The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth

Nour Ammar, BDS

Status and phase: Terminated; Phase 3

Conditions: Dental Caries in Children; Primary Teeth; Microbial Colonization; Caries

Treatments: Drug: Nanosilver Fluoride (NSF); Drug: Silver diamine fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT05221749

AlexandriaU1

Details and patient eligibility

About

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).

Full description

Fifty children aged 4 to 6 years old with active dentin caries lesions (score 5 according to International Detection and Assessment System (ICDAS II) criteria) will be enrolled in the study. They will be equally and randomly allocated into 2 groups: a group receiving NSF and a control group receiving SDF treatment. Microbiological samples will be collected from the carious lesions and from unstimulated saliva at the baseline and at the 1 and 3 months' follow-up appointments. Bacterial counts will be assessed using Mitis Salivarius agar (selective culture media for S. mutans) and Rogosa agar (selective culture media for lactobacilli), and the results will be expressed in colony-forming units. Data regarding the children's oral health will be collected and their dmf index will be scored. The arrest of active carious lesions will be measured at the follow-up appointments according to ICDAS II criteria.

Enrollment: 50 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Silver diamine fluoride

Active Comparator group

Description:

These active caries lesions will receive silver diamine fluoride treatment

Treatment:

Drug: Silver diamine fluoride

Nanosilver fluoride

Experimental group

Description:

These active caries lesions will receive nanosilver fluoride treatment

Treatment:

Drug: Nanosilver Fluoride (NSF)