Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:31 PM
Study NCT ID:
NCT07280260
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of Nobel N1 System
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Organization:
Study Overview
Official Title:
Effects of Early Loading Protocol on the Survival of the Nobel N1 Implant System: A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-12
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 the study is to evaluate whether N1 dental implants are successful when a final crown is placed on them at 6 weeks from implant placement surgery.
Detailed Description:
This study aims to evaluate the survival and stability of the Nobel N1 dental implant and its accompanying crown over a one-year period when the crown is placed either 6 or 12 weeks after implant placement. The Nobel N1 implant is an FDA-approved, newly designed implant featuring an innovative surgical placement protocol intended to minimize bone trauma, promote faster integration, and potentially allow for the placement of final crowns earlier-at 6 weeks instead of the traditional 4 to 5 months. This study will enroll adult participants who are missing a single tooth in the back of the mouth.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: