Condition category
Oral Health
Date applied
17/02/2020
Date assigned
17/04/2020
Last edited
17/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
The ageing population is increasing in number. Currently, half of all residents enter care homes with some of their own natural teeth and this proportion is likely to increase. Preventing dental disease for care homes residents is important for their function and quality of life. Good oral health affects the ability to eat and communicate, appearance and self-esteem through, for example, the willingness to smile. It also reduces the need to provide treatment in care homes, which is often difficult and costly. A study exploring the priorities for older people as their needs change and they move into supported accommodation, found that preventing oral disease was considered paramount. A national survey, however, found that current prevention practices and services in care homes are poor. There are also large gaps in the scientific literature about how best to prevent oral disease among care home residents. NICE guidelines on the maintenance of oral health in care homes have been published, but it is not known how feasible and effective these recommendations are in practice. As a result, a feasibility study is necessary to inform the design of a larger definitive trial. This study aims to assess the feasibility of an intervention to improve the oral health of older people (defined as those who are 65 or older) in care homes, based on the NICE guideline.

Who can participate?
Residents aged over 65 in participating care homes who have their own natural teeth

What does the study involve?
Care homes will be randomly divided into two groups: intervention and control. The intervention consists of an oral health assessment of residents, daily “support worker assisted” tooth brushing with fluoride toothpaste, and a staff training package on how to improve oral health. Trained dentists will collect clinical information at the start of the study. Other data will be collected via questionnaires administered by researchers. After 12 months, the health of the residents’ mouths will be assessed again and the questionnaires administered again and findings will be compared to those at the start of the study. Residents, managers and staff will be interviewed to assess the acceptability of the proposed intervention.

What are the possible benefits and risks of participating?
This research will contribute towards helping public health programs improve oral health for a large number of care home patients. Care homes will be provided with an educational package to help train staff. The intervention will raise awareness of oral health and improve assisted self-care. The intervention in its entirety, including the educational package, is expected to be sustainable and suitable for implementation in care homes across the UK. The researchers do not anticipate any major issues associated with this study and the potential risks for research participants are considered to be very low. Inconvenience and time commitment taking part in the study will be the largest burden for participants.

Where is the study run from?
1. South Eastern Health & Social Care (UK)
2. Whittington Health NHS Trust (UK)
3. Central and North West London NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
December 2018 to January 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Prof. Georgios Tsakos
g.tsakos@ucl.ac.uk
2. Dr Gerald McKenna
g.mckenna@qub.ac.uk
3. Prof. Paul Brocklehurst
p.brocklehurst@bangor.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Georgios Tsakos

ORCID ID

http://orcid.org/0000-0002-5086-235X

Contact details

Chief Investigator
Department of Epidemiology and Public Health
University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
+44 (0)207 6795614
g.tsakos@ucl.ac.uk

Type

Scientific

Additional contact

Dr Gerald McKenna

ORCID ID

http://orcid.org/0000-0001-8478-1673

Contact details

Co-Principal Investigator
Queen’s University Belfast
Centre for Public Health
Belfast
BT12 6BA
United Kingdom
+44 (0)28 9097 8999
g.mckenna@qub.ac.uk

Type

Scientific

Additional contact

Prof Paul Brocklehurst

ORCID ID

http://orcid.org/0000-0002-6789-2774

Contact details

Co-Principal Investigator
Bangor University
School of Healthcare Sciences
Bangor
LL57 2EF
United Kingdom
+44 (0)1248 383218
p.brocklehurst@bangor.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 42666, IRAS 254421

Study information

Scientific title

Improving the oral healTh of Older People In Care homes: a feasibility study (TOPIC)

Acronym

TOPIC

Study hypothesis

This study aims to assess the feasibility of an intervention to improve the oral health of older people (aged 65 years or older) in care homes, based on the NICE guideline.

Ethics approval

Approved 14/02/2020, London – City & East REC (Health Research Authority, Bristol HRA Centre, Level 3 Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8033, +44 (0)7413516923; nrescommittee.london-cityandeast@nhs.net), REC ref: 19/LO/1107

Study design

Randomised; Both; Design type: Prevention, Complex Intervention, Other, Qualitative

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 the contact details to request a patient information sheet

Condition

Oral health

Intervention

Care homes will be randomly divided into two groups: intervention and control. The intervention consists of:

1. An oral health assessment of residents

2. Daily “support worker assisted” tooth brushing with 1,500 fluoride toothpaste
3. A staff training package on how to improve oral health

Three workstreams (WS) are proposed. WS1 will assess the feasibility of undertaking the intervention. Eligible residents who have their own natural teeth will be recruited. Baseline assessments will be conducted, using trained dentists to collect clinical information. Questionnaires will be used to collect other data (e.g. sociodemographic, quality of life). Recruitment, retention and the acceptability of the intervention for residents, staff and managers will be determined. After 12 months, the assessments will be repeated and findings will be compared to those at baseline.

