Using silver diamine fluoride to treat dental caries in young children
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
This study is testing if silver diamine fluoride can effectively treat cavities in young children aged 2-6 years, compared to regular dental care, to see if it helps improve their dental health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield) |
| Trial ID | NCT06092151 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of silver diamine fluoride (SDF) as a non-invasive treatment for dental caries in children aged 2-6 years. It aims to assess the feasibility of implementing SDF in primary dental care settings in the UK, where traditional methods have proven inadequate in managing pain and preventing hospital admissions. The study will compare the effectiveness of SDF against usual dental care practices to determine its potential benefits in improving oral health outcomes for young children. By focusing on a population with significant dental health challenges, the study seeks to provide insights into a promising alternative treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-6 years with cavitated dentinal caries in primary teeth but without pulp involvement or secondary infections.
Not a fit: Patients with dental infections, pulp involvement, or specific medical conditions that complicate dental management may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and the need for hospital admissions due to dental caries in children.
How similar studies have performed: Previous studies outside Europe have shown promising results for the use of silver diamine fluoride in managing dental caries, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sheffield
- University of Sheffield — Sheffield, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.