PANDA study - An evaluation of an alternative child-friendly dental pathway
| ISRCTN | ISRCTN16214896 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16214896 |
| IRAS number | 323977 |
| Secondary identifying numbers | IRAS 323977, NIHR151661, CPMS 56016 |
- Submission date
- 27/04/2023
- Registration date
- 28/04/2023
- Last edited
- 16/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Children in the poorest areas of England have much more tooth decay than those in wealthier areas, and this is a major health inequality. These children are often referred by regular dentists to a Community Dental Service (CDS) for specialist treatment and many are sent on to hospital to have teeth removed while asleep under general anaesthetic. At present, about 15,000 children need teeth removed in hospital each year in England, and this is the commonest reason for children being admitted. Unfortunately waiting times for CDS and hospital referrals have increased during the Covid 19 pandemic.
During Covid 19, a potential alternative to treating these children was introduced; a special kind of dental practice known as a “Child Friendly Dental Practice” (CFDP). These practices have additional support that allows them the time to manage children with lots of decay and their waiting times are only a few weeks. By seeing these children earlier there is a good chance we can reduce the need to send them to a CDS or to hospital for extractions. This option should reduce demands on hospitals and enable them to focus on those children who have the most urgent complex dental needs.
We have some pilot study information which suggests that around 50% of children referred to Child Friendly Dental Practice can be treated there without the need to visit another service.The working assumption underpinning the pilot was that the Child Friendly Dental Practices would improve things. We will test that assumption using a 'realist approach' and unravel the mechanisms which could determine how it works. We are therefore going to test these Child Friendly Dental Practices at a much larger scale than our very small pilot study, and we want to do this in a research project that measures all the different aspects of the children, their treatment, whether they ultimately still need teeth taken out under general anaesthetic, and costs and savings.
Who can participate?
Patients and their families who have been referred through the dental paediatric referral system in Greater Manchester who meet the criteria to be seen within a Child Friendly Dental Practice
What does the study involve?
The study involves information collected through interviews with dental teams and families as well as information collected through patient dental records from their original referral and then over a two year period.
What are the possible benefits and risks of participating?
The burden on participants is incredibly low. Participants are being asked to consent to the study team to access their records in relation to their dental health/treatment and to complete short text message survey (which they will be compensated for - £10 voucher).
The potential risk is access to their dental records/data. This will be minimised by keeping the data in the UoM Data Safe Haven, developed to keep NHS data safe and according to NHS data requirements
Where is the study run from?
The study sponsor is the University of Manchester (UK)
When is the study starting and how long is it expected to run for?
February 2023 to November 2025
Who is funding the study?
This project is funded through the National Institute for Health Research (NIHR151661).
Who is the main contact?
Dr Michaela Goodwin, michaela.goodwin@manchester.ac.uk
Contact information
Principal Investigator
Dental Health Unit
Williams House
Manchester Science Park
Manchester
M15 6SE
United Kingdom
 ORCID ID |
0000-0002-0375-3118 |
|---|---|
| Phone | +44 161 2324711 |
| michaela.goodwin@manchester.ac.uk |
Study information
| Study design | Observational prospective cohort |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | ISRCTN16214896 CHILD PIS for PANDA age 4 to 11 V2 04May2023.pdf |
| Scientific title | An evaluation of an alternative child-friendly dental pathway for paediatric patients |
| Study acronym | PANDA |
| Study hypothesis | The aim of this research is to determine the performance of Child Friendly Dental Practice pathway compared to a traditional Specialist Paediatric Dental pathway on the longer term oral health and treatment outcomes for children referred to specialist care due to severe decay and the associated health economic costs. |
| Ethics approval(s) |
Approved 11/05/2023, East Midlands - Nottingham 2 Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 20 71048016; nottingham2.rec@hra.nhs.uk), ref: 23/EM/0093 |
| Condition | Dental decay (caries) |
| Intervention | Overall the evaluation of Child Friendly Dental Practices will utilise a realist approach. This will not only allow the evaluation to determine the impact of the scheme on patients and access to services but will allow us to determine ‘what works, for whom, and in what circumstances’. A logic model has been developed based on the initial pilot data, this model will be tested using a mixed methods design using Context Mechanism Outcome configuration. The realist approach therefore will allow us to understand what the linkages are between these different components. The realist approach focuses on the mechanisms which operate in real time along the treatment and referral pathway. The mechanisms reveal the way things really happen, rather than what practitioners, researchers, funders, assume or think happens. Given the complexity of the evaluation and range of perspectives the study aims to capture; a parallel mixed methods study will be undertaken. The mixed methods will include quantitative data collected from clinical records through dental settings such as dental practices, dental referral, treatment through dental hospitals. Qualitative data will focus on two groups: (a) dental professionals (incl. triage and in-practice dental teams) and (b) patients (incl. parents and children) accessing and using CFDPs. Further qualitative research will involve a qualitative researcher attending and observing sessions at the Child Friendly Dental Practices to record what happens during the sessions to detail how they work, the way they are organised, how patients are welcomed and looked after, etc. Potential participants will be approached and provided the Patient Information Sheet and consent form when they attend for a dental appointment at either a Child