A randomised controlled trial to evaluate the cost effectiveness of prescribing high concentration fluoride toothpaste to prevent tooth decay in older adults

ISRCTN	ISRCTN11992428
DOI	https://doi.org/10.1186/ISRCTN11992428
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	2017-002402-13
Protocol serial number	HTA 16/23/01
Sponsor	Manchester University NHS Foundation Trust
Funder	Health Technology Assessment Programme

Submission date: 01/06/2017
Registration date: 02/06/2017
Last edited: 03/08/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims:
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 so 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 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. The aim of this study is 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.

Who can participate?
People aged 50 and over who have a high-risk of developing decay, based on their recent dental history and the opinion of their dentist.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive prescriptions for 5000ppm fluoride toothpaste from their dentist. Those in the second group receive usual care (any advice will be to use 1350-1500ppm toothpaste, available from pharmacies and supermarkets). Information about whether or not participants get fillings or extractions due to tooth decay is collected from participants’ dentists over a 3-year period. In addition, in a sub-group of patients in Scotland more precise measurements are undertaken to understand how much tooth decay develops in the 5000 ppm and usual care groups over the 3-years.

What are the possible benefits and risks of participating?
There are no notable benefits involved with participating. Risks for patents participating are very low, in some rare cases (less than 1 in 1000 people treated) allergic (hypersensitivity) reactions can occur, causing rash, itching swelling and redness.

Where is the study run from?
The study is run from the Centre for Healthcare Randomised Trials in Aberdeen and takes place in at least 60 NHS dental practices in Northern Ireland, Scotland and Greater Manchester (UK)

When is study starting and how long is it expected to run for?
May 2017 to December 2023

Who is funding the study?
National Institute for Health Research, Health Technology Assessment Programme (UK)

Who is the main contact?
Professor Janet Clarkson, j.e.clarkson@dundee.ac.uk

Contact information

Prof Janet Clarkson
Public

School of Dentistry
University of Dundee
Park Place
Dundee
DD1 4HN
United Kingdom

ORCID ID	0000-0001-5940-2926
Phone	+44 (0)1382 381707
Email	j.e.clarkson@dundee.ac.uk

