Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388746
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
Arresting Carious Lesions With Minimal Intervention Techniques
Sponsor:
National and Kapodistrian University of Athens
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
Minimal Intervention Techniques for Arresting Caries in Primary Molars a Randomized Clinical Trial With 12 Months Follow-up
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques one using a chemo-mechanical caries removal agent and one using a caries arresting agent for the treatment of deep caries in primary molars
Detailed Description:
Fifty children 100 teeth aged 4 to 8 years with a non-contributary medical history and at least two carious primary molars ICDAS 5 and 6 on different quadrants will be randomly assigned to either treatment group using computer-generated numbers
Each cavitated lesion will be isolated with cotton rolls and air-dried before being treated with one of the two types of minimal intervention technique according to the manufacturers instructions After the application of the agents all teeth will be restored using a high viscosity glass ionomer cement
Patients will be followed clinically at 6 and 12 months and radiographically at 12 months to evaluate success of the procedures
Each cavitated lesion will be isolated with cotton rolls and air-dried before being treated with one of the two types of minimal intervention technique according to the manufacturers instructions After the application of the agents all teeth will be restored using a high viscosity glass ionomer cement
Patients will be followed clinically at 6 and 12 months and radiographically at 12 months to evaluate success of the procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None