FiCTION (Filling Children's Teeth: Indicated or Not)
There is a lack of evidence for effective management of dental caries (decay) in children’s primary (baby) teeth and an apparent failure of conventional dental restorations (fillings) to prevent dental pain and infection for UK children in Primary Care. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned.
The NIHR HTA funded FiCTION study (project number 07/44/03) is a primary care-based multi-centre, three-arm, parallel group, patient-randomised controlled trial evaluating the clinical and cost effectiveness of filling caries in primary teeth, compared to no treatment.
Practitioners are recruiting 1461 children, (3-7 years) with at least one primary molar tooth where caries extends into dentine. Children are randomised and treated according to one of three treatment approaches:
- conventional caries management (drill and fill) with best practice prevention;
- biological management of caries (sealing-in) with best practice prevention;
- best practice prevention alone.
The primary outcome measure is the incidence of either pain or infection related to dental caries. Secondary outcomes are:
- incidence of caries in primary and permanent teeth;
- patient quality of life;
- acceptability of treatment strategies to patients and parents and their experiences;
- dentists’ preferences.
Recruitment, intervention phase and data collection ongoing.
Marshman, Z., Innes, N.P.T., Deery, C.H., Hall, M.J., Speed, C., Douglas, G.V., Clarkson, J.E., Rodd, H., Deery, C., 2012. The management of dental caries in primary teeth – involving service providers and users in the design of a trial. Trials 13:143
Innes, N.P., Clarkson, J.E., Speed, C., Douglas, G.V., Maguire, A., 2013 The FiCTION dental trial protocol – filling children’s teeth; indicated or not?. (Hyperlink: http://www.biomedcentral.com/1472-6831/13/25) BMC Oral Health, 13 (25)
Joint chief investigators
- Professor Jan Clarkson, University of Dundee, Director SDPBRN, NHS Education for Scotland
- Dr Nicola Innes, University of Dundee
- Professor Gail Douglas, University of Leeds
- Professor Anne Maguire, Newcastle University