The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth

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

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).

Study Overview

• Status: Terminated
• Conditions: Dental Caries in Children; Microbial Colonization; Caries; Primary Teeth
• Intervention / Treatment: Drug: Silver diamine fluoride; Drug: Nanosilver Fluoride (NSF)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	3 month
Antibacterial Effect in Active Dental Caries Lesions	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.	3 month
Antibacterial Effect in Unstimulated Saliva Samples	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.	3 months

Collaborators and Investigators

• Sponsor: Nour Ammar, BDS
• Investigators: Principal Investigator: Nour Ammar, BDS, Faculty of dentistry, Alexandria University, Alexandria, Egypt.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: December 25, 2021
• First Submitted That Met QC Criteria: January 29, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pediatric; clinical trial; antibacterial; silver diamine fluoride; microbiology; caries arrest; primary teeth; SDF; Nano silver fluoride; nanosilver
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Infections; Communicable Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: AlexandriaU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Each participant will be provided with a serial number that will only be accessible to the principal investigator. No data regarding the identity of the participants will be shared under any circumstances. All participants or their guardians must provide a written informed consent prior to any procedures.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes