Primary TeethPhase 3NCT05221749
The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth
A Phase 3 study testing Nanosilver Fluoride (NSF) and Silver diamine fluoride in people with Primary Teeth and Microbial Colonization, run by Nour Ammar, BDS at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Teeth, Microbial Colonization, Caries
- What is being tested?
- Nanosilver Fluoride (NSF) and Silver diamine fluoride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 15 Jun 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The presence of at least one active carious lesion on a primary tooth.
- Completion of an informed consent to participate in the study.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Nanosilver Fluoride (NSF), Silver diamine fluoride
- Keywords
- Nano silver fluoride, silver diamine fluoride, antibacterial, caries arrest, microbiology, primary teeth, pediatric, clinical trial, nanosilver, SDF
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanosilver Fluoride (NSF)Drug
Also called Nanosilver Fluoride
Optimized synthesis of Nanosilver Fluoride
Silver diamine fluorideDrug
Also called Advantage Arrest by Elevate Oral care, 38% SDF
Silver Diamine Fluoride
| Study group | Role | What they receive |
|---|---|---|
| Silver diamine fluoride | Active comparator | These active caries lesions will receive silver diamine fluoride treatment Receives: Drug: Silver diamine fluoride |
| Nanosilver fluoride | Experimental | These active caries lesions will receive nanosilver fluoride treatment Receives: Drug: Nanosilver Fluoride (NSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 1 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start15 Mar 2022
- Primary completion15 Apr 2022
- Study completion15 Jun 2022
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nour Ammar, BDS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nour Ammar, BDS, Alexandria University
- Investigators
- Nour Ammar, BDS, Principal investigator, Faculty of dentistry, Alexandria University, Alexandria, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221749
- Sponsor's protocol ID
- AlexandriaU1
- Status last verified
- Jul 2023
- First submitted
- 25 Dec 2021
- Last updated
- 18 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40490725Ammar 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.
PubMed 36585664Ammar 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.
PubMed 35804457
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antibacterial Effect of Nanosilver Fluoride in Relation to Caries Activity in Primary Teeth: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05221749
- Acronym / sponsor ID
- AlexandriaU1
- Keywords
- Nano silver fluoride, silver diamine fluoride, antibacterial, caries arrest, microbiology, primary teeth, pediatric, clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nour Ammar, BDSUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Posted 18 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver diamine fluoride | Active comparator | Drug: Silver diamine fluorideThese active caries lesions will receive silver diamine fluoride treatment |
| Nanosilver fluoride | Experimental | Drug: Nanosilver Fluoride (NSF)These active caries lesions will receive nanosilver fluoride treatment |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The presence of at least one active carious lesion on a primary tooth.
- Completion of an informed consent to participate in the study.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanosilver Fluoride (NSF)Also: Nanosilver FluorideOptimized synthesis of Nanosilver Fluoride | Drug | Nanosilver fluoride |
| Silver diamine fluorideAlso: Advantage Arrest by Elevate Oral care, 38% SDFSilver Diamine Fluoride | Drug | Silver diamine fluoride |
Primary outcome
Antibacterial Effect in Active Dental Caries Lesions
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
The Relation Between the Antibacterial Activity and the Caries Activity in Dental Caries Lesions
Time frame: 3 month
Antibacterial Effect in Active Dental Caries Lesions
Time frame: 3 month
Antibacterial Effect in Unstimulated Saliva Samples
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40490725Ammar 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.
- Derived from this study: PubMed 36585664Ammar 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.
- Derived from this study: PubMed 35804457Ammar 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nour Ammar, BDS principal investigator
Faculty of dentistry, Alexandria University, Alexandria, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nanosilver Fluoride (NSF) and Silver diamine fluoride in people with Primary Teeth and Microbial Colonization, run by Nour Ammar, BDS at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibacterial Effect in Active Dental Caries Lesions (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05221749, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.