Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06092151
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-06-15
Brief Title:
SDF for the Management of Dental Caries in Children in Primary Dental Care Protocol for a Feasibility Study
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
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 Childrens Primary Teeth is Feasible in UK Primary Dental Care
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens 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 childrens 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 recruitmentretention strategies participant documentation analysis engagement and dissemination
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 childrens 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 childrens 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 recruitmentretention strategies participant documentation analysis engagement and dissemination
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None