Early Childhood Caries (ECC)Phase 2SDFNCT07371117
Effect Of Three Remineralizing Agents On Early Childhood Caries
A Phase 2 study testing Silver Diamine Fluoride (SDF, 38%), Sodium Fluoride with CPP-ACP and Acidulated phospahate fluoride gel 1.23% in people with Early Childhood Caries (ECC) and Dental Caries, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
Early Childhood Caries (ECC) remains a global public health concern, necessitating minimally invasive, fluoride-based alternatives to conventional restorative therapy. Silver Diamine Fluoride (SDF), Sodium Fluoride with Casein Phosphopeptide-Amorphous Calcium Phosphate (NaF + CPP-ACP), and Acidulated Phosphate… Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Early Childhood Caries (ECC), Dental Caries
- What is being tested?
- Silver Diamine Fluoride (SDF, 38%), Sodium Fluoride with CPP-ACP and Acidulated phospahate fluoride gel 1.23%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2025to 25 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participants who had at least one untreated cavitated active caries lesion with dentin exposed based on the Nyvad criteria (level 3: "Enamel/dentin cavity easily visible with the naked eye where the surface of cavity feels soft or leathery on gentle probing", characterized by dentin exposure without signs of pulp involvement, pain, abscess, sinus tract, or mobility.
- Medically healthy children with no systemic disorders or developmental anomalies
Who cannot join
- Parents refused consent for study
- Any child with special health care needs or with any systemic ailments will be excluded from the study
- Teeth exhibiting irreversible pulpitis, abscess, pathological mobility, pathological radiographic changes
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Dentistry, jazan University
Jizan, Jazan Region
About this study
Official title: Effect Of Silverdiamine Fluoride Gel, Sodium Fluoride With CPP-ACP, APF On Early Childhood Caries - A Randomised Controlled Trial
Early Childhood Caries (ECC) remains a global public health concern, necessitating minimally invasive, fluoride-based alternatives to conventional restorative therapy. Silver Diamine Fluoride (SDF), Sodium Fluoride with Casein Phosphopeptide-Amorphous Calcium Phosphate (NaF + CPP-ACP), and Acidulated Phosphate Fluoride (APF) gel are widely employed chemotherapeutic agents; however, comparative clinical evidence of their effectiveness in ECC management remains limited.
This randomized controlled clinical trial will evaluate and compare the efficacy of SDF gel, NaF + CPP-ACP, and APF gel in arresting and preventing ECC.
- Conditions
- Early Childhood Caries (ECC), Dental Caries
- Being tested
- Silver Diamine Fluoride (SDF, 38%), Sodium Fluoride with CPP-ACP, Acidulated phospahate fluoride gel 1.23%
- Keywords
- silver diamine fluoride
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine Fluoride (SDF, 38%)Drug
Silver diamine fluoride gel is applied in gel form
Sodium Fluoride with CPP-ACPDrug
This is in a Topical fluoride varnish
Acidulated phospahate fluoride gel 1.23%Drug
This is a topical fluoride application for 1 minute application
| Study group | Role | What they receive |
|---|---|---|
| Cavitated/Non cavitated caries lesions involving only enamel | Experimental | Reversible pulpitis Receives: Drug: Silver Diamine Fluoride (SDF, 38%); Drug: Sodium Fluoride with CPP-ACP; Drug: Acidulated phospahate fluoride gel 1.23% |
| Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p | Active comparator | Not described Receives: Drug: Silver Diamine Fluoride (SDF, 38%); Drug: Sodium Fluoride with CPP-ACP; Drug: Acidulated phospahate fluoride gel 1.23% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries arrest
A lesion was considered active if a blunt dental probe penetrated the dentinal surface easily, whereas arrested caries resisted probe penetration, indicating surface hardening.
