REFLeCt trial

REFLECt trial: A Randomised controlled trial to Evaluate the clinical and cost effectiveness of prescribing high concentration FLuoride toothpaste in preventing and treating dEntal Caries in high-risk older adulTs

The RELFECT study is a two arm, parallel group pragmatic open label randomised controlled trial with 36 month follow.  The trial will randomise participants from Manchester, Scotland and Northern Ireland.  The primary clinical outcome for the study is restoration or extraction due to caries.  The health economic outcomes for the study are NHS and patient perspective costs, willingness to pay and net benefit.  Two economic analyses will be completed, the first, a within trial analysis over a three year time horizon.  Discrete choice experiments will be used to value the trial outcomes within a cost-benefit analysis framework to reflect broader measures of value to patients.  The findings will be compared with a standard cost-utility analysis.  A micro-simulation modelling study will be conducted to extrapolate the findings of the trial over a participant’s lifetime.   This study will provide important information on the value of prescribing a treatment which is increasing in use, without any evidence to support its effectiveness or cost-effectiveness.

HERU researchers involved in this research project: Dwayne Boyers

External collaborators:  Tickle, M., Walsh, T., Worthington, H., Glenny, A-M., Pretty, I., Birch, S. (University of Manchester); Clarkson, J. (University of Dundee).

Publications

Tickle, M., Ricketts, D.J.N., Duncan, A., O’Malley, L., Donaldson, P.M., Clarkson, J.E., Black, M., Boyers, D., Donaldson, M., Floate, R., Forrest, M.M., Fraser, A., Glenny, A.M., Goulao, B., McDonald, A., Ramsay, C.R., Ross, C., Walsh, T., Worthington, H.V., Young, L., Bonetti, D.L., Gouick, J., Mitchell, F.E., Macpherson, L.E., Lin, Y.L., Pretty, I.A. and Birch, S. (2019) 'Protocol for 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)', BMC Oral Health, 19(1), 88.

Presentations

Tickle, M., Ling-Lin, Y., Floate, R., Duncan, A., Donaldson, P., Ross, C., MacPherson, L., Glenny, A.M., O'Malley, L., Worthington, H., Clarkson, J., Ramsay, C., Bonetti, D., Boyers, D., Ricket, D., Pretty, I., Walsh, T., Black, M., Donald, L., Gouick, J. and Mitchell, F. (2019) 'REFLECT RCT: Prescribing high-dose fluoride toothpaste to high-risk older adults', International Association for Dental Research (IADR) General Session, Vancouver Convention Centre, Vancouver, Canada, 19-22 June 2019.