Abstract
BackgroundDental 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/DesignA 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.DiscussionThis 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 registrationEudraCT No: 2009 - 010725 - 39ISRCTN: ISRCTN36180119Ethics Reference No: 09/H1008/93:
Highlights
Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years
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 children in general dental practice
Summary
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. A subsequently published trial of 2-4 year old children [20] examined the effect of 22,600 ppm varnish applied twice a year over 2 years and reported a 57% reduction in caries increment compared to a control group Another recent trial in the USA [21] investigated the use of 22,600 ppm varnish on infants with a mean age of 1.8 years resident in an area supplied with artificially fluoridated water at 1 ppm. A Cochrane review of fluoride toothpaste use [22] in children aged 5-16 years reported clear evidence that fluoride toothpastes are efficacious in preventing caries in permanent teeth but there was little information concerning the primary dentition or adverse effects. If the interventions are shown not to be an efficient use of resources this will influence policy and commissioning, to perhaps focus prevention resources on population interventions such as water fluoridation
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