Seal or Varnish? A randomised controlled trial to determine the relative cost and effectiveness of pit and fissure sealant and fluoride varnish in preventing dental decay

Abstract

Background Fissure sealant (FS) and fluoride varnish (FV) have been shown to be effective in preventing dental caries when tested against a no-treatment control. However, the relative clinical effectiveness and cost-effectiveness of these interventions is unknown. Objective To compare the clinical effectiveness and cost-effectiveness of FS and FV in preventing dental caries in first permanent molars (FPMs) in 6- and 7-year-olds and to determine their acceptability. Design A randomised controlled allocation-blinded clinical trial with two parallel arms. Setting A targeted population programme using mobile dental clinics (MDCs) in schools located in areas of high social and economic deprivation in South Wales. Participants In total, 1016 children were randomised, but one parent subsequently withdrew permission and so the analysis was based on 1015 children. The randomisation of participants was stratified by school and balanced for sex and primary dentition baseline caries levels using minimisation in a 1 : 1 ratio for treatments. A random component was added to the minimisation algorithm, such that it was not completely deterministic. Of the participants, 514 were randomised to receive FS and 502 were randomised to receive FV. Interventions Resin-based FS was applied to caries-free FPMs and maintained at 6-monthly intervals. FV was applied at baseline and at 6-month intervals over the course of 3 years. Main outcome measures The proportion of children developing caries into dentine (decayed, missing, filled teeth in permanent dentition, i.e. D4–6MFT) on any one of up to four treated FPMs after 36 months. The assessors were blinded to treatment allocation; however, the presence or absence of FS at assessment would obviously indicate the probable treatment received. Economic measures established the costs and budget impact of FS and FV and the relative cost-effectiveness of these technologies. Qualitative interviews determined the acceptability of the interventions. Results At 36 months, 835 (82%) children remained in the trial: 417 in the FS arm and 418 in the FV arm. The proportion of children who developed caries into dentine on a least one FPM was lower in the FV arm (73; 17.5%) than in the FS arm (82, 19.6%) [odds ratio (OR) 0.84, 95% confidence interval (CI) 0.59 to 1.21; p = 0.35] but the difference was not statistically significant. The results were similar when the numbers of newly decayed teeth (OR 0.86, 95% CI 0.60 to 1.22) and tooth surfaces (OR 0.85, 95% CI 0.59 to 1.21) were examined. Trial fidelity was high: 95% of participants received five or six of the six scheduled treatments. Between 74% and 93% of sealants (upper and lower teeth) were intact at 36 months. The costs of the two technologies showed a small but statistically significant difference; the mean cost to the NHS (including intervention costs) per child was £500 for FS, compared with £432 for FV, a difference of £68.13 (95% CI £5.63 to £130.63; p = 0.033) in favour of FV. The budget impact analysis suggests that there is a cost saving of £68.13 (95% CI £5.63 to £130.63; p = 0.033) per child treated if using FV compared with the application of FS over this time period. An acceptability score completed by the children immediately after treatment and subsequent interviews demonstrated that both interventions were acceptable to the children. No adverse effects were reported. Limitations There are no important limitations to this study. Conclusions In a community oral health programme utilising MDCs and targeted at children with high caries risk, the twice-yearly application of FV resulted in caries prevention that is not significantly different from that obtained by applying and maintaining FSs after 36 months. FV proved less expensive. Future work The clinical effectiveness and cost-effectiveness of FS and FV following the cessation of active intervention merits investigation. Trial registration EudraCT number 2010-023476-23, Current Controlled Trials ISRCTN17029222 and UKCRN reference 9273. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 21. See the NIHR Journals Library website for further project information.

Management of compromised first permanent molars in children: Cross‐Sectional analysis of attitudes of UK general dental practitioners and specialists in paediatric dentistry

“…Any of these approaches comply with the Department of Health's "Delivering Better Oral Health Toolkit" guidelines for high-risk children. 24 However, Chestnutt et al 25 have shown that twice-yearly application of fluoride varnish resulted in caries prevention that is not significantly different from that obtained by applying and maintaining fissure sealants after 36 months, with fluoride varnish being more cost-effective, although this was in a deprived population and in a community rather than dental clinic setting. 25…”

The Impact of an Interprofessional Pediatric Oral Health Clerkship on Advancing Interprofessional Education Outcomes

“…[2][3][4][5][6][7][8][9][10][11][12][13][14][15] Around the same time that non-dental providers were being included as key partners in increasing access to oral health, the Interprofessional Education Collaborative (IPEC), a group of leaders in health care education from nursing, medicine, dentistry, osteopathy, public health, and pharmacy, developed the Core Competencies for Interprofessional Collaborative Practice. Primary care providers have been asked to incorporate oral health into their primary care practices by performing an oral health assessment on all children starting at six months or irst tooth eruption, whichever comes irst; initiating preventive oral health interventions such as FV every three to six months (depending on risk status) and/or luoride supplementation; counseling on nutrition and oral hygiene as needed; and establishing a dental home by the age of one year.…”

“…Primary care providers have been asked to incorporate oral health into their primary care practices by performing an oral health assessment on all children starting at six months or irst tooth eruption, whichever comes irst; initiating preventive oral health interventions such as FV every three to six months (depending on risk status) and/or luoride supplementation; counseling on nutrition and oral hygiene as needed; and establishing a dental home by the age of one year. [2][3][4][5][6][7][8][9][10][11][12][13][14][15] Around the same time that non-dental providers were being included as key partners in increasing access to oral health, the Interprofessional Education Collaborative (IPEC), a group of leaders in health care education from nursing, medicine, dentistry, osteopathy, public health, and pharmacy, developed the Core Competencies for Interprofessional Collaborative Practice. 16,17 This document delineates basic interprofessional competencies, such as respecting each other's values, understanding each other's roles and responsibilities, communicating, collaborating, and team functioning, which all students in the health professions need to develop to provide better, safer, more cost-efective whole person care.…”

Application of geographic information systems and simulation modelling to dental public health: Where next?

“…Similar to spatial microsimulation, there is also the potential for agent‐based models to help reduce costs associated with research. For example, recent trials in dentistry have been funded for sums of £1.3 million and £2.9 million, for studies comparing the clinical efficacy and cost‐effectiveness of fissure sealants and fluoride varnish in preventing caries, and an investigation of effective approaches to managing decay in children's teeth, respectively. Given the open source nature of many datasets, and even accounting for the cost of researchers and computing power, agent‐based modelling approaches are likely to present substantial savings.…”