Incipient CariesSDF and AgFNCT07366645
Clinical and Cost-Effectiveness of Silver Diamine Fluoride and Silver Fluoride, With or Without Application of LED, in Arresting Incipient Permament Molar Caries
A study testing International Sliver Diamine Fluoride, Local brand Egyptian Silver Diamine Fluoride and Silver Fluoride in people with Incipient Caries, run by Cairo University.
Trial summary
The study aims to compare the effect of international brand ammonia based 38% SDF, water based silver fluoride solution (AgF), an aqueous silver fluoride solution, and local brand ammonia based SDF with and without LED light application on caries arrest of initial enamel pits and fissure caries for permanent teeth of… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Incipient Caries
- What is being tested?
- International Sliver Diamine Fluoride, Local brand Egyptian Silver Diamine Fluoride and Silver Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jul 2027
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- high caries risk dental students
- Males or females
- Medically free
- Not taking medication
- At least had one active carious tooth
- Posterior permanent teeth
- ICDAS 2
Who cannot join
- non-Egyptian students
- Lack of compliance
- Allergic reaction to the materials used
- Pregnancy
- Dental students cannot give consent
- Teeth that will be extracted for orthodontic reasons
Show all 10Show fewer
- Dental fluorosis
- Hypo calcified teeth
- Systemic diseases affecting teeth, such as amelogenesis imperfecta
- Severe periodontal affection
About this study
Official title: Clinical Efficacy and Cost-Effectiveness of Silver Diamine Fluoride and Silver Fluoride to Arrest Incipient Carious Lesions in Permanent Molar Teeth With or Without Application of LED Light: A Randomized Clinical Trial
The study aims to compare the effect of international brand ammonia based 38% SDF, water based silver fluoride solution (AgF), an aqueous silver fluoride solution, and local brand ammonia based SDF with and without LED light application on caries arrest of initial enamel pits and fissure caries for permanent teeth of young adults
- Conditions
- Incipient Caries
- Being tested
- International Sliver Diamine Fluoride, Local brand Egyptian Silver Diamine Fluoride, Silver Fluoride, International Sliver Diamine Fluoride with LED light, Local brand Egyptian Silver Diamine Fluoride with LED light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Sliver Diamine FluorideOther
It is the gold standard; it is an international brand, it is ammonia-based, and it is a remineralizing agent with an application time of 60 seconds.
Local brand Egyptian Silver Diamine FluorideOther
It is a new Egyptian brand of SDF; it is ammonia-based, and it is a remineralizing agent with an application time of 60 seconds.
Silver FluorideOther
It is a water-based remineralizing agent with an application time of 60 seconds.
International Sliver Diamine Fluoride with LED lightOther
It is an international brand, it is ammonia-based, and it is a remineralizing agent with an application time of 10 seconds, followed by LED light application for 20 seconds.
Local brand Egyptian Silver Diamine Fluoride with LED lightOther
It is a new Egyptian brand of SDF; it is ammonia-based, and it is a remineralizing agent with an application time of 10 seconds, followed by LED application for 20 seconds.
Silver Fluoride with LED lightOther
It is a water-based remineralizing agent with an application time of 10 seconds, followed by LED light application for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Pits and fissures receive International Silver Diamine Fluoride for caries arrest | Active comparator | Remineralization and prevention of incipient pits and fissure caries of permanent molars by International Silver Diamine Fluoride application for 60 seconds Receives: Other: International Sliver Diamine Fluoride |
| Pits and fissures receive Local brand Egyptian Sliver Diamine Fluoride for caries arrest | Experimental | Remineralization and prevention of incipient pits and fissure caries of permanent molars by local brand Egyptian Silver Diamine Fluoride application for 60 seconds Receives: Other: Local brand Egyptian Silver Diamine Fluoride |
| Pits and fissures receive Sliver Fluoride for caries arrest | Experimental | Remineralization and prevention of incipient pits and fissure caries of permanent molars by Silver Fluoride application for 60 seconds Receives: Other: Silver Fluoride |
| Pits and fissures receive International Silver Diamine Fluoride with LED for caries arrest | Experimental | Remineralization and prevention of incipient pits and fissure caries of permanent molars by Silver Diamine Fluoride application for 10 seconds, followed by the application LED light for 20 seconds Receives: Other: International Sliver Diamine Fluoride with LED light |
| Pits and fissures receive local brand Egyptian Silver Diamine Fluoride with LED for caries arrest | Experimental | Remineralization and prevention of incipient pits and fissure caries of permanent molars by local brand Egyptian Silver Diamine Fluoride application for 10 seconds, followed by LED light for 20 seconds Receives: Other: Local brand Egyptian Silver Diamine Fluoride with LED light |
| Pits and fissures receive Sliver Fluoride with LED for caries arrest | Experimental | Remineralization and prevention of incipient pits and fissure caries of permanent molars by Silver Fluoride application for 10 seconds, followed by application of LED light for 20 seconds Receives: Other: Silver Fluoride with LED light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries arrest
Lesion activity will be assessed by caries status (active/inactive) using visual and tactile inspection for surface discontinuities and texture. The participants will be examined under unit light using a 0.5 mm ball-ended (CPI) probe and a dental mirror. The teeth will be cleaned and dried by a water-air spray syringe before the examination.