WS2 will interview residents, managers and staff to understand the proposed intervention’s acceptability.

WS3 will explore issues relating to an economic evaluation that presents costs and different outcomes in order to help decision-making. It will identify the outcomes considered important to different stakeholders and determine the possibility of reducing these to a core set of indicators.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

TOPIC is a feasibility study and will primarily focus on the following feasibility-related outcomes:
1. Proportion of care homes that agree to participate in the study
2. Proportion of residents in the participating care that are eligible and able to consent
3. Proportion of eligible residents that agree to participate in the study
4. Proportion of participating residents in the intervention arm that receive the intervention per the protocol
5. Proportion of care homes and residents that remain in the study at 12 months follow-up
6. Proportion of completed measures used in the study (at least 75% completion rate required): i) oral health assessments; ii) quality of life questionnaires; iii) clinical measurement records; iv) oral symptoms checklist diaries

Secondary outcome measures

1. Clinical outcomes, including the number of teeth with coronal and root caries lesions, the proportion of teeth with visible plaque and the proportion of teeth that bleed on probing (BoP), assessed by dental examiners at baseline and 12 months
2. Oral symptoms and domiciliary dental care: number of reported episodes of dental pain, sepsis, discomfort and domiciliary visits, reported weekly by care home staff and at baseline, 6 and 12 months by researchers
3. Health-related quality of life using EuroQol’s five dimensions (EQ-5D5L) at baseline, 6 and 12 months
4. Oral health-related quality of life using the OIDP at baseline, 6 and 12 months)
5. Oral health needs assessed with the OHAT by dental examiners at baseline and 12 months

Overall trial start date

01/12/2018

Overall trial end date

31/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Care home providers in London and Northern Ireland will be recruited using the following eligibility criteria:
1. Care homes will require to have a minimum of 20 residents (as approximately half are expected to be edentate)

Residents in the recruited care homes will be screened to determine whether they meet the eligibility criteria:
1. Over the age of 65 years
2. Dentate or partially dentate
3. Full-time resident in care facility

Participant type

Other

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant exclusion criteria

The exclusion criteria for the care homes will be:
1. Have high-dependency units and end-of-life care

The exclusion criteria for the residents will be:
1. Residents who are receiving end-of-life or palliative care
2. Residents with severe cognitive impairment (6-CIT score of 10 or higher)

A trained dental examiner will screen the participants for eligibility using a screening questionnaire covering the above criteria. Participants will also be asked the Six-item Cognitive Impairment Test (6-CIT) in order to assess their level of cognitive function. Residents with normal cognitive function (6-CIT score of 0-7) and those with mild cognitive impairment (6-CIT score of 8-9) will be included in the study, while those with severe cognitive impairment (6-CIT score of 10 or higher) will be excluded. As cognitive function tends to fluctuate in this population, we will attempt the 6-CIT screening test at different days and times on residents identified with severe cognitive impairment in order to identify potential time periods that would facilitate higher inclusion of participants in the study.

Recruitment start date

01/07/2020

Recruitment end date

30/09/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Eastern Health & Social Care
Top Floor Thompson House Hospital 19/21 Magheralave Road
Belfast
BT28 3BP
United Kingdom

Trial participating centre

Whittington Health NHS Trust
The Whittington Hospital Magdala Avenue
London
N19 5NF
United Kingdom

Trial participating centre

Central and North West London NHS Foundation Trust
Stephenson House 75 Hampstead Road
London
NW1 2PL
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

c/o Ms Suzanne Emerton
UCL/UCLH Joint Research Office
1st Floor Maple House (Suite B)
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 (0)2034477430
randd@uclh.nhs.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/03/11

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol will be submitted to a peer-reviewed international journal in 2020.

The researchers already have two abstracts accepted in international conferences with TOPIC related content. The study protocol was presented in a poster presentation at the European College of Gerontology Congress in 2019, while an abstract that covered the content adaptation phase of the work was accepted for an oral presentation at the International Association of Dental Research General Session in 2020.

The researchers plan to submit a paper with the study protocol to an international peer-reviewed journal in 2020, and plan to publish the main study findings separately in 2022.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request. A data request form will need to be completed and permission granted from the CI (Prof. Georgios Tsakos; g.tsakos@ucl.ac.uk) to share any data. Data will be stored for 5 years and will be anonymised and stripped of personal identifiers.

Intention to publish date

31/01/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/02/2020: Trial's existence confirmed by the NIHR.