Silver Diamine FluorideNCT07586631
Long-term Effect of Silver Diamine Fluoride on the Dentin-Pulp Complex in Primary Teeth
An observational study of Silver Diamine Fluoride, run by Cairo University at 1 site in Egypt.
Trial summary
Children with primary teeth with dentin carious lesions without pulp involvement, who have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or with Resin Modified Glass Ionomer alone, will be retrieved from the Pediatric Dentistry and Dental Public Health… Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Silver Diamine Fluoride
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jan 2026to 15 May 2026
- Phase
- Observational
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with primary teeth that have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or Resin Modified Glass Ionomer alone.
Who may be able to join
- Primary teeth that have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or Resin Modified Glass Ionomer alone.
Who cannot join
- Treated primary teeth with clinical or radiographic signs of infection
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
Faculty of Dentistry, Cairo University
Cairo
Mariam Mohsen Aly, +20100678872, theblueocean@yahoo.com
About this study
Official title: Evaluation of the Long-term Effect of Silver Diamine Fluoride on the Dentin-Pulp Complex in Primary Teeth: A Histological Study
Children with primary teeth with dentin carious lesions without pulp involvement, who have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or with Resin Modified Glass Ionomer alone, will be retrieved from the Pediatric Dentistry and Dental Public Health Department records. The aim of the study, a detailed description of the procedure, and how the tooth will be used, will be explained to the parents and their child, and written informed consent from the parents and assent from the child will be obtained.
- Conditions
- Silver Diamine Fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Children treated with Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer | |
| Arm 2 | Children treated with Resin Modified Glass Ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological evaluation of dental pulp under light microscope
After teeth extraction, they will be fixed in a 10% formalin buffer for at least 48 hours, after which they will be decalcified in 10% nitric acid for 7 days. Then they will be embedded in paraffin, and mesiodistal histological sections approximately 8 μm thick will be cut. Sections will be stained with hematoxylin and Eosin, and a qualitative histological evaluation of dental pulp will be performed under light microscopy.
Measured: 7 days after extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start29 Jan 2026
- Primary completion7 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silver Diamine FluorideStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohsen Aly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586631
- Sponsor's protocol ID
- SDF histological evaluation
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Long-term Effect of Silver Diamine Fluoride on the Dentin-Pulp Complex in Primary Teeth: A Histological Study
- ClinicalTrials.gov ID
- NCT07586631
- Acronym / sponsor ID
- SDF histological evaluation
- Conditions
- Silver Diamine Fluoride
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 7 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 14 May 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.
Children with primary teeth with dentin carious lesions without pulp involvement, who have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or with Resin Modified Glass Ionomer alone, will be retrieved from the Pediatric Dentistry and Dental Public Health Department records. The aim of the study, a detailed description of the procedure, and how the tooth will be used, will be explained to the parents and their child, and written informed consent from the parents and assent from the child will be obtained.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | –Children treated with Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer |
| Arm 2 | – | –Children treated with Resin Modified Glass Ionomer |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with primary teeth that have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or Resin Modified Glass Ionomer alone.
Key inclusion criteria (1 listed)
- Primary teeth that have previously been treated with either Silver Diamine Fluoride (SDF) followed by Resin Modified Glass Ionomer or Resin Modified Glass Ionomer alone.
Key exclusion criteria (1 listed)
- Treated primary teeth with clinical or radiographic signs of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histological evaluation of dental pulp under light microscope
Time frame: 7 days after extraction
After teeth extraction, they will be fixed in a 10% formalin buffer for at least 48 hours, after which they will be decalcified in 10% nitric acid for 7 days. Then they will be embedded in paraffin, and mesiodistal histological sections approximately 8 μm thick will be cut. Sections will be stained with hematoxylin and Eosin, and a qualitative histological evaluation of dental pulp will be performed under light microscopy.
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 14 May 2026.
Related trials for Silver Diamine Fluoride
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Not yet recruiting
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Dental Caries, Cervical Caries
Not yet recruitingPhase 3
Effectiveness of Single and Dual Silver Fluoride Application
Dentine Caries
Active, not recruiting
Comparing Two Brands of Silver Diamine Fluoride for Stopping Cavities in Children
Dental Caries
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?
An observational study of Silver Diamine Fluoride, run by Cairo 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 1 inclusion and 1 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 14 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological evaluation of dental pulp under light microscope (time frame: 7 days after extraction). 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 14 May 2026.