Every year, hundreds of thousands of young children with tooth decay are given fillings that may not be necessary—or may not be enough. Dental decay is the most common childhood disease, yet there is no solid evidence on the best way to treat it in baby teeth. Most cavities in young children go unfilled, despite conventional opinion that they should be restored. This trial directly tests three approaches: conventional fillings (drills and injections), intermediate fillings (sealing decay in without drilling), and no fillings at all. If the results show that one approach clearly prevents pain and infection better than the others—or that simpler, less invasive methods work just as well—it could change standard practice across the NHS. That would spare thousands of children unnecessary procedures, reduce anxiety around dental visits, and save the health service significant money. Because the trial runs in real dental practices across diverse UK settings, its findings will apply directly to everyday care, not just specialist clinics. The outcome will give dentists, parents, and policymakers clear guidance on what actually works for the most common disease of childhood.
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Dental decay is the most common disease of childhood, with a large health and economic impact. Although conventional clinical opinion is that carious primary (baby) teeth should be restored (filled), the majority of cavities in young children are unrestored. There is, as yet, no conclusive evidence for the most effective approach to managing decay in baby teeth. The results of this multi-centre randomised control clinical trial will provide evidence on the clinical and cost-effectiveness of three treatment approaches. Consenting children, attending for regular dental care, will be randomly assigned to one of the three treatment groups; with 'conventional fillings' (using dental drills and local anaesthetic injections to cut away decay, then filling the cavity), 'intermediate fillings' (sealing decay into teeth with filling materials, generally without using dental drills or injections), or 'no fillings'. They will then be reviewed yearly (and at any extra dental visits) for episodes of dental pain, and abscess formation. In addition, the impact of the disease, and its treatment, on their quality of life will be assessed. The follow up period is for 4 years in the first instance. Specific objectives are: 1. to compare the effectiveness, in terms of clinical and patient-centred outcomes, of three treatment approaches to the management of decay in primary teeth i.e. conventional fillings, intermediate treatment and no fillings. Specifically: (i) to compare the incidence of pain and sepsis that occur with the three treatment approaches; (ii) to compare the incidence and pattern of new decay in both primary and permanent teeth, quality of life issues, and the cost-effectiveness of the three treatment approaches; and 2. to examine patient, parent and dentist preferences for the three treatment approaches. The results of this study will have important implications for individual care for children with dental caries and, as dental caries is such a common disease, there will be implications for service management. In order to ensure the results are widely applicable, the study will be conducted in Primary Care, where most children's dentistry is carried out, and will run in practices which have varying local factors; inner-city London, the North of England, Wales and Scotland. The research will be led from the University of Dundee (in collaboration with others from the Universities of Cardiff, Glasgow, Leeds, London, Newcastle and Sheffield) but a strong multi-disciplinary research team has been established to work alongside a UK-wide team of specialist paediatric, and Primary Care dentists, ensuring that whilst the trial design and conduct is of the highest standard, it remains practical and pragmatic.
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