Title: 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)
Funder: Department of Health and Social Care

Abstract: DESIGN: Two arm, parallel group, pragmatic, open label RCT comparing the effectiveness and cost benefit of prescribing high dose fluoride toothpaste compared to usual care in preventing and treating dental caries in older patients. The duration of follow-up is 36 months. We will undertake a qualitative project to inform recruitment and understand attitudes towards prescribing and use of high dose fluoride toothpaste. A full economic evaluation of the intervention will be undertaken. The trial includes an internal pilot study with pre-determined stop/go criteria for progression to a full trial to assess recruitment and fulfilment of prescriptions. SETTING: Up to 60 NHS Dental Practices in Greater Manchester, Scotland, Northern Ireland. POPULATION: Patients 50 years and over with high risk of caries Inclusion Criteria: Adults aged 50 years or over, with a diagnosis of active coronal caries (into dentine) in the last 12 months which may or may not have been treated, or any root caries; and/or other risk factors as determined by their General Dental Practitioner (GDP). Participants can be living in any residential setting attending at a GDP. Exclusion criteria: Adults who are currently prescribed high dose fluoride toothpaste or those unable to provide informed consent. INTERVENTION: Prescription of 5000 parts per million (ppm) fluoride toothpaste, as recommended by the BNF Comparator: Usual care. Any advice given by the GDP will be to use standard fluoride toothpast (1350-1500 ppm). OUTCOMES: Primary outcome: - Restoration or extraction due to caries. Secondary outcomes - Clinical: Caries increment (DMFS), progression of early caries lesions, bleeding on probing - Patient: Oral health-related QoL (OHIP-14), health-related QoL (EQ5D), oral health behaviour, episodes of pain - Economic: NHS and patient perspective costs, willingness to pay, net benefit (analyses over 3 year trial follow-up and modelled lifetime horizon). SAMPLE SIZE: Based on an absolute target difference of 10% (75% vs 65%) in the primary outcome measure. This difference was determined to be both a realistic and important difference from discussion with dentists, PPI groups and from published estimates. The control group proportion is based on published data and Scottish treatment data. At a two-sided 5% significance level and 90% power, 440 participants (880 in total) are required at 3 years. Assuming 25% attrition, 587 participants per group are required (1174 in total). 60 practices will recruit an average of 20 participants each. Based on a consent rate of 50%, 2348 eligible patients will be screened. PROJECT TIMETABLE: 3 months set-up, 13 months recruitment (reporting on internal pilot after 9 months), 36 month follow-up and 5 months shut-down/ write up: total 57 months. EXPERTISE IN TEAM: Project led by the NIC PIP RCT principal investigator (Tickle) and IQuaD RCT principal investigators (Clarkson and Ramsay); coordinated by a Trial Office in the Dental Health Services Research Unit (University of Dundee) and CHaRT (registered CTU, University of Aberdeen). The team comprises experienced dentist researchers, caries diagnostics experts, health economists, statisticians, PPI representatives and trial managers. We have a strong track record of undertaking large pragmatic trials in both adults and children, including CTIMPs, in dental practice. We have close links to policy makers across the UK that will support dissemination.

Lay abstract: Aim of the research: To evaluate the costs and effectiveness of high dose fluoride toothpaste prescribed in general dental practice to older individuals who have a high-risk of tooth decay. We want to see if prescribing the toothpaste can improve the dental health of older adults and reduce costs for both patients and the NHS. Background: Since the 1970s fluoride toothpaste has been widely used to prevent tooth decay. People who grew up before the 1970s did not have the benefits of fluoride toothpaste and consequently have lots of fillings, and have an increased risk of further tooth decay. There has been a huge increase in the number of older people keeping their teeth. In England in 2009 only 6% of people aged over 65 years had no teeth, compared to 28% in 1978. There is a concern that unless there is effective prevention of decay in older people, many will require complex dental treatment which may not be affordable. Standard fluoride toothpaste, available to buy on the high street, tends to contain around 1400 parts per million (ppm) of fluoride. High dose fluoride toothpaste, containing 5000ppm fluoride, is available by prescription from doctors/dentists. It is thought to be better than standard fluoride toothpaste at preventing tooth decay in people at high risk. In England in 2014 prescriptions of high concentration fluoride toothpaste cost £17 million and these costs are increasing. There is a lack of evidence to demonstrate that this use of resources benefits patients and is cost-effective for the NHS. Design and methods: We will recruit 1174 people aged 50 years and over from 60 NHS dental practices in Northern Ireland, Scotland and Greater Manchester. We will only include people who have a high-risk of developing decay, based on their recent dental history and the opinion of their dentist. Once recruited they will be randomised into 2 groups; one receiving prescriptions for 5000ppm fluoride toothpaste from their dentist and the other group to receive usual care (any advice will be to use 1350-1500ppm toothpaste, available from pharmacies/supermarkets). At the beginning of the trial, we will run a pilot trial to ensure we can meet pre-set targets for recruitment of both dental practices and patients. Our main outcome measure will be whether or not participants get fillings or extractions due to tooth decay. We will collect this data from participants’ dentists over a 3-year period. In a sub-group of patients in Scotland we will undertake more precise measurements to understand how much tooth decay develops in the 5000 ppm and usual care groups over the 3-years. This information will be collected by independent dental professionals who won’t know which group each person belongs to. We will also measure: impact on quality of life; pain; costs of the toothpaste and costs of any treatment patients receive and if people collect their prescriptions. We will also collect information on patients' exposure to other fluoride containing products. Patient and public involvement: We have discussed the project with groups of older people who felt that the trial was needed, as the evidence for how well the toothpaste works is not clear-cut, but costs to the NHS for high fluoride toothpaste are rising. They also felt that preventing the need for fillings and extractions would be a major benefit for patients. This guided our choice of our outcome measure.

Research activity codes: 3.3 NUTRITION AND CHEMOPREVENTION;6.1 PHARMACEUTICALS
Health categories: ORAL AND GASTROINTESTINAL