Dental CariesNCT07250009
Effect of Silver Diamine Fluoride and LED Activation on Residual Caries Activity in Class II Cavities
A study testing DIAGNOdent measurement in people with Dental Caries, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This observational clinical study investigates the effect of silver diamine fluoride (SDF) and its activation with light-emitting diode (LED) on residual caries activity after caries excavation in Class II primary molar cavities. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- DIAGNOdent measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2025to 30 Jan 2026
- Phase
- Interventional
- 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 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4 to 9 years who apply to the Department of Pediatric Dentistry, Faculty of Dentistry, Çanakkale Onsekiz Mart University.
- Medically healthy children with no systemic or chronic disease.
- Cooperative children who can tolerate clinical procedures and measurements.
- Presence of at least one Class II carious lesion in a primary molar tooth.
- Teeth that have undergone caries excavation by another clinician and received 38% silver diamine fluoride (SDF) application (with or without LED activation).
- Teeth that have not yet been restored after SDF (± LED) treatment.
- Written informed consent obtained from parents or legal guardians through an approved consent form.
Who cannot join
- Children with systemic or chronic diseases.
- History of allergic reactions or known hypersensitivity to silver, ammonia, or fluoride compounds.
- Uncooperative children or those with insufficient mouth opening during measurement procedures.
- Teeth with pulpal exposure, fistula, abscess, or signs of acute infection.
- Teeth that have previously received any restorative or endodontic treatment.
- Participants who miss the follow-up appointment or whose DIAGNOdent measurements could not be completed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Canakkale Onsekiz Mart University
Çanakkale, 17100
About this study
Official title: Effect of Silver Diamine Fluoride (SDF) and LED Activation on Residual Caries Activity After Caries Excavation in Class II Primary Molar Cavities"
This observational clinical study investigates the effect of silver diamine fluoride (SDF) and its activation with light-emitting diode (LED) on residual caries activity after caries excavation in Class II primary molar cavities. Dental caries in children remains highly prevalent worldwide, and conventional restorative treatments can be difficult in young or uncooperative patients. Minimally invasive approaches such as Atraumatic Restorative Treatment (ART) often leave softened dentin near the pulp, which may remain metabolically active. SDF has been introduced as a simple and effective agent for caries arrest due to its antibacterial and remineralizing effects. However, its optimal application protocol is still under investigation.
Recent studies suggest that LED light exposure after SDF application may enhance its mineralizing effect by accelerating silver ion precipitation, though clinical data remain limited. This study aims to compare the short-term impact of SDF alone and SDF with LED activation on residual caries activity measured quantitatively with the DIAGNOdent laser fluorescence device.
The study will include healthy, cooperative children aged 4-9 years with Class II carious lesions in primary molars. After caries excavation, cavities will receive either SDF alone or SDF followed by 20 seconds of blue LED light (470 nm, 1000-1200 mW/cm²). Residual caries activity will be recorded immediately after application and after one week. The primary outcome is the change in DIAGNOdent readings between groups, while secondary analyses will consider factors such as cavity size, tooth type, and location. The study seeks to clarify whether LED activation enhances the caries-arresting potential of SDF and contributes to evidence-based, minimally invasive strategies in pediatric dentistry.
Read the detailed description
Dental caries remains one of the most common chronic diseases in childhood, particularly in primary molars where conventional restorative treatment can be difficult due to limited cooperation and treatment-related anxiety. In minimally invasive approaches such as Atraumatic Restorative Treatment (ART), some softened dentin may be intentionally left near the pulp, resulting in residual carious tissue that could remain metabolically active. Preventing this residual activity is critical to ensure lesion arrest and long-term tooth preservation.
Silver diamine fluoride (SDF), especially at 38% concentration, is an established material for caries arrest because of its antibacterial and remineralizing properties. The American Academy of Pediatric Dentistry supports its use as part of minimally invasive dentistry, particularly for young, fearful, or special-needs children. Recent in vitro research suggests that exposure to blue LED light after SDF application may accelerate silver ion precipitation and enhance dentin microhardness, potentially improving the caries-arresting effect. However, clinical data confirming this benefit are limited and inconsistent.
This study aims to evaluate the effect of LED activation on the residual caries activity of SDF-treated Class II primary molar cavities following caries excavation. The research is designed as a non-interventional observational clinical study conducted at the Department of Pediatric Dentistry, Çanakkale Onsekiz Mart University. After caries excavation performed by a pediatric dental specialist, cavities will receive either 38% SDF alone or SDF followed by LED light exposure (470 nm wavelength, 1000-1200 mW/cm² intensity for 20 seconds). All procedures are part of standard clinical practice; researchers will perform only non-invasive fluorescence measurements using the DIAGNOdent device.