Study information

Primary study design	Interventional
Study design	Pragmatic open label randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific 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
Study acronym	REFleCt
Study objectives	5000 parts per million fluoride toothpaste prescribed by General Dental Practitioners is effective in reducing the need for dental treatment due to dental caries in patients aged 50 years and over attending dental practices who have a high-risk of developing caries.
Ethics approval(s)	Approved 17/11/2017, North East - Newcastle & North Tyneside 1 Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)2071048103; nrescommittee.northeast-newcastleandnorthtyneside1@nhs.net), REC ref: 17/NE/0329
Health condition(s) or problem(s) studied	Dental Caries
Intervention	Current intervention as of 15/07/2022: Eligible and consenting participants will be randomised to one of the two intervention groups using the web-based application, both hosted by the CTU. The randomisation algorithm will use recruitment site, residential setting (own home/care home), exemption from dental treatment charges (yes/no) and age (50-65 years/over 65 years) as minimisation covariates to allocate treatment to intervention and control groups in a 1:1 ratio. A random element will be incorporated into the randomisation algorithm. The PI at site, or individual with delegated authority, will access the telephone or web-based system. Patient screening identification, initials and recruiting site (the stratifying variable) will be entered into the web-based system, which will return the allocation status. Participants will be informed of their allocated treatment group following randomisation. Intervention: Prescription of 5000 parts per million (ppm) fluoride toothpaste. The amount and frequency of the toothpaste will be prescribed by the participant’s dentist according to their clinical judgement of their patient’s needs. Participants will redeem prescriptions from community pharmacists. Comparator: Usual care. Any advice given by the GDP will be to use standard, off-the-shelf, fluoride toothpaste (1350-1500 ppm). The content and frequency of advice will be provided by the participant’s dentist according to their clinical judgement of their patient’s needs. The total duration of both treatment and follow-up study arms will be 3 years. _____ Previous intervention: Eligible and consenting participants will be randomised to one of the two intervention groups using the proven 24-hour telephone Interactive Voice Response randomisation application or via the web-based application, both hosted by the CTU. The randomisation algorithm will use recruitment site, residential setting (own home/care home), exemption from dental treatment charges (yes/no) and age (50-65 years/over 65 years) as minimisation covariates to allocate treatment to intervention and control groups in a 1:1 ratio. A random element will be incorporated into the randomisation algorithm. The PI at site, or individual with delegated authority, will access the telephone or web-based system. Patient screening identification, initials and recruiting site (the stratifying variable) will be entered into the voice-activated or web-based system, which will return the allocation status. Participants will be informed of their allocated treatment group following randomisation. Intervention: Prescription of 5000 parts per million (ppm) fluoride toothpaste. The amount and frequency of the toothpaste will be prescribed by the participant’s dentist according to their clinical judgement of their patient’s needs. Participants will redeem prescriptions from community pharmacists. Compliance will be assessed by self report questionnaires and by reference to national datasets Comparator: Usual care. Any advice given by the GDP will be to use standard, off-the-shelf, fluoride toothpaste (1350-1500 ppm).The content and frequency of advice will be provided by the participant’s dentist according to their clinical judgement of their patient’s needs. Compliance will be assessed by self report questionnaires. The total duration of both treatment and follow-up study arms will be 3 years.
Intervention type	Drug
Phase	Phase III/IV
Drug / device / biological / vaccine name(s)	5000 ppm fluoride toothpaste
Primary outcome measure(s)	Current primary outcome measure as of 15/07/2022: Restoration or extraction or endodontic treatment due to dental caries (dichotomous outcome yes/no) will be recorded at scheduled and unscheduled dental visits on the Case Report Form (CRF) completed by PIs at each site on a rolling basis during the 3-year follow-up period _____ Previous primary outcome measure: Restoration or extraction due to dental caries (dichotomous outcome yes/no) will be recorded at scheduled and unscheduled dental visits on the Case Report Form (CRF) completed by PIs at each site on a rolling basis during the 3 year follow up period.
Key secondary outcome measure(s)	Current secondary outcome measures as of 15/07/2022: Clinical: 1. Coronal and root caries increment , including dentist replacement fillings for caries, at tooth surface (DMFS) level is assessed using the ICDAS method to assess caries as it provides flexibility to analyse and present caries data at different diagnostic thresholds at baseline and 3 year (+/- 3 months) follow-up. This will also be used for collecting early caries lesion progression data (DMFS measured in Scottish practices only). 2. Early caries lesion progression data is measured using ICDAS (in Scottish practices only) at baseline and 3 year (+/- 3 months) follow-up 3. Bleeding on probing (BoP) will be recorded by the independent clinical examiners (in Scottish practices only) at baseline and 3 year (+/- 3 months) follow-up Patient: 1. Oral health status using OHIP14, a measure of oral health-related Quality of Life (QoL), collected at baseline and annual follow up over the 3 year follow up period through patient administered questionnaires 2. The EQ-5D-5L profile measure of generic health status will be collected at baseline and annual follow up through patient questionnaires over the 3 year follow up period 3. Episodes of dental pain (number and an assessment of severity using a visual analogue scale) will be recorded at scheduled and unscheduled dental visits on the CRF. In addition questions about dental pain experience will be included in annual questionnaires sent to participants. 4. Oral health behaviour, including self-reported brushing/other sources of fluoride. Evaluated at baseline and through annual questionnaires sent to participants over the 3-year follow-up period of the trial Economic: 1. Provision of NHS dental treatments will be collected using the CRF completed at each visit and by routinely collected data held by the Information Services Division (ISD) of NHS National Services Scotland, Business Services Authority (BSA, England) and Business Services Organisation (BSO, Northern Ireland) 2. All remaining resource use data will be use data collected using the CRF and annual patient-reported questionnaires over the 3-year follow-up period 3. A discrete choice experiment (DCE) with an online representative sample of the UK general population (aged 50 and over) will be undertaken to elicit willingness to pay (WTP) for high fluoride toothpaste and associated patient-relevant outcomes. 4. The “within trial” economic analyses will assess and report on the costs and outcomes of high fluoride vs. standard treatment up to 3 years post-randomisation _____ Previous secondary outcome measures: Clinical: 1. Caries increment , including dentist replacement fillings for caries, at tooth surface (DMFS) level is assessed using the ICDAS method to assess caries as it provides flexibility to analyse and present caries data at different diagnostic thresholds at baseline and 3 year (+/- 3 months) follow-up. This will also be used for collecting early caries lesion progression data (DMFS measured in Scottish practices only). 2. Early caries lesion progression data is measured using ICDAS (in Scottish practices only) at baseline and 3 year (+/- 3 months) follow-up 3. Bleeding on probing (BoP) will be recorded by the independent clinical examiners (in Scottish practices only) at baseline and 3 year (+/- 3 months) follow-up Patient: 1. Oral health status using OHIP14, a measure of oral health-related Quality of Life (QoL), collected at baseline and annual follow up over the 3 year follow up period through patient administered questionnaires 2. The EQ-5D-5L profile measure of generic health status will be collected at baseline and annual follow up through patient questionnaires over the 3 year follow up period 3. Episodes of dental pain (number and an assessment of severity using a visual analogue scale) will be recorded at scheduled and unscheduled dental visits on the CRF. In addition questions about dental pain experience will be included in annual questionnaires sent to participants. 4. Oral health behaviour, including self-reported brushing/other sources of fluoride. Evaluated at baseline and through annual questionnaires sent by mail to the home address of participants over the 3 year follow up period of the trial Economic: 1. Provision of NHS dental treatments will be collected using the CRF completed at each visit and by routinely collected data held by the Information Services Division (ISD) of NHS National Services Scotland, Business Services Authority (BSA, England) and Business Services Organisation (BSO, Northern Ireland) 2. All remaining resource use data will be use data will be collected using the CRF and annual mailed questionnaires over the 3 year follow up period 3. A discrete choice experiment (DCE) with an online representative sample of the UK general population (aged 50 and over) will be undertaken to elicit willingness to pay (WTP) for high fluoride toothpaste and associated patient relevant outcomes. 4. The “within trial” economic analyses will assess and report on the costs and outcomes of high fluoride vs. standard treatment up to 3 years post-randomisation
Completion date	31/12/2023

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	1174
Total final enrolment	1161
Key inclusion criteria	Current inclusion criteria as of 15/07/2022: 1. Patients attending dental practices participating in the trial 2. Aged 50 years or older 3. Diagnosis of active coronal caries (into dentine) in the last 12 months which may/may not have been treated, or any root caries; and\or other risk factors as determined by their GDP 4. Living in any residential setting 5. Receive their dental care in part or fully as an NHS patient 6. Patients whose GDP decides prescription of high concentration fluoride toothpaste is appropriate _____ Previous inclusion criteria: 1. Patients attending dental practices participating in the trial 2. Aged 50 years of age or older 3. Diagnosis of active coronal caries (into dentine) in the last 12 months which may/may not have been treated, or any root caries; and\or other risk factors as determined by their GDP 4. Living in any residential setting
Key exclusion criteria	Current exclusion criteria as of 15/07/2022: 1. Currently prescribed (by GDP or GP) high concentration fluoride toothpaste (for GDPs, prescription must have been issued at last examination visit) 2. Unable to provide informed consent 3. Hypersensitivity for sodium fluoride and/or other ingredients used in 5000ppm toothpaste 4. Are living in the same household as someone already recruited to REFLECT, or someone who is routinely using a high concentration fluoride toothpaste _____ Previous exclusion criteria: 1. Currently prescribed high concentration fluoride toothpaste 2. Unable to provide informed consent
Date of first enrolment	10/02/2018
Date of final enrolment	13/03/2020

