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Only the 1 month follow-up was completed. The principal investigator could not complete the 3 month follow-up appointments and was not calibrated with other dentists who were available at the time.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver diamine fluoride | Active Comparator | These active caries lesions will receive silver diamine fluoride treatment |
|
| Nanosilver fluoride | Experimental | These active caries lesions will receive nanosilver fluoride treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanosilver Fluoride (NSF) | Drug | Optimized synthesis of Nanosilver Fluoride |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nour Ammar, BDS | Faculty of dentistry, Alexandria University, Alexandria, Egypt. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria Univeristy | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40490725 | Derived | 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. | |
| 36585664 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silver Diamine Fluoride (SDF) | These active caries lesions will receive one application of 38% silver diamine fluoride at the baseline appointment. |
| FG001 | Nanosilver Fluoride (NSF) | These active caries lesions will receive one application of nanosilver fluoride at the baseline appointment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Children 4-6 years old with at least 1 active dentin caries lesion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Silver Diamine Fluoride | These active caries lesions will receive silver diamine fluoride treatment Silver diamine fluoride: Silver Diamine Fluoride |
| BG001 | Nanosilver Fluoride |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | CFU/mL | 1 month |
|
1 month
Participant's carers were contacted within a day of the baseline appointment where the intervention was applied to ask about any side effects or unusual occurrences that may have occurred. However, no side effects were reported for both agents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silver Diamine Fluoride (SDF) | These active caries lesions will receive silver diamine fluoride treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nour Ammar | Alexandria University | 4868066 | 201 | nour.ammar@alexu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2023 | Jul 25, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
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| Silver diamine fluoride | Drug | Silver Diamine Fluoride |
|
|
| 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 |
| 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. |
| 35804457 | 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. |
These active caries lesions will receive nanosilver fluoride treatment
Nanosilver Fluoride (NSF): Optimized synthesis of Nanosilver Fluoride
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
These active caries lesions will receive nanosilver fluoride treatment |
|
|
| 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. | This investigation and consequent analysis were not conducted. | Posted | 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. | This investigation and consequent analysis were not conducted. | Posted | 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. | This investigation and consequent analysis were not conducted. | Posted | 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. | This investigation and consequent analysis were not conducted. | Posted | 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. | This investigation and consequent analysis were not conducted. | Posted | 3 months |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Nanosilver Fluoride (NSF) | These active caries lesions will receive nanosilver fluoride treatment | 0 | 25 | 0 | 25 | 0 | 25 |
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