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)

M. Tickle (Corresponding Author), D. J. N. Ricketts, A. Duncan, L. O'Malley, P. M. Donaldson, J. E. Clarkson, M. Black, D. Boyers, M. Donaldson, R. Floate, M. M. Forrest, A. Fraser, A. M. Glenny, B. Goulao, A. McDonald, C. R. Ramsay, C. Ross, T. Walsh, H. V. Worthington, L. Young & 7 others D. L. Bonetti, J. Gouick, F. E. Mitchell, L. E. Macpherson, Y. L. Lin, I. A. Pretty, S. Birch

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Dental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern. Elderly individuals with heavily restored dentitions represent a clinical challenge and significant financial burden for healthcare systems, especially when their physical and cognitive abilities are in decline. Prescription of higher concentration fluoride toothpaste to prevent caries in older populations is expanding in the UK, significantly increasing costs for the National Health Services (NHS) but the effectiveness and cost benefit of this intervention are uncertain. The Reflect trial will evaluate the effectiveness and cost benefit of General Dental Practitioner (GDP) prescribing of 5000 ppm fluoride toothpaste and usual care compared to usual care alone in individuals 50 years and over with high-risk of caries.

METHODS/DESIGN: A pragmatic, open-label, randomised controlled trial involving adults aged 50 years and above attending NHS dental practices identified by their dentist as having high risk of dental caries. Participants will be randomised to prescription of 5000 ppm fluoride toothpaste (frequency, amount and duration decided by GDP) and usual care only. 1200 participants will be recruited from approximately 60 dental practices in England, Scotland and Northern Ireland and followed up for 3 years. The primary outcome will be the proportion of participants receiving any dental treatment due to caries. Secondary outcomes will include coronal and root caries increments measured by independent, blinded examiners, patient reported quality of life measures, and economic outcomes; NHS and patient perspective costs, willingness to pay, net benefit (analysed over the trial follow-up period and modelled lifetime horizon). A parallel qualitative study will investigate GDPs' practises of and beliefs about prescribing the toothpaste and patients' beliefs and experiences of the toothpaste and perceived impacts on their oral health-related behaviours.

DISCUSSION: The Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice.

TRIAL REGISTRATION: ISRCTN: 2017-002402-13 registered 02/06/2017, first participant recruited 03/05/2018. Ethics Reference No: 17/NE/0329/233335. Funding Body: Health Technology Assessment funding stream of National Institute for Health Research. Funder number: HTA project 16/23/01. Trial Sponsor: Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL. The Trial was prospectively registered.

Original languageEnglish
Article number88
Number of pages13
JournalBMC Oral Health
Volume19
Issue number1
DOIs
Publication statusPublished - 24 May 2019

Fingerprint

Toothpastes
Dental Caries
Fluorides
Cost-Benefit Analysis
National Health Programs
Tooth
Randomized Controlled Trials
General Practitioners
Prescriptions
Student Health Services
Root Caries
Dental General Practices
Costs and Cost Analysis
Northern Ireland
Biomedical Technology Assessment
Dentition
Oral Health
National Institutes of Health (U.S.)
Scotland
Dentists

Keywords

  • Caries
  • High-concentration
  • Fluoride
  • Toothpaste
  • Adults
  • Older
  • General dental practise
  • General dental practice

ASJC Scopus subject areas

  • Dentistry(all)

Cite this

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). / Tickle, M. (Corresponding Author); 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.; Birch, S.

In: BMC Oral Health, Vol. 19, No. 1, 88, 24.05.2019.

