Title: FiCTION - Filling Children's Teeth: Indicated Or Not?
Funder: Chief Scientist Office, Scotland

Abstract: 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.

Lay abstract: Dental decay is the most common disease of childhood, with a large health and economic impact. Surprisingly, there is as yet no conclusive evidence for the most effective approach to treatment of decay in baby teeth; whether it is 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'. This proposal will provide that evidence by means of a randomised controlled clinical trial. Consenting children, attending for regular dental care, will be randomly assigned to one of three treatment groups; 'conventional fillings', 'intermediate fillings', 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. In order to ensure the results are widely applicable, the study will be conducted in primary dental 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. A successful outcome for the study will be the ability to make a firm recommendation regarding the most effective approach for managing decay in children's teeth. Undoubtedly, the principal ethical issue will be having a 'no fillings' arm. For justification of this, the lack of evidence base for any of the three approaches must be noted. Only around 10% of cavities in 5 year-olds are currently filled, and placing a conventional filling is not always a pleasant experience for the child. Children, and parents, will be able to opt out of a particular arm at any time, and analysis of results will be carried out as the trial progresses. Evidence that children in a particular arm are being disadvantaged will result in them being transferred to one of the two remaining arms. The study team is multidisciplinary and broad based, involving half of the UK dental schools, as well as acknowledged experts in other relevant fields, and most members have experience of successfully completing clinical trials. This study is comprehensive, involving children from around the UK and scientifically well founded to provide the answer to the important question of whether baby teeth should be filled or not.

Research activity codes: 6.4 SURGERY
Health categories: ORAL AND GASTROINTESTINAL