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Clinical trial

Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride in a Group of Preschool Children

ID
Name
14422021493714
Description
This study will be conducted to test the cariostatic effect of Nano Silver Fluoride in a comparison to Silver Diamine Fluoride in a group of preschool children.
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-06-01
Trial end
2024-07-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Nano-Silver Fluoride
NSF is a varnish which has been introduced as experimental formulation . the laboratory synthesis of NSF was carried out in a nano techonolgy center .
Arms:
Nano-Silver Fluoride
Other names:
NSF
Silver diamine fluoride
38% silver diamine fluoride
Arms:
Silver Diamine Fluoride
Other names:
SDF
Size
78
Primary endpoint
caries lesion activity and severity assessment using Nyvad criteria
baseline
caries lesion activity and severity assessment using Nyvad criteria
3 weeks
caries lesion activity and severity assessment using Nyvad criteria
6 months
Eligibility criteria
Inclusion Criteria: * Children aged from 3 to 5 years * clinical diagnosis of active dentinal caries in primary teeth * Co-operative participants and free of any systemic diseases Exclusion Criteria: * Children whose parents refuse to sign consent * Primary teeth with pulp involvement, pain, mobility, abscess, sinus, fistula; or discoloration related to tooth non-vitality.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double blinded study. Participants were blinded towards agents used in the study by using two identical squeezable plastic droppers with tag codes A and B. Also the bio-statistician will be blinded from the meaning of codes.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}
Updated at
2023-07-12

1 organization

2 products

1 indication

Organization
Cairo University
Product
Nano-Silver Fluoride
Indication
Dental Caries in Children
Product
Silver diamine fluoride