The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth

NCT05221749 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: AlexandriaU1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Teeth; Microbial Colonization; Caries; Dental Caries in Children

Keywords

Nano silver fluoride; silver diamine fluoride; antibacterial; caries arrest; microbiology; primary teeth; pediatric; clinical trial; nanosilver; SDF

Outcome Measures

Primary Outcomes (3)

• Antibacterial Effect in Active Dental Caries Lesions

  Measuring the percent 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 immediately before application of the intervention (baseline) and one month after the intervention application (1 month follow-up). The CFU counts will be used to calculate the percentage change in bacterial prevalence which will be used for assessment and reporting results

  1 month

• The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions

  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.

  1 month

• Antibacterial Effect in Unstimulated Saliva Samples

  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.

  1 months

Secondary Outcomes (3)

• The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions

  3 month

• Antibacterial Effect in Active Dental Caries Lesions

  3 month

• Antibacterial Effect in Unstimulated Saliva Samples

  3 months

Study Arms (2)

Silver diamine fluoride

ACTIVE COMPARATOR

These active caries lesions will receive silver diamine fluoride treatment

Drug: Silver diamine fluoride

Nanosilver fluoride

EXPERIMENTAL

These active caries lesions will receive nanosilver fluoride treatment

Drug: Nanosilver Fluoride (NSF)

Interventions

Nanosilver Fluoride (NSF) DRUG

Optimized synthesis of Nanosilver Fluoride

Also known as: Nanosilver Fluoride

Nanosilver fluoride

Silver diamine fluoride DRUG

Silver Diamine Fluoride

Also known as: Advantage Arrest by Elevate Oral care, 38% SDF

Silver diamine fluoride

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The presence of at least one active carious lesion on a primary tooth.
• Completion of an informed consent to participate in the study.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nour Ammar, BDS: lead

Study Sites (1)

Faculty of Dentistry, Alexandria Univeristy

Alexandria, Egypt

Location

Related Publications (3)

• Ammar N, El-Tekeya MM, Talat DM, Essa S, Essawy MM, Kuhnisch J, Hamed H, Nabil N, Achy SE, Tantawi ME. Effect of silver diamine fluoride and nanosilver on salivary bacterial counts in children with early childhood caries: a randomized controlled clinical trial. BMC Oral Health. 2025 Jun 9;25(1):945. doi: 10.1186/s12903-025-06325-3.

  PMID: 40490725 DERIVED

• Ammar N, El-Tekeya MM, Essa S, Essawy MM, Talaat DM. Antibacterial effect and impact on caries activity of nanosilver fluoride and silver diamine fluoride in dentin caries of primary teeth: a randomized controlled clinical trial. BMC Oral Health. 2022 Dec 30;22(1):657. doi: 10.1186/s12903-022-02697-y.

  PMID: 36585664 DERIVED

• Ammar N, El-Tekeya MM, Essa S, Essawy MM, El Achy SN, Talaat DM. The antibacterial effect of nanosilver fluoride in relation to caries activity in primary teeth: a protocol for a randomized controlled clinical trial. Trials. 2022 Jul 8;23(1):558. doi: 10.1186/s13063-022-06477-5.

  PMID: 35804457 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nour Ammar
• Organization: Alexandria University

nour.ammar@alexu.edu.eg

4868066

Study Officials

• Nour Ammar, BDS

  Faculty of dentistry, Alexandria University, Alexandria, Egypt.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: December 25, 2021
• First Posted: February 3, 2022
• Study Start: March 15, 2022
• Primary Completion: April 15, 2022
• Study Completion: June 15, 2022
• Last Updated: August 18, 2023
• Results First Posted: August 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)