Dental CariesNCT07903155
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
A study testing Silver diamine Fluoride 38% and LED light curing in people with Dental Caries, run by Cairo University.
Trial summary
This randomized clinical trial aims to evaluate and compare the clinical and radiographic performance of 38% silver diamine fluoride (SDF) with 38% silver diamine fluoride followed by light curing in children with carious primary molars. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Silver diamine Fluoride 38% and LED light curing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Nov 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy and cooperative children aged 4-8 years.
- Children with active carious lesions in mandibular primary molars, with ICDAS scores of 3-6.
- Teeth with normal pulp or reversible pulp inflammation.
- Children able to attend the scheduled follow-up visits.
Who cannot join
- Teeth with pulpal involvement.
- Teeth with abscess or fistula.
- Teeth with pathological mobility or non-restorable carious lesions.
- Children unable to attend follow-up visits.
- Children with general health conditions that make them unsuitable for participation.
- Children with a known allergy to silver.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Tarteel Abdelrahman Alsmani Mohammed Ali, Principal Investigator contact
About this study
Official title: Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light Cured Silver Diamine Fluoride in Carious Primary Molars A Randomized Clinical Trial.
This randomized clinical trial aims to evaluate and compare the clinical and radiographic performance of 38% silver diamine fluoride (SDF) with 38% silver diamine fluoride followed by light curing in children with carious primary molars.
Children aged 4-8 years with active caries in mandibular primary molars will be included in the study. One group will receive 38% silver diamine fluoride followed by LED light curing, while the comparison group will receive 38% silver diamine fluoride without light curing.
Read more
The primary outcome is postoperative pain, assessed using the visual analogue scale (VAS). Secondary outcomes include caries lesion arrest, lesion extension and severity, signs of infection, pain on percussion, pathological tooth mobility, and radiographic changes.
Participants will be followed for 12 months. The findings may help determine whether adding light curing to silver diamine fluoride application improves the management of caries in primary molars.
- Conditions
- Dental Caries
- Being tested
- Silver diamine Fluoride 38%, LED light curing
- Keywords
- Silver Diamine Fluoride, 38% SDF, Light Curing, Primary Teeth, Pediatric Dentistry
- 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 38%Drug
Topical application of 38% silver diamine fluoride to carious lesions in primary molars for 1 minute, followed by gentle air drying for 10 seconds, without light curing.
LED light curingDevice
LED light curing applied for 20 seconds after topical application of 38% silver diamine fluoride, using a wavelength of 420-480 nm and an intensity of 1200-1500 mW/cm².
| Study group | Role | What they receive |
|---|---|---|
| Conventional Silver Diamine Fluoride (SDF | Experimental | Participants will receive topical application of 38% silver diamine fluoride (SDF) without light curing. The solution will be applied to the carious lesion using a microbrush for 1 minute, followed by gentle air drying for 10 seconds and natural drying without light curing Receives: Drug: Silver diamine Fluoride 38% |
| Light-Cured Silver Diamine Fluoride (SDF) | Experimental | Participants will receive topical application of 38% silver diamine fluoride (SDF), followed by LED light curing for 20 seconds using a light-curing unit with a wavelength of 420-480 nm and an intensity of 1200-1500 mW/cm². Receives: Drug: Silver diamine Fluoride 38%; Device: LED light curing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be assessed using a visual analogue scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.
Measured: At baseline and at 3, 6, 9, and 12 months after treatment.
Secondary outcomes (9)
Caries lesion arrest
Assessment of whether the carious lesion has arrested (yes/no).
Measured: At baseline and at 3, 6, 9, and 12 months after treatment.
Caries lesion severity (ICDAS)
Assessment of caries lesion severity using ICDAS scores 3-6.
Measured: At baseline and at 3, 6, 9, and 12 months after treatment.
Caries lesion activity (Nyvad criteria)
Assessment of lesion activity using Nyvad criteria scores 0-9.
Measured: At baseline and at 3, 6, 9, and 12 months after treatment.
Soft-tissue pathology
Presence or absence of swelling, sinus tract, or fistula.
Measured: At baseline and at 3, 6, 9, and 12 months after treatment.
Pain on percussion
Presence or absence of pain on percussion.
Measured: At baseline and at 3, 6, 9, and 12 months after treatment.
Pathological tooth mobility
Presence or absence of pathological mobility.
Measured: At baseline and at 3, 6, 9, and 12 months after treatment.
Furcation or periapical radiolucency
Presence or absence of furcation or periapical radiolucency on radiographic examination.
Measured: At baseline, 6 months, and 12 months after treatment.
Widening of the periodontal ligament space
Presence or absence of widening of the periodontal ligament space on radiographic examination.
Measured: At baseline, 6 months, and 12 months after treatment.
Internal or external root resorption
Presence or absence of internal or external root resorption on radiographic examination.
Measured: At baseline, 6 months, and 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarteel Abdelrahman Alsmani MohammedAli, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903155
- Sponsor's protocol ID
- Code: 3-7-1
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light Cured Silver Diamine Fluoride in Carious Primary Molars A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07903155
- Acronym / sponsor ID
- Code: 3-7-1
- Conditions
- Dental Caries
- Keywords
- Silver Diamine Fluoride, 38% SDF, Light Curing, Primary Teeth, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 29 Oct 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 randomized clinical trial aims to evaluate and compare the clinical and radiographic performance of 38% silver diamine fluoride (SDF) with 38% silver diamine fluoride followed by light curing in children with carious primary molars.
Children aged 4-8 years with active caries in mandibular primary molars will be included in the study. One group will receive 38% silver diamine fluoride followed by LED light curing, while the comparison group will receive 38% silver diamine fluoride without light curing.
The primary outcome is postoperative pain, assessed using the visual analogue scale (VAS). Secondary outcomes include caries lesion arrest, lesion extension and severity, signs of infection, pain on percussion, pathological tooth mobility, and radiographic changes.
Participants will be followed for 12 months. The findings may help determine whether adding light curing to silver diamine fluoride application improves the management of caries in primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Silver Diamine Fluoride (SDF | Experimental | Drug: Silver diamine Fluoride 38%Participants will receive topical application of 38% silver diamine fluoride (SDF) without light curing. The solution will be applied to the carious lesion using a microbrush for 1 minute, followed by gentle air drying for 10 seconds and natural drying without light curing |
| Light-Cured Silver Diamine Fluoride (SDF) | Experimental | Drug: Silver diamine Fluoride 38%, Device: LED light curingParticipants will receive topical application of 38% silver diamine fluoride (SDF), followed by LED light curing for 20 seconds using a light-curing unit with a wavelength of 420-480 nm and an intensity of 1200-1500 mW/cm². |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy and cooperative children aged 4-8 years.
- Children with active carious lesions in mandibular primary molars, with ICDAS scores of 3-6.
- Teeth with normal pulp or reversible pulp inflammation.
- Children able to attend the scheduled follow-up visits.
Key exclusion criteria (6 listed)
- Teeth with pulpal involvement.
- Teeth with abscess or fistula.
- Teeth with pathological mobility or non-restorable carious lesions.
- Children unable to attend follow-up visits.
- Children with general health conditions that make them unsuitable for participation.
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 38%Topical application of 38% silver diamine fluoride to carious lesions in primary molars for 1 minute, followed by gentle air drying for 10 seconds, without light curing. | Drug | Conventional Silver Diamine Fluoride (SDF, Light-Cured Silver Diamine Fluoride (SDF) |
| LED light curingLED light curing applied for 20 seconds after topical application of 38% silver diamine fluoride, using a wavelength of 420-480 nm and an intensity of 1200-1500 mW/cm². | Device | Light-Cured Silver Diamine Fluoride (SDF) |
Primary outcome
Postoperative pain
Time frame: At baseline and at 3, 6, 9, and 12 months after treatment.
Postoperative pain will be assessed using a visual analogue scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.
9 secondary outcomes
Caries lesion arrest
Time frame: At baseline and at 3, 6, 9, and 12 months after treatment.
Caries lesion severity (ICDAS)
Time frame: At baseline and at 3, 6, 9, and 12 months after treatment.
Caries lesion activity (Nyvad criteria)
Time frame: At baseline and at 3, 6, 9, and 12 months after treatment.
Soft-tissue pathology
Time frame: At baseline and at 3, 6, 9, and 12 months after treatment.
Pain on percussion
Time frame: At baseline and at 3, 6, 9, and 12 months after treatment.
Pathological tooth mobility
Time frame: At baseline and at 3, 6, 9, and 12 months after treatment.
Furcation or periapical radiolucency
Time frame: At baseline, 6 months, and 12 months after treatment.
Widening of the periodontal ligament space
Time frame: At baseline, 6 months, and 12 months after treatment.
Internal or external root resorption
Time frame: At baseline, 6 months, and 12 months after treatment.
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 29 Oct 2026.
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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.
Tarteel Abdelrahman Alsmani Mohammed Ali, Principal Investigator contact
Questions about this trial
What is this clinical trial studying?
A study testing Silver diamine Fluoride 38% and LED light curing in people with Dental 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 4 inclusion and 6 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 29 Oct 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?
Contact Tarteel Abdelrahman Alsmani Mohammed Ali, Principal Investigator (+201091380858, Tarteel.alsmani@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: At baseline and at 3, 6, 9, and 12 months after treatment.). 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 29 Oct 2026.