Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries

Alexandria University

Status: Completed

Conditions: Early Childhood Caries

Treatments: Drug: Nanosilver; Drug: Silver diamine fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT05255913

0265-07/2021

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 2 to 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

group 1

Experimental group

Treatment:

Drug: Nanosilver

group 2

Active Comparator group

Treatment:

Drug: Silver diamine fluoride