Caries; DentinNCT06645860
SMART With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.
A study testing SDF+KI+LED Light 20s and SDF+KI in people with Caries; Dentin, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the clinical success of the 'Silver Modified Atraumatic Restorative Technique '(SMART) with different modifications in asymptomatic deep carious lesions of primary molars. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries; Dentin
- What is being tested?
- SDF+KI+LED Light 20s and SDF+KI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jan 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients and parents of the patients who accept to participate and sign the informed consent.
- Children between the ages of 4-9
- Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
- Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS II index: code 4,5,6) affecting primary molars.
- Absence of former history of spontaneous pain from the offending tooth/teeth.
- Patients with an appropriate level of cooperation to complete treatment under clinical conditions.
- Teeth are in a restorable condition.
- Natural exfoliation of primary teeth to be treated should not be expected within two years.
Who cannot join
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Patients with proven allergy to silver compounds or any component of dental materials to be applied.
- Patients with special health care needs or any medical conditions.
- Primary molar teeth with excessive crown damage that cannot be restored.
- Primary molar teeth in which bone loss exceeds 1/3 of the roots.
- Primary molar teeth that have previously undergone root canal treatment or pulpotomy treatment.
- Presence of internal/external and root resorption in primary teeth to be treated.
- Root fracture, ankylosis or mobility in the primary teeth to be treated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Burak Çarıkçıoğlu Assoc. Prof. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Canakkale Onsekiz Mart University
Çanakkale, Kepez, 17100
Faculty of Dentistry, 2862180018, dishekimligi@comu.edu.tr
Hilal ÖZTÜRK Research Assistant
About this study
Official title: Silver Modified Atraumatic Restorative Technique (SMART) With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.
This study aimed to evaluate the clinical success of the 'Silver Modified Atraumatic Restorative Technique '(SMART) with different modifications in asymptomatic deep carious lesions of primary molars.
Read the detailed description
The SMART technique, which stands for "Silver Modified Atraumatic Restorative Treatment," combines the use of Silver Diamine Fluoride (SDF) with atraumatic restorative treatment methods to manage dental caries.SDF helps strengthen the tooth structure and arrests caries, while atraumatic restorative treatment utilizes high-viscosity glass ionomer cements to remove decayed tissue and repair the tooth with minimal invasion.
Patients between the ages of 4-9 who meet ICDAS II (International Caries Detection and Assessment System) 4-5-6 criteria and need restoration of asymptomatic primary molars with unilateral or multifaceted carious cavities will be included. Volunteers will be randomly divided into 2 groups and the treatments of primary molars will be completed using SMART, SMART + LED light techniques.The teeth in all groups will be cleaned of decay using an excavator first, and then Diagnodent values will be checked.
Group 1 (SMART only): 1 drop of SDF solution will be applied to the cavity for 1 minute with a rubbing motion using a bond brush. Then potassium iodide solution will be applied to prevent discoloration. Following the application, the lesion will be washed with water for 10 seconds and the unreacted SDF solution will be removed from the cavity with cotton pellets, leaving a moist shiny surface.
Group 2: (SMART + LED): 1 drop of SDF will be applied to the cavity for 1 min by rubbing the solution. Then LED light (D-Light Pro, GC Europe) will be applied for 20 s in continuous mode from a distance of approximately 1 cm. The following procedure will be the same as SMART only group.
Following SDF applications and activation, 2 weeks later all groups will be checked by diagnodent and restored with high viscosity glass ionomer cements (EQUIA Forte HT, GC, Tokyo, Japan) in accordance with the manufacturers instructions, and the restoration will be covered with a sealing agent (EQUIA Forte Coat, GC, Tokyo, Japan).
Before the procedure, demographic and dental data of the child volunteer, such as age, gender, brushing frequency, and number of teeth treated, will be recorded.
The US Public Health Service criteria (retention,anatomical form, surface roughness, , secondary caries, marginal discoloration and marginal integrity) and Modified FDI criteria will be used for clinical evaluation of restorations. The restorations will be evaluated clinically and radiologically at baseline 3., 6. and 12. months.
- Conditions
- Caries; Dentin
- Being tested
- SDF+KI+LED Light 20s, SDF+KI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDF+KI+LED Light 20sProcedure or surgery
After the silver diamine fluoride (SDF) and potassiım iodide (KI) application, 20-second LED light will be applied to the cavity.
SDF+KIProcedure or surgery
Silver diamine fluoride (SDF) and potassium iodide(KI) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluoride+Potassium Iodide+Led Light | Experimental | Following the silver diamine fluoride and potassium iodide application, LED light will be applied for 20 seconds. Receives: Procedure: SDF+KI+LED Light 20s; Procedure: SDF+KI |
| Silver Diamine Fluoride(Control) | Other | Only silver diamine fluoride and potassium iodide solution will be applied. Receives: Procedure: SDF+KI |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Change from 3 months to 12 months regarding "Anatomic form"
alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Marginal adaptation"
alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Surface roughness"
alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Marginal staining"
alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Retention"
alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
Measured: 3-month,6-month,12 month
Change from 3 months to 12 months regarding "Incisal wear"
alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure
Measured: 3-month,6-month,12 month
Functional properties according to revised FDI (World Dental Federation) criteria.
Functional properties:
F2: Marginal adaptation measured by visual examination, short air drying, 250 μm probe.
F3:Proximal contact point measured by visual examination and 25/50/100 μm blades.
F4: Form and contour measured by visual examination. F5: Occlusion and occlusal wear measured by visual examination and articulation paper.
Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 3-month,6-month,12 month
Biological properties according to revised FDI criteria.
Biological properties:
B1: Caries at restoration margin (CAR) measured by visual examination, short air drying, and 250 μm probe.
B2: Dental hard tissue defects at restoration margin measured by visual examination.
B3: Postoperative hypersensitivity reported by patient and pulp status tested with cold stimulus.
Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 3-month,6-month,12 month
Aesthetic properties according to revised FDI criteria.
Aesthetic properties:
A1: Surface luster and surface texture measured by visual examination and short air drying.
A2: Marginal staining measured by visual examination and short air drying. A3: color match measured by visual examination. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Measured: 3-month,6-month,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Jan 2025
- Primary completion1 Mar 2025
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries; DentinStudies 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Ozturk, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645860
- Sponsor's protocol ID
- CanakkaleOMU5616
- Status last verified
- Aug 2025
- First submitted
- 5 Apr 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In this study, we are committed to sharing our findings while ensuring the privacy and confidentiality of our participants. Therefore, we will only be disseminating aggregated statistical results derived from the data, rather than individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silver Modified Atraumatic Restorative Technique (SMART) With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.
- ClinicalTrials.gov ID
- NCT06645860
- Acronym / sponsor ID
- CanakkaleOMU5616
- Conditions
- Caries; Dentin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 17 Oct 2024 (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 aimed to evaluate the clinical success of the 'Silver Modified Atraumatic Restorative Technique '(SMART) with different modifications in asymptomatic deep carious lesions of primary molars.
Detailed description
The SMART technique, which stands for "Silver Modified Atraumatic Restorative Treatment," combines the use of Silver Diamine Fluoride (SDF) with atraumatic restorative treatment methods to manage dental caries.SDF helps strengthen the tooth structure and arrests caries, while atraumatic restorative treatment utilizes high-viscosity glass ionomer cements to remove decayed tissue and repair the tooth with minimal invasion.
Patients between the ages of 4-9 who meet ICDAS II (International Caries Detection and Assessment System) 4-5-6 criteria and need restoration of asymptomatic primary molars with unilateral or multifaceted carious cavities will be included. Volunteers will be randomly divided into 2 groups and the treatments of primary molars will be completed using SMART, SMART + LED light techniques.The teeth in all groups will be cleaned of decay using an excavator first, and then Diagnodent values will be checked.
Group 1 (SMART only): 1 drop of SDF solution will be applied to the cavity for 1 minute with a rubbing motion using a bond brush. Then potassium iodide solution will be applied to prevent discoloration. Following the application, the lesion will be washed with water for 10 seconds and the unreacted SDF solution will be removed from the cavity with cotton pellets, leaving a moist shiny surface.
Group 2: (SMART + LED): 1 drop of SDF will be applied to the cavity for 1 min by rubbing the solution. Then LED light (D-Light Pro, GC Europe) will be applied for 20 s in continuous mode from a distance of approximately 1 cm. The following procedure will be the same as SMART only group.
Following SDF applications and activation, 2 weeks later all groups will be checked by diagnodent and restored with high viscosity glass ionomer cements (EQUIA Forte HT, GC, Tokyo, Japan) in accordance with the manufacturers instructions, and the restoration will be covered with a sealing agent (EQUIA Forte Coat, GC, Tokyo, Japan).