Friendly Dental Practice or Community Dental service, or sent this information in a letter home. If parents/guardians consent to take part this will allow the research team to access their child’s dental records concerning the referral and treatment from that dental appointment and any information collected regarding dental attendance or treatment over the next two years. Following consent, they will complete a short survey to collect demographic/sociodemographic data. Parents/guardians will also receive a short text message survey to complete one month after treatment and again at one year and two years after treatment. A subgroup will be invited to take part in qualitative interviews lasting 60 minutes to further understand their experience through the dental referral system and treatment provided. Observational research at dental practices will also be carried out to understand what works within the service, what are the barriers and facilitators to patients using the service and what is provided by the service for example is the service located in an area easily accessible by public transport, does it have a car park, what is provided in the reception area (toys, child friendly environment) how are patients greeted and treated by staff. |
| Intervention type | Other |
| Primary outcome measure | Whether a child has had a dental extraction under General Anaesthetic two years after referral as indicated in electronic patient records (recorded through HES data or through CDS patient records). |
| Secondary outcome measures | Measured using patient records unless otherwise noted: 1. Waiting time until first appointment 2. Number of sessions of treatment 3. Whether a child was successfully seen and treated. For this outcome success is defined as treatment completed by a dentist that results in a child being referred back to their own dentist or discharged, pain free. 4. The number of extractions and restorations as reported in NHS BSA data 5. The courses of antibiotics taken during wait and treatment 6. Participants referred back into the specialist pathway within two years of referral. 7. Dental pain experienced by a child 8. Participants views of their treatment and engagement with the dental profession (follow up of dental appointment) as indicated by the responses to the text message. Questions will include an adapted version of the NHS Friends and Family Test, questions on satisfaction, possible negative/adverse experiences, possible positive experiences, and an option for free text comments at the end of the survey. |
| Overall study start date | 01/02/2023 |
| Overall study end date | 01/11/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 864 |
| Total final enrolment | 708 |
| Participant inclusion criteria | 1. Paediatric patients (aged 0 to 16 years old) referred through the Greater Manchester dental referral system and who have been triaged as appropriate for treatment at a CFDP 2. Patients with parents/guardians who have the capacity to consent |
| Participant exclusion criteria | Patients referred for orthodontic treatment |
| Recruitment start date | 01/06/2023 |
| Recruitment end date | 31/05/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Maclure Road
Rochdale
OL11 1DN
United Kingdom
Sponsor information
University/education
5.011 Carys Bannister Building
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 1612324711 |
|---|---|
| fbmhethics@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Health and Social Care Delivery Research Programme, HSDR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Patient/public focused dissemination: We will produce plain-language summaries, an infographic and a PPI-inspired animated video. The development of the non-academic dissemination products will be led by the PPI members of the study team. We will seek input and feedback on the products from key stakeholder representatives during their development. Professional/academic stakeholder focused dissemination: We will issue press releases coordinated with the CDO’s office and the Office for Health Improvement and disparities (OHID) as well as holding webinars for the UK public health community, promoted via links with the Faculty of Public Health and NIHR. We will distribute the briefing materials, infographic and animated video through NHS England regional offices for distribution to their individual dental and medical contract holders via newsletters, meeting notes or webpages. We will also share our dissemination products through social media channels that are context-sensitive and relevant for that particular target group, for example, the British Association for the Study of Community Dentistry (BASCD), or the popular members-only Facebook group “For Dentists, By Dentists”, which has 14,000 General Dental Council registered members. The results will be published in a high-impact journal and will be presented nationally for example, at conferences held by the Faculty of Public Health and the British Association for the Study of Community Dentistry, |
| IPD sharing plan | The datasets generated during the study are not expected to be made available as the majority of the data will come from third parties (dental clinical records, NHS BSA, NHS digital) and, given participants' permission and data sharing agreements, may not be possible to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | protocol version 1.1 |
04/05/2023 | 26/05/2023 | No | No |
| Participant information sheet | For child version 2 |
04/05/2023 | 16/06/2023 | No | Yes |
| Participant information sheet | For parent version 2 |
04/05/2023 | 16/06/2023 | No | Yes |
| Participant information sheet | One page summary poster version 1 |
16/06/2023 | No | Yes |
Additional files
- ISRCTN16214896_Procotol_v1.1_04May2023.pdf
- protocol
- ISRCTN16214896 One page summary poster PIS for PANDA V1.pdf
- One page summary poster
- ISRCTN16214896 CHILD PIS for PANDA age 4 to 11 V2 04May2023.pdf
- For child
- ISRCTN16214896 Panda Parent PIS V2 04May2023.pdf
- For parent
Editorial Notes
16/03/2024: The following changes were made:
1. Lower age limit and unit were added.
2. The recruitment end date was changed from 01/03/2024 to 31/05/2024.
20/11/2023: The recruitment end date has been changed from 01/11/2023 to 01/03/2024.
16/06/2023: The following changes were made to the trial record:
1. The participant information sheets were uploaded as additional files.
2. The ethics approval was added.
3. The study website was added.
26/05/2023: Uploaded protocol (not peer reviewed).
02/05/2023: Internal review.
27/04/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
