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NIHR Signal Fluoride-based treatments alone are not enough to stop tooth decay in young children

Published on 22 November 2016

doi: 10.3310/signal-000334

Providing a set of additional fluoride-based treatments at dental appointments for children aged two to three years was no better than health education at preventing tooth decay. A range of public health measures to reduce sugar consumption are also needed.

The treatment involved providing fluoride toothpaste and applying a fluoride varnish to the teeth at each six-monthly appointment for three years.

This large NIHR-funded trial in Northern Ireland found no difference in the number of children developing tooth decay, though children in the treatment arm had fewer teeth showing signs of decay. The estimated cost was £2,093 per child who avoided tooth decay.

The minimal effect reported in this study must be interpreted in light of the population-level benefits achieved with fluoride products to date. In addition, children from the most deprived areas were most likely to experience tooth decay and may be more likely to benefit from fluoride products. These children were under-represented in this study.

Dental practitioners should continue to follow Public Health England guidance and offer all children advice on fluoride-based products. It seems that healthy eating and particularly reductions in sugar consumption might also be part of the solution.

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Why was this study needed?

Around a third of 5 year-old children in England, Wales and Northern Ireland have tooth decay (caries) in their primary (baby) teeth. Children with tooth decay experience pain and are more likely to need teeth extracted, at significant cost to the NHS.

Tooth decay happens when mouth bacteria break down dietary sugars, producing acids that erode the tooth enamel. Fluoride toothpastes, mouth rinses and varnishes have been shown to prevent this process.

Guidance from Public Health England recommends that dentists offer all children advice on use of fluoride-based products, dental hygiene and eating healthily, avoiding sugary drinks for example.

However, this advice has improved dental health or social inequalities in outcomes as much as hoped for. So, these researchers were interested in seeing if delivering additional fluoride via varnish and free toothpaste to these children was more effective and cost effective.

What did this study do?

This study assessed whether a comprehensive fluoride intervention provided by dentists was effective at preventing tooth decay in young children. This randomised controlled trial recruited 1248 children aged 2-3 years from 22 NHS dental practices in Northern Ireland. All children were free from tooth decay at study start.

Half of the children were randomly assigned to receive the fluoride-based intervention. This involved applying a fluoride varnish to the teeth and providing a free fluoride toothpaste and toothbrush at every six-month check-up, for three years. They also received dental health education on optimal use of the toothpaste and restricting sugar consumption. The parents in the control group received health education alone.

The study had a large sample size and good follow-up rate, with around 86% of children attending every six-month check-up. Assessors were unaware of group allocation. However, the study had limited scope to understand all behaviours that may influence the results.

What did it find?

  • The fluoride-based intervention was no better than health education alone at preventing caries. Around a third of children in both the intervention (34%) and control groups (39%) developed caries in at least one tooth during the three-year study period (odds ratio 0.81, 95% confidence interval 0.64 to 1.04).
  • Among children who developed caries, the average number of affected tooth surfaces was significantly lower in the intervention group (7.2) than the control group (9.6). An adjusted mean difference of 2.29 fewer surfaces (95% CI 3.96 to 0.63 fewer). Toothache was more common among children who developed caries compared with those who didn’t, but there was no difference in pain rates between study groups.
  • There was little difference between groups in reported adverse effects (7.2% of the intervention group vs 5.9% of controls), and most adverse effects were considered unrelated to treatment. However, 10 children in the intervention group experienced minor effects that were attributed to treatment, including abdominal complaints.
  • The average total cost per child over the three-year study (including the cost of the intervention and any other dental care) was £1,027 in the intervention group and £816 in the control group. The cost of the intervention to prevent one child developing tooth decay was £2,093.
  • Across all participants, children in the most deprived areas were more likely to develop caries than those in less deprived areas (44% vs 28%).

What does current guidance say on this issue?

NICE guidance on oral health promotion for general dental practices (2015) recommends that all patients (or their parents or carers) are given advice during dental examinations, including advice on the use of fluoride, oral hygiene and diet.

