Using other members of the dental team to provide oral care for residents in care homes
| ISRCTN | ISRCTN16332897 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16332897 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 297182 |
| Protocol serial number | IRAS 297182, CPMS 49709 |
| Sponsor | Bangor University |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) |
- Submission date
- 29/10/2020
- Registration date
- 03/12/2021
- Last edited
- 18/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Poor oral health for older adults residing in care homes is a significant public health problem. Unlike previous generations, about half of all care home residents now have some of their own natural teeth, but their oral health is much worse than their community living peers. These can give rise to significant avoidable health and social care costs. Despite this, dental service provision in care homes is poor and extremely variable.
The aim of this study is to undertake a cluster-randomised controlled trial to determine whether Dental Care Professionals (DCPs) could reduce plaque levels (improve the oral cleanliness) of older adults (over 65 years of age) residing in care homes over a 6-month period, when compared to ‘treatment as usual’ (commonly a reactive and ad hoc service provided by dentists). In addition, the researchers aim to determine whether this effect is sustainable over a further 6-month follow-up period.
Who can participate?
Residents over the age of 65 years; who are dentate or partially dentate (at least six natural teeth); and a full-time resident in the care facility
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. Dental therapists will visit the care home every 6 months and undertake any treatment the participating residents require. Dental nurses will visit the care home monthly for the first three months then 3-monthly afterwards to provide advice on how to improve the oral health of the participating residents, apply fluoride to teeth as required. They may also provide advice on the Eatwell guide.
The control will be routine practice.
Trained dentists will collect clinical information at the start of the study. Other data will be collected via questionnaires administered by trial managers. 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?
The study will help the researchers to understand whether using different members of the dental team can improve oral health. If the results are positive, this will help us to plan future services. Other than the time commitment taking part in the study, the researchers do not anticipate there being any risks.
Where is the study run from?
Bangor University (UK)
When is the study starting and how long is it expected to run for?
August 2018 to September 2025
Who is funding the study?
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) (UK)
Who is the main contact?
Prof. Paul Brocklehurst
p.brocklehurst@bangor.ac.uk
Contact information
Scientific
Bangor University
School of Healthcare Sciences
Bangor
LL57 2EF
United Kingdom
 ORCID ID |
0000-0002-6789-2774 |
|---|---|
| Phone | +44 (0)1248 383218 |
| p.brocklehurst@bangor.ac.uk |
Scientific
Queen’s University Belfast
Centre for Public Health
Belfast
BT12 6BA
United Kingdom
| ORCID ID |
0000-0001-8478-1673 |
|---|---|
| Phone | +44 (0)28 9097 8999 |
| g.mckenna@qub.ac.uk |
Scientific
Department of Epidemiology and Public Health
University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
| ORCID ID |
0000-0002-5086-235X |
|---|---|
| Phone | +44 (0)207 6795614 |
| g.tsakos@ucl.ac.uk |
Public
NWORTH
Meirion Building
Normal Site
Bangor University
Holyhead Road
Bangor
LL57 2PZ
United Kingdom
| ORCID ID |
0000-0003-1963-4903 |
|---|---|
| Phone | +44 (0)1248 382442 |
| a.jenkins@bangor.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster-randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | uSing rolE-substitutioN In care-homes to improve oRal health |
| Study acronym | SENIOR |
| Study objectives | The aim of this study is to undertake a cluster-randomised controlled trial to determine whether Dental Care Professionals (DCPs) could reduce plaque levels (improve the oral cleanliness) of dentate older adults (over 65 years of age) residing in care-homes over a 6-month period, when compared to ‘treatment as usual’ (commonly a reactive and ad hoc service provided by dentists). In addition, the researchers aim to determine whether this effect is sustainable over a further 6-month follow-up period. |
| Ethics approval(s) | Approved 05/05/2021, Wales Research Ethics Committee 5 Bangor (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920 785738; Wales.REC5@wales.nhs.uk), REC ref: 21/WA/0116 |
