Clinical trial NCT06645860: SMART With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.
Official title: Silver Modified Atraumatic Restorative Technique (SMART) With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries; Dentin
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients and parents of the patients who accept to participate and sign the informed consent.
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:

1. Patients and parents of the patients who does not accept to participate and sign the informed consent
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.

Primary outcomes:
measure: 1.Change from 3 months to 12 months regarding "Anatomic form"
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Marginal adaptation"
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Surface roughness"
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Marginal staining"
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Retention"
timeFrame: 3-month,6-month,12 month
measure: Change from 3 months to 12 months regarding "Incisal wear"
timeFrame: 3-month,6-month,12 month
measure: Functional properties according to revised FDI (World Dental Federation) criteria.
timeFrame: 3-month,6-month,12 month
measure: Biological properties according to revised FDI criteria.
timeFrame: 3-month,6-month,12 month
measure: Aesthetic properties according to revised FDI criteria.
timeFrame: 3-month,6-month,12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Canakkale
country: Turkey
facility: Canakkale Onsekiz Mart University
state: Kepez
Study officials:
References: