Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-27
Brief Title:
Resin Polymer NuSmile BioFlx Compared to Stainless Steel Crowns 3M ESPE for Restoration of Primary Molar Teeth
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Clinical and Radiographic Success of Resin Polymer NuSmile BioFlx Compared to Stainless Steel 3M ESPE Crowns for Restoration of Primary Molar Teeth a Split Mouth Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this research study is to test the effectiveness of two different crownscaps on teeth for restoration of primary molar teeth The two different materials of crowns are resin polymer and stainless steel crowns These crowns are placed on the teeth to restore function and prevent further caries and infection
Detailed Description:
There is a lack of literary evidence for assessment of the properties of Bioflx crowns and their effect on clinical outcomes and parental satisfaction compared to traditionally available options including stainless steel crowns and zirconia crowns Hence this study plans to assess the clinical performance and child and parental satisfaction of Bioflx compared to the gold standard stainless steel crowns in pediatric patients
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