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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2023-08-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Early Childhood Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group 1

Group Type EXPERIMENTAL

Nanosilver

Intervention Type DRUG

preventive material for arresting caries

group 2

Group Type ACTIVE_COMPARATOR

Silver diamine fluoride

Intervention Type DRUG

preventive material for arresting caries

Interventions

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Nanosilver

preventive material for arresting caries

Intervention Type DRUG

Silver diamine fluoride

preventive material for arresting caries

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No