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

Launched by SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called silver diamine fluoride (SDF) to see if it is more effective than usual care for managing tooth decay in young children. Tooth decay, or dental caries, is a common problem that affects many children in the UK, causing pain and leading to hospital visits. The goal of the study is to understand if a larger trial comparing SDF to standard treatments can be successfully conducted in UK dental practices.

To be eligible for this study, children between the ages of 2 and 6 who have cavities in their baby teeth can participate, as long as the decay hasn’t reached the tooth's pulp or caused an infection. Parents or caregivers will need to provide consent for their child to join the trial. Participants will receive either SDF or usual care, and the study will follow them for one year to gather important information on how well each treatment works. Throughout the trial, families will be involved in providing feedback to help shape the study’s design and processes.

Gender

ALL

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.