Clinical trial

Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial)

Name
0265-07/2021
Description
Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions. The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.
Trial arms
Trial start
2022-03-15
Estimated PCD
2023-07-25
Trial end
2023-08-03
Status
Completed
Treatment
Nanosilver
preventive material for arresting caries
Arms:
group 1
Silver diamine fluoride
preventive material for arresting caries
Arms:
group 2
Size
360
Primary endpoint
caries arrest
6 months and 1 year
Eligibility criteria
Inclusion Criteria: * Children younger than 4 years old. * The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II) * Completion of an informed consent to participate in the study. Exclusion Criteria: * Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility. * Parental refusal to participate in the study. * Allergy or sensitivity to silver or any of the materials included in the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 360, 'type': 'ACTUAL'}}
Updated at
2023-09-26

1 organization

2 products

1 indication

Product
Nanosilver