Early Childhood Caries (ECC)NCT07382245
Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children
A study testing Nano-Silver Fluoride and Silver Diamine Fluoride in people with Early Childhood Caries (ECC) and Active Dentin Caries in Primary Molars, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
Early childhood caries is a major public health problem affecting preschool children worldwide. Silver Diamine Fluoride is a well-established non-invasive treatment for arresting caries; however, it causes black discoloration of treated lesions. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Early Childhood Caries (ECC), Active Dentin Caries in Primary Molars
- What is being tested?
- Nano-Silver Fluoride and Silver Diamine Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2026to 15 Mar 2026
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Apparently healthy children.
- Children with age ranged from 3-5 years from both genders.
- Children who refused dental treatment with Frankl Behavior Rating Scale 1 and 2.
- Children having molars with active dentin caries score (2,3,4) according to International Caries Detection and Assessment System- ICDAS II, detected by visual and tactile.
- Parents/guardians accept treatment and write informed consent.
Who cannot join
- Children with allergy to silver from their medical history.
- Children with ulcerative gingivitis.
- Children with primary molars with the following criteria:
- Symptomatic
- Involving the pulp
- Presence of fistula or sinus
- Presence of gingival inflammation and Pain on percussion
- Close to exfoliation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Khaled Abdelmonem Sayed Assistant Lecturer at Pediatric Dentistry Department, Master Holder contact
Egypt1 site
Faculty of Dentistry, MSA University
Giza, Giza Governorate, 12611
Khaled Abdelmonem, Master degree, 01114537612, kasayed@msa.edu.eg
khaled Abdelmonem, master degree
About this study
Official title: Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children: A Randomized Clinical Trial
Early childhood caries is a major public health problem affecting preschool children worldwide. Silver Diamine Fluoride is a well-established non-invasive treatment for arresting caries; however, it causes black discoloration of treated lesions. Nano-Silver Fluoride has been introduced as an alternative that may arrest caries without discoloration.
This randomized clinical trial aims to compare the efficacy of Silver Diamine Fluoride and Nano-Silver Fluoride in arresting active dentin caries in primary teeth and to assess discoloration, post-operative pain, and parental satisfaction over a 12-month follow-up period.
Read the detailed description
This randomized clinical trial will be conducted on 30 children aged 3-5 years attending the outpatient clinic of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University. Children with active dentin caries in primary molars will be randomly allocated into two groups: Silver Diamine Fluoride group and Nano-Silver Fluoride group.
Both materials will be applied topically without caries excavation. Clinical evaluation will be performed at baseline and at 1, 3, 6, 9, and 12 months using ICDAS criteria, visual and tactile examination, assessment of post-operative pain, discoloration through standardized photographs, and parental satisfaction questionnaires.
The primary outcome is caries arrest. Secondary outcomes include discoloration, pain, and parental satisfaction.
- Being tested
- Nano-Silver Fluoride, Silver Diamine Fluoride
- Keywords
- Early Childhood Caries, primary molar, Nano-Silver Fluoride, Silver Diamine Fluoride, SDF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-Silver FluorideDrug
Chitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml)
Silver Diamine FluorideDrug
38% Silver Diamine Fluoride
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Nano-Silver Fluoride | Experimental | Topical application of Nano-Silver Fluoride varnish containing silver nanoparticles, chitosan, and fluoride applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration. Receives: Drug: Nano-Silver Fluoride |
| Arm B: Silver Diamine Fluoride | Active comparator | Topical application of 38% Silver Diamine Fluoride varnish applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration. Receives: Drug: Silver Diamine Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries arrest of active dentin caries
Arrest of caries assessed clinically by hardness of dentin using blunt periodontal probe and ICDAS criteria
Measured: 1, 3, 6, 9 and 12 months
Secondary outcomes (3)
Discoloration of carious lesions
Assessment of color change using standardized pre- and post-operative photographs
Measured: 1, 3, 6, 9 and 12 months
Post-operative pain
Presence or absence of pain assessed through parental interview
Measured: 1, 3, 6, 9 and 12 months
Parental satisfaction
Evaluation using a structured parental satisfaction questionnaire
Measured: 1, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start30 Jan 2026 (estimated)
- Primary completion25 Feb 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood Caries (ECC)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled sayed, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382245
- Sponsor's protocol ID
- Khaled SDF
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07382245
- Acronym / sponsor ID
- Khaled SDF
- Keywords
- Early Childhood Caries, primary molar, Nano-Silver Fluoride, Silver Diamine Fluoride, SDF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 25 Feb 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 2 Feb 2026 (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.
