Condition category
Oral Health
Date applied
01/06/2017
Date assigned
02/06/2017
Last edited
02/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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 June 2022

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

Who is the main contact?
Professor Martin Tickle
martin.tickle@manchester.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Prof Martin Tickle

ORCID ID

http://orcid.org/0000-0001-5348-5441

Contact details

Division of Dentistry
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 275 6610
martin.tickle@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA Project: 16/23/01

Study information

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

Acronym

REFleCt trial

Study hypothesis

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

Not provided at time of registration

Study design

Pragmatic open label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Dental Caries

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 names

5000 ppm fluoride toothpaste

Primary outcome measures

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.

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

Overall trial start date

12/05/2017

Overall trial end date

30/06/2022

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

1174

Participant exclusion criteria

1. Currently prescribed high concentration fluoride toothpaste
2. Unable to provide informed consent

Recruitment start date

10/02/2018

Recruitment end date

31/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Healthcare Randomised Trials (CHaRT)
Health Services Research Unit University of Aberdeen 3rd Floor, Health Sciences Building Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

Central Manchester University Hospitals NHS Foundation Trust

Sponsor details

Research Office
NOWGEN Building
29 Grafton Street
Manchester
M13 9WU
United Kingdom
+44 161 276 4125
lynne.webster@cmft.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Dissemination of the study findings will be via academic publications in high impact, peer reviewed journals, through presentations at national and international conferences and through press releases to mass media organisations.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/06/2023

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes