Dental CariesSDFNCT07708883
Comparing Two Brands of Silver Diamine Fluoride for Stopping Cavities in Children
A study testing SDF, ToothMate®, Egypt and SDF, Advantage Arrest USA in people with Dental Caries, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
this study aims to evaluate two different materials used to stop dental caries in children. both materials are available at the market. both materials leave black stain after application. we follow up the patients for 1 year to evaluate which one is more effective in stopping dental caries. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- SDF, ToothMate®, Egypt and SDF, Advantage Arrest USA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2025to 4 Oct 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who are apparently healthy with primary carious teeth aged from 4-7 years.
- Uncooperative children.
- Children with financial barrier in accessing dental care
- Clinically: absence of any pathology or pain except of sensitivity with eating.
- Parents and patients accepting the new treatment modality and parents assigned the informed consent.
Who cannot join
- Known sensitivity to silver or other heavy-metal ions.
- Children who will not comply to recall program.
- Teeth with pulp involvement.
- Tooth mobility (more than grade 1 (grade 1:1-2 mm tooth mobility).
- History of pain for a long period of time that may indicate chronic pulp inflammation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Two Different Marketed Brands of Silver Diamine Fluoride SDF in Arresting Dental Caries in Children (Randomized Control Trial)
this study aims to evaluate two different materials used to stop dental caries in children. both materials are available at the market. both materials leave black stain after application. we follow up the patients for 1 year to evaluate which one is more effective in stopping dental caries.
Read the detailed description
Before application of SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. SDF in both groups will be applied directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up.
- Conditions
- Dental Caries
- Being tested
- SDF, ToothMate®, Egypt, SDF, Advantage Arrest USA
- Keywords
- dental caries, SDF, Silver Diamine fluoride, caries arrest
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDF, ToothMate®, EgyptOther
38% silver diamine fluoride manufactured in Egypt
SDF, Advantage Arrest USAOther
38% silver diamine fluoride , manufactured in USA
| Study group | Role | What they receive |
|---|---|---|
| SDF, ToothMate®, Egypt. | Experimental | Egyptian manufactured SDF, 38% silver diamine fluoride is applied. Before application of tooth mate SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Tooth mate SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up Receives: Other: SDF, ToothMate®, Egypt; Other: SDF, Advantage Arrest USA |
| SDF, Advantage arrest®, USA | Active comparator | USA manufactured SDF, 38% silver diamine fluoride. Before application of Advantage arrest SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Advantage arrest SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up Receives: Other: SDF, ToothMate®, Egypt; Other: SDF, Advantage Arrest USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of tooth with arrested caries in each group
Arrest of caries through:
- tactile examination to assess hardness of treated lesions using gentle pressure with a probe,
- color examination (yellow, brown or black)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start4 Oct 2025
- Primary completion4 Oct 2026 (estimated)
- Study completion4 Oct 2026 (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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Mahmoud Abd Elhakam, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708883
- Sponsor's protocol ID
- 0341
- Acronym
- SDF
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Different Marketed Brands of Silver Diamine Fluoride SDF in Arresting Dental Caries in Children (Randomized Control Trial)
- ClinicalTrials.gov ID
- NCT07708883
- Acronym / sponsor ID
- SDF / 0341
- Conditions
- Dental Caries
- Keywords
- dental caries, SDF, Silver Diamine fluoride, caries arrest
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 134 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 4 Oct 2025 (actual)
- Primary completion
- 4 Oct 2026 (estimated)
- Study completion
- 4 Oct 2026 (estimated)
- First posted
- 16 Jul 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.
this study aims to evaluate two different materials used to stop dental caries in children. both materials are available at the market. both materials leave black stain after application. we follow up the patients for 1 year to evaluate which one is more effective in stopping dental caries.
Detailed description
Before application of SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. SDF in both groups will be applied directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes.
All children will be recalled after 6 and 12 months for follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDF, ToothMate®, Egypt. | Experimental | Other: SDF, ToothMate®, Egypt, Other: SDF, Advantage Arrest USAEgyptian manufactured SDF, 38% silver diamine fluoride is applied. Before application of tooth mate SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Tooth mate SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes. All children will be recalled after 6 and 12 months for follow up |
| SDF, Advantage arrest®, USA | Active comparator | Other: SDF, ToothMate®, Egypt, Other: SDF, Advantage Arrest USAUSA manufactured SDF, 38% silver diamine fluoride. Before application of Advantage arrest SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. Advantage arrest SDF will be applied by bond brush directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes. All children will be recalled after 6 and 12 months for follow up |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children who are apparently healthy with primary carious teeth aged from 4-7 years.
- Uncooperative children.
- Children with financial barrier in accessing dental care
- Clinically: absence of any pathology or pain except of sensitivity with eating.
- Parents and patients accepting the new treatment modality and parents assigned the informed consent.
Key exclusion criteria (5 listed)
- Known sensitivity to silver or other heavy-metal ions.
- Children who will not comply to recall program.
- Teeth with pulp involvement.
- Tooth mobility (more than grade 1 (grade 1:1-2 mm tooth mobility).
- History of pain for a long period of time that may indicate chronic pulp inflammation.
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 |
|---|---|---|
| SDF, ToothMate®, Egypt38% silver diamine fluoride manufactured in Egypt | Other | SDF, Advantage arrest®, USA, SDF, ToothMate®, Egypt. |
| SDF, Advantage Arrest USA38% silver diamine fluoride , manufactured in USA | Other | SDF, Advantage arrest®, USA, SDF, ToothMate®, Egypt. |
Primary outcome
number of tooth with arrested caries in each group
Time frame: 12 months
Arrest of caries through: * tactile examination to assess hardness of treated lesions using gentle pressure with a probe, * color examination (yellow, brown or black)
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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 study testing SDF, ToothMate®, Egypt and SDF, Advantage Arrest USA in people with Dental Caries, run by National Research Centre, Egypt 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 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 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?
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?
number of tooth with arrested caries in each group (time frame: 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 28 Jul 2026.