Before the procedure, demographic and dental data of the child volunteer, such as age, gender, brushing frequency, and number of teeth treated, will be recorded.
The US Public Health Service criteria (retention,anatomical form, surface roughness, , secondary caries, marginal discoloration and marginal integrity) and Modified FDI criteria will be used for clinical evaluation of restorations. The restorations will be evaluated clinically and radiologically at baseline 3., 6. and 12. months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride+Potassium Iodide+Led Light | Experimental | Procedure: SDF+KI+LED Light 20s, Procedure: SDF+KIFollowing the silver diamine fluoride and potassium iodide application, LED light will be applied for 20 seconds. |
| Silver Diamine Fluoride(Control) | Other | Procedure: SDF+KIOnly silver diamine fluoride and potassium iodide solution will be applied. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Patients and parents of the patients who accept to participate and sign the informed consent.
- Children between the ages of 4-9
- Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
- Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS II index: code 4,5,6) affecting primary molars.
- Absence of former history of spontaneous pain from the offending tooth/teeth.
Key exclusion criteria (8 listed)
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Patients with proven allergy to silver compounds or any component of dental materials to be applied.
- Patients with special health care needs or any medical conditions.
- Primary molar teeth with excessive crown damage that cannot be restored.
- Primary molar teeth in which bone loss exceeds 1/3 of the roots.
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+KI+LED Light 20sAfter the silver diamine fluoride (SDF) and potassiım iodide (KI) application, 20-second LED light will be applied to the cavity. | Procedure or surgery | Silver Diamine Fluoride+Potassium Iodide+Led Light |
| SDF+KISilver diamine fluoride (SDF) and potassium iodide(KI) will be applied. | Procedure or surgery | Silver Diamine Fluoride(Control), Silver Diamine Fluoride+Potassium Iodide+Led Light |
Primary outcome
1.Change from 3 months to 12 months regarding "Anatomic form"
Time frame: 3-month,6-month,12 month
alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does
Change from 3 months to 12 months regarding "Marginal adaptation"
Time frame: 3-month,6-month,12 month
alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin
Change from 3 months to 12 months regarding "Surface roughness"
Time frame: 3-month,6-month,12 month
alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects
Change from 3 months to 12 months regarding "Marginal staining"
Time frame: 3-month,6-month,12 month
alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin
Change from 3 months to 12 months regarding "Retention"
Time frame: 3-month,6-month,12 month
alpha: intact bravo: chipped/loss of material charlie: complete loss of crown
Change from 3 months to 12 months regarding "Incisal wear"
Time frame: 3-month,6-month,12 month
alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure
Functional properties according to revised FDI (World Dental Federation) criteria.
Time frame: 3-month,6-month,12 month
Functional properties: F2: Marginal adaptation measured by visual examination, short air drying, 250 μm probe. F3:Proximal contact point measured by visual examination and 25/50/100 μm blades. F4: Form and contour measured by visual examination. F5: Occlusion and occlusal wear measured by visual examination and articulation paper. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Biological properties according to revised FDI criteria.
Time frame: 3-month,6-month,12 month
Biological properties: B1: Caries at restoration margin (CAR) measured by visual examination, short air drying, and 250 μm probe. B2: Dental hard tissue defects at restoration margin measured by visual examination. B3: Postoperative hypersensitivity reported by patient and pulp status tested with cold stimulus. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
Aesthetic properties according to revised FDI criteria.
Time frame: 3-month,6-month,12 month
Aesthetic properties: A1: Surface luster and surface texture measured by visual examination and short air drying. A2: Marginal staining measured by visual examination and short air drying. A3: color match measured by visual examination. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).
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 8 Aug 2025.
- Individual participant dataSharing planned: No. In this study, we are committed to sharing our findings while ensuring the privacy and confidentiality of our participants. Therefore, we will only be disseminating aggregated statistical results derived from the data, rather than individual participant data.
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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.
Burak Çarıkçıoğlu Assoc. Prof. contact
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+KI+LED Light 20s and SDF+KI in people with Caries; Dentin, 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 8 inclusion and 8 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 8 Aug 2025. 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?
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 HİLAL ÖZTÜRK Research Assistant (00905312591404, hilalozturk98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Change from 3 months to 12 months regarding "Anatomic form" (time frame: 3-month,6-month,12 month). The study lists 9 primary outcomes in all. 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 8 Aug 2025.