Dental CariesStreptococcusNCT07181967
SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children
A study testing Sodium Fluoride Varnish (5%) and Silver Diamine Fluoride (38%) in people with Dental Caries, run by Assiut University at 1 site in Egypt.
Trial summary
This randomized split-mouth clinical trial will compare the effectiveness of 38% silver diamine fluoride (SDF) versus 5% sodium fluoride varnish (FV) in reducing salivary Streptococcus mutans levels in children with bilateral caries. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Sodium Fluoride Varnish (5%) and Silver Diamine Fluoride (38%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-8 years; cooperative (Frankl ≥2).
- ≥2 contralateral primary molars with active dentin caries (ICDAS 3-5) of comparable severity.
- Parent/guardian consent; child assent when appropriate.
Who cannot join
- Silver allergy; ulcerative gingivitis/stomatitis.
- Systemic antibiotics within 4 weeks.
- Fixed appliances interfering with plaque assessment.
- Conditions precluding safe participation per clinician judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, Asyut Governorate, 71511
ِAhmed K Soliman, PDF, 01061553007, a.k.soliman@hotmail.com
About this study
Official title: Evaluation of Streptococcus Mutans Reduction by Silver Diamine Fluoride vs. Fluoride Varnish: A Split-Mouth Study in Children
This randomized split-mouth clinical trial will compare the effectiveness of 38% silver diamine fluoride (SDF) versus 5% sodium fluoride varnish (FV) in reducing salivary Streptococcus mutans levels in children with bilateral caries. Each participant will receive SDF on one side of the mouth and FV on the contralateral side. The primary outcome is change in Dentocult SM Strip Mutans scores in plaque over 3 months. Secondary outcomes include plaque index, bleeding on probing, and adverse events.
- Conditions
- Dental Caries
- Being tested
- Sodium Fluoride Varnish (5%), Silver Diamine Fluoride (38%)
- Keywords
- Silver Diamine Fluoride; Fluoride Varnish; Streptococcus mutans; Dental Plaque
- Medical subject headings
- Dental Caries, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Fluoride Varnish (5%)Drug
Topical application of 5% sodium fluoride varnish (22,600 ppm fluoride) to cavitated dentin caries lesions (ICDAS 3-5) on the contralateral side of the mouth. Applied once using a disposable applicator per manufacturer's instructions. This distinguishes it from lower-concentration fluoride gels or multiple-application protocols in other clinical trials.
Silver Diamine Fluoride (38%)Drug
Topical application of 38% silver diamine fluoride solution (44,800 ppm fluoride) to cavitated dentin caries lesions (ICDAS 3-5) on the assigned side of the mouth. Applied once with a microbrush for 1 minute, per manufacturer's instructions, without subsequent rinsing. This concentration and protocol distinguish it from other concentrations of SDF or repeated-application protocols used in other clinical studies."