Residual caries activity will be recorded at three time points: immediately after excavation (D₁), immediately after SDF or SDF + LED application (D₂), and one week later (D₃). The primary outcome is the change in DIAGNOdent values over time, comparing SDF-only and SDF + LED groups. Secondary outcomes include the influence of cavity size, tooth location, tooth type, and patient sex on these measurements.
Healthy, cooperative children aged 4-9 years with at least one Class II carious lesion in a primary molar that has undergone excavation but not restoration will be included. Children with systemic diseases, allergies to silver, ammonia, or fluoride, pulpal exposure, or infection will be excluded.
By clarifying whether LED activation enhances the effectiveness of SDF, this study aims to contribute clinical evidence for optimizing minimally invasive, child-friendly approaches in pediatric dentistry.
- Conditions
- Dental Caries
- Being tested
- DIAGNOdent measurement
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAGNOdent measurementDevice
Residual caries activity will be evaluated with the DIAGNOdent laser fluorescence device (KaVo, Germany) at three time points:
- Immediately after caries excavation (D₁ - baseline),
- Immediately after SDF application (D₂),
- One week after application (D₃). At each time point, DIAGNOdent readings will be recorded three times per site and averaged for analysis.
| Study group | Role | What they receive |
|---|---|---|
| SDF Group | Active comparator | Following caries excavation in Class II primary molar cavities, 38% silver diamine fluoride (SDF) will be applied using a microbrush for 1 minute. Excess material will be gently removed with an air-water spray. No light activation will be performed. Receives: Device: DIAGNOdent measurement |
| SDF-LED Group | Experimental | Following caries excavation, 38% SDF will be applied using a microbrush for 1 minute, followed by LED light activation using a blue curing unit (470 nm wavelength, 1000-1200 mW/cm² intensity) for 20 seconds. Receives: Device: DIAGNOdent measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in residual caries activity measured by DIAGNOdent laser fluorescence
Residual caries activity in Class II primary molar cavities will be quantitatively assessed using the DIAGNOdent laser fluorescence device (KaVo, Germany).
The DIAGNOdent readings (0-99 scale) reflect the fluorescence of carious dentin; higher values indicate greater caries activity. The mean of three consecutive readings per site will be recorded. The primary outcome is the change in DIAGNOdent value from D₁ to D₃, comparing the SDF and SDF + LED groups.
Measured: 1-Immediately after caries excavation (baseline - D₁) 2-Immediately after SDF or SDF + LED application (D₂) 3-One week after treatment (follow-up - D₃)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start10 Dec 2025
- Primary completion20 Jan 2026
- Study completion30 Jan 2026
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Carıkcıoglu, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250009
- Sponsor's protocol ID
- CanakkaleOMU3
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Silver Diamine Fluoride (SDF) and LED Activation on Residual Caries Activity After Caries Excavation in Class II Primary Molar Cavities"
- ClinicalTrials.gov ID
- NCT07250009
- Acronym / sponsor ID
- CanakkaleOMU3
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 25 Nov 2025 (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 observational clinical study investigates the effect of silver diamine fluoride (SDF) and its activation with light-emitting diode (LED) on residual caries activity after caries excavation in Class II primary molar cavities. Dental caries in children remains highly prevalent worldwide, and conventional restorative treatments can be difficult in young or uncooperative patients. Minimally invasive approaches such as Atraumatic Restorative Treatment (ART) often leave softened dentin near the pulp, which may remain metabolically active. SDF has been introduced as a simple and effective agent for caries arrest due to its antibacterial and remineralizing effects. However, its optimal application protocol is still under investigation.
Recent studies suggest that LED light exposure after SDF application may enhance its mineralizing effect by accelerating silver ion precipitation, though clinical data remain limited. This study aims to compare the short-term impact of SDF alone and SDF with LED activation on residual caries activity measured quantitatively with the DIAGNOdent laser fluorescence device.
The study will include healthy, cooperative children aged 4-9 years with Class II carious lesions in primary molars. After caries excavation, cavities will receive either SDF alone or SDF followed by 20 seconds of blue LED light (470 nm, 1000-1200 mW/cm²). Residual caries activity will be recorded immediately after application and after one week. The primary outcome is the change in DIAGNOdent readings between groups, while secondary analyses will consider factors such as cavity size, tooth type, and location. The study seeks to clarify whether LED activation enhances the caries-arresting potential of SDF and contributes to evidence-based, minimally invasive strategies in pediatric dentistry.
Detailed description
Dental caries remains one of the most common chronic diseases in childhood, particularly in primary molars where conventional restorative treatment can be difficult due to limited cooperation and treatment-related anxiety. In minimally invasive approaches such as Atraumatic Restorative Treatment (ART), some softened dentin may be intentionally left near the pulp, resulting in residual carious tissue that could remain metabolically active. Preventing this residual activity is critical to ensure lesion arrest and long-term tooth preservation.
