assigned to two treatment groups of 114 each. In the first group, pit and fissure sealants will be applied, whereas the second group will receive a fluoride varnish. The work will be carried out in schoolchildren that attend public elementary schools in the state of Hidalgo, Mexico. The result variable will be the incidence of caries and the total cost of each of the interventions will be calculated in order to calculate the intervention's cost-effectiveness. CONCLUSION: This work will allow us to compare the cost-effectiveness of the pit and fissure sealants and the fluoride varnish in order to determine which offers the best results.

Cost-Savings of Fluoride Varnish Application in Primary Care for Medicaid-Enrolled Children in Virginia.

OBJECTIVES: To determine the cost-benefit of fluoride varnish application during pediatric well-visits for the Medicaid/Children's Health Insurance Program population in Virginia (VA) from a Medicaid payer perspective. To provide initial cost estimates from the primary care provider (PCP) perspective. STUDY DESIGN: A systematic search of recent literature was completed to obtain input data for a Monte Carlo cost-benefit simulation and for the fluoride varnish application time, labor, and materials costs for PCPs. The analysis was conducted from a Medicaid perspective; costs and savings related to fluoride varnish application in primary dentition through 7.5 years were calculated for all Medicaid-eligible children up to 3 years of age in VA. Sensitivity analysis was performed to mitigate the effects of parameter uncertainty. RESULTS: Delivering fluoride varnish to all children <3 years old in VA who annually receive well-visits through Medicaid but did not receive fluoride varnish at those visits would reduce the percent of 7.5 year olds with decay from 63.2% to 39.8%. Accounting for averted restoration cost, PCP fluoride varnish application would save $75.32 per child, or a total population savings of almost $2 million/year for VA Medicaid. From the PCP perspective, the Medicaid reimbursement rate for fluoride varnish is 3.8-12.0 times the direct fluoride varnish application cost (labor and materials). CONCLUSIONS: Application of fluoride varnish by a PCP to children under 3 years of age is cost-saving in this study population. Costs to provide fluoride varnish from the PCP perspective are favorable compared with the Medicaid reimbursement, but additional studies on optimizing fluoride varnish application into the well-visit workflow are needed.

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-effectiveness of caries-preventive fluoride varnish applications in clinic settings among patients of low, moderate and high risk.

OBJECTIVES: The total body of evidence finds fluoride varnish effective to prevent caries. However, most trials were conducted in high-risk populations, with more recent trials on low-risk groups finding a lower efficacy. We aimed to assess the cost-effectiveness of fluoride varnish application in clinic setting in populations with different caries risk. METHODS: A mixed public-private-payer perspective in the context of German health care was performed using a lifetime Markov model. Effectiveness data were derived from an update of the most recent systematic Cochrane review and synthesized in three different risk groups according to control group caries increment via random-effects meta-analysis. Varnish was assumed to be applied twice yearly between age 6 and 18 years. Teeth with carious defects would be treated restoratively and could experience further follow-up treatments. Costs were deduced from German fee item catalogues. Monte Carlo microsimulations were used for to analyse lifetime treatment costs and caries increment (Euro/Decayed, Missing, Filled Teeth (DMFT)). RESULTS: In low-risk groups, fluoride varnish was nearly twice as costly and minimally more effective (293 Euro, 8.1 DMFT) than no varnish (163 Euro, 8.5 DMFT). The incremental cost-effectiveness ratio (ICER) was 343 Euro spent per avoided DMFT. The ICER was lower in medium-risk (ICER 93 Euro/DMFT) and high-risk groups (8 Euro/DMFT). CONCLUSIONS: Application of fluoride varnish in the clinic setting is unlikely to be cost-effective in low-risk populations. There is the need to either target high-risk groups or to provide fluoride varnish at lower costs, possibly in nonclinic settings.

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.

