Dental caries is one of the commonest diseases of childhood but is almost completely preventable. It affects about 90% of children in low- and middle-income countries and 30-50% of children in high income countries. The increasing use of minimally invasive procedures in recent studies is challenging the traditional restorative approach to the management of carious lesions in primary teeth.
The aim of this randomised controlled trial was to compare both 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 (PA): 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+P): As prevention group with restoration under local anaesthesia and complete mechanical removal of caries.
- Biological with prevention (B+P): 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.
Time/materials-based costing was used to estimate the costs at every visit to manage dental caries in primary teeth. Data was collected by clinical staff and categorised as staffing, preventive treatments, operative treatments (restoration materials), other associated items (e.g. radiographs), referrals, and prescriptions. Capital costs were excluded, and all costs are expressed in 2018 pounds Sterling.
The co- primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The economic analysis was on an intention to treat basis. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%. An arbitrary threshold of £1000 was used as there is no national or internationally agreed willingness to pay threshold to avoid dental pain and/or infection.
- 1144 children were randomised with data from 1054 (354 in PA group, 352 in C+P group and 352 in 354 in B+P group) being used in the economic analysis.
- The median follow-up was 33.8 months (IQR 23.8, 36.7).
- 7713 visits recorded across the three arms.
- On average, it cost £230 to manage dental caries in a young child with at least one primary tooth with a dentinal carious lesion over a period of up to 36 months.
- C + P was the most costly and PA was the least costly strategy.
|Prevention alone (PA)||Conventional with prevention (C+P)||Biological with prevention (B+P)|
|Total treatment cost per child||£211.32 (257.28) *||£250.48 (221.70) *||£ 231.27 (214.47) *|
|Total practice level treatment cost (exc. referrals) per child per visit||£22.86 (8.11) *
|£28.36(11.08) *||£27.40 (10.81) *|
|Number of visits||6.8 (3.7)||7.7 (4.2)||7.4 (4.1)|
|Duration of visits||20.1 mins (6.7)||21.8 mins (6.9)||21.2mins (7.2)|
*Mean non-discounted costs and standard deviation
- In terms of effectiveness, on average, there were fewer incidences of, and fewer episodes of dental pain and/or infection in B + P compared to PA.
- C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P.
The authors concluded: –
on average, PA is the least costly, despite having more referrals requiring GA, but the least effective strategy for managing dental caries in primary teeth. B + P has the potential to provide more oral health benefits to children with dentinal carious lesion in at least one primary molar tooth, however this comes at an additional cost. Over the willingness to pay values considered, the probability of B + P being considered cost-effective was approximately no higher than 65% to avoid an incidence of dental pain and/or infection and no higher than 75% to avoid an episode of dental pain and/or infection. It is unlikely that C + P would be considered cost-effective.
Earlier this year we reported on the results from the FiCTION trial (Dental Elf – 6th Jan 2020). This open access publication from the same study presents additional details from the cost-effectiveness element of the study. The findings show that prevention alone (PA) was the cheapest strategy although not the most clinically effective. It also demonstrated that the biological approach with prevention was more effective and less costly that the traditional approach to the management of dental caries in primary teeth for children aged 3 to 7yrs. It is important to remember that all 3 approaches were for managing established carious lesions so primary prevention of caries remains a key element for children.
Homer, T., Maguire, A., Douglas, G.V.A. et al. Cost-effectiveness of child caries management: a randomised controlled trial (FiCTION trial). BMC Oral Health 20, 45 (2020). https://doi.org/10.1186/s12903-020-1020-1
Dental Elf – 6th Jan 2020
“British Pound Sterling” by joegoauk70 is licensed under CC BY-SA 2.0
Awesome blog, Thank you Mr. Derek Richards for giving us such a blog. It was interesting to read. Good luck, Cheers.
Would have been nice if preventive care had included use of silver nitrate plus fluoride varnish, some papers below. “Prevention alone” looks rather expensive compared to the treatment alternatives.
1. Duffin S. Back to the future: the medical management of caries introduction. J Calif Dent Assoc 2012;40(11):852–8.
2. Gao SS, Zhao IS, Duffin S, Duangthip D, Lo ECM, Chu CH. Revitalising Silver Nitrate for Caries Management. Int J Environ Res Public Health 2018;15(1).
3. Horst JA. Silver Fluoride as a Treatment for Dental Caries. Adv. Dent. Res. 2018;29(1):135–40.
4. Gao SS, Duangthip D, Wong MCM, Lo ECM, Chu CH. Randomized Trial of Silver Nitrate with Sodium Fluoride for Caries Arrest. JDR Clin Trans Res 2019;4(2):126–34.
Professor Gail Douglas, co-Chief Investigator, Dept of Dental Public Health, University of Leeds School of Dentistry has forwarded this response to you query
Thank you for your comments about the study. It would have been interesting to test other preventive elements as you suggest. However, the original call for research asked for a trial to compare ‘fillings’ versus ‘no treatment’. We felt that it was unethical to randomise children with dental caries to a ‘no treatment’ arm. Instead we opted to include a ‘prevention only’ arm as the control group and to make this the comparative equivalent of ‘no treatment’ by including the same preventive care in the other two trial arms. We used guidance from ‘Delivering better oral health: an evidence based toolkit for prevention’ to determine what preventive care should be included in the study.
In terms of the costs of the three trial arms, you are right in saying that the ’prevention only’ arm looks more costly than you might have expected in comparison to the two other arms, especially since they also included preventive care. However, there is an important reason for this. The costings for each arm did not only include the direct costs of providing each of the three caries management strategies in primary care but also included costs associated with any child referred for dental general anaesthetic (GA). While the numbers of children referred for GA in the trial were small, and too small to allow for significance testing between arms, there were more dental GA referrals from the ‘prevention only’ than from the ‘conventional’ or ’biological’ arms. Since the costs of a GA are large in comparison to regular clinical care these extra GA referrals raised the average cost of care in the ‘prevention only’ arm.
We hope these details help address your comments, thanks again for your interest in the FiCTION trial.
Professor Gail Douglas.
Two more papers from the FiCTION study are now available:-
1. Dental professionals experience of managing children with carious lesions in their primary teeth https://bit.ly/2Wa1Ymj
2. Children and parents’ perspectives on the acceptability of three management strategies for dental caries in primary teeth.
This is a good reminder that PA is always the cheapest strategy but also the least effective one. It only means clinical dental care should be considered to avoid further issues with your dental caries.
Patients were only entered into this trial if they had caries into dentine which has implications for the effectiveness of a prevention only (PA) strategy. Effective early primary prevention prevention cavitation in the first place is a better option