Abstract
Abstract
Background
Many children require dental extractions under general anaesthesia (DGA) due to their young age, the number of carious primary teeth and their inability to cope with treatment under local anaesthetic. Children in England are waiting up to 80 weeks for a DGA. While children await the DGA, a high proportion experience pain (76%), infection and antibiotic prescription (49%), missed school time (26%) and sleepless nights (29–38%).
Silver diamine fluoride (SDF) is an evidence-based and minimally invasive topical treatment to arrest progression of tooth decay. It is proposed if SDF is applied while children are waiting for DGA it may halt disease progression and reduce the chances of children experiencing further pain or infection.
However, there are several uncertainties that require answering to inform the design of a trial to evaluate whether SDF reduces negative impacts for children with caries while waiting for a DGA. These uncertainties are the ability to recruit and retain participants, the ability to collect sufficient high quality outcome data and the number of children recruited into the study that are able to accept the SDF treatment.
Aim
This study aims to address key uncertainties (ability to recruit and retain participants, ability to collect sufficient high quality outcome data and the proportion of children recruited who can accept the SDF treatment) to inform a larger randomised controlled trial.
Methods
A pragmatic sample size of 30 child/parent dyads will be recruited across three sites in the UK. Participants will be child/parent dyads comprising children aged 1–8 years (and their parents), who are awaiting DGA for carious primary teeth.
Children will have SDF applied to carious primary teeth at the time of placement on a DGA waiting list. Data will be collected to determine: proportion of child/parent dyads who accept SDF and numbers approached, declined, accepted, recruited and retained up to DGA. A questionnaire about children’s oral health-related quality of life (OHRQoL) will be completed at the DGA visit. Short parental questionnaires will review pain and infection whilst the child is awaiting their DGA. Qualitative interviews will explore study processes and SDF treatment experience with child/parent dyads. Data analysis will be simple descriptive statistics for quantitative data and framework analysis for qualitative data.
Discussion
Anticipated barriers to feasibility study success include local approval, data collection and quality, loss to follow-up and ability to arrange qualitative interviews. Progression to a fully powered clinical trial will be based on information from the feasibility study on child recruitment, collection of primary outcome data and SDF acceptability.
Trial registration
ISRCTN42409963, Protocol version: 1.1 23/02/2025.