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

BACKGROUND: Dental caries is the most common disease of childhood. The NHS guidelines promote preventative care in dental practices, particularly for young children. However, the cost-effectiveness of this policy has not been established. OBJECTIVE: To measure the effects and costs of a composite fluoride intervention designed to prevent caries in young children attending dental services. DESIGN: The study was a two-arm, parallel-group, randomised controlled trial, with an allocation ratio of 1 : 1. Randomisation was by clinical trials unit, using randomised permuted blocks. Children/families were not blinded; however, outcome assessment was blinded to group assessment. SETTING: The study took place in 22 NHS dental practices in Northern Ireland, UK. PARTICIPANTS: The study participants were children aged 2-3 years, who were caries free at baseline. INTERVENTIONS: The intervention was composite in nature, comprising a varnish containing 22,600 parts per million (p.p.m.) fluoride, a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m. fluoride; plus standardised, evidence-based prevention advice provided at 6-monthly intervals over 3 years. The control group received the prevention advice alone. MAIN OUTCOME MEASURES: The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were the number of decayed, missing or filled tooth surfaces in primary dentition (dmfs) in caries-active children, the number of episodes of pain, the number of extracted teeth and the costs of care. Adverse reactions (ARs) were recorded. RESULTS: A total of 1248 children (624 randomised to each group) were recruited and 1096 (549 in the intervention group and 547 in the control group) were included in the final analyses. A total of 87% of the intervention children and 85% of control children attended every 6-month visit (p = 0.77). In total, 187 (34%) children in the intervention group converted to caries active, compared with 213 (39%) in the control group [odds ratio (OR) 0.81, 95% confidence interval (CI) 0.64 to 1.04; p = 0.11]. The mean number of tooth surfaces affected by caries was 7.2 in the intervention group, compared with 9.6 in the control group (p = 0.007). There was no significant difference in the number of episodes of pain between groups (p = 0.81). However, 164 out of the total of 400 (41%) children who converted to caries active reported toothache, compared with 62 out of 696 (9%) caries-free children (OR 7.1 95% CI 5.1 to 9.9; p < 0.001). There was no statistically significant difference in the number of teeth extracted in caries-active children (p = 0.95). Ten children in the intervention group had ARs of a minor nature. The average direct dental care cost was £155.74 for the intervention group and £48.21 for the control group over 3 years (p < 0.05). The mean cost per carious surface avoided over the 3 years was estimated at £251.00. LIMITATIONS: The usual limitations of a trial such as generalisability and understanding the underlying reasons for the outcomes apply. There is no mean willingness-to-pay threshold available to enable assessment of value for money. CONCLUSIONS: A statistically significant effect could not be demonstrated for the primary outcome. Once caries develop, pain is likely. There was a statistically significant difference in dmfs in caries-active children in favour of the intervention. Although adequately powered, the effect size of the intervention was small and of questionable clinical and economic benefit. FUTURE WORK: Future work should assess the caries prevention effects of interventions to reduce sugar consumption at the population and individual levels. Interventions designed to arrest the disease once it is established need to be developed and tested in practice. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36180119 and EudraCT 2009-010725-39. 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. 20, No. 71. See the NIHR Journals Library website for further project information.

Cost-Effectiveness Analysis of Dental Sealants versus Fluoride Varnish in a School-Based Setting.

While sealants are more effective than fluoride varnish in reducing the development of new carious lesions on occlusal surfaces, and a course of treatment requires fewer clinical visits, they are more expensive per application. This analysis assessed which treatment is more cost-effective. We estimate the costs of sealants and fluoride varnish over a 4-year period in a school-based setting, and compare this to existing estimates of the relative benefits in terms of caries reduction to calculate the relative cost-effectiveness of these two preventive treatments. In our base case scenario, varnish is more cost-effective in preventing caries. Allowing for caries benefits to nonocclusal surfaces further improves the cost-effectiveness of varnish. Although we found that varnish is more cost-effective, the results are context specific. Sealants become equally cost-effective if a dental hygienist applies the sealants instead of a dentist, while varnish becomes increasingly cost-effective when making comparisons outside of a traditional dental clinic setting.

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.