Caries management in children. The FiCTION trial

caries upper arch

Although almost completely preventable dental caries is the commonest childhood disease. About 90% of children in low- and middle-income countries are affected with a smaller though significant number of children from high income countries (30-50%) also suffering.  Treatment and management of caries has a significant health and economic impact worldwide. Recent studies have challenged the effectiveness of the traditional restorative approach to the management of carious lesions in primary teeth with increasing use of minimally invasive approaches.

The aim of this randomised controlled trial was to compare the clinical and cost-effectiveness of 3 strategies for the management of dental caries in primary teeth for children aged 3 to 7yrs in UK primary dental care.


This multicenter randomised controlled trial (RCT) was carried out in NHS dental practices in the UK with 5 administrative areas 3 in England and one each in Scotland and Wales.  Children aged 3-7 years with at least 1 primary molar tooth with caries into dentine, but no associated pain or infection were randomised to one of three groups. ICDAS was used to define carious lesions.

  • Prevention alone (P): Dietary investigation, analysis and intervention reducing carbohydrates; Toothbrushing with fluoride paste and fluoride mouth rinsing; Fluoride varnish application and permanent teeth fissure sealants (as per SDCEP guidance).
  • Conventional with prevention (C): As prevention group with restoration under local anaesthesia and complete mechanical removal of caries.
  • Biological with prevention (B):  As prevention group with caries being sealed in with an adhesive restorative material or a preformed metal crown using the Hall Technique. Removal of superficial caries could be undertaken to achieve a good seal, but no affected dentine was removed so local anaesthesia was not routinely required

Treatment for irreversible pulpitis, infection or exposed pulp was the same in each group ie. Pulp therapy or extraction. Treatments were provided in practice by any appropriately trained dental professional (general dental practitioner (GDP), dental hygienist/ therapist, or dental nurse). Dental professionals attended training on trial procedures and clinical procedures.The primary outcomes were the proportion of participants with at least 1 episode of dental pain and/or infection (incidence) over the study period and the total number of episodes of dental pain and/or infection for each patient. The methods for assessing secondary outcomes (cost-effectiveness, Children’s oral health related quality of life [COHRQoL] )are reported in full by Maguire et al (2019). Randomisation was via a secure web-based system, but parents, patients and dental professionals were not blind to the allocation. Analysis was conducted blindly according to the predetermined analysis plan.


  • 93 dental practices were recruited with 72 contributing at least 1 patient.
  • 1144 patients were randomised, 354 to group P, 352 to group C, 352 to group B, 86 did not attend.
  • There were 7,713 study visits with at least 1 component of prevention at 81% of visits (mainly by GDPs). Rates were higher in group P (85%) but similar in groups C&B (79% in each).
  • Operative care was provided at 34% of all visits (C 42%; B 42%; P 19%) primarily by dentists (91% visits).
  • X-rays were taken for less than half the patients at any stage (511 of 1,058; 48%).
  • There was no evidence of a statistically significant difference between the 3 groups although the incidence was higher than anticipated.
  Prevention alone (P) Conventional with prevention(C) Biological with prevention(B)
Incidence of Dental Pain ever 39.5% 35.8% 32.1%
Incidence of Dental Infection ever 25.7% 25.7% 24.7%
Incidence of Dental Pain or infection ever 45.5% 42.0% 40.1%
Mean number of episodes of pain or infection (± SD) 0.72 (0.87) 0.62 (0.95) 0.58 (0.87)


The authors concluded:

There was no evidence of a difference among the 3 treatment approaches for incidence or number of episodes of dental pain and/or infection experienced by these participants with high caries risk and established disease


This large pragmatic multi-centre RCT was conducted in primary care dental practices in the UK. Large RCTs conducted in a primary care setting are still relatively novel and this presented challenges to the researchers with extended recruitment phases and the need for longer support and additional training for participating practices.  This longer recruitment led to a recalculation of the required sample size (1,113) from the original 1,460 children with a slight loss in the study power from 90% to 82%.

Of the 7,699 children screened for participation a majority (6,555, 85%) were ineligible as they had no dentinal caries. This suggests that only 15% of the children attending these dental practices had dentinal caries which is lower that national epidemiological programmes would indicate.  Randomisation was at child level so included practices delivered all three intervention to patients. It should also be noted that the children, parents and dental professionals were not blind to the allocation because of the differences between the interventions.

The study found no differences between the three treatment approaches for either the co-primary outcomes or the secondary outcomes, with an average cost of £230 for a child with at least 1 primary tooth with dentine caries over the 33.8 month follow up period.  As there is little difference between the 3 strategies tested for managing established dentine caries the importance of promoting and employing strategies for the primary prevention of dental caries altogether as noted by the authors.


Primary paper

Innes, N. P., Clarkson, J. E., Douglas, G. V. A., Ryan, V., Wilson, N., Homer, T., … Maguire, A. (2020). Child Caries Management: A Randomized Controlled Trial in Dental Practice. Journal of Dental Research, 99(1), 36–43.

Trial protocol

Trial Registration

Other references

Maguire A, Clarkson JE, Douglas GV, Ryan V, Homer T, Marshman Z, McColl E, Wilson N, Vale L, Robertson M, et al. 2019. Best practice prevention alone or with conventional or biological caries management for 3-7-year olds: the FiCTION three-arm randomized controlled trial. Health Technology Assessment; in press.

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