Investigating the Management of Carious Primary Teeth in General Dental Practice: An Overview of the Development and Conduct of the Fiction Trial

Stewart, Matthew; Keightley, Alexander J.; Maguire, Anne; Chadwick, Barbara Lesley; Vale, Luke; Homer, Tara; Douglas, Gail; Deery, Chris; Marshman, Zoe; Ryan, Vicky; Innes, Nicola

doi:10.1308/205016815816682146

Cited by 3 publications

(2 citation statements)

References 26 publications

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“…Nevertheless, it is clear from the literature, 71 and was highlighted in the FiCTION pilot trial and feasibility study, 72,73 that radiograph use in children does not follow the expected frequency.…”

Section: Evidence From Good Practice Prevention Approaches To Managinmentioning

confidence: 99%

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT

Maguire

Clarkson

Douglas

et al. 2020

Health Technol Assess

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Background Historically, lack of evidence for effective management of decay in primary teeth has caused uncertainty, but there is emerging evidence to support alternative strategies to conventional fillings, which are minimally invasive and prevention orientated. Objectives The objectives were (1) to assess the clinical effectiveness and cost-effectiveness of three strategies for managing caries in primary teeth and (2) to assess quality of life, dental anxiety, the acceptability and experiences of children, parents and dental professionals, and caries development and/or progression. Design This was a multicentre, three-arm parallel-group, participant-randomised controlled trial. Allocation concealment was achieved by use of a centralised web-based randomisation facility hosted by Newcastle Clinical Trials Unit. Setting This trial was set in primary dental care in Scotland, England and Wales. Participants Participants were NHS patients aged 3–7 years who were at a high risk of tooth decay and had at least one primary molar tooth with decay into dentine, but no pain/sepsis. Interventions Three interventions were employed: (1) conventional with best-practice prevention (local anaesthetic, carious tissue removal, filling placement), (2) biological with best-practice prevention (sealing-in decay, selective carious tissue removal and fissure sealants) and (3) best-practice prevention alone (dietary and toothbrushing advice, topical fluoride and fissure sealing of permanent teeth). Main outcome measures The clinical effectiveness outcomes were the proportion of children with at least one episode (incidence) and the number of episodes, for each child, of dental pain or dental sepsis or both over the follow-up period. The cost-effectiveness outcomes were the cost per incidence of, and cost per episode of, dental pain and/or dental sepsis avoided over the follow-up period. Results A total of 72 dental practices were recruited and 1144 participants were randomised (conventional arm, n = 386; biological arm, n = 381; prevention alone arm, n = 377). Of these, 1058 were included in an intention-to-treat analysis (conventional arm, n = 352; biological arm, n = 352; prevention alone arm, n = 354). The median follow-up time was 33.8 months (interquartile range 23.8–36.7 months). The proportion of children with at least one episode of pain or sepsis or both was 42% (conventional arm), 40% (biological arm) and 45% (prevention alone arm). There was no evidence of a difference in incidence or episodes of pain/sepsis between arms. When comparing the biological arm with the conventional arm, the risk difference was –0.02 (97.5% confidence interval –0.10 to 0.06), which indicates, on average, a 2% reduced risk of dental pain and/or dental sepsis in the biological arm compared with the conventional arm. Comparing the prevention alone arm with the conventional arm, the risk difference was 0.04 (97.5% confidence interval –0.04 to 0.12), which indicates, on average, a 4% increased risk of dental pain and/or dental sepsis in the prevention alone arm compared with the conventional arm. Compared with the conventional arm, there was no evidence of a difference in episodes of pain/sepsis among children in the biological arm (incident rate ratio 0.95, 97.5% confidence interval 0.75 to 1.21, which indicates that there were slightly fewer episodes, on average, in the biological arm than the conventional arm) or in the prevention alone arm (incident rate ratio 1.18, 97.5% confidence interval 0.94 to 1.48, which indicates that there were slightly more episodes in the prevention alone arm than the conventional arm). Over the willingness-to-pay values considered, the probability of the biological treatment approach being considered cost-effective was approximately no higher than 60% to avoid an incidence of dental pain and/or dental sepsis and no higher than 70% to avoid an episode of pain/sepsis. Conclusions There was no evidence of an overall difference between the three treatment approaches for experience of, or number of episodes of, dental pain or dental sepsis or both over the follow-up period. Future work Recommendations for future work include exploring barriers to the use of conventional techniques for carious lesion detection and diagnosis (e.g. radiographs) and developing and evaluating suitable techniques and strategies for use in young children in primary care. Trial registration Current Controlled Trials ISRCTN77044005. 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. 24, No. 1. See the NIHR Journals Library website for further project information.