Early childhood caries is a major public health problem affecting preschool children worldwide. Silver Diamine Fluoride is a well-established non-invasive treatment for arresting caries; however, it causes black discoloration of treated lesions. Nano-Silver Fluoride has been introduced as an alternative that may arrest caries without discoloration.
This randomized clinical trial aims to compare the efficacy of Silver Diamine Fluoride and Nano-Silver Fluoride in arresting active dentin caries in primary teeth and to assess discoloration, post-operative pain, and parental satisfaction over a 12-month follow-up period.
Detailed description
This randomized clinical trial will be conducted on 30 children aged 3-5 years attending the outpatient clinic of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University. Children with active dentin caries in primary molars will be randomly allocated into two groups: Silver Diamine Fluoride group and Nano-Silver Fluoride group.
Both materials will be applied topically without caries excavation. Clinical evaluation will be performed at baseline and at 1, 3, 6, 9, and 12 months using ICDAS criteria, visual and tactile examination, assessment of post-operative pain, discoloration through standardized photographs, and parental satisfaction questionnaires.
The primary outcome is caries arrest. Secondary outcomes include discoloration, pain, and parental satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Nano-Silver Fluoride | Experimental | Drug: Nano-Silver FluorideTopical application of Nano-Silver Fluoride varnish containing silver nanoparticles, chitosan, and fluoride applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration. |
| Arm B: Silver Diamine Fluoride | Active comparator | Drug: Silver Diamine FluorideTopical application of 38% Silver Diamine Fluoride varnish applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Apparently healthy children.
- Children with age ranged from 3-5 years from both genders.
- Children who refused dental treatment with Frankl Behavior Rating Scale 1 and 2.
- Children having molars with active dentin caries score (2,3,4) according to International Caries Detection and Assessment System- ICDAS II, detected by visual and tactile.
- Parents/guardians accept treatment and write informed consent.
Key exclusion criteria (8 listed)
- Children with allergy to silver from their medical history.
- Children with ulcerative gingivitis.
- Children with primary molars with the following criteria:
- Symptomatic
- Involving the pulp
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 |
|---|---|---|
| Nano-Silver FluorideChitosan (28,585 μg/ml), Silver (376.5 μg/ml) and Sodium fluoride (5028.3 μg/ml) | Drug | Arm A: Nano-Silver Fluoride |
| Silver Diamine Fluoride38% Silver Diamine Fluoride | Drug | Arm B: Silver Diamine Fluoride |
Primary outcome
Caries arrest of active dentin caries
Time frame: 1, 3, 6, 9 and 12 months
Arrest of caries assessed clinically by hardness of dentin using blunt periodontal probe and ICDAS criteria
3 secondary outcomes
Discoloration of carious lesions
Time frame: 1, 3, 6, 9 and 12 months
Post-operative pain
Time frame: 1, 3, 6, 9 and 12 months
Parental satisfaction
Time frame: 1, 3, 6, 9 and 12 months
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 2 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
Khaled Abdelmonem Sayed Assistant Lecturer at Pediatric Dentistry Department, Master Holder contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-Silver Fluoride and Silver Diamine Fluoride in people with Early Childhood Caries (ECC) and Active Dentin Caries in Primary Molars, run by October University for Modern Sciences and Arts 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Feb 2026. 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 Khaled Abdelmonem Sayed Assistant Lecturer at Pediatric Dentistry Department, Master Holder (+201114537612, kasayed@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries arrest of active dentin caries (time frame: 1, 3, 6, 9 and 12 months). 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 2 Feb 2026.