Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645860
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-05
Brief Title:
SMART With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Silver Modified Atraumatic Restorative Technique SMART With Different Modifications in Asymptomatic Deep Carious Lesions of Primary Molars
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cariesSDF 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 techniquesThe 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 retentionanatomical 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
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 techniquesThe 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 retentionanatomical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None