NIHR HTA FiCTION Trial

Filling Children’s Teeth: Indicated Or Not?

Trial Overview

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. UK dental schools’ teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed. However, the evidence base for this is limited in volume and quality, and comes from studies conducted in either secondary care or specialist practices. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned.

Aims and Objectives

The FiCTION study addresses the Health Technology Assessment (HTA) Programme’s commissioning brief and research question, “What is the clinical and cost effectiveness of filling caries in primary teeth, compared to no treatment?”  It compares conventional restorations with an intermediate treatment strategy based on the biological (sealing-in) management of caries and with no restorations.

Trial Design

This study is a primary care-based multi-centre, three-arm, parallel group, patient-randomised controlled trial.  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 FiCTION Trial flow diagram shows the projected number of participants throughout the trial.

 

Baseline measures and outcome data (at review/treatment during three year follow-up) are assessed through direct reporting, clinical examination including blinded radiograph assessment, and child/parent questionnaires.

Outcome Measures

The primary outcome measure is the incidence of either pain or infection related to dental caries and the secondary outcomes are:

  • incidence of caries in primary and permanent teeth
  • patient quality of life
  • cost-effectiveness
  • acceptability of treatment strategies to patients and parents and their experiences
  • dentists’ preferences

FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children’s primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth.

Recruitment

The map identifies the areas where participant recruitment is taking place in dental practices across the UK.

Dissemination

The results of the Trial will be published as widely as possible in academic and professional dental journals as well as the popular press as an aid to decision making by policy makers, dental practitioners and patients.

Presentations

2013

Innes, N., "What's New in Paediatric Dentistry - an Update", BDA East of Scotland Branch, The Auditorium at the Royal College of Surgeons, Edinburgh, 23 October 2013

Keightley, A., FiCTION Filling Children's Teeth: Indicated Or Not? Findings Answers in Primary Dental Care, HSE Dental Surgeons Group Annual Seminar, Mullingar 2013, 16 October 2013

Maguire, A., Filling Children's Teeth: Indicated or Not? Update for COHR: Who? What? & How?, Centre for Oral Health Research, 7 October 2013

Maguire, A., FiCTION Fillings in Children's teeth; Indicated or Not? An update, BSPD Northern Branch, 30 April 2013

Innes, N., FiCTION Filling Children's Teeth: Indicated or Not?, BDA Conference, 27 April 2013

Maguire, A., on behalf of the FiCTION Trial Collaboration, Filling Children's Teeth: Indicated or Not? The FiCTION Trial Protocol, IADR Seattle 2013, 20 March 2013

Douglas, G.V.A., on behalf of the FiCTION Trial Collaboration, Usefulness of the FiCTION Pilot Rehearsal Trial and Feasibility Study, IADR Seattle 2013, 20 March 2013

2012

Lamont, T., NIHR HTA Dental Trials Update, Faculty of General Dental Practitioners - Scotland Study Day, 7 December 2012

Douglas, G.V.A., Evidence informed care for Children, York BDA, 22 November 2012

Innes, N., FiCTION Trial: Filling children's teeth; indicated or not? Where are we now?, The British Society of Paediatric Dentistry, 18-21 September 2012

2011

Innes, N., FiCTION Trial, Scottish Dental Practice Based Research Network (SDPBRN) Annual Symposium, 09 November 2011

Clarkson, J.E., FiCTION Trial, EBD (Evidence Based Dentistry) Champion Conference, Chicago, USA, 30 July 2011

Douglas, G.V.A., FiCTION Trial, Leeds Jewish Dental Society, 07 March 2011

Clarkson, J.E., FiCTION Trial, Precedent Conference, Portland, Oregon, USA, 04 March 2011

Douglas, G.V.A., FiCTION Trial, Leeds Dental Institute Reseach Seminar Series, 12 October 2010

Publications

The Dentist. 2011. Child Tooth Decay Study. The Dentist, 27 (4) http://www.the-dentist.co.uk/archive/article/590/child-tooth-decay-study

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. BMC Trials

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?. BMI Oral Health, 13 (25)

British Dental Journal. 2013, Fifty Practices Address Caries Management. British Dental Journal 215 (2), p. 64.

Salma Chanawala. (2013). The search for clinical evidence whether to fill children's teeth; indicated or not? The Probe. (February)

The Vital. 2013. Fifty Practices Address Caries Management. The Vital, 10.

 

Other Information Sources

Further information about this Trial can be found at http://research.ncl.ac.uk/fictiontrial/

UNIVERSITY OF DUNDEE.

Joint Chief Investigators

The Joint Chief Investigators are based at the Universities of Dundee, Leeds and Newcastle.  The full 

includes collaborators from the Universities of Cardiff, Glasgow, Leeds, Newcastle, Sheffield and in London.  The multi-disciplinary research team has been established to work alongside a UK-wide team of specialist paediatric and Primary Care dentists and members of their teams.  This is to ensure that whilst the Trial design and conduct is of the highest standard, it remains practical and pragmatic.

 

NIHR Disclaimer

This project was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 07/44/03) and will be published in full in Health Technology Assessment.  The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.

 

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