Measured: Caries arrest will be assessed 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Nov 2025
- Primary completion20 Feb 2026
- Study completion25 Feb 2026
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This three-arm phase 2 clinical trial will be conducted to evaluate the effectiveness of silver diamine fluoride (SDF) for preventing or arresting dental caries.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Renuga Lakshmi Apathsakayan, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371117
- Sponsor's protocol ID
- CODJU-21041
- Acronym
- SDF
- Status last verified
- Sep 2026
- First submitted
- 18 Jan 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the IPD because the study can be continued for long term in future
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Silverdiamine Fluoride Gel, Sodium Fluoride With CPP-ACP, APF On Early Childhood Caries - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07371117
- Acronym / sponsor ID
- SDF / CODJU-21041
- Conditions
- Early Childhood Caries (ECC), Dental Caries
- Keywords
- silver diamine fluoride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 27 Jan 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 (ECC) remains a global public health concern, necessitating minimally invasive, fluoride-based alternatives to conventional restorative therapy. Silver Diamine Fluoride (SDF), Sodium Fluoride with Casein Phosphopeptide-Amorphous Calcium Phosphate (NaF + CPP-ACP), and Acidulated Phosphate Fluoride (APF) gel are widely employed chemotherapeutic agents; however, comparative clinical evidence of their effectiveness in ECC management remains limited.
This randomized controlled clinical trial will evaluate and compare the efficacy of SDF gel, NaF + CPP-ACP, and APF gel in arresting and preventing ECC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This three-arm phase 2 clinical trial will be conducted to evaluate the effectiveness of silver diamine fluoride (SDF) for preventing or arresting dental caries.
| Arm | Type | Receives |
|---|---|---|
| Cavitated/Non cavitated caries lesions involving only enamel | Experimental | Drug: Silver Diamine Fluoride (SDF, 38%), Drug: Sodium Fluoride with CPP-ACP, Drug: Acidulated phospahate fluoride gel 1.23%Reversible pulpitis |
| Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p | Active comparator | Drug: Silver Diamine Fluoride (SDF, 38%), Drug: Sodium Fluoride with CPP-ACP, Drug: Acidulated phospahate fluoride gel 1.23% |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The participants who had at least one untreated cavitated active caries lesion with dentin exposed based on the Nyvad criteria (level 3: "Enamel/dentin cavity easily visible with the naked eye where the surface of cavity feels soft or leathery on gentle probing", characterized by dentin exposure without signs of pulp involvement, pain, abscess, sinus tract, or mobility.
- Medically healthy children with no systemic disorders or developmental anomalies
Key exclusion criteria (3 listed)
- Parents refused consent for study
- Any child with special health care needs or with any systemic ailments will be excluded from the study
- Teeth exhibiting irreversible pulpitis, abscess, pathological mobility, pathological radiographic changes
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 |
|---|---|---|
| Silver Diamine Fluoride (SDF, 38%)Silver diamine fluoride gel is applied in gel form | Drug | Cavitated/Non cavitated caries lesions involving only enamel, Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p |
| Sodium Fluoride with CPP-ACPThis is in a Topical fluoride varnish | Drug | Cavitated/Non cavitated caries lesions involving only enamel, Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p |
| Acidulated phospahate fluoride gel 1.23%This is a topical fluoride application for 1 minute application | Drug | Cavitated/Non cavitated caries lesions involving only enamel, Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p |
Primary outcome
Dental caries arrest
Time frame: Caries arrest will be assessed 6 months after intervention
A lesion was considered active if a blunt dental probe penetrated the dentinal surface easily, whereas arrested caries resisted probe penetration, indicating surface hardening.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. There is no plan to share the IPD because the study can be continued for long term in future
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Silver Diamine Fluoride (SDF, 38%), Sodium Fluoride with CPP-ACP and Acidulated phospahate fluoride gel 1.23% in people with Early Childhood Caries (ECC) and Dental Caries, run by University of Jazan at 1 site in Saudi Arabia.
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 3 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: finished, as of the sponsor's last update on 10 Sep 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 Saudi Arabia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dental caries arrest (time frame: Caries arrest will be assessed 6 months after intervention). 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 10 Sep 2026.