Research output: Contribution to journalArticle

Tickle, M, Ricketts, DJN, Duncan, A, O'Malley, L, Donaldson, PM, Clarkson, JE, Black, M, Boyers, D, Donaldson, M, Floate, R, Forrest, MM, Fraser, A, Glenny, AM, Goulao, B, McDonald, A, Ramsay, CR, Ross, C, Walsh, T, Worthington, HV, Young, L, Bonetti, DL, Gouick, J, Mitchell, FE, Macpherson, LE, Lin, YL, Pretty, IA & 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, vol. 19, no. 1, 88. https://doi.org/10.1186/s12903-019-0749-x
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. ; Birch, S. / 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). In: BMC Oral Health. 2019 ; Vol. 19, No. 1.
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abstract = "BACKGROUND: Dental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern. Elderly individuals with heavily restored dentitions represent a clinical challenge and significant financial burden for healthcare systems, especially when their physical and cognitive abilities are in decline. Prescription of higher concentration fluoride toothpaste to prevent caries in older populations is expanding in the UK, significantly increasing costs for the National Health Services (NHS) but the effectiveness and cost benefit of this intervention are uncertain. The Reflect trial will evaluate the effectiveness and cost benefit of General Dental Practitioner (GDP) prescribing of 5000 ppm fluoride toothpaste and usual care compared to usual care alone in individuals 50 years and over with high-risk of caries.METHODS/DESIGN: A pragmatic, open-label, randomised controlled trial involving adults aged 50 years and above attending NHS dental practices identified by their dentist as having high risk of dental caries. Participants will be randomised to prescription of 5000 ppm fluoride toothpaste (frequency, amount and duration decided by GDP) and usual care only. 1200 participants will be recruited from approximately 60 dental practices in England, Scotland and Northern Ireland and followed up for 3 years. The primary outcome will be the proportion of participants receiving any dental treatment due to caries. Secondary outcomes will include coronal and root caries increments measured by independent, blinded examiners, patient reported quality of life measures, and economic outcomes; NHS and patient perspective costs, willingness to pay, net benefit (analysed over the trial follow-up period and modelled lifetime horizon). A parallel qualitative study will investigate GDPs' practises of and beliefs about prescribing the toothpaste and patients' beliefs and experiences of the toothpaste and perceived impacts on their oral health-related behaviours.DISCUSSION: The Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice.TRIAL REGISTRATION: ISRCTN: 2017-002402-13 registered 02/06/2017, first participant recruited 03/05/2018. Ethics Reference No: 17/NE/0329/233335. Funding Body: Health Technology Assessment funding stream of National Institute for Health Research. Funder number: HTA project 16/23/01. Trial Sponsor: Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL. The Trial was prospectively registered.",
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note = "Acknowledgements The authors would like to thank all the patients, dentists and dental team members who are participating in the Reflect Trial. We would also like to thank our sponsor, TSC and DMC and PPI group for their advice and support. Funding The study is funded by the National Institute for Health Research Health Technology Assessment Programme (Project Number 16/23/01). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS, or the Departments of Health. The funder (through their peer review and funding board review process) approved the study proposal but had no role in the collection, analysis, or interpretation of data, or writing of the report.",
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T1 - 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)

AU - Tickle, M.

AU - Ricketts, D. J. N.

AU - Duncan, A.

AU - O'Malley, L.

AU - Donaldson, P. M.

AU - Clarkson, J. E.

AU - Black, M.

AU - Boyers, D.

AU - Donaldson, M.

AU - Floate, R.

AU - Forrest, M. M.

AU - Fraser, A.

AU - Glenny, A. M.

AU - Goulao, B.

AU - McDonald, A.

AU - Ramsay, C. R.

AU - Ross, C.

AU - Walsh, T.

AU - Worthington, H. V.

AU - Young, L.

AU - Bonetti, D. L.

AU - Gouick, J.

AU - Mitchell, F. E.

AU - Macpherson, L. E.

AU - Lin, Y. L.

AU - Pretty, I. A.

AU - Birch, S.

N1 - Acknowledgements The authors would like to thank all the patients, dentists and dental team members who are participating in the Reflect Trial. We would also like to thank our sponsor, TSC and DMC and PPI group for their advice and support. Funding The study is funded by the National Institute for Health Research Health Technology Assessment Programme (Project Number 16/23/01). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS, or the Departments of Health. The funder (through their peer review and funding board review process) approved the study proposal but had no role in the collection, analysis, or interpretation of data, or writing of the report.

PY - 2019/5/24

Y1 - 2019/5/24

N2 - BACKGROUND: Dental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern. Elderly individuals with heavily restored dentitions represent a clinical challenge and significant financial burden for healthcare systems, especially when their physical and cognitive abilities are in decline. Prescription of higher concentration fluoride toothpaste to prevent caries in older populations is expanding in the UK, significantly increasing costs for the National Health Services (NHS) but the effectiveness and cost benefit of this intervention are uncertain. The Reflect trial will evaluate the effectiveness and cost benefit of General Dental Practitioner (GDP) prescribing of 5000 ppm fluoride toothpaste and usual care compared to usual care alone in individuals 50 years and over with high-risk of caries.METHODS/DESIGN: A pragmatic, open-label, randomised controlled trial involving adults aged 50 years and above attending NHS dental practices identified by their dentist as having high risk of dental caries. Participants will be randomised to prescription of 5000 ppm fluoride toothpaste (frequency, amount and duration decided by GDP) and usual care only. 1200 participants will be recruited from approximately 60 dental practices in England, Scotland and Northern Ireland and followed up for 3 years. The primary outcome will be the proportion of participants receiving any dental treatment due to caries. Secondary outcomes will include coronal and root caries increments measured by independent, blinded examiners, patient reported quality of life measures, and economic outcomes; NHS and patient perspective costs, willingness to pay, net benefit (analysed over the trial follow-up period and modelled lifetime horizon). A parallel qualitative study will investigate GDPs' practises of and beliefs about prescribing the toothpaste and patients' beliefs and experiences of the toothpaste and perceived impacts on their oral health-related behaviours.DISCUSSION: The Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice.TRIAL REGISTRATION: ISRCTN: 2017-002402-13 registered 02/06/2017, first participant recruited 03/05/2018. Ethics Reference No: 17/NE/0329/233335. Funding Body: Health Technology Assessment funding stream of National Institute for Health Research. Funder number: HTA project 16/23/01. Trial Sponsor: Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL. The Trial was prospectively registered.

AB - BACKGROUND: Dental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern. Elderly individuals with heavily restored dentitions represent a clinical challenge and significant financial burden for healthcare systems, especially when their physical and cognitive abilities are in decline. Prescription of higher concentration fluoride toothpaste to prevent caries in older populations is expanding in the UK, significantly increasing costs for the National Health Services (NHS) but the effectiveness and cost benefit of this intervention are uncertain. The Reflect trial will evaluate the effectiveness and cost benefit of General Dental Practitioner (GDP) prescribing of 5000 ppm fluoride toothpaste and usual care compared to usual care alone in individuals 50 years and over with high-risk of caries.METHODS/DESIGN: A pragmatic, open-label, randomised controlled trial involving adults aged 50 years and above attending NHS dental practices identified by their dentist as having high risk of dental caries. Participants will be randomised to prescription of 5000 ppm fluoride toothpaste (frequency, amount and duration decided by GDP) and usual care only. 1200 participants will be recruited from approximately 60 dental practices in England, Scotland and Northern Ireland and followed up for 3 years. The primary outcome will be the proportion of participants receiving any dental treatment due to caries. Secondary outcomes will include coronal and root caries increments measured by independent, blinded examiners, patient reported quality of life measures, and economic outcomes; NHS and patient perspective costs, willingness to pay, net benefit (analysed over the trial follow-up period and modelled lifetime horizon). A parallel qualitative study will investigate GDPs' practises of and beliefs about prescribing the toothpaste and patients' beliefs and experiences of the toothpaste and perceived impacts on their oral health-related behaviours.DISCUSSION: The Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice.TRIAL REGISTRATION: ISRCTN: 2017-002402-13 registered 02/06/2017, first participant recruited 03/05/2018. Ethics Reference No: 17/NE/0329/233335. Funding Body: Health Technology Assessment funding stream of National Institute for Health Research. Funder number: HTA project 16/23/01. Trial Sponsor: Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL. The Trial was prospectively registered.

KW - Caries

KW - High-concentration

KW - Fluoride

KW - Toothpaste

KW - Adults

KW - Older

KW - General dental practise

KW - General dental practice

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