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 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.

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:

Cost-effectiveness of an experimental caries-control regimen in a 3.4-yr randomized clinical trial among 11-12-yr-old Finnish schoolchildren.

The aim of this study was to assess the cost-effectiveness of an experimental caries-control regimen in a randomized clinical trial (RCT) conducted in Pori, Finland, in 2001-2005. Children (n = 497) who were 11-12 yr of age and had at least one active initial caries lesion at baseline were studied. The children in the experimental group (n = 250) were offered an individually designed patient-centered regimen for caries control. The children in the control group (n = 247) received standard dental care. Furthermore, the whole population was exposed to continuous community-level oral health promotion. Individual costs of treatment procedures and outcomes (DMFS increment score) for the follow-up period of 3.4 yr were calculated for each child in both groups. The incremental cost-effectiveness ratio was euro 34.07 per averted DMF surface. The experimental regimen was more effective, and also more costly. However, the total costs decreased year after year, and for the last 2 yr the experimental regimen was less expensive than the standard dental care. The experimental regimen would probably have been more cost-effective than standard dental care if the follow-up period had been longer, the regimen less comprehensive, and/or if dental nurses had conducted the preventive procedures.

Utilization of toothpaste and fluoride content in toothpaste manufactured in Tanzania.

OBJECTIVE: To determine the use of toothpaste, the reasons behind its irregular use, the cost perceptions, and the fluoride concentrations in locally manufactured toothpaste. MATERIAL AND METHODS: A total of 978 dental patients attending 13 dental clinics for 2 weeks in June 2007 completed a pre-tested questionnaire on toothpaste use. Toothpaste was collected from shops in Dar es Salaam and analyzed at the laboratory of the Dental School in Amsterdam. Logistic regression was applied to determine the relative importance of independent variables on usage and perceptions about the cost of toothpaste. RESULTS: Eighty-six percent of respondents used toothpaste daily. Of the 130 who used toothpaste less than once a day, 57.7% gave financial reasons for their irregular use. Toothpaste was perceived as expensive by 34.8% of respondents. Urban residents were five times more likely than rural residents to use toothpaste. Younger respondents were more likely than older respondents: to perceive toothpaste as important, to brush their teeth, to use toothpaste, and to brush their teeth regularly. All toothpaste manufactured in Tanzania had free fluoride concentrations below 400 ppm. CONCLUSIONS: Most respondents used toothpaste regularly and one-third regarded it as expensive. Toothpaste manufactured in Tanzania had free fluoride concentrations below the optimum levels for dental caries prevention. For a well-functioning Basic Package of Oral Care, the authority responsible for oral health has to take measures aimed at lowering the price of toothpaste, and toothpaste manufacturers have to ensure that their products have the optimal fluoride concentration for dental caries prevention.

Correlates of dental caries in 12-year-old children in Europe: a cross-sectional analysis.

OBJECTIVE: To investigate, from current cross-sectional data, the relationships between dental caries experience of 12-year-old children in 29 countries of Europe and four independent variables: national wealth (GDP), expressed as purchasing power parity (PPP x 1,000US$)/ capita/year; population per active dentist; sugar consumption, expressed as Kg/capita/year; and volume sales of toothpaste, expressed as litres/capita/year. METHOD: Most of the data were abstracted from relevant websites. Information on toothpaste sales was from personal communication and obtainable for 16 countries of Western Europe only. Relationships were examined using Spearman's rank correlation method. RESULTS: Mean DMFT showed a strong negative association with national GDP (rho = -0.729, p < 0.01), whilst toothpaste sales showed a statistically significant positive association with GDP (rho = 0.599, p < 0.05) as did sugar consumption (rho = 0.575, p < 0.01). Paradoxically, caries experience yielded a strong negative correlation with sugar consumption (rho = -0.561, p < 0.01) such that ranked increases in mean DMFT were significantly associated with decreasing levels of sugar consumption. None of the other rank correlations was statistically significant. CONCLUSIONS: Unavoidable shortcomings of the available data and their incompleteness meant that any conclusions that could be drawn were speculative. A possible explanation for the anomalous association of low mean DMFT with high sugar consumption in Western Europe is that the extensive use of, mainly fluoride containing, toothpaste neutralises the potential damage from high sugar consumption. Use of sugar principally as a commercial food or drink additive in modern times, with potential for buffering of its acidic fermentation products, together with a possibly more rapid oral clearance of sugar in additive form, may also be a contributory factor.

A cost-benefit analysis of an advocacy project to fluoridate toothpastes in Nepal.

OBJECTIVES: The aim of this paper is to provide a limited cost-benefit analysis of a health promotion project based on advocacy to increase the availability and consumption of fluoride toothpaste. BASIC RESEARCH DESIGN: The cost-benefit analysis method uses the cost-of-illness approach to analyse the costs and benefits of the health promotion project. SETTING: The setting for the health promotion project was the country of Nepal. PARTICIPANTS: A sub-set of the population (6-18 year-olds) was used to compute the financial burden of treating projected caries in the permanent dentition. INTERVENTIONS: The paper compares the projected effect of fluoride toothpaste versus non-fluoride toothpaste on the financial burden of dental caries for a sub-set of the Nepali population over a period of 6 years. OUTCOME MEASURES: The net present value (NPV) and the benefit-cost ratio are the main outcome measures. RESULTS: Over a period of 6 years the NPV was US dollar 594,466 for a projected 10% reduction in dental caries of this population group as a result of fluoridation of toothpastes: US dollar 1,035,640 for a projected 20% reduction; and US dollar 2,442,333 for a projected 40% reduction in caries increment. For every US dollar 1 spent on the advocacy project to increase the availability and consumption of fluoride toothpaste, there is a potential saving in the direct cost of treating caries ranging from US dollar 87 to US dollar 356. CONCLUSIONS: The cost benefit analysis presented shows the project was efficient. Tangible benefits resulting from the intervention of fluoride toothpaste were quantified as well as the risks from having no intervention.

