Status:
UNKNOWN
SDF for the Management of Dental Caries in Children in Primary Dental Care: Protocol for a Feasibility Study
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Sheffield
National Institute for Health Research, United Kingdom
Conditions:
Dental Caries in Children
Eligibility:
All Genders
2-6 years
Phase:
NA
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 qua...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06092151
Start Date
June 22 2023
End Date
February 28 2025
Last Update
October 23 2023
Active Locations (1)
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1
University of Sheffield
Sheffield, United Kingdom, S102TA