Public Health England’s 2014 prevention toolkit for dental health professionals recommends that children up to six years brush their teeth twice daily with fluoride toothpaste. Children aged 3-6 years, or younger if there are dental concerns, should be offered fluoride varnish applied to their teeth twice a year. The frequency and amount of sugary food and drinks should be reduced.

Northern Ireland has an oral health strategy published in 2007 and this recommends that preventing caries in children, particularly among those from disadvantaged backgrounds, should be a key health objective for all Boards and Trusts in Northern Ireland. Northern Ireland does not have a water fluoridation scheme.

What are the implications?

The fluoride-based treatment had a minimal effect on preventing tooth decay that was of questionable clinical benefit. However, the study was conducted against a background of recent population-level improvements in dental health as a result of fluoride-based interventions.

Children from the most disadvantaged areas were under-represented in this study. Practice-based interventions may be unable reach high-risk populations.

Alternative community-based interventions, such as distributing fluoride-containing toothpaste through the post, may have greater potential to reach disadvantaged groups. However, whether such strategies give value for money in preventing tooth decay in young children would need to be addressed.

It seems that two approaches to improving the dental health of children are required, ensuring regular tooth-brushing with fluoride and reducing the intake of sugar and sugary drinks. Fluoride varnish might add little to these actions.

Citation and Funding

Tickle M, O'Neill C, Donaldson M, et al. 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. Health Technol Assess. 2016;20(71):1-96.

This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 08/14/19).

Bibliography

DHSSPS. Oral Health Strategy for Northern Ireland. Belfast: Department of Health, Social Services and Public Safety; 2007.

NHS Choices. Children’s teeth. London: Department of Health; 2015.

NHS Digital. Child Dental Health Survey 2013, England, Wales and Northern Ireland. Leeds: NHS Digital; 2015.

NICE. Oral health promotion for general dental practices. London: National Institute for Health and Care Excellence; 2015.

Public Health England. Delivering better oral health: an evidence-based toolkit for prevention. London: Public Health England; 2014.

Why was this study needed?

Around a third of 5 year-old children in England, Wales and Northern Ireland have tooth decay (caries) in their primary (baby) teeth. Children with tooth decay experience pain and are more likely to need teeth extracted, at significant cost to the NHS.

Tooth decay happens when mouth bacteria break down dietary sugars, producing acids that erode the tooth enamel. Fluoride toothpastes, mouth rinses and varnishes have been shown to prevent this process.

Guidance from Public Health England recommends that dentists offer all children advice on use of fluoride-based products, dental hygiene and eating healthily, avoiding sugary drinks for example.

However, this advice has improved dental health or social inequalities in outcomes as much as hoped for. So, these researchers were interested in seeing if delivering additional fluoride via varnish and free toothpaste to these children was more effective and cost effective.

What did this study do?

This study assessed whether a comprehensive fluoride intervention provided by dentists was effective at preventing tooth decay in young children. This randomised controlled trial recruited 1248 children aged 2-3 years from 22 NHS dental practices in Northern Ireland. All children were free from tooth decay at study start.

Half of the children were randomly assigned to receive the fluoride-based intervention. This involved applying a fluoride varnish to the teeth and providing a free fluoride toothpaste and toothbrush at every six-month check-up, for three years. They also received dental health education on optimal use of the toothpaste and restricting sugar consumption. The parents in the control group received health education alone.

The study had a large sample size and good follow-up rate, with around 86% of children attending every six-month check-up. Assessors were unaware of group allocation. However, the study had limited scope to understand all behaviours that may influence the results.

What did it find?

  • The fluoride-based intervention was no better than health education alone at preventing caries. Around a third of children in both the intervention (34%) and control groups (39%) developed caries in at least one tooth during the three-year study period (odds ratio 0.81, 95% confidence interval 0.64 to 1.04).
  • Among children who developed caries, the average number of affected tooth surfaces was significantly lower in the intervention group (7.2) than the control group (9.6). An adjusted mean difference of 2.29 fewer surfaces (95% CI 3.96 to 0.63 fewer). Toothache was more common among children who developed caries compared with those who didn’t, but there was no difference in pain rates between study groups.
  • There was little difference between groups in reported adverse effects (7.2% of the intervention group vs 5.9% of controls), and most adverse effects were considered unrelated to treatment. However, 10 children in the intervention group experienced minor effects that were attributed to treatment, including abdominal complaints.
  • The average total cost per child over the three-year study (including the cost of the intervention and any other dental care) was £1,027 in the intervention group and £816 in the control group. The cost of the intervention to prevent one child developing tooth decay was £2,093.
  • Across all participants, children in the most deprived areas were more likely to develop caries than those in less deprived areas (44% vs 28%).

