How to fix holes in baby teeth?
Research type
Research Study
Full title
How to fix holes in baby teeth? Silver diamine fluoride for the management of dental caries in children in primary dental care: A feasibility study to determine whether a randomised controlled trial of silver diamine fluoride compared to usual care for the management of caries in children’s primary teeth is feasible in UK primary dental care.
IRAS ID
324432
Contact name
Laura Timms
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Dental decay in primary (baby) teeth in children is common. In England 23%, of 5-year-olds have decay in their primary teeth. Untreated decay can cause pain, difficulty eating and sleeping and can lead to reduced school performance. When teeth are not treated, the decay often progresses, requiring children to have their teeth removed. For young children this frequently necessitates removal of teeth under general anaesthetic (GA). Paediatric dental GAs cost the NHS £50 million in 2015-2016.
Many treatments are available for decayed primary teeth and guidance is provided for dentists. Research has shown that, despite this guidance, many children (43%) still develop pain or infection.
Alternative solutions are required that are effective at stopping tooth decay progressing, and reducing pain and infection. Silver diamine fluoride (SDF) is a treatment that is widely used internationally, but its use is not as common in the UK. It is a quick and non-invasive procedure. SDF has a side effect; it changes the yellow-brown colour of tooth decay to black. Research has shown that it is effective at stopping decay progressing, but it has not been compared to usual care in the UK, so it is unknown which is more effective.
To determine whether a randomised clinical trial can be conducted in dental practice to compare SDF to usual care, there are several important considerations/uncertainties requiring investigation. The proposed research seeks to investigate these uncertainties through a study to assess the feasibility of the definitive trial.
Children aged 2-6 years with dental decay in their primary teeth will be randomly assigned to either have SDF treatment or usual care. This treatment will be provided by eight dentists in different dental practices involving a total of 80 children. Data will be collected and interviews carried out with families and dental professionals to explore the uncertainties.Lay Summary of Results:
t was possible to involve eight NHS dental sites in the research. Eight sites NHS Dental sites recruited 54 children in total. Five of the sites recruited at least 70% of the target of 10 children, whereas the other three recruited between 10 and 50% of the target. The speed to recruit children was different across sites and overall slower than expected. We hoped to recruit 80 children in total, but only 54 (67.5%) were recruited. However, from children that were approached and were suitable to take part, 94% of them agreed to take part.
The average age of children that took part was 5. They had an average of 3 decayed baby teeth. Over 60% were living in the most deprived areas in England. The majority were of White British ethnicity.
Most children (74%) attended for their last visit at around 12 months. Although they did not all attend the 3 monthly appointments between their first and last check ups.
Children were allocated a treatment at random. For 11 of these children, they received a different treatment than they were allocated. Mostly this was because children received silver diamine fluoride than were planned. This was mainly because they were not able to co-operate with usual care. This was because families and dental professionals felt this was in the child’s best interest. When children received silver diamine fluoride, often a filling was added over the top. This was because families and professionals were concerned over leaving a tooth without a filling due to the aesthetics but also worry about this meaning the treatment would not be successful. On the whole, children found the silver diamine fluoride treatment acceptable.
The recording of pain and infection, child’s wellbeing, their treatment experience, costs associated with treatments were all well completed. We planned to measure if the child’s dental decay had progressed after children but this was not accurately completed often enough for this to be a reliable way of measuring this, for this group of patients. This involved use of a specific recording system, that while dental professionals thought was useful, they found it too time consuming to complete.
We also looked at the success of implementing the use of silver diamine fluoride in NHS primary care. This was through discussion with professionals who write policy and make decisions on care at a regional and national leave, dental teams and parents and their children. We completed 61 interviews. This showed that it was possible for silver diamine fluoride to be used in the NHS Dental setting, but that there were issues about the way it made teeth look, that teeth did not have a filling placed and how dental teams were paid and contracted to use the silver diamine fluoride. People were concerned that because silver diamine fluoride makes the appearance of the tooth decay black, it may mark children out as having dental decay. Professionals and parents were worried about the impact on children. This was particularly the case for those from deprived areas. Parents were worried people would judge their parenting as it would appear their children had not had their teeth treated. Despite this, many still had a favourable opinion of the silver diamine fluoride treatment as it provided an option for children to be treated, that could not manage other treatments such as fillings or crowns. This was seen as a positive by all groups and potentially a way to avoid children having to have a general anaesthetic to have teeth removed. It was thought that silver diamine fluoride could lead to cost savings for the NHS, but because of how dental practices are paid, it would cost them more to purchase the silver diamine fluoride, and they felt they were not paid well enough to cover this. While in many circumstances they would use it anyway as they felt it would be best for their patients, they acknowledged this would limit its wider use.Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fregister.clinicaltrials.gov%252Fprs%252Fbeta%252Fstudies%252FS000DAOS00000051%252Fresults%252FresultsSummary%2FNBTI%2Fi-rGAQ%2FAQ%2Fe72978e5-f86a-426f-a785-e246387491a2%2F2%2F227_iPWnkQ&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C761748ce62574cb731bd08deebe7b367%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639207577585161848%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=zbxRH95soVq6MjgEzj7nJqWFYdKI4AsZOTsmCcja6t4%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 30/09/2026
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Pending
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected: 30/09/2026
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: Anonymised data is available on request, subject to the consent provided by participants, but is not in a public repository
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: Not applicable - no tissue samples collected
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Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0053
Date of REC Opinion
17 Mar 2023
REC opinion
Favourable Opinion