| Health condition(s) or problem(s) studied | Oral health in care-home residents |
| Intervention | Three workstreams (WSs) are proposed. WS1 will be a two-arm cluster-randomised controlled trial, with a 3-month internal pilot. Recruitment will be a two-stage process. The first stage will be the recruitment of the care homes. The second stage of recruitment is for dentate or partially dentate residents of the included homes. This is a cluster randomised trial and will be conducted in 40 care homes in England, Northern Ireland and Wales. They will be randomised (via NWORTH CTU) based on a 1:1 ratio (20 intervention and 20 control). Stratification of care homes will be based on the following factors care home site (England, Northern Ireland, Wales) and care-home size (based on the number of available beds within the home: small 1-10 beds; medium 11-49 beds; large 50+). The researchers will seek to balance these factors a priori using NWORTH’s dynamic adaptive algorithm (http://nworth-ctu.bangor.ac.uk/randomisation/index.php.en) and will adjust for these factors post-hoc as part of the analysis. The intervention consists of: 1. Professional application of fluoride (2.2% NaF varnish) every 3 months 2. Prescription of 5,000 ppm fluoride toothpaste (should active coronal or root caries be detected at baseline) 3. Oral hygiene advice 4. Recommendation of the Eatwell Guide On entry into the study, residents will complete the Six-item Cognitive Impairment Test (6-CIT) in order to assess their level of cognitive function. In order to be as inclusive as possible, all residents that are able to provide consent will be included in the study, but a record will be kept of their 6-CIT scores. A log will be kept of residents who decide not to participate (explored in WS2) and the number of residents who were unable to provide consent. WS2 will run alongside WS 1 to undertake a process evaluation of the trial. The researchers will use semi-structured interviews with residents, staff, managers, D-Ts, DNs and informal carers to assess the intervention’s acceptability. Managers and residents that refuse participation will also be interviewed, to explore their narrative. The sampling frame will account for geographic differences, care-home size, staffing ratios and proportion of residents with severe cognitive impairment. They will also interview Chief Dental Officers, dental commissioners, Directors of the CDS and high street dentists. WS3 will be a cost-effectiveness analysis from an NHS perspective and examine potential long-term costs and benefits. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Plaque coverage measured using the Silness & Loë plaque index measured at baseline, 6 and 12 months |
| Key secondary outcome measure(s) |
1. Oral health measured using bleeding on probing at baseline, 6 and 12 months |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 280 |
| Total final enrolment | 327 |
| Key inclusion criteria | Care homes: 1. Care homes are expected to have a minimum of ten residents over the age of 65 years Residents: 1. Over the age of 65 years 2. Dentate or partially dentate (at least six natural teeth) 3. Full-time resident in a care facility |
| Key exclusion criteria | Care home: 1. High-dependency units 2. Current participation in TOPIC, Gwên am Byth or other oral health programme 3. Care-homes that specialize in end-of-life or palliative care Residents: 1. Residents who are receiving end-of-life or palliative care |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 11/10/2024 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. Anonymised data will be stored according to Bangor regulations (Bangor server). See https://www.bangor.ac.uk/planning/InfSecGuid.php.en |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol version 3 | 18/03/2021 | 18/08/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/03/2025: The overall end date was changed from 31/03/2025 to 30/09/2025.
03/12/2024: The following changes were made:
1. The recruitment end date was changed from 31/10/2024 to 11/10/2024.
2. Total final enrolment was added.
25/09/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2024 to 31/10/2024.
2. The overall end date was changed from 30/06/2024 to 31/03/2025.
3. The intention to publish date was changed from 01/03/2024 to 31/12/2025.
4. The plain English summary was updated to reflect these changes.
15/03/2024: The recruitment end date was changed from 30/08/2022 to 30/06/2024.
18/08/2022: Protocol file uploaded.
11/01/2022: The IRAS number was changed from 277548 to 297182.
01/12/2021: Trial's existence confirmed by the NIHR.