What does current guidance say on this issue?

NICE guidance on oral health promotion for general dental practices (2015) recommends that all patients (or their parents or carers) are given advice during dental examinations, including advice on the use of fluoride, oral hygiene and diet.

Public Health England’s 2014 prevention toolkit for dental health professionals recommends that children up to six years brush their teeth twice daily with fluoride toothpaste. Children aged 3-6 years, or younger if there are dental concerns, should be offered fluoride varnish applied to their teeth twice a year. The frequency and amount of sugary food and drinks should be reduced.

Northern Ireland has an oral health strategy published in 2007 and this recommends that preventing caries in children, particularly among those from disadvantaged backgrounds, should be a key health objective for all Boards and Trusts in Northern Ireland. Northern Ireland does not have a water fluoridation scheme.

What are the implications?

The fluoride-based treatment had a minimal effect on preventing tooth decay that was of questionable clinical benefit. However, the study was conducted against a background of recent population-level improvements in dental health as a result of fluoride-based interventions.

Children from the most disadvantaged areas were under-represented in this study. Practice-based interventions may be unable reach high-risk populations.

Alternative community-based interventions, such as distributing fluoride-containing toothpaste through the post, may have greater potential to reach disadvantaged groups. However, whether such strategies give value for money in preventing tooth decay in young children would need to be addressed.

It seems that two approaches to improving the dental health of children are required, ensuring regular tooth-brushing with fluoride and reducing the intake of sugar and sugary drinks. Fluoride varnish might add little to these actions.

Citation and Funding

Tickle M, O'Neill C, Donaldson M, et al. 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. Health Technol Assess. 2016;20(71):1-96.

This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 08/14/19).

Bibliography

DHSSPS. Oral Health Strategy for Northern Ireland. Belfast: Department of Health, Social Services and Public Safety; 2007.

NHS Choices. Children’s teeth. London: Department of Health; 2015.

NHS Digital. Child Dental Health Survey 2013, England, Wales and Northern Ireland. Leeds: NHS Digital; 2015.

NICE. Oral health promotion for general dental practices. London: National Institute for Health and Care Excellence; 2015.

Public Health England. Delivering better oral health: an evidence-based toolkit for prevention. London: Public Health England; 2014.

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

Published on 1 September 2016

Tickle M, O'Neill C, Donaldson M, Birch S, Noble S, Killough S, Murphy L, Greer M, Brodison J, Verghis R, Worthington HV

Health Technology Assessment Volume 20 Issue 71 , 2016

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. 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.

The toothpaste provided in this study had a fluoride concentration of 1,450 parts per million (ppm). Toothpaste containing between 1,350 and 1,500 ppm of fluoride is thought to be most effective at preventing tooth decay. Public Health England recommends that children under 3 years brush their teeth twice daily using a smear of toothpaste containing at least 1000 ppm of fluoride; children aged three to six years should use a pea-sized amount. Children above 6 years through to adulthood should use toothpaste with a fluoride concentration of 1,350 to 1,500 ppm.

The varnish used in this study contained 22,600 ppm of sodium fluoride, or 2.2%, which is the government recommended concentration for all children.

Expert commentary

Dental caries (decay) despite being preventable remains a very common condition in both children and adults. This very well designed trial has demonstrated that fluoride alone cannot prevent this condition from developing. Despite the intensive and costly nature of the fluoride intervention, 34% of children attending the intervention dental practices still developed caries.

As the authors highlight greater emphasis now needs to be given to tackling the underlying causes of caries – the high consumption of sugars across the population. A range of public health measures to reduce sugars consumption are therefore urgently needed.

Richard G Watt, Professor and Honorary Consultant in Dental Public Health, Research Department of Epidemiology and Public Health, UCL