The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05221749
• Other study ID #: AlexandriaU1
• Status: Terminated
• Phase: Phase 3
• Start date: March 15, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: July 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Caries
• Communicable Diseases
• Dental Caries
• Dental Caries in Children
• Infections
• Microbial Colonization
• Primary Teeth

Intervention

Drug:
• Nanosilver Fluoride (NSF)
Optimized synthesis of Nanosilver Fluoride
• Silver diamine fluoride
Silver Diamine Fluoride

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria Univeristy	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Nour Ammar, BDS

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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