Background:
In the UK, there is uncertainty over the generalisability, to a primary care setting, of evidence for different treatment strategies used to manage decay in primary teeth.
The FiCTION Trial will address the research question “What is the clinical and cost effectiveness of restoring primary teeth, compared to no treatment? A third approach based on biological (sealing-in) management of dental caries is also included.
Objectives:
To compare three treatment strategies for managing dental caries in primary teeth over three years in a general dental practice setting. Primary outcomes: incidence of pain and sepsis. Secondary outcomes: incidence of caries in primary and secondary teeth, patient quality of life, cost-effectiveness over the study period, acceptability and associated experiences and preferences of patients and parents.
Methods:
This multi-centre, three arm, parallel design randomised control trial, will enrol 1460 children (3-7 years old) attending 50 general dental practices in the UK. Treatment planning and follow-up care will be provided and recorded by General Dental Practitioners (GDPs), following random allocation of the children to one of the three trial arms: 1. Conventional management of caries (local anaesthetic, caries removal, restoration), with best practice prevention; 2. Biological management of caries (sealing decay with crowns, partial caries removal, fissure sealants), with best practice prevention or 3. Best practice prevention alone.
Results:
Outcomes will be measured at baseline and during 3 years' follow-up. Secondary outcome data will be collected by the patients' dentists, through patient and parent completion of questionnaires and blinded assessment of radiographs.
Conclusion:
The FiCTION Trial will provide the necessary evidence to support GDPs in their decision-making for management of decay in primary teeth, suitable for their child patients and to minimize pain and sepsis in primary teeth.