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)

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.