NCT06645860

SMART With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.

Silver Modified Atraumatic Restorative Technique (SMART) With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Çanakkale Onsekiz Mart University · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	SDF+KI	Silver diamine fluoride (SDF) and potassium iodide(KI) will be applied.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-03-01
• Completion: 2026-01-01
• First posted: 2024-10-17
• Last updated: 2025-08-08

Locations

1 site across 1 country: Turkey (Türkiye)