Improving the adoption of clinical guidelines for the treatment of gum disease in primary dental care

ISRCTN	ISRCTN38351718
DOI	https://doi.org/10.1186/ISRCTN38351718
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	344120
Protocol serial number	COCR0047
Sponsor	Queen Mary University of London
Funder	Barts Charity

Submission date: 04/07/2025
Registration date: 11/07/2025
Last edited: 11/07/2025

Recruitment status: Recruiting
Overall study status: Ongoing
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
Gum disease is a common problem for adults in East London. It can cause bleeding gums, bad breath, loose teeth, and even tooth loss if not treated. The good news is that gum disease can be prevented and managed in dental practices. In 2020, new guidelines were published to help dental teams treat gum disease. However, many NHS dental practices are not using these guidelines.
This study aims to work with dental teams, patients, and NHS managers to create a solution that helps more practices follow the guidelines.

Who can participate?
Dental practices in North East London will be invited to take part. Within each practice, we will invite dentists, dental hygienists, reception staff, and patients with gum disease to join the study.

What does the study involve?
The study has four stages:
1. Dental practices will receive a postal survey asking if they want to take part in research.
2. We will speak with dental staff, patients, and NHS managers to understand what makes it hard to follow the guidelines.
3. Together, we will design a solution to help practices use the guidelines more effectively.
4. We will test this solution in a small number of practices to see how well it works and make improvements if needed.

What are the possible benefits and risks of participating?
Taking part could help improve care for patients with gum disease and reduce the need for hospital referrals. It may also help dental teams work more effectively.
There are no major risks to taking part. All information will be kept confidential, and participants can choose to leave the study at any time.

Where is the study run from?
Queen Mary University of London (UK)

When is the study starting and how long is it expected to run for?
April 2025 to March 2028

Who is funding the study?
Barts Charity (UK)

Who is the main contact?
1. Prof. Eduardo Bernabe, e.bernabe@qmul.ac.uk
2. Prof. Aalia Karamat, a.karamat@qmul.ac.uk

Contact information

Prof Eduardo Bernabe
Scientific, Principal investigator

Centre for Dental Public Health & Primary Care
Institute of Dentistry, Queen Mary University of London
Royal London Dental Hospital
Turner Street
London
E1 2AD
United Kingdom

ORCID ID	0000-0002-1858-3713
Phone	+44 (0)20 7882 3704
Email	e.bernabe@qmul.ac.uk

Dr Aalia Karamat
Public

Centre for Dental Public Health & Primary Care
Institute of Dentistry, Queen Mary University of London
Royal London Dental Hospital
Turner Street
London
E1 2AD
United Kingdom

ORCID ID	0000-0002-0580-1064
Phone	+44 (0)20 7882 3704
Email	a.karamat@qmul.ac.uk

Study information

Primary study design	Other
Study design	Mixed methods participatory implementation study carried out in four work packages
Secondary study design
Study type	Participant information sheet
Scientific title	Co-development and feasibility of an implementation strategy to improve the adoption of clinical guidelines for periodontal treatment in primary dental care
Study objectives	The current proposal aims to co-develop and evaluate the feasibility of an implementation strategy to improve the adoption of BSP guidelines for treatment of periodontitis in NHS primary dental care. The objectives are to: 1. Evaluate the willingness of primary dental care practices to engage in research (WP1). 2. Identify contextual barriers to and facilitators of the implementation of BSP guidelines in primary dental care practices (WP2). 3. Co-design a theoretically-based implementation strategy that addresses perceived barriers to and maximizes the potential facilitators of implementation (WP3). 4. Evaluate the feasibility of delivering the implementation strategy in primary dental care practices and gather data to inform a definitive implementation trial (WP4).
Ethics approval(s)	Not yet submitted (United Kingdom)
Health condition(s) or problem(s) studied	Periodontal disease
Intervention	The intervention will be an implementation strategy that will be codeveloped with key informants (clinical teams, service commissioners and patients) to address identified barriers and leverage facilitators. The project will recruit participants into different work packages (WP). For WP 2 and 3, key informant groups (commissioners of dental services, patients, dentists, dental hygienists and receptionists) will be interviewed to identify factors that can encourage or impede the implementation of the BSP guidelines in primary dental care. In WP3, the key informant groups will participate in two co-design workshops to develop an implementation strategy. In WP4, patients with periodontal disease will be recruited into the study and will receive periodontal treatment, over multiple visits, as recommended by the BSP guidelines.
Intervention type	Other
Primary outcome measure(s)	The feasibility study (WP4) will evaluate implementation outcomes using the RE-AIM framework. The following indicators will be measured for each RE-AIM domain (including their corresponding timing during the 12-month life of the feasibility study): 1. Reach: numbers of periodontal patients who were approached and deemed eligible, recruitment rates, and reasons for non-participation (measured after all patients have been recruited). 2. Effectiveness: proportion of engaging patients after step 1, engaging patients with periodontitis remission/control (probing pocket depth <4 mm) and stable periodontitis (probing pocket depth = 4 mm and no bleeding on probing) after step 2, and appropriate referrals to specialised services (measured after each step of periodontal treatment). 3. Adoption (uptake): participation rates at GDP-level and clinical staff-level, reasons for non-participation, and representativeness of participating GDPs and clinical staff (measured after the recruitment stage is completed). 4. Implementation: adaptations made to the implementation strategy, consistency of its delivery across GDPs and clinical staff, and direct costs of implementing the strategy (measured at 12 months). A full economic evaluation will not be carried out, only the feasibility of collecting such data. 5. Maintenance: patients’ attendance to maintenance recalls (attrition rate), comparison of the characteristics of recall attenders versus non-attenders and the number of periodontal patients that were treated as per the BSP guidelines after recruitment targets were achieved (measured at 12 months). The above quantitative indicators will be complemented with qualitative data from interviews with members of the clinical team (dentists, dental hygienists and receptionists) and patients to gather in-depth information on the different domains of the RE-AIM framework.
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	31/03/2028

Eligibility

Participant type(s)	Patient, Health professional
Age group	Adult
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	61
Key inclusion criteria	1. Work Package 1: Practice Recruitment 1.1. All general dental practices (GDPs) within the NHS North East London Integrated Care Board area — including City of London, Hackney, Tower Hamlets, Waltham Forest, Newham, Redbridge, Barking and Dagenham, and Havering — will be invited to participate. 1.2. To be eligible, GDPs must: 1.2.1. Have a cohort of at least 250 patients who regularly attend the practice. 1.2.2. Provide periodontal care under an active NHS contract. 1.2.3. Include a dental hygienist as part of the clinical team (i.e. they provide routine scaling and polishing in primary care). 2. Work Packages 2 and 3: Staff and Patient Recruitment 2.1. From each participating GDP, the following staff will be recruited: 2.1.1. At least one dentist 2.1.2. At least one dental hygienist 2.1.3. At least one receptionist involved in the administrative (e.g. referral process, booking appointments) and/or clinical management of periodontal patients 2.2. Up to two adult periodontal patients will also be recruited from each GDP. These patients should be at different stages of treatment. 3. Work Package 4: Patient Eligibility and Volume 3.1. Eligible GDPs should see at least one eligible patient with periodontal disease per week.
Key exclusion criteria	GDPs that are not situated in the Northeast of London, do not see patients with periodontal disease or do not provide treatment for periodontal patients Children or adult patients without periodontal disease.
Date of first enrolment	01/10/2025
Date of final enrolment	31/03/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

General dental practices

North East London
London
E1 2AD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository, Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository hosted by Queen Mary University of London. The datasets can be made available upon request from the PI of this project (see contact details below).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/07/2025: Trial's existence confirmed by Barts Charity