The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth

Sponsor

Nour Ammar (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05221749

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Primary Teeth Microbial Colonization Caries Dental Caries in Children	Drug: Nanosilver Fluoride (NSF) Drug: Silver diamine fluoride	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Silver diamine fluoride These active caries lesions will receive silver diamine fluoride treatment	Drug: Silver diamine fluoride Silver Diamine Fluoride Other Names: Advantage Arrest by Elevate Oral care, 38% SDF
Experimental: Nanosilver fluoride These active caries lesions will receive nanosilver fluoride treatment	Drug: Nanosilver Fluoride (NSF) Optimized synthesis of Nanosilver Fluoride Other Names: Nanosilver Fluoride

Arm

Intervention/Treatment

Active Comparator: Silver diamine fluoride

These active caries lesions will receive silver diamine fluoride treatment

Drug: Silver diamine fluoride

Silver Diamine Fluoride

Other Names:

Advantage Arrest by Elevate Oral care, 38% SDF

Experimental: Nanosilver fluoride

These active caries lesions will receive nanosilver fluoride treatment

Drug: Nanosilver Fluoride (NSF)

Optimized synthesis of Nanosilver Fluoride

Other Names:

Nanosilver Fluoride

Outcome Measures

Primary Outcome Measures

Antibacterial effect in active dental caries lesions [1 month]
Measuring the change in prevalence of cariogenic bacteria from baseline to 1 month using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.
The relation between the antibacterial activity and the caries activity in dental caries lesions [1 month]
A statistical analysis will be done to correlate between the change in number of available cariogenic bacteria from baseline to 1 month (measured in colony forming units) and the caries activity of the lesion (as specified by the international caries detection and assessment system (ICDAS II) criteria.
Antibacterial effect in unstimulated saliva samples [1 months]
Measuring the change in prevalence of cariogenic bacteria using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.

Secondary Outcome Measures

The relation between the antibacterial activity and the caries activity in dental caries lesions [3 month]
A statistical analysis will be done to correlate between the change in number of available cariogenic bacteria from baseline to 3 months (measured in colony forming units) and the caries activity of the lesion (as specified by the international caries detection and assessment system (ICDAS II) criteria.
Antibacterial effect in active dental caries lesions [3 month]
Measuring the change in prevalence of cariogenic bacteria from baseline to 3 months using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.
Antibacterial effect in unstimulated saliva samples [3 months]
Measuring the change in prevalence of cariogenic bacteria from baseline to 3 months using standard microbiological culturing methods, outcome assessment will be done using colony forming units (CFU) from every sample collected. Samples will be collected before and after the intervention application.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).