SDF for the Management of Dental Caries in Children in Primary Dental Care: Protocol for a Feasibility Study

Study Overview
=================
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.

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

Conditions
-----------------
Dental Caries in Children

Intervention / Treatment
-----------------
* Device: Silver diamine fluoride
* Procedure: Usual dental care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver Diamine Fluoride<br>SDF treatment for caries in the primary teeth of children included | Device: Silver diamine fluoride<br>* silver diamine fluoride - maximum 1 drop to be applied per visit (manufacturer advises this would treat up to 5 teeth)<br>|
| Active Comparator: Usual Care<br>Usual care determined by child's dentist for caries in their primary teeth | Procedure: Usual dental care<br>* Usual restorative or preventative care determined by the child's dentist - for examples fillings or crowns<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data quality of candidate primary outcome measures - ICDAS | • International Caries Detection and Assessment System (ICDAS) - by measuring percentage of completion and data quality | 18 months | 
| Data quality of candidate primary outcome measure - pain and infection including PUFA | Occurrence or report of pain or infection and Pulpal involvement, Ulceration, Fistula, Abscess (PUFA) index by measuring percentage of completion and data quality | 18 months | 
| Data quality of candidate secondary outcome measure; referral to secondary care | Referral to secondary care; measuring percentage of completion and data quality | 18 months | 
| Data quality of candidate secondary outcome measure; Completion course of treatment | Completion course of treatment; measuring percentage of completion and data | 18 months | 
| Data quality of candidate secondary outcome measure; number of appointments taken for completion of a course of treatment | The number of appointments taken for completion of a course of treatment; measuring percentage of completion and data quality | 18 months | 
| Data quality of secondary outcome measure; Adherence to intervention protocol or usual care guidelines. | Adherence to intervention protocol or usual care guidelines. ; measuring percentage of completion and data quality | 18 months | 
| Data quality of candidate secondary outcome measure; Adverse effect(s). | Adverse effect(s). ; measuring percentage of completion and data quality | 18 months | 
| Data quality of candidate secondary outcome measure; Appointment length | Appointment length; measuring percentage of completion and data quality | 18 months | 
| Data quality of candidate secondary outcome measure; • number of units of dental activity claimed | Number of units of dental activity claimed; measuring percentage of completion and data quality | 18 months | 
| Data quality of candidate secondary outcome measure; child and parental/carer reported experience of treatment | Child and parental/carer reported experience of treatment. measuring percentage of completion and data quality | 18 months | 
| Data quality of candidate secondary outcome measure; Parental/carer reported oral health-related quality of life; P-CPQ16 | Parental/carer reported oral health-related quality of life; measuring percentage of completion and data quality | 18 months | 
| Variability of primary outcome measure; ICDAS or pain and infection | This will be calculated once the specific measure has been chosen based on completion rates and data quality, and discussion with the study panel. Calculation of the variability of the primary outcome measure that is ultimately chosen for a trial should it be deemed feasible. | 18 months | 
| recruitment, randomisation and retention rates of child participants | Percentage rates of recruitment, randomisation and retention of child participants | 18 months | 
| recruitment and retention rates of dental professionals | Percentage rates of recruitment and retention of dental professionals | 18 months | 
| rate of dentists' adherence to the study protocol (treatment allocation) | Percentage of dentists which adhered to the randomisation determined treatment choice for the child | 18 months | 
| Data quality and percentage completion rates of cost effectiveness data; cost data completed in case report forms by dental professional | Data quality and percentage completion rates of cost effectiveness data; cost data completed in case report forms (time of appointments, treatment carried out, number of UDAs claimed) by dental professional | 18 months | 
| Data quality of cost effectiveness data; parental questionnaires | Data quality and percentage completion rates of cost effectiveness data; cost questionnaires completed by parents | 18 months |