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Fiction Dental Trial



FiCTION Dental Trial
Fillings in Children’s Teeth; Indicated Or Not

FiCTION is a randomised control trial, investigating three different approaches to managing dental caries in primary teeth. It provided evidence from general practice, for practice. Children were assigned by random allocation to have: (1) Conventional management of caries - local anaesthetic, restorations with best practice prevention; (2) Biological management of caries - sealing-in with crowns, partial caries removal and fissure sealants with best practice prevention or (3) Best practice prevention alone. Each child was then followed up for 3 years to look at the clinical and cost-effectiveness of these approaches and children’s, dentists’ and parents’ preferences.

Who is funding the trial?

The NIHR HTA Programme funded this trial.

What will be the benefits of the trial?

Dental caries in children is still highly prevalent in the UK and dentists carry out many thousands of procedures up and down the country every day to manage this. However, currently there is uncertainty within the profession as to the best way of managing caries in primary teeth. This trial addresses this uncertainty by investigating three different approaches in the general practice setting. The results of the trial will inform policy, guidance and future teaching on managing dental caries in children.

What stage is the study at now?

The Pilot Trial has been completed and we are now looking for 50 Dental Practices from across the UK to join us, and participate in the trial by recruiting, treating and following up 1460 children. Each dentist will recruit around 15 children and more than one dentist within the practice can be involved.

Which GDPs and Practises can take part in the trial?

  • Dentists who see children under NHS contracts
  • Practices with computerised patient management systems and internet access.

Which child patients are eligible to participate?

  • 3-7 year olds, with at least one dentinal lesion in primary molar
  • Able to cooperate with a dental exam and agreeing to participate
  • With no toothache or dental infection at the time of examination

What would GDPs and the practice team have to do?

Recruitment of patients will take place over one year beginning in Summer 2012. Children of the correct age will be identified through the practice and a letter inviting them to take part sent with their next check-up appointment. Eligible children may also be identified at a routine dental visit. Parents and children who are interested will have the study discussed with them, and consent to participation. Following random allocation of the child to one of the three treatment strategies, GDPs will treatment plan and manage the child (within their team) according to their allocation. A record of treatment will be kept and the parents and children will complete questionnaires about their oral health. The children will be followed up annually for three years, when treatment carried out will be recorded, and the parents and children will answer questionnaires.

What support will be available?

Financially: Additional costs of being involved in the trial will be covered through local research networks. Reimbursement will include an initial ‘set up’ cost and ‘per patient’ fee.

Practically: The FiCTION study team (based locally in Clinical Centres and centrally through the Newcastle Clinical Trials Unit and Dundee Trials Office) will be available throughout the trial to support participating practices. GDPs and practice staff will attend a training event with other FiCTION practices where there will be clinical training provided in specific Children’s Dentistry procedures and the study team will explain about taking part in the trial effectively and safely. The local research network will assist with the first approach to patients.