Abstract
BackgroundThe number and proportion of older people globally is growing faster than that of any other age group. At the same time the number of people retaining some of their own teeth is rising. There significant differences between those living in care and their community dwelling peers, with evidence showing those in care having fewer teeth and significantly higher levels of dental decay. There are numerous Cochrane reviews linking the use of fluoride to a reduction in dental decay, however, the majority of research on effectiveness has been conducted on children and consequently, children and adolescents tend to be the main recipients of fluoride interventions. There are to date no studies comparing the effectiveness of fluoride interventions in older people in care homes in the UK. However, prior to developing an appropriate protocol for full-scale trial comparing clinical effectiveness of fluoride interventions, there are a number of trial feasibility and statistical parameters that need to be clarified.MethodsThis trial is a single centre, multi-site randomised controlled assessor blind parallel group (three groups) trial, with the primary objective of establishing the feasibility, practicability and compliance of fluoride interventions to prevent dental decay in care homes. Secondary and tertiary objectives will aim to explore the acceptability of the interventions from resident, care home and dental services perspectives, and estimate the efficacy of the three different fluoride treatments.DiscussionThis feasibility trial will produce new knowledge and add value to a landscape that is under researched. Although the efficacy of fluoride interventions is proven, the feasibility of dental research and prevention in this vulnerable group and in the complex care home setting is novel. This work will not only add to our understanding of the interface of dental care and social care but will also contribute to our broader understanding on undertaking research in care home settings. Dental care for older people has been a longstanding issue, and the events of this past year has shone a light on the vulnerabilities of those residing in care homes and so this research is landing at a pivotal time.Trial registration EudraCT Registration 2017-002248-34. Registered 20th February 2018 https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-002248-34.
Highlights
The number and proportion of older people globally is growing faster than that of any other age group
The majority of research on effectiveness has been conducted on children and children and adolescents tend to be the main recipients of fluoride interventions
A review of the evidence pertaining to the use of fluoride supplements in older people in care homes concluded there is good evidence of dental decay reduction with 22,000 ppm fluoride varnish professionally applied 3–4 times per year [16]
Summary
Trial objectives The aim of this randomised feasibility study is to establish and compare the feasibility of fluoride programmes to prevent dental decay in older people in care homes. The nested qualitative component of the trial will gain views from care home managers, carers, residents and family members as well as the dental team. These views are vital in assessing the acceptability objective of the study. Favourable ethical approval for the FInCH trial was granted in February 2018 by the East of England—Cambridge South Social Care Research Ethics Committee (reference 17/EE/0475) Monitoring of this trial will be to ensure compliance with Good Clinical Practice and scientific integrity will be managed and oversight retained, by the King’s College Hospital Clinical Trials Quality Team.
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