Dental Caries in ChildrenNCT06092151
SDF for the Management of Dental Caries in Children in Primary Dental Care: Protocol for a Feasibility Study
A study testing Silver diamine fluoride and Usual dental care in people with Dental Caries in Children, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Silver diamine fluoride and Usual dental care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Sheffield
Sheffield, S102TA
Miss Timms, 0114 2159310, l.timms@sheffield.ac.uk
About this 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
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.
Read more
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
- Being tested
- Silver diamine fluoride, Usual dental care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver diamine fluorideDevice
silver diamine fluoride - maximum 1 drop to be applied per visit (manufacturer advises this would treat up to 5 teeth)
Usual dental careProcedure or surgery
Usual restorative or preventative care determined by the child's dentist - for examples fillings or crowns
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluoride | Experimental | SDF treatment for caries in the primary teeth of children included Receives: Device: Silver diamine fluoride |
| Usual Care | Active comparator | Usual care determined by child's dentist for caries in their primary teeth Receives: Procedure: Usual dental care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data quality of candidate primary outcome measures - ICDAS
- International Caries Detection and Assessment System (ICDAS) - by measuring percentage of completion and data quality
Measured: 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
Measured: 18 months
Data quality of candidate secondary outcome measure; referral to secondary care
Referral to secondary care; measuring percentage of completion and data quality
Measured: 18 months
Data quality of candidate secondary outcome measure; Completion course of treatment
Completion course of treatment; measuring percentage of completion and data
Measured: 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
Measured: 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
Measured: 18 months
Data quality of candidate secondary outcome measure; Adverse effect(s).
Adverse effect(s). ; measuring percentage of completion and data quality
Measured: 18 months
Data quality of candidate secondary outcome measure; Appointment length
Appointment length; measuring percentage of completion and data quality
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 18 months
recruitment, randomisation and retention rates of child participants
Percentage rates of recruitment, randomisation and retention of child participants
Measured: 18 months
recruitment and retention rates of dental professionals
Percentage rates of recruitment and retention of dental professionals
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start22 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- feasibility study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092151
- Sponsor's protocol ID
- STH21666
- Status last verified
- Aug 2023
- First submitted
- 15 Jun 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Timms L, Rodd H, Brocklehurst P, Deery C, Marshman Z. A mixed methods evaluation of the implementation of silver diamine fluoride in NHS primary dental care. BMC Oral Health. 2026 Jul 2;26(1):1368. doi: 10.1186/s12903-026-08618-7.
PubMed 42393620Timms L, Rodd H, Brocklehurst P, Deery C, Marshman Z. Is it feasible to conduct a randomised controlled trial of silver diamine fluoride compared to usual care for the management of caries in children's primary teeth in UK primary dental care? A randomised feasibility study. BMC Oral Health. 2026 Jun 5. doi: 10.1186/s12903-026-08442-z. Online ahead of print.
PubMed 42249372Timms 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.
PubMed 38915111
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06092151
- Acronym / sponsor ID
- STH21666
- Conditions
- Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield, National Institute for Health Research, United Kingdom
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- feasibility study
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride | Experimental | Device: Silver diamine fluorideSDF treatment for caries in the primary teeth of children included |
| Usual Care | Active comparator | Procedure: Usual dental careUsual care determined by child's dentist for caries in their primary teeth |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver diamine fluoridesilver diamine fluoride - maximum 1 drop to be applied per visit (manufacturer advises this would treat up to 5 teeth) | Device | Silver Diamine Fluoride |
| Usual dental careUsual restorative or preventative care determined by the child's dentist - for examples fillings or crowns | Procedure or surgery | Usual Care |
Primary outcome
Data quality of candidate primary outcome measures - ICDAS
Time frame: 18 months
• International Caries Detection and Assessment System (ICDAS) - by measuring percentage of completion and data quality
Data quality of candidate primary outcome measure - pain and infection including PUFA
Time frame: 18 months
Occurrence or report of pain or infection and Pulpal involvement, Ulceration, Fistula, Abscess (PUFA) index by measuring percentage of completion and data quality
Data quality of candidate secondary outcome measure; referral to secondary care
Time frame: 18 months
Referral to secondary care; measuring percentage of completion and data quality
Data quality of candidate secondary outcome measure; Completion course of treatment
Time frame: 18 months
Completion course of treatment; measuring percentage of completion and data
Data quality of candidate secondary outcome measure; number of appointments taken for completion of a course of treatment
Time frame: 18 months
The number of appointments taken for completion of a course of treatment; measuring percentage of completion and data quality
Data quality of secondary outcome measure; Adherence to intervention protocol or usual care guidelines.
Time frame: 18 months
Adherence to intervention protocol or usual care guidelines. ; measuring percentage of completion and data quality
Data quality of candidate secondary outcome measure; Adverse effect(s).
Time frame: 18 months
Adverse effect(s). ; measuring percentage of completion and data quality
Data quality of candidate secondary outcome measure; Appointment length
Time frame: 18 months
Appointment length; measuring percentage of completion and data quality
Data quality of candidate secondary outcome measure; • number of units of dental activity claimed
Time frame: 18 months
Number of units of dental activity claimed; measuring percentage of completion and data quality
Data quality of candidate secondary outcome measure; child and parental/carer reported experience of treatment
Time frame: 18 months
Child and parental/carer reported experience of treatment. measuring percentage of completion and data quality
Data quality of candidate secondary outcome measure; Parental/carer reported oral health-related quality of life; P-CPQ16
Time frame: 18 months
Parental/carer reported oral health-related quality of life; measuring percentage of completion and data quality
Variability of primary outcome measure; ICDAS or pain and infection
Time frame: 18 months
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.
recruitment, randomisation and retention rates of child participants
Time frame: 18 months
Percentage rates of recruitment, randomisation and retention of child participants
recruitment and retention rates of dental professionals
Time frame: 18 months
Percentage rates of recruitment and retention of dental professionals
rate of dentists' adherence to the study protocol (treatment allocation)
Time frame: 18 months
Percentage of dentists which adhered to the randomisation determined treatment choice for the child
Data quality and percentage completion rates of cost effectiveness data; cost data completed in case report forms by dental professional
Time frame: 18 months
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
Data quality of cost effectiveness data; parental questionnaires
Time frame: 18 months
Data quality and percentage completion rates of cost effectiveness data; cost questionnaires completed by parents
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 42393620Timms L, Rodd H, Brocklehurst P, Deery C, Marshman Z. A mixed methods evaluation of the implementation of silver diamine fluoride in NHS primary dental care. BMC Oral Health. 2026 Jul 2;26(1):1368. doi: 10.1186/s12903-026-08618-7.
- Derived from this study: PubMed 42249372Timms L, Rodd H, Brocklehurst P, Deery C, Marshman Z. Is it feasible to conduct a randomised controlled trial of silver diamine fluoride compared to usual care for the management of caries in children's primary teeth in UK primary dental care? A randomised feasibility study. BMC Oral Health. 2026 Jun 5. doi: 10.1186/s12903-026-08442-z. Online ahead of print.
- Derived from this study: PubMed 38915111Timms 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver diamine fluoride and Usual dental care in people with Dental Caries in Children, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data quality of candidate primary outcome measures - ICDAS (time frame: 18 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06092151, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.