The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial

AlexandriaU1

To assess the antibacterial effect of Nanosilver Fluoride (NSF) in relation to caries activity in dentin caries lesions of primary teeth in comparison to Silver Diamine Fluoride (SDF).

2022-03-15

2022-04-15

2022-06-15

Terminated

Early phase I

50

Inclusion Criteria: * The presence of at least one active carious lesion on a primary tooth. * 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, abscess, obvious discoloration of the tooth, or premature mobility. * Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks. * Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow. * Allergy or sensitivity to silver or any of the materials included in the study. * Child weight less than 10 Kg (to avoid concerns for toxicity).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

2023-08-18