Clinical trial NCT06092151: SDF for the Management of Dental Caries in Children in Primary Dental Care: Protocol for a Feasibility Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries in Children
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
name: National Institute for Health Research, United Kingdom
First posted: 2023-10-23
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: feasibility study
Primary purpose: TREATMENT

Brief summary: Dental caries remains a significant health problem in England, effecting 11% of 3-year-olds and 23% of 5-year- olds. Children with dental caries suffer pain, infection and poor oral health-related quality of life. There are different approaches for the management of childhood dental caries but it remains the most common reason for a hospital admission in the UK for children aged 5-9 years, costing the NHS £50 million in 2015-2016. While current approaches have been extensively investigated, their ability to: 1) control pain and infection; 2) prevent hospital admissions, and 3) be implemented within the current NHS contractual arrangements, remains unsatisfactory. Silver diamine fluoride (SDF) is an alternative and non-invasive approach that is applied topically (simple to manage for children) and has proven efficacy in arresting caries progression in primary teeth, principally from studies conducted outside Europe. Its use in primary dental care practice in the UK is limited despite acknowledged need.

However, the clinical and cost effectiveness of SDF has not been compared to usual care in the UK, so it is unknown which treatment is more effective. Before a pragmatic randomised controlled trial (RCT) can be conducted into the clinical and cost effectiveness of SDF compared to usual care, there are several uncertainties related to recruitment, retention and fidelity that require investigation in a feasibility study.

Research Question Is a randomised controlled trial (RCT) to compare the effectiveness of silver diamine fluoride (SDF) to usual care for the treatment of caries in children's primary teeth feasible in UK primary dental care? Aim The overall aim is to establish whether conducting a RCT to compare SDF to usual care for the treatment of caries in children's primary teeth is feasible.

Methods This mixed-method study is a feasibility study with an embedded process evaluation, to compare SDF with usual treatment in primary dental care in the UK. It will be individually randomised, with at least eight dentists, each in a different dental practice and a sample size of 80 participants. There will be ten participants per dentist and equal arm allocation. Follow-up will be for one year. The study will inform whether an RCT is feasible by resolving several key uncertainties. Acceptability and implementation of SDF and the research processes will be explored. Patient and Public Involvement and Engagement (PPIE) representatives will be involved throughout, further informing design including recruitment/retention strategies, participant documentation, analysis, engagement and dissemination.


Eligibility criteria: Inclusion Criteria:

* Children aged 2-6 years
* Cavitated dentinal caries in any primary tooth
* No carious involvement of the tooth pulp
* No dental infection secondary to a non-vital tooth
* Parent/carer able to complete consent forms (with the support of an interpreter if necessary)

Exclusion Criteria:

* Allergy to any treatment component
* Caries effecting the pulp
* Infection secondary to a non-vital tooth
* Conditions requiring special considerations for the child's dental management where randomisation would not be appropriate for example a medical history including cardiac defects, oncology, hereditary bleeding, or being immunocompromised.
* Dental anomalies effecting the carious teeth involved: amelogenesis imperfecta, dentinogenesis imperfecta, molar incisor hypomineralisation, abnormal morphology such as double teeth.

Primary outcomes:
measure: Data quality of candidate primary outcome measures - ICDAS
timeFrame: 18 months
measure: Data quality of candidate primary outcome measure - pain and infection including PUFA
timeFrame: 18 months
measure: Data quality of candidate secondary outcome measure; referral to secondary care
timeFrame: 18 months
measure: Data quality of candidate secondary outcome measure; Completion course of treatment
timeFrame: 18 months
measure: Data quality of candidate secondary outcome measure; number of appointments taken for completion of a course of treatment
timeFrame: 18 months
measure: Data quality of secondary outcome measure; Adherence to intervention protocol or usual care guidelines.
timeFrame: 18 months
measure: Data quality of candidate secondary outcome measure; Adverse effect(s).
timeFrame: 18 months
measure: Data quality of candidate secondary outcome measure; Appointment length
timeFrame: 18 months
measure: Data quality of candidate secondary outcome measure; • number of units of dental activity claimed
timeFrame: 18 months
measure: Data quality of candidate secondary outcome measure; child and parental/carer reported experience of treatment
timeFrame: 18 months
measure: Data quality of candidate secondary outcome measure; Parental/carer reported oral health-related quality of life; P-CPQ16
timeFrame: 18 months
measure: Variability of primary outcome measure; ICDAS or pain and infection
timeFrame: 18 months
measure: recruitment, randomisation and retention rates of child participants
timeFrame: 18 months
measure: recruitment and retention rates of dental professionals
timeFrame: 18 months
measure: rate of dentists' adherence to the study protocol (treatment allocation)
timeFrame: 18 months
measure: Data quality and percentage completion rates of cost effectiveness data; cost data completed in case report forms by dental professional
timeFrame: 18 months
measure: Data quality of cost effectiveness data; parental questionnaires
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield
Study officials:
References: