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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05221749
Other study ID # AlexandriaU1
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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).

Study Design


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
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