The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2022-06-15

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Primary Teeth Microbial Colonization Caries Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Silver diamine fluoride

These active caries lesions will receive silver diamine fluoride treatment

Group Type ACTIVE_COMPARATOR

Silver diamine fluoride

Intervention Type DRUG

Silver Diamine Fluoride

Nanosilver fluoride

These active caries lesions will receive nanosilver fluoride treatment

Group Type EXPERIMENTAL

Nanosilver Fluoride (NSF)

Intervention Type DRUG

Optimized synthesis of Nanosilver Fluoride

Interventions

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Nanosilver Fluoride (NSF)

Optimized synthesis of Nanosilver Fluoride

Intervention Type DRUG

Silver diamine fluoride

Silver Diamine Fluoride

Intervention Type DRUG

Other Intervention Names

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Nanosilver Fluoride Advantage Arrest by Elevate Oral care, 38% SDF

Eligibility Criteria

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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).

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes