REFLECT
Research type
Research Study
Full 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)
IRAS ID
233335
Contact name
Jan Clarkson
Contact email
Sponsor organisation
Central Manchester University Hospitals NHS Foundation Trust
Eudract number
2017-002402-13
ISRCTN Number
ISRCTN11992428
Duration of Study in the UK
4 years, 8 months, 30 days
Research summary
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 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.
The REFLECT trial will 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.
We will recruit 1174 people aged 50 years and over from approximately 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 recent dental history and opinion of their dentist. Once consented, participants will be randomised into 2 groups; one receiving prescriptions for 5000ppm fluoride toothpaste from their dentist and the other to receive usual care (any advice will be to use 1350-1500ppm toothpaste, available from pharmacies/supermarkets). Our main outcome measure will be whether or not participants get fillings or endodontic treatment or extractions due to tooth decay. We will collect this data from participants and their 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.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0329
Date of REC Opinion
17 Nov 2017
REC opinion
Further Information Favourable Opinion