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluoride (SDF) | Experimental | Application of 38% silver diamine fluoride (44,800 ppm F) to all eligible dentin caries lesions on the assigned side of the mouth. Single application per manufacturer's instructions. Receives: Drug: Silver Diamine Fluoride (38%) |
| Fluoride Varnish (FV) | Active comparator | Application of 5% sodium fluoride varnish (22,600 ppm F) to all eligible dentin caries lesions on the contralateral side of the mouth. Single application per manufacturer's instructions. Receives: Drug: Sodium Fluoride Varnish (5%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Streptococcus mutans levels measured by Dentocult SM Strip Mutans test at baseline, 1 week, 1 month, and 3 months
Streptococcus mutans levels will be assessed using the Dentocult SM Strip Mutans test (Orion Diagnostica/Aidian). The test provides a semi-quantitative estimate of salivary S. mutans based on colony density on a selective culture strip.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start15 Sep 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth randomized controlled trial. Each child receives 38% silver diamine fluoride (SDF) on one side and 5% sodium fluoride varnish (FV) on the contralateral side. This within-subject design minimizes inter-individual variability, with each participant serving as their own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ِAhmed kamel Abdel Naser soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181967
- Sponsor's protocol ID
- 17-2025-00013
- Other IDs
- 17-2025-00013
- Acronym
- Streptococcus
- Status last verified
- Nov 2025
- First submitted
- 9 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Streptococcus Mutans Reduction by Silver Diamine Fluoride vs. Fluoride Varnish: A Split-Mouth Study in Children
- ClinicalTrials.gov ID
- NCT07181967
- Acronym / sponsor ID
- Streptococcus / 17-2025-00013
- Conditions
- Dental Caries
- Keywords
- Silver Diamine Fluoride; Fluoride Varnish; Streptococcus mutans; Dental Plaque
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized split-mouth clinical trial will compare the effectiveness of 38% silver diamine fluoride (SDF) versus 5% sodium fluoride varnish (FV) in reducing salivary Streptococcus mutans levels in children with bilateral caries. Each participant will receive SDF on one side of the mouth and FV on the contralateral side. The primary outcome is change in Dentocult SM Strip Mutans scores in plaque over 3 months. Secondary outcomes include plaque index, bleeding on probing, and adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth randomized controlled trial. Each child receives 38% silver diamine fluoride (SDF) on one side and 5% sodium fluoride varnish (FV) on the contralateral side. This within-subject design minimizes inter-individual variability, with each participant serving as their own control.
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride (SDF) | Experimental | Drug: Silver Diamine Fluoride (38%)Application of 38% silver diamine fluoride (44,800 ppm F) to all eligible dentin caries lesions on the assigned side of the mouth. Single application per manufacturer's instructions. |
| Fluoride Varnish (FV) | Active comparator | Drug: Sodium Fluoride Varnish (5%)Application of 5% sodium fluoride varnish (22,600 ppm F) to all eligible dentin caries lesions on the contralateral side of the mouth. Single application per manufacturer's instructions. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 3-8 years; cooperative (Frankl ≥2).
- ≥2 contralateral primary molars with active dentin caries (ICDAS 3-5) of comparable severity.
- Parent/guardian consent; child assent when appropriate.
Key exclusion criteria (4 listed)
- Silver allergy; ulcerative gingivitis/stomatitis.
- Systemic antibiotics within 4 weeks.
- Fixed appliances interfering with plaque assessment.
- Conditions precluding safe participation per clinician judgment.
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 |
|---|---|---|
| Sodium Fluoride Varnish (5%)Topical application of 5% sodium fluoride varnish (22,600 ppm fluoride) to cavitated dentin caries lesions (ICDAS 3-5) on the contralateral side of the mouth. Applied once using a disposable applicator per manufacturer's instructions. This distinguishes it from lower-concentration fluoride gels or multiple-application protocols in other clinical trials. | Drug | Fluoride Varnish (FV) |
| Silver Diamine Fluoride (38%)Topical application of 38% silver diamine fluoride solution (44,800 ppm fluoride) to cavitated dentin caries lesions (ICDAS 3-5) on the assigned side of the mouth. Applied once with a microbrush for 1 minute, per manufacturer's instructions, without subsequent rinsing. This concentration and protocol distinguish it from other concentrations of SDF or repeated-application protocols used in other clinical studies." | Drug | Silver Diamine Fluoride (SDF) |
Primary outcome
Change in Streptococcus mutans levels measured by Dentocult SM Strip Mutans test at baseline, 1 week, 1 month, and 3 months
Time frame: 3 month
Streptococcus mutans levels will be assessed using the Dentocult SM Strip Mutans test (Orion Diagnostica/Aidian). The test provides a semi-quantitative estimate of salivary S. mutans based on colony density on a selective culture strip.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Fluoride Varnish (5%) and Silver Diamine Fluoride (38%) in people with Dental Caries, run by Assiut University 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ِAhmed Kamel soliman, PHD (+201061553007, a.k.soliman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Streptococcus mutans levels measured by Dentocult SM Strip Mutans test at baseline, 1 week, 1 month, and 3 months (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2025.