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Section: Evidence From Good Practice Prevention Approaches To Managinmentioning

confidence: 99%

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT

Maguire

Clarkson

Douglas

et al. 2020

Health Technol Assess

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“…The pilot trial began in 2009 (Marshman et al 2012) and the main trial began in 2012, involving 72 dental practices and 1,124 children with dentinal caries (3 to 7 y old on enrollment). Children are randomized to receive 1 of 3 caries management strategies (in a 1:1:1 ratio) and are followed up over 3 y (Keightley et al 2014; Stewart et al 2015). However, the management strategies used mean that it is not possible to blind the parents, children, or dentists to the arm of the trial.…”

Section: Fiction (Filling Children’s Teeth: Indicated or Not?) Nihr-hmentioning

confidence: 99%

Cariology Clinical Trials: What Are We—and What Should We Be—Looking At?

Innes

2018

Adv Dent Res.

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Randomized control trial (RCT) methodology has compared interventions for the prevention and management of dental caries since the late 1960s. Despite almost 50 years and evidence of significant wastage within the wider biomedical research field, there has been little investigation into what works well and where weaknesses lie. This paper aims to draw attention to areas for improvement within cariology clinical trial methodology by summarizing systematic reviews on interventions and outcomes, and using examples to illustrate some challenges with intervention delivery fidelity, outcome analyses, and intervention co-production. Trial design stage choices are critical to ensure that optimum information is obtained when testing interventions. Intervention choice, outcome choice, and analyses are particularly important, and cariology trials have specific issues associated with them. A systematic search and review of cariology RCTs found 650 RCT reports. Social Network Analysis of interventions revealed a high degree of separation between prevention and management trials, gaps in clinically important comparisons, and a tendency for there to be comparisons within groups; e.g., comparison of interventions within the same, rather than different, levels of invasiveness. Outcomes measured for the same trial reports show: a focus on restoration performance and individual/population caries burden; the growing use of carious lesion activity and economic-related outcomes; and sparse, although an increase in the use of, patient-reported/patient-centered outcomes. Fidelity of adherence to complex interventions can be challenging to measure but is important in interpreting trial findings. Involving target populations in intervention design, delivery, and relating it to the planned rollout, are opportunities to ensure intervention relevance and improved uptake. Outcomes analyses should consider the minimum clinically important differences and outcome relevance measures for the target population. Factors underlying trialists' comparator and outcome choices need to be identified, and there is a need to ensure that a minimum dataset of outcomes allow for combination and comparisons of trial data for systematic review.

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Guidelines relevant to paediatric dentistry – do foundation dentists and general dental practitioners follow them? Part 2: Treatment and recall

Harford

Sharpling²,

Williams

et al. 2018

Br Dent J

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Investigating the Management of Carious Primary Teeth in General Dental Practice: An Overview of the Development and Conduct of the Fiction Trial

Cited by 3 publications

References 26 publications

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT

Cariology Clinical Trials: What Are We—and What Should We Be—Looking At?

Guidelines relevant to paediatric dentistry – do foundation dentists and general dental practitioners follow them? Part 2: Treatment and recall

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