Status:
COMPLETED
A Clinical Trial of Silver Diamine Fluoride to Arrest Early Childhood Caries in Young Children
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Children's Hospital Research Institute of Manitoba
Conditions:
Early Childhood Caries
Eligibility:
All Genders
Up to 72 years
Phase:
NA
Brief Summary
Silver diamine fluoride (SDF) is an antibiotic liquid that has the potential to arrest Early Childhood Caries in young children and delay treatment until children can be seen in outpatient settings. W...
Detailed Description
Good oral health during early childhood sets the foundation for a lifetime of optimal dental health. Unfortunately, many Canadian children develop Early Childhood Caries (ECC), defined as caries in th...
Eligibility Criteria
Inclusion
- Child is \< 72 months of age with early childhood caries (ECC) with active lesions (International Caries Detection and Assessment System codes 5 or 6).
- Child has ≥ 1 primary tooth with caries that is eligible to receive SDF. Eligible primary teeth must: a) have soft cavitated caries lesions extending into dentin; b) the cavitated lesions must allow for direct application of silver diamine fluoride (SDF). Teeth that meet any of the PUFA (pulpal involvement, ulceration, fistula, and abscess) index criteria (i.e. spontaneous pain due to caries, pulp exposure, mobility, signs of pulpal infection such as abscess, fistula, or swelling) will be excluded. However, a child would still be eligible even if they have at least one tooth that meets PUFA criteria, but other eligible teeth with caries do not.
Exclusion
- Child is allergic or has a sensitivity to silver or other heavy metal ions.
- Child has hereditary generalized developmental defects of enamel (e.g. Amelogenesis Imperfecta, Dentinogenesis Imperfecta)
- Child has severe medical problems that limit participation.
- Child requires immediate rehabilitation under general anesthesia (GA) because of severe infection or pain.
- Antibiotic use within the last 2 weeks.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04054635
Start Date
October 1 2019
End Date
July 31 2023
Last Update
September 13 2023
Active Locations (1)
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1
Children's Hospital Research Institute of Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4