Protocol for a Randomised controlled trial to Evaluate the effectiveness and cost benefit of prescribing high dose FLuoride toothpaste in preventing and treating dEntal Caries in high-risk older adulTs (reflect trial)

Martin Tickle ,David Ricketts ,Anne Duncan ,Margaret E Black ,Anne‐Marie Glenny ,Tanya Walsh ,Helen V Worthington ,Dwayne Boyers ,Craig R Ramsay ,Michael Donaldson ,Yin-Ling Lin ,Alison Mcdonald ,Lorna Macpherson ,Ruth Floate ,Mark Forrest ,Carly Ross ,Jill Gouick ,Liza Young ,Fiona E Mitchell ,Iain A Pretty ,Pina Donaldson ,Beatriz Goulão ,Debbie Bonetti ,A Fraser ,Lucy O’malley ,Jan E Clarkson ,Stephen Birch

doi:10.1186/s12903-019-0749-x

Abstract

BackgroundDental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern. Elderly individuals with heavily restored dentitions represent a clinical challenge and significant financial burden for healthcare systems, especially when their physical and cognitive abilities are in decline. Prescription of higher concentration fluoride toothpaste to prevent caries in older populations is expanding in the UK, significantly increasing costs for the National Health Services (NHS) but the effectiveness and cost benefit of this intervention are uncertain. The Reflect trial will evaluate the effectiveness and cost benefit of General Dental Practitioner (GDP) prescribing of 5000 ppm fluoride toothpaste and usual care compared to usual care alone in individuals 50 years and over with high-risk of caries.Methods/designA pragmatic, open-label, randomised controlled trial involving adults aged 50 years and above attending NHS dental practices identified by their dentist as having high risk of dental caries. Participants will be randomised to prescription of 5000 ppm fluoride toothpaste (frequency, amount and duration decided by GDP) and usual care only. 1200 participants will be recruited from approximately 60 dental practices in England, Scotland and Northern Ireland and followed up for 3 years. The primary outcome will be the proportion of participants receiving any dental treatment due to caries. Secondary outcomes will include coronal and root caries increments measured by independent, blinded examiners, patient reported quality of life measures, and economic outcomes; NHS and patient perspective costs, willingness to pay, net benefit (analysed over the trial follow-up period and modelled lifetime horizon). A parallel qualitative study will investigate GDPs’ practises of and beliefs about prescribing the toothpaste and patients’ beliefs and experiences of the toothpaste and perceived impacts on their oral health-related behaviours.DiscussionThe Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice.Trial registrationISRCTN: 2017-002402-13 registered 02/06/2017, first participant recruited 03/05/2018.Ethics Reference No: 17/NE/0329/233335.Funding Body: Health Technology Assessment funding stream of National Institute for Health Research.Funder number: HTA project 16/23/01.Trial Sponsor: Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL.The Trial was prospectively registered.

Highlights

Dental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern
The Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice
Our decision to use the lower limit of 50 years of age was based on: in the United Kingdom (UK) high concentration fluoride toothpaste is currently being prescribed to individuals between 50 and 60 years [17]; individuals 50 years and over have grown up in the absence of widespread use of fluoride toothpaste and many individuals in this age group

Summary

Discussion

The Reflect Trial is an NIHR HTA funded trial that is being undertaken across England, Northern Ireland and Scotland. The trial is pragmatic in nature, designed as far as possible to mirror ‘real life’ This pragmatic approach is reflected in: the population: involved in the trial, high caries risk older adults, have been identified by national guidance in England as a key target group for prescribing high concentration fluoride toothpaste [12]. The evidence base for high concentration fluoride toothpaste is not strong both in terms of both efficacy and for how well this health technology works in day-to-day general dental practice The results of this pragmatic trial should complement the findings of efficacy trials to provide high quality evidence on the costs and benefits of high concentration fluoride toothpaste to support the decisions of dental practitioners, patients and policy makers on its use.

Methods/design

Findings

Office of National Statistics National Population Projections