Silver diamine fluoride (SDF), especially at 38% concentration, is an established material for caries arrest because of its antibacterial and remineralizing properties. The American Academy of Pediatric Dentistry supports its use as part of minimally invasive dentistry, particularly for young, fearful, or special-needs children. Recent in vitro research suggests that exposure to blue LED light after SDF application may accelerate silver ion precipitation and enhance dentin microhardness, potentially improving the caries-arresting effect. However, clinical data confirming this benefit are limited and inconsistent.
This study aims to evaluate the effect of LED activation on the residual caries activity of SDF-treated Class II primary molar cavities following caries excavation. The research is designed as a non-interventional observational clinical study conducted at the Department of Pediatric Dentistry, Çanakkale Onsekiz Mart University. After caries excavation performed by a pediatric dental specialist, cavities will receive either 38% SDF alone or SDF followed by LED light exposure (470 nm wavelength, 1000-1200 mW/cm² intensity for 20 seconds). All procedures are part of standard clinical practice; researchers will perform only non-invasive fluorescence measurements using the DIAGNOdent device.
Residual caries activity will be recorded at three time points: immediately after excavation (D₁), immediately after SDF or SDF + LED application (D₂), and one week later (D₃). The primary outcome is the change in DIAGNOdent values over time, comparing SDF-only and SDF + LED groups. Secondary outcomes include the influence of cavity size, tooth location, tooth type, and patient sex on these measurements.
Healthy, cooperative children aged 4-9 years with at least one Class II carious lesion in a primary molar that has undergone excavation but not restoration will be included. Children with systemic diseases, allergies to silver, ammonia, or fluoride, pulpal exposure, or infection will be excluded.
By clarifying whether LED activation enhances the effectiveness of SDF, this study aims to contribute clinical evidence for optimizing minimally invasive, child-friendly approaches in pediatric dentistry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDF Group | Active comparator | Device: DIAGNOdent measurementFollowing caries excavation in Class II primary molar cavities, 38% silver diamine fluoride (SDF) will be applied using a microbrush for 1 minute. Excess material will be gently removed with an air-water spray. No light activation will be performed. |
| SDF-LED Group | Experimental | Device: DIAGNOdent measurementFollowing caries excavation, 38% SDF will be applied using a microbrush for 1 minute, followed by LED light activation using a blue curing unit (470 nm wavelength, 1000-1200 mW/cm² intensity) for 20 seconds. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 4 to 9 years who apply to the Department of Pediatric Dentistry, Faculty of Dentistry, Çanakkale Onsekiz Mart University.
- Medically healthy children with no systemic or chronic disease.
- Cooperative children who can tolerate clinical procedures and measurements.
- Presence of at least one Class II carious lesion in a primary molar tooth.
- Teeth that have undergone caries excavation by another clinician and received 38% silver diamine fluoride (SDF) application (with or without LED activation).
Key exclusion criteria (6 listed)
- Children with systemic or chronic diseases.
- History of allergic reactions or known hypersensitivity to silver, ammonia, or fluoride compounds.
- Uncooperative children or those with insufficient mouth opening during measurement procedures.
- Teeth with pulpal exposure, fistula, abscess, or signs of acute infection.
- Teeth that have previously received any restorative or endodontic treatment.
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 |
|---|---|---|
| DIAGNOdent measurementResidual caries activity will be evaluated with the DIAGNOdent laser fluorescence device (KaVo, Germany) at three time points: 1. Immediately after caries excavation (D₁ - baseline), 2. Immediately after SDF application (D₂), 3. One week after application (D₃). At each time point, DIAGNOdent readings will be recorded three times per site and averaged for analysis. | Device | SDF Group, SDF-LED Group |
Primary outcome
Change in residual caries activity measured by DIAGNOdent laser fluorescence
Time frame: 1-Immediately after caries excavation (baseline - D₁) 2-Immediately after SDF or SDF + LED application (D₂) 3-One week after treatment (follow-up - D₃)
Residual caries activity in Class II primary molar cavities will be quantitatively assessed using the DIAGNOdent laser fluorescence device (KaVo, Germany). The DIAGNOdent readings (0-99 scale) reflect the fluorescence of carious dentin; higher values indicate greater caries activity. The mean of three consecutive readings per site will be recorded. The primary outcome is the change in DIAGNOdent value from D₁ to D₃, comparing the SDF and SDF + LED groups.
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 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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 DIAGNOdent measurement in people with Dental Caries, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 9 Feb 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 Turkey (Türkiye). 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?
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?
Change in residual caries activity measured by DIAGNOdent laser fluorescence (time frame: 1-Immediately after caries excavation (baseline - D₁) 2-Immediately after SDF or SDF + LED application (D₂) 3-One week after treatment (follow-up - D₃)). 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 9 Feb 2026.