Measured: After 3, 6, 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 posted26 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incipient CariesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Amr Khodair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366645
- Sponsor's protocol ID
- 3344515
- Acronym
- SDF and AgF
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 26 Jan 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Cost-Effectiveness of Silver Diamine Fluoride and Silver Fluoride to Arrest Incipient Carious Lesions in Permanent Molar Teeth With or Without Application of LED Light: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07366645
- Acronym / sponsor ID
- SDF and AgF / 3344515
- Conditions
- Incipient Caries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 26 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.
The study aims to compare the effect of international brand ammonia based 38% SDF, water based silver fluoride solution (AgF), an aqueous silver fluoride solution, and local brand ammonia based SDF with and without LED light application on caries arrest of initial enamel pits and fissure caries for permanent teeth of young adults
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pits and fissures receive International Silver Diamine Fluoride for caries arrest | Active comparator | Other: International Sliver Diamine FluorideRemineralization and prevention of incipient pits and fissure caries of permanent molars by International Silver Diamine Fluoride application for 60 seconds |
| Pits and fissures receive Local brand Egyptian Sliver Diamine Fluoride for caries arrest | Experimental | Other: Local brand Egyptian Silver Diamine FluorideRemineralization and prevention of incipient pits and fissure caries of permanent molars by local brand Egyptian Silver Diamine Fluoride application for 60 seconds |
| Pits and fissures receive Sliver Fluoride for caries arrest | Experimental | Other: Silver FluorideRemineralization and prevention of incipient pits and fissure caries of permanent molars by Silver Fluoride application for 60 seconds |
| Pits and fissures receive International Silver Diamine Fluoride with LED for caries arrest | Experimental | Other: International Sliver Diamine Fluoride with LED lightRemineralization and prevention of incipient pits and fissure caries of permanent molars by Silver Diamine Fluoride application for 10 seconds, followed by the application LED light for 20 seconds |
| Pits and fissures receive local brand Egyptian Silver Diamine Fluoride with LED for caries arrest | Experimental | Other: Local brand Egyptian Silver Diamine Fluoride with LED lightRemineralization and prevention of incipient pits and fissure caries of permanent molars by local brand Egyptian Silver Diamine Fluoride application for 10 seconds, followed by LED light for 20 seconds |
| Pits and fissures receive Sliver Fluoride with LED for caries arrest | Experimental | Other: Silver Fluoride with LED lightRemineralization and prevention of incipient pits and fissure caries of permanent molars by Silver Fluoride application for 10 seconds, followed by application of LED light for 20 seconds |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- high caries risk dental students
- Males or females
- Medically free
- Not taking medication
- At least had one active carious tooth
Key exclusion criteria (10 listed)
- non-Egyptian students
- Lack of compliance
- Allergic reaction to the materials used
- Pregnancy
- Dental students cannot give consent
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 |
|---|---|---|
| International Sliver Diamine FluorideIt is the gold standard; it is an international brand, it is ammonia-based, and it is a remineralizing agent with an application time of 60 seconds. | Other | Pits and fissures receive International Silver Diamine Fluoride for caries arrest |
| Local brand Egyptian Silver Diamine FluorideIt is a new Egyptian brand of SDF; it is ammonia-based, and it is a remineralizing agent with an application time of 60 seconds. | Other | Pits and fissures receive Local brand Egyptian Sliver Diamine Fluoride for caries arrest |
| Silver FluorideIt is a water-based remineralizing agent with an application time of 60 seconds. | Other | Pits and fissures receive Sliver Fluoride for caries arrest |
| International Sliver Diamine Fluoride with LED lightIt is an international brand, it is ammonia-based, and it is a remineralizing agent with an application time of 10 seconds, followed by LED light application for 20 seconds. | Other | Pits and fissures receive International Silver Diamine Fluoride with LED for caries arrest |
| Local brand Egyptian Silver Diamine Fluoride with LED lightIt is a new Egyptian brand of SDF; it is ammonia-based, and it is a remineralizing agent with an application time of 10 seconds, followed by LED application for 20 seconds. | Other | Pits and fissures receive local brand Egyptian Silver Diamine Fluoride with LED for caries arrest |
| Silver Fluoride with LED lightIt is a water-based remineralizing agent with an application time of 10 seconds, followed by LED light application for 20 seconds. | Other | Pits and fissures receive Sliver Fluoride with LED for caries arrest |
Primary outcome
Caries arrest
Time frame: After 3, 6, and 12 months.
Lesion activity will be assessed by caries status (active/inactive) using visual and tactile inspection for surface discontinuities and texture. The participants will be examined under unit light using a 0.5 mm ball-ended (CPI) probe and a dental mirror. The teeth will be cleaned and dried by a water-air spray syringe before the examination.
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 26 Jan 2026.
Related trials for Incipient Caries
Enrolling by invitationPhase 4
Can SAP P11-4 Affect The Appearance of Interproximal Cavities on an X-ray in a Military Population
Incipient Interproximal Caries
RecruitingPhase 4
A Randomized Controlled Trial of Vitamin D Supplementation on Salivary Biomarkers and Cariogenic Oral Microbiome
Dental Caries, White Spot Lesion
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing International Sliver Diamine Fluoride, Local brand Egyptian Silver Diamine Fluoride and Silver Fluoride in people with Incipient Caries, run by Cairo University.
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 7 inclusion and 10 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Caries arrest (time frame: After 3, 6, 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 26 Jan 2026.