Title: Fluoride interventions to prevent dental decay in care home residents: A randomised feasibility study.
Funder: Department of Health and Social Care

Abstract: Background: The oral health profile of our aging population is changing. Improvements in oral health, namely through the widespread availability of fluoride toothpastes, has resulted in a shift from an older population, which was largely edentulous (had no natural teeth) to one which is dentate. This shift in oral health means we now have an older population that can benefit from prevention, restoration and maintenance of the dentition. In care homes, this presents a particular challenge. A greater proportion of older people with natural teeth, but limited self-care abilities and increased vulnerabilities mean care home residents are at significantly higher risk of dental decay. This is further compounded by frequent sugar intake, poor carer attitudes to oral care [16] and reduced salivary flow due to medications. Research has shown people in care have significantly higher level of dental decay and fewer teeth than their free-living peers [39,44], and care home residents report that oral health impacts their ability to eat, type of diet, social interaction and quality of life [32]. Dental decay is entirely preventable. There is a strong body of evidence linking the use of fluoride to a reduction in dental decay in children and adults [29, 30, 31]. Usual toothpaste contains 1450ppm (parts per million) fluoride and widespread evidence has shown a dose related response between decay reduction and fluoride concentration. As a result, higher dose fluoride interventions (toothpaste doses 2800ppm or 5000ppm, or professionally applied varnish) are recommended as part of usual care in dental practice [19] and are widely delivered as part of community based public health programmes for children and adults. There is emerging evidence on the clinical effectiveness of professionally applied fluoride varnish [46], and high dose (5000ppm) fluoride toothpaste [9] on older people in care homes. However, there is no study showing the effectiveness of 2800ppm sodium fluoride toothpaste, nor any evidence directly comparing this to a professionally applied fluoride varnish intervention in older people in care homes. Rationale: Fluoride delivery as part of daily brushing and professional applied varnish are simple and effective methods to prevent tooth decay. For older people in care, this would help support maintenance of the dentition for function and prevent pain and so improving quality of life. This would also offer NHS cost savings from dental care. However, decision-making on which intervention would be most suitable is hindered by the limited research comparing fluoride programmes in the care home setting. Aim: The aim of this randomised feasibility study is to establish the acceptability, compliance and fidelity of residents and care staff to fluoride programmes for the prevention of tooth decay. Plan of Investigation: This study will be a randomised feasibility study to be conducted in 6 care homes. The trial will be an individually randomised, assessor blinded, 3-armed trial (1450ppm toothpaste, 1450ppm toothpaste with quarterly fluoride varnish application, and 2800ppm toothpaste) . Delivery of the intervention will be over a period of 12 months. As high dose fluoride toothpaste (Duraphat 2800ppm) is a licensed product in the UK, this trial is a CTIMP. As the product will be used in this study for the purpose it is licensed for, it has been deemed a low risk trial, and all legislative requirements will be met accordingly. This is a mixed methods study. Qualitative and quantitative research methods will be used to assess the outcome measures, as well as economic assessment of costs. The outcome measures will be measurement of study recruitment, consent and attrition, compliance and acceptability to trial processes, fidelity to intervention delivery in care home and assessment of resources and costs utilised.

Lay abstract: The dental health of people in care homes is known to be poor. These problems affect nutrition, general health and cause significant pain. Over time, there is a downward spiral whereby the presence of poor oral health impacts other diseases, and as medical problems progress, oral health deteriorates. Tooth decay is entirely preventable. Fluoride toothpastes and varnishes are routinely prescribed in dental practice to prevent tooth decay. However, there is little research on fluoride programmes for older people in care. This project will explore the feasibility of fluoride delivery in care homes to prevent tooth decay and maintain oral health.

Research activity codes: 3.3 NUTRITION AND CHEMOPREVENTION;8.1 ORGANISATION AND DELIVERY OF SERVICES;3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: ORAL AND GASTROINTESTINAL