The FiCTION dental trial protocol – filling children’s teeth: indicated or not?

BMC Oral Health

Anne Maguire³  Gail VA Douglas²  Chris Speed¹  Jan E Clarkson⁴  Nicola PT Innes⁴ 

[1] Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, 4th Floor William Leech Building, Framlington Place, Newcastle upon Tyne NE2 4HH, UK;Dental Institute, Leeds University, Clarendon Way, Leeds LS2 9LU, UK;Centre for Oral Health Research, School of Dental Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne NE2 4BW, UK;Dundee Dental Hospital and School, University of Dundee, Park Place, Dundee DD1 4HN, UK

关键词: Primary care;    RCT;    Fillings;    Restoration;    Paediatric Dentistry;    Prevention;    Primary teeth;    Caries prevention;    Dental caries;   

Others  :  1126091
DOI  :  10.1186/1472-6831-13-25

 received in 2013-05-15, accepted in 2013-05-23,  发布年份 2013

【 摘 要 】

Background

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.

The FiCTION trial addresses the Health Technology Assessment (HTA) Programme’s commissioning brief and research question “What is the clinical and cost effectiveness of restoration 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.

Methods/Design

This 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 randomized and treated according to one of three treatment approaches; conventional caries management with best practice prevention, biological management of caries with best practice prevention or best practice prevention alone.

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.

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, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists’ preferences.

Discussion

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. The trial is currently recruiting patients.

Trial registration

Protocol ID: NCTU: ISRCTN77044005

【 授权许可】

   
2013 Innes et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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