Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT02175550
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2014-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 5-year Clinical Evaluation Study on NobelReplace Conical Connection Implants
Sponsor:
Nobel Biocare
Organization:
Study Overview
Official Title:
An Open, Prospective, Single Cohort, Multi-centre Study Evaluating the NobelReplace Conical Connection Implants Supported Single -Unit Crowns in the Maxilla.
Status:
COMPLETED
Status Verified Date:
2021-03
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 new Nobel Biocare implant, NobelReplace Conical Connection (NR CC) has been developed. The implant is a two piece design to allow both one- and two- stage surgical procedures. The entire implant surface has a porous titanium oxide of approximately 10µm thick (TiUnite) to promote and maintain primary stability, which later on leads to secondary stability.
NR CC implants are used as the foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to an entire arch of bridgework. The implants are also intended as retentive elements for overdenture applications.
The present study is designed to evaluate, after the insertion of the NR CC, the marginal bone levels and bone remodelling at the implant sites over various time points up to 5 years. Parameters as soft tissue index, pink aesthetic score (PES) and bleeding on probing (BoP) are as well evaluated together with implant success and survival rate.
Using the OHIP-14 questionnaire patients satisfaction is assessed. The results of this clinical investigation will demonstrate clinical safety and reliability of the NR CC using different treatment options.
NR CC implants are used as the foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to an entire arch of bridgework. The implants are also intended as retentive elements for overdenture applications.
The present study is designed to evaluate, after the insertion of the NR CC, the marginal bone levels and bone remodelling at the implant sites over various time points up to 5 years. Parameters as soft tissue index, pink aesthetic score (PES) and bleeding on probing (BoP) are as well evaluated together with implant success and survival rate.
Using the OHIP-14 questionnaire patients satisfaction is assessed. The results of this clinical investigation will demonstrate clinical safety and reliability of the NR CC using different treatment options.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: