SMART With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.
NCT ID: NCT06645860
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-01-01
2026-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Silver Diamine Fluoride+Potassium Iodide+Led Light
Following the silver diamine fluoride and potassium iodide application, LED light will be applied for 20 seconds.
SDF+KI+LED Light 20s
After the silver diamine fluoride (SDF) and potassiım iodide (KI) application, 20-second LED light will be applied to the cavity.
SDF+KI
Silver diamine fluoride (SDF) and potassium iodide(KI) will be applied.
Silver Diamine Fluoride(Control)
Only silver diamine fluoride and potassium iodide solution will be applied.
SDF+KI
Silver diamine fluoride (SDF) and potassium iodide(KI) will be applied.
Interventions
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SDF+KI+LED Light 20s
After the silver diamine fluoride (SDF) and potassiım iodide (KI) application, 20-second LED light will be applied to the cavity.
SDF+KI
Silver diamine fluoride (SDF) and potassium iodide(KI) will be applied.
Eligibility Criteria
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Inclusion Criteria
2. Children between the ages of 4-9
3. Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
4. Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS II index: code 4,5,6) affecting primary molars.
5. Absence of former history of spontaneous pain from the offending tooth/teeth.
6. Patients with an appropriate level of cooperation to complete treatment under clinical conditions.
7. Teeth are in a restorable condition.
8. Natural exfoliation of primary teeth to be treated should not be expected within two years.
Exclusion Criteria
2. Patients with proven allergy to silver compounds or any component of dental materials to be applied.
3. Patients with special health care needs or any medical conditions.
4. Primary molar teeth with excessive crown damage that cannot be restored.
5. Primary molar teeth in which bone loss exceeds 1/3 of the roots.
6. Primary molar teeth that have previously undergone root canal treatment or pulpotomy treatment.
7. Presence of internal/external and root resorption in primary teeth to be treated.
8. Root fracture, ankylosis or mobility in the primary teeth to be treated.
4 Years
9 Years
ALL
Yes
Sponsors
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Çanakkale Onsekiz Mart University
OTHER
Responsible Party
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Hilal Ozturk
Research Assistant
Locations
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Canakkale Onsekiz Mart University
Çanakkale, Kepez, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CanakkaleOMU5616
Identifier Type: -
Identifier Source: org_study_id
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