Background: FiCTION (Filling Children's Teeth: indicated or Not) is a multi-centre three-arm parallel group, randomised design trial involving UK general dental practitioners (GDPs) comparing three approaches to managing caries in the primary dentition: 1.Conventional, 2.Biological, 3.Prevention Alone. Funding for the 3-year trial was conditional on findings of Pilot Rehearsal Trial (PRT) and Feasibility Study (FS).
Objectives: To test methods and interventions in a PRT and assess practice and patient recruitment/retention, acceptability of treatment strategies, feasibility of data collection tools and screening/sample size for the main trial. The FS gauged GDPs preparedness to participate.
Methods: PRT: Practices in 3 UK regions were purposively recruited, trained and asked to recruit 13 children (3-7y) with untreated decay in at least one primary molar and to manage this according to a randomly allocated management strategy for 6 months. FS: Questionnaire-based survey of a random sample of 273 NHS GDPs in the five trial areas.
Results: Eleven of the 12 practices approached, agreed to take part. Screening target numbers of children were exceeded (766 compared to 741), however only 15% of children screened were eligible to participate (22% were predicted). Recruitment was extended from 3 to 6 months. Although only 96 patients were recruited due to time constraints, uptake from eligible patients was high at 80% recruitment rate (96/121). No patients withdrew. For the FS, 72% of practices stated they would be prepared to host the FiCTION Trial with the number of GDPs expressing interest in participating exceeding main trial targets.
Conclusions: These experiences and findings supported improvements to main trial design in: strategies to recruit and train dentists, child recruitment, engagement and retention, and streamlining of patient/ parent information and questionnaires. They also informed an increase in child screening numbers and confirmed that the target number of GDPs for the trial could be recruited.