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

NCT ID: NCT06092151

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-22
• Study Completion Date: 2025-02-28

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.

Conditions

Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Silver Diamine Fluoride

SDF treatment for caries in the primary teeth of children included

Group Type: EXPERIMENTAL

Silver diamine fluoride

Intervention Type: DEVICE

silver diamine fluoride - maximum 1 drop to be applied per visit (manufacturer advises this would treat up to 5 teeth)

Usual Care

Usual care determined by child's dentist for caries in their primary teeth

Group Type: ACTIVE_COMPARATOR

Usual dental care

Intervention Type: PROCEDURE

Usual restorative or preventative care determined by the child's dentist - for examples fillings or crowns

Interventions

Silver diamine fluoride

silver diamine fluoride - maximum 1 drop to be applied per visit (manufacturer advises this would treat up to 5 teeth)

Intervention Type: DEVICE

Usual dental care

Usual restorative or preventative care determined by the child's dentist - for examples fillings or crowns

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sheffield

OTHER

Sponsor Role: collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Sheffield

Sheffield, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Miss Timms

Role: primary

l.timms@sheffield.ac.uk

0114 2159310

References

Timms L, Rodd H, Deery C, Brocklehurst P, Marshman Z. Silver diamine fluoride for the management of dental caries in children in primary dental care: protocol for a feasibility study. Pilot Feasibility Stud. 2024 Jun 24;10(1):95. doi: 10.1186/s40814-024-01519-y.

Reference Type: DERIVED

PMID: 38915111 (View on PubMed)

Other Identifiers

STH21666

Identifier Type: -

Identifier Source: org_study_id