CompletedPregnancy, Children & Inherited ConditionsPublic Health & Healthcare
A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services
Recipient organisationUniversity of ManchesterSource-published name: The University of Manchester
Funding£1.5M
PeriodOct 2009 — Sept 2015
In plain English
AI plain-English summary
A large-scale trial in Northern Ireland will test whether giving toddlers a twice-yearly fluoride varnish treatment, alongside fluoride toothpaste and toothbrushes, can prevent cavities more effectively than dental health advice alone. Tooth decay is the most common chronic disease of childhood in the UK, yet many young children develop cavities despite receiving standard preventive advice from their dentist. This trial directly addresses a gap in evidence: no previous study has tested this combined preventive package—fluoride varnish, toothpaste, and education—against education alone in a real-world primary care setting with children as young as two. If the intervention proves effective, it could provide a simple, scalable protocol for dental practices across the UK. The trial also measures costs, so the NHS could assess whether the upfront expense of supplying varnish and toothpaste is offset by savings from fewer fillings, extractions, and hospital visits for severe decay. For families, this could mean fewer painful dental emergencies and less time away from school and work. The results will inform whether this preventive regime should become standard care for young children attending NHS dental services.
View original technical description
Abstract Trial Phase: Phase IV (pragmatic trial) Trial Objective: To compare over a 3 year period the costs and effects of 22,600 ppm fluoride varnish, 1,450 ppm fluoride toothpaste and toothbrush and standardised health education, provided twice a year, as a preventive package, with standardised health education provided twice a year alone. Patient Population: Healthy, female and male caries-free children aged 2-4-years- old at recruitment who are regular attenders at primary care dental services in Northern Ireland. Trial Setting: The General Dental Service and the Community Dental Service in Northern Ireland Trial Intervention: Prevention Package Fluoride varnish applied two times per year for three years Active Ingredients: Sodium Fluoride Study Dosage: 22,600 ppm F Route of Administration: Intraoral/To - Varnish Fluoride toothpaste (plus toothbrush) supplied twice per year Active Ingredients: Sodium Fluoride Study Dosage: 1,450 ppm F Route of Administration: To- dentifrice Standardised health education delivered by the dentist or hygienist. Concurrent Control: Standardised health education delivered by the dentist or hygienist. Total Sample Size: A minimum of 2356 children attending a minimum of 40 dental practices and CDS sites will be invited for eligibility assessment for this trial. We aim to recruit 1200 participants in total. Method of Participant Assignment: Participants will be individually randomised after their parent / legal guardian has provided informed consent and their eligibility checked. Blinding: A placebo will not be used so the allocated interventions will not be blind to parents, children or their dentists. Strenuous efforts will be used to conceal the allocated intervention from the dentists undertaking outcome examinations. Examination Points: Baseline and 3 years Primary Outcome: The proportion of children converting from caries free to caries active (cavitation into dentine) over three years Secondary Outcomes: The number of carious surfaces (caries into dentine) in the primary dentition in children who convert from caries free to caries active states; episodes of pain and extraction of primary teeth; other adverse events; costs
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