Status:
COMPLETED
SDF With or Without Fluoride Varnish for Caries Arrest in Primary Teeth of Young Children
Lead Sponsor:
Beaty Dent
Conditions:
Dental Caries
Eligibility:
All Genders
18-8 years
Phase:
NA
Brief Summary
Tooth decay (dental caries) occurs when acids dissolve tooth structure. If not treated, cavities in primary teeth can progress quickly, leading to caries, infection and early tooth loss. These problem...
Detailed Description
Dental caries is a biofilm-mediated disease driven by dietary sugars and bacterial acid production. The prevalence in primary dentition is high worldwide, especially in low- and middle-income countrie...
Eligibility Criteria
Inclusion
- Children aged 1.5 to 8 years
- Uncooperative to dental procedures (Frankl Behavior Rating 1 or 2)
- Presence of at least one active, cavitated carious lesion in primary teeth, without pulp involvement
- Eligible primary teeth: active caries without pulp involvement
Exclusion
- Children with clinical signs of infection (pain, parulis, fistula, or abscess)
- Cooperative to dental procedures
- Children who are candidates for conscious sedation
- Known allergy to silver, fluoride, or ammonia
- Teeth with pulpal complications, non-restorable, exfoliating, or scheduled for extraction
Key Trial Info
Start Date :
January 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2024
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT07153328
Start Date
January 7 2021
End Date
March 25 2024
Last Update
September 3 2025
Active Locations (2)
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1
Beaty Dent
Tirana, Tirana, Albania, 1001
2
Happy Dent
Tirana, Tirana, Albania, 1001