Caries, Dental Caries in Children, Microbial Colonization, Primary Teeth
Conditions
Keywords
Nano silver fluoride, silver diamine fluoride, antibacterial, caries arrest, microbiology, primary teeth, pediatric, clinical trial, nanosilver, SDF
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).
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.
Interventions
DRUGNanosilver Fluoride (NSF)
Optimized synthesis of Nanosilver Fluoride
DRUGSilver diamine fluoride
Silver Diamine Fluoride
Sponsors
Nour Ammar, BDS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibacterial Effect in Active Dental Caries Lesions | 1 month | 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 |
| The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions | 1 month | 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. |
| Antibacterial Effect in Unstimulated Saliva Samples | 1 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions | 3 month | 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. |
| Antibacterial Effect in Active Dental Caries Lesions | 3 month | 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. |
| Antibacterial Effect in Unstimulated Saliva Samples | 3 months | 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. |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Silver Diamine Fluoride These active caries lesions will receive silver diamine fluoride treatment
Silver diamine fluoride: Silver Diamine Fluoride | 25 |
| Nanosilver Fluoride These active caries lesions will receive nanosilver fluoride treatment
Nanosilver Fluoride (NSF): Optimized synthesis of Nanosilver Fluoride | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Nanosilver Fluoride | Total | Silver Diamine Fluoride |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 50 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.9 years STANDARD_DEVIATION 0.9 | 4.75 years STANDARD_DEVIATION 0.8 | 4.6 years STANDARD_DEVIATION 0.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Egypt | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 13 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Male | 12 Participants | 26 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: 1 month
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Silver Diamine Fluoride (SDF) | Antibacterial Effect in Active Dental Caries Lesions | Baseline | 70000 CFU/mL |
| Silver Diamine Fluoride (SDF) | Antibacterial Effect in Active Dental Caries Lesions | Follow-up | 20000 CFU/mL |
| Nanosilver Fluoride (NSF) | Antibacterial Effect in Active Dental Caries Lesions | Baseline | 50000 CFU/mL |
| Nanosilver Fluoride (NSF) | Antibacterial Effect in Active Dental Caries Lesions | Follow-up | 5000 CFU/mL |
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.
Time frame: 1 months
Population: This investigation and consequent analysis were not conducted.
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.
Time frame: 1 month
Population: This investigation and consequent analysis were not conducted.
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.
Time frame: 3 month
Population: This investigation and consequent analysis were not conducted.
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.
Time frame: 3 months
Population: This investigation and consequent analysis were not conducted.
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.
Time frame: 3 month
Population: This investigation and consequent analysis were not conducted.