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

Alexandria University360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

360

Conditions

Early Childhood Caries

Interventions

NanosilverDRUG

preventive material for arresting caries

Silver diamine fluorideDRUG

preventive material for arresting caries

Eligibility

Sex: ALLMin age: 2 YearsMax age: 4 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry

Alexandria, Egypt

Outcomes

Primary Outcomes

caries arrest

percentage of arresting caries in primary teeth

Time frame: 6 months and 1 year

Secondary Outcomes

Comparing parental satisfaction and adverse effects with interventions

assessed by a self-rated questionnaire with responses on a 4-point Likert scale ranging from very satisfied, satisfied, unsatisfied, to very unsatisfied - Parents were also asked about adverse effects

Time frame: 6 months

Evaluating oral health related quality of life of children and their families.

by using the Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS)

Time frame: 6 months and 1 year

Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent

caries increment which is the number of new caries lesions developed over the study period detected using dmfs (change in dmfs score)

Time frame: 6 months and 1 year

Data from ClinicalTrials.gov

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