Locations

Countries of recruitment

United Kingdom
England
Northern Ireland
Scotland

Study participating centres

Centre for Healthcare Randomised Trials (CHaRT)

Health Services Research Unit
University of Aberdeen
3rd Floor, Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

North Street Dental Care

42 North Street
Lurgan
Craigavon
BT67 9AH
United Kingdom

Brownlow Family Dental Care

5 Legahory Centre
Craigavon
BT65 5BE
United Kingdom

DJ Maguire & associates

83a Bridge Street
Portadown
BT63 5AA
United Kingdom

Bell & Thom Dental Surgery

17/19 Main Street
Portglenone
Ballymena
BT44 8AA
United Kingdom

Bishop Street Dentalcare

21 Bishop Street Within
Derry/Londonderry
BT48 6PR
United Kingdom

The Grange Dental Care

2 Crevenagh Rd
Omagh
BT79 0AL
United Kingdom

Newcastle family Dental Care

Iveagh Court
2 Railway Street
Newcastle
BT33 0SP
United Kingdom

Main Street Dental Care

45A Main Street
Thornliebank
G46 7SF
United Kingdom

Kelvingrove Dental Care Ltd

1180 Argyle Street
Glasgow
G3 8TE
United Kingdom

Lossiemouth Dental Practice

2 Clifton Road
Lossiemouth
IV31 6DJ
United Kingdom

Bute Dental Surgery

14-16 West Princes Street
Rothesay
PA20 9AF
United Kingdom

Montrose Dental Practice

Montrose
-
United Kingdom

Discovery Dental Care

1 West Bell Street
Dundee
DD1 1EX
United Kingdom

One Dental

1 Queen St
Derry/Londonderry
BT48 7EF
United Kingdom

Haugh Dental Care

Newcastle St. Kilkeel
Newry
BT34 4AF
United Kingdom

L.C. Milton BDS

1356 Barrhead Road
Glasgow
G53 7DE
United Kingdom

Quinndental

53 Main Street
Randalstown
Antrim
BT41 3BB
United Kingdom

Salisbury Villa Dental Surgery

1 Salisbury Terrace
Teignmouth
TQ14 8JG
United Kingdom

Chudleigh Dental Practice

21 Old Exeter Street
Chudleigh
Newton Abbot
TQ13 0LD
United Kingdom

Nethergate Dental Practice

86 Nethergate
Dundee
DD1 4EL
United Kingdom

Camlough Dental Practice

27 Main Street
Camlough
Newry
BT35 7JG
United Kingdom

Blairgowrie Dental Care

64 High Street
Blairgowrie
PH10 6DF
United Kingdom

Livingston Dental Healthcare

38 Hamilton Road
Bangor
BT20 4LE
United Kingdom

Cardonald Dental Practice

5 Lamington Road
Cardonald
Glasgow
G52 2SF
United Kingdom

The Glens Dental Practice

2 Gortaclee Rd
Cushendall
Ballymena
BT44 0TE
United Kingdom

Dental bees

1 St Andrew Street
Castle Douglas
DG7 1DE
United Kingdom

Tannochside Dental Centre

499 Old Edinburgh
Tannochside
Glasgow
G71 6PL
United Kingdom

Harpers Dental Practice

32 Bradford St
Haulgh
Bolton
BL2 1JJ
United Kingdom

Craigentinny Dental Care

57 Duddingston Crescent
Edinburgh
EH15 3AY
United Kingdom

Stevenston Cross Dental

14 Fullarton Place
Stevenston
KA20 3EH
United Kingdom

McNally Dental Care

248 Drumchapel Road
Glasgow
G15 6EG
United Kingdom

Rankin Dental

30 Ellon Road
Aberdeen
AB23 8BX
United Kingdom

Links Lodge Dental Practice

26 John Street
Montrose
DD10 8LZ
United Kingdom

Castlebawn Dental Practice

32-34 Victoria Road
Bangor
BT20 5EX
United Kingdom

The Dental House

6-12 Derby Ln
Old Swan
Liverpool
L13 3DL
United Kingdom

Sheil Road Dental Practice

74 Sheil Road
Liverpool
L6 3AF
United Kingdom

Canmore Dental Practice

8 Abbey Park Place
Dunfermline
KY12 7PD
United Kingdom

Hyland Dental Care

6 Park Road
Hamilton
ML3 6PD
United Kingdom

Canmore Dental Practice

126 Main Street
Lochgelly
KY5 9AA
United Kingdom

The Collegiate Dental Practice

76 Brideoak St
Cheetham Hill
Manchester
M8 0AB
United Kingdom

Clark & Watson Dental Practice

27 Newmarket Street
Falkirk
FK1 1JJ
United Kingdom

Sankey St. Dental Practice

61a Sankey Street
Warrington
WA1 1SL
United Kingdom

Delicate Dental

106 Main Street
Lisnaskea
BT92 0JD
United Kingdom

Dr Philip Chai K Wee

102a Cricklewood Broadway
London
NW2 3EJ
United Kingdom

Abbey Dental Care

47 Causeyside St
Paisley
PA1 1YN
United Kingdom

Montgomery Street Dental Care

96 Montgomery St
Edinburgh
EH7 5HE
United Kingdom

Abbey Dental Clinic

620-630 Shore Road
Newtownabbey
BT37 0ST
United Kingdom

Tarbert Dental

Harbour Street
Tarbert
PA29 6UB
United Kingdom

Maryhill Smile Care

283 Maryhill Rd
Glasgow
G20 7YA
United Kingdom

Truss Dental

85 East Road
Irvine
KA12 0AA
United Kingdom

Ethos Dental Surgery

126 Wellington Road North
Stockport
SK4 2LL
United Kingdom

Kirkmuirhill Dental Practice

14a Thornton Road
Kirkmuirhill
Lanark
ML11 9QE
United Kingdom

Simply Smiles Dental Surgery

35 Holden Rd
Salford
M7 4LR
United Kingdom

Alyth Dental Care

20 Commercial Street
Alyth
Blairgowrie
PH11 8AF
United Kingdom

Hafren House Dental Practice

1 Cressy Rd
Alfreton
DE55 7BR
United Kingdom

Cottage Dental Practice

58 Moor Street
Ormskirk
L39 2AW
United Kingdom

Glumangate Dental Practice

46 Glumangate
Chesterfield
S40 1TX
United Kingdom

Pearl Dental

1242 London Road
Alvaston
Derby
DE24 8QH
United Kingdom

Church Road Dental Practice

-
-
United Kingdom

Woodlands Dental Practice

-
-
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from the sponsor (research.sponsor@mft.nhs.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	24/05/2019	29/05/2019	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/08/2022: The following changes have been made:
1. The sponsor has been changed from Central Manchester University Hospitals NHS Foundation Trust to Manchester University NHS Foundation Trust.
2. The IPD sharing statement has been updated to include the contact email address.
15/07/2022: The following changes have been made:
1. The overall trial end date has been changed from 30/06/2022 to 31/12/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 01/06/2023 to 31/12/2024.
3. The intervention has been changed.
4. The primary outcome measure has been changed.
5. The secondary outcome measures have been changed
6. The participant inclusion criteria have been changed.
7. The participant exclusion criteria have been changed.
8. Northern Ireland and England have been added to the countries of recruitment.
9. The public contact has changed.
10. All of the trial participating centres apart from Centre for Healthcare Randomised Trials (CHaRT) have been added.
11. The IPD sharing statement has been added.
13/02/2020: Ethics approval details and trial website added.
12/03/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2019 to 13/03/2020.
2. Total final enrolment number added.
29/05/2019: The following changes were made to the trial record:
1. Publication reference added.
2. EudraCT number was added.
08/04/2019: The recruitment end date was changed from 31/03/2019 to 30/09/2019.