An assessment of the cost effectiveness of a postal toothpaste programme to prevent caries among five-year-old children in the North West of England.

OBJECTIVE: To assess the cost effectiveness of a postal toothpaste programme to prevent caries in 5-year-old children in the north west of England. PARTICIPANTS: Birth cohorts of children aged 12 months were recruited from high caries risk populations in nine health districts. DESIGN: The results of a randomised controlled trial to measure the effects of a postal toothpaste programme are used and related to the costs of running a similar programme. Children in the trial received free toothpaste on four occasions a year and a toothbrush once a year for four years from age 12 months to 5 years. When aged 5-6 years children were examined by trained, calibrated examiners using BASCD standards. Those who received toothpaste containing 1450 ppm F were found to have a significantly lower mean dmft than those who had not. The costs that would be incurred by a public dental service running such a postal toothpaste programme are identified, measured and related to the likely health improvement that could be achieved. MAIN OUTCOME MEASURES: The cost per tooth saved and the cost per child saved from caries experience and extraction experience. RESULTS: The estimated cost per tooth saved from carious attack was pounds sterling 80.83 and the cost per child of preventing caries experience was pounds sterling 424.38 and avoiding any extractions was pounds sterling 679.01. Analysis resulted in an overestimation of costs and underestimation of benefits. CONCLUSION: The programme achieved a significant caries reduction in children who received the 1450 ppm F toothpaste and the costs are now available to those considering provision of treatment services in areas where children are at high caries risk.

An advocacy project to fluoridate toothpastes in Nepal.

AIMS: To describe a recent health promotion project undertaken by the United Mission to Nepal Oral Health Programme (UMN OHP) to increase the availability and consumption of affordable, fluoridated toothpaste in Nepal. METHOD: The process of advocating for the fluoridation of toothpastes in Nepal is based on Tearfund's advocacy cycle. RESULTS: The project achieved health promotion outcomes including healthy corporate and public policies and organisational practice and intermediate outcomes such as increased availability and consumption of affordable fluoridated toothpaste. Prior to implementation of the advocacy project in 1997, availability and consumption of fluoridated toothpaste was negligible. By March 2002 total market share of fluoridated toothpaste was approximately 90%. This represents an annual tonnage of 900 tons of fluoridated toothpaste. CONCLUSIONS: The health promotion activity of advocacy for the fluoridation of toothpastes in Nepal achieved measurable gains in health promotion outcomes and intermediate outcomes. Gains in health and social outcomes will take longer to evaluate but based on epidemiological evidence and the experience of other countries increased availability of affordable fluoridated toothpaste will have a significant and ongoing impact on the oral health of the people of Nepal.

A randomised controlled trial of the effectiveness of providing free fluoride toothpaste from the age of 12 months on reducing caries in 5-6 year old children.

OBJECTIVE: To assess the impact of regularly supplying free fluoride toothpaste regularly to children, initially aged 12 months, and living in deprived areas of the north west of England on the level of caries in the deciduous dentition at 5-6 years of age. A further aim was to compare the effectiveness of a programme using a toothpaste containing 440 ppmF (Colgate 0-6 Gel) with one containing 1,450 ppmF (Colgate Great Regular Flavour) in reducing caries. DESIGN: Randomised controlled parallel group clinical trial. Clinical data were collected from test and control groups when the children were 5-6 years old. SETTING: A programme of posting toothpaste with dental health messages to the homes of children initially aged 12 months. Clinical examinations took place in primary schools. PARTICIPANTS: 7,422 children born in 3-month birth cohorts living in high caries areas in nine health districts in north west England. Within each district children were randomly assigned to test or control groups. INTERVENTIONS: Toothpaste, containing either 440 ppmF or 1450 ppmF, and dental health literature posted at three monthly intervals to children in test groups until they were aged 5-6 years. MAIN OUTCOME MEASURES: The dmft index, missing teeth and the prevalence of caries experience. RESULTS: An analysis of 3,731 children who were examined and remained in the programme showed the mean dmft to be 2.15 for the group who had received 1,450 ppmF toothpaste and 2.49 for the 440 ppmF group. The mean dmft for the control group was 2.57. This 16% reduction between the 1,450 ppmF and control group was statistically significant (P<0.05). The difference between the 440 ppmF group and control was not significant. Further analyses to estimate the population effect of the programme also confirmed this relationship. CONCLUSION: This study demonstrates that a programme distributing free toothpaste containing 1,450 ppmF provides a significant clinical benefit for high caries risk children living in deprived, non-fluoridated districts.

The role of fluoride dentifrices in a national strategy for the oral health of children.

The Department of Health's recent publication 'An Oral Health Strategy for England' proposes a number of targets for improving the oral health of children by the year 2003. It recognises that the prevalence and severity of dental caries have decreased considerably in England over the last 25 years but, water fluoridation apart, it suggests no specific measures to ensure that this improvement continues. There is evidence to suggest that in many regions this will not be sufficient, and that in the medium term a more coordinated approach involving